Unit-1

1INTELLECTUAL PROPERTY IN BIOTECHNOLOGY

Biotechnology is a term used by those in the life sciences industry to indicate

the use of, and methods involving, living organisms or their products for
making new useful products, which could include new varieties of living
organisms. This definition is quite broad, but that is an accurate reflection of
the technical range associated with the field. The term Life Sciences
Industry, itself, can indicate a wide range of entities from a pharmaceutical
manufacturer, to a farmer, to a food processor or medical diagnostics
company.

Even in the strictest sense, biotechnology is not a new field and throughout
human history, biotechnology assets have been generated through human
ingenuity. Biotechnology has been used in the form of fermentative
processes to manufacture beer, bread, wine and cheese for generations. The
Egyptians used yeasts in bread and wine-making around 4000 B.C. Till today,
we use micro-organisms to produce many products in the food and
pharmaceutical industries. Turning biotechnology inventions into protected
intellectual property, with concomitant intellectual property rights, has also
been happening for over a century. Louis Pasteur was granted a French
patent in 1865 for yeast clones that he had isolated from mixtures of yeast
species. He had a U.S. Patent, which was issued in 1873, entitled,
“Improvement in Brewing Beer and Ale”. This covered a new method of
making beer and ale (with the process we now call pasteurization) and also
involved the production of cultures of particular yeast species.

Since then protection of products isolated from living materials and methods
to produce them became quite commonplace, Biotechnological inventions
may have a very significant effect on our future, in particular in the fields of
medicine, food, energy and protection of the environment.

Generally, Biotechnology concerns living organisms, such as plants, animals

and micro-organisms, as well as non-living biological material, such as seed,
cells, enzymes, plasmids (which are used in genetic engineering) and the
like. Biotechnological inventions fall into three categories. They are the
processes for the creation or modification of living organisms and biological
material, the results of such processes, and the use of such results.

In more recent times, as a result of scientific discoveries, it has become

possible to develop biological processes which manipulate living organisms.
These processes may be entirely controlled by man. The most notable
examples of such processes occur in the artificial modification of genes
(genetic engineering). These processes are able to change the material
determining the hereditary characteristics of living organisms, and thus it is
possible to create modified organisms which have certain desirable features.
For example, the micro-organism created by Chakrabarty (an inventor in the
United States of America) is able to absorb oil pollution from oceans and
rivers. It was the subject of a landmark decision of the Supreme Court of the
United States of America, when the micro-organism created by Chakrabarty
was recognized as patentable.

Genetic engineering processes are also used in the modification of micro-

organisms for the production of new medicines. Biotechnology is expected to
lead to important breakthroughs in medicine which may be effective in
combating diseases such as cancer and AIDS. It may also lead to new
opportunities for obtaining food and energy, and may provide solutions to
the problems of pollution of the environment.

Traditionally, in scientific circles, the concept of invention was generally

limited to the fields of physics and chemistry because living organisms were
considered to be outside the scope of technology. However, with the
possibility of controlling and describing processes in the field of
biotechnology, the concept of invention will have to be enlarged to cover
biotechnological inventions. If it is possible to control a biotechnological
process and to describe such a process in a way that experts in the field can
carry out on the basis of the description, then an invention in the field of
biotechnology has been made.
To protect such developments in biotechnology field different intellectual
property protection tools can be used. These may include patents for
inventions, trademarks for identifying products, copyright for various data
bases or their presentation, geographical indications for plant varieties with
specific geographical origins.

In order to stream-line the patents of micro-organisms, a convention for

international recognition of the deposit of micro-organisms for purposes of
patenting was established in 1977.

In this Unit we will be discussing the issues related with intellectual property
protection in case of biotechnology area. You will be learning various tools of
intellectual property protection used in the field. Since this is an emerging
field, different countries are attempting to create mechanisms for tackling
the biotechnology related issues of intellectual property. We will briefly
discuss about these efforts citing some typical examples.

Objectives

After studying this unit, you should be able to:

• explain the specific obstacles arising in biotechnology IPR Protection;

• describe various intellectual property rights related to biotechnology;
• explain the protection mechanisms for IPR in biotechnology;
• Cite examples of mechanisms evolved by different countries to address
biotechnology IPR issues; and
• explain the important features of Budapest treaty.

NEED FOR IPR PROTECTION IN BIOTECHNOLOGY

As in other fields of technology, there is a need for legal protection in respect

of biotechnological inventions. Such inventions are creations of the human
mind just as much as other inventions, and typically they are the result of
substantial research and inventive effort and investment in sophisticated
laboratories. Typically, enterprises engaged in research only make
investments if legal protection is available for the results of their research.
Thus, there is an obvious need for the protection of biotechnological
inventions just like inventions in any other technology field. This is not only
in the interest of inventors and their employers, but also in the public
interest in order to promote technological progress.

Legal protection of inventions is normally effected through the grant of

patents or other titles for the protection of inventions. However, inventors in
the field of biotechnology are faced with several obstacles when seeking
protection for their inventions. These obstacles do not exist to the same
degree in other areas of technology.

The first obstacle is the problem of whether there really is an invention

rather than a discovery. If, for example, a micro-organism as yet unknown is
isolated by a sophisticated process, it may be argued that such a micro-
organism is not an invention but is a scientific discovery. The counter-
argument would be that the isolation requires an important human
intervention using a highly sophisticated process, and therefore the result is
a solution of a technical problem. It may also be argued that the isolated
micro-organism is not different from a chemical substance extracted from
nature, which is patentable subject matter.

The second obstacle is the existence of express legislative provisions that

exclude certain categories of biotechnological inventions from patent
protection, in particular, in view of public order and morality. Those
provisions have their origin in developments which took place in Europe, but
have also influenced countries outside Europe.

Although not all questions have been answered yet at the international level,
a number of legal issues with respect to patent protection for
biotechnological inventions have been addressed by the TRIPS Agreement
and the EC Directive on the Legal Protection of Biotechnological Inventions.
EXISTING PROTECTION

In general, a biotechnological invention is not different from other inventions

with respect to its protection under patents. Article 27.1 of the TRIPS
Agreement requires that patents be available in all fields of technology,
provided that they are new, involve an inventive step and are capable of
industrial application. However, Article 27.2 enables a Member to exclude
from patentability inventions whose commercial exploitation may be
contrary to public order or morality. Further, Article 27.3 also allows
Members to exclude from patentability plants and animals other than micro-
organisms, and essentially biological processes for the production of plants
or animals other than non-biological and microbiological processes.

In Europe, the EC Directive 98/44 on the Legal Protection of Biotechnological

Inventions, which entered into force on July 30, 1998, has harmonized the
rules concerning patent protection for biotechnological inventions. It
provides that biological material which is isolated from its natural
environment or produced by means of a technical process may be the
subject of a patentable invention even if it previously occurred in nature. It
however excludes from patentability plant and animal varieties and
essentially biological processes for the production of plants or animals. As
regards public order and morality, it provides a non-exhaustive list of
inventions which should be considered non-patentable. These are processes
for cloning human beings, processes for modifying the germ line genetic
identity of human beings, uses of human embryos for industrial or
commercial purposes and processes for modifying the genetic identity of
animals which are likely to cause them suffering without any substantial
medical benefit to man or animal, and also animals resulting from such
processes.

Concerning protection of plant varieties, Article 27.3(b) of the TRIPS

Agreement provides that plant varieties shall be protected either by patents
or by an effective sui generis system or by any combination thereof. The
special system of protection for plant varieties is different from patent
protection in respect of the conditions for protection and the protected acts.
The special nature of this system is demonstrated by the fact that an
international convention was concluded for the protection of new varieties of
plants which is administered by a special organization, namely the
International Union for the Protection of New Varieties of Plants (UPOV).

DIFFERENT TYPES OF IPRs IN BIOTECHNOLOGY

For some, it seemed a new era was ushered in with the advent of gene
sequencing and the intellectual property assets derived from techniques
associated with the manipulation of DNA. Perhaps the public only began to
be concerned about biotechnology inventions when patents were granted to
claims involving DNA sequences. Protection of this new type of
biotechnology asset can be traced to the invention involving DNA isolated
from frogs and bacteria using genetic engineering methods invented by
Herbert Boyer and Stanley Cohen

People have long considered plant seed and animal breeding stocks to be
property. Commercial seed companies, with which we are familiar, are
commercial enterprises based on the production and selling of human-
selected plant germplasm. There are many ways of protecting this type of
asset but the methods by which plant materials can be bred or reproduced
or genetically changed can also represent intellectual property assets.

In some nations, you can protect these types of assets with a patent, but
that might not be the only mode. The U.S. Board of Appeals ruled in 1985
that new plant varieties were inventions that could be granted intellectual
property rights with the grant of a patent. The records of breeding trials,
records of experiments involving the effects of different fertilizers also
represent assets that involve creative ideas and the hand of man. Therefore,
they too can be considered intellectual property assets and can have IPRs
associated with them.
Biotechnology inventions in the field of medicine, notably therapeutic methods, such as a new
type of laser surgery to correct visual acuity or diagnostic methods used in the treatment of
diseases or methods of surgery are inventions that can be protected by patents in some nations,
whilst in other countries patent protection can be controversial. Article 52(4) of the European
Patent Convention provides that methods for treatment of the human or animal body by surgery
or therapy or diagnostic methods practiced on the human or animal body shall not be regarded as
patentable subject matter.

However the case law with regard to the way, in which this regulation is
interpreted, is quite complex and can be confusing. A fine distinction has
been put forward, in which the European Patent Office Technical Board of
Appeal has made a list of what is necessary for an invention to be called a
diagnostic method. This includes:

• recording case history and results of tests;

• comparing the test data with normal values;
• recording any deviations; and
• attributing the deviation to a particular clinical situation.

All of these steps must be included or this is not a diagnostic method, but
instead might be called, for example, a data acquisition or data processing
method. This data acquisition or data processing might itself be in the realm
of patentable subject matter.

In addition to legal considerations, contemplation of whether therapeutic methods should be

afforded restricted or exclusive distribution is an ethical dilemma in some societies.

Also legal requirements for performing a search to determine novelty or non-

obviousness may vary between international agreement regulations, such as
those for Patent Cooperation Treaty (PCT) applications and those of national
patent offices. This may also impact on the way in which patent prosecution
regulations are applied to therapeutic types of inventions.

Patent protection is available for diagnostic and therapeutic inventions,

mainly in the U.S. However, regarding diagnostic methods, European case
law indicates that the definition of a diagnostic method has been challenged,
successfully, in the courts.

If we consider other, less obvious assets, produced as a result of more recent biotechnology
investigations, (many involving practicing inventions), we see that a vast amount of information
is being produced: records from drug efficacy clinical trials, information from nucleic acid
sequencing studies or dose-response studies. This information is fuelling the production of large
databases. These databases can be collections of information, or a database in which people have
organized and annotated information. This information can be protected, quite apart from the
underlying invention. These annotated databases are especially central to stimulate the useful
application of this information for industrial purposes and to allow pharmaceutical companies
and seed companies to pass stiff regulatory hurdles. Such databases can represent a very valuable
intellectual property asset. Protection of such an asset, in a manner that also encourages
distribution of the information, requires both legal and technical skill.

Text in a scientific report or patent, pictures or drawings, records in a

notebook, seeds stored in a gene bank, hybridomas in the incubator can all
be put into a form that allows another person to make and use these
improvements. Often however, there are intellectual property assets that
may be difficult to capture in a traditional mode. One of these is what we
often term, know-how. Know-how is usually an intellectual property asset
that is transferred by having the inventor show another person what has
been invented. It consists often of those small details that allow the
invention to work, an experience not too different from having someone
show you a cooking technique, such as creaming the butter in a cake recipe,
rather than trying to figure it out from reading a description in a cookbook.
Putting together a legal description of such an asset requires good drafting
skills.

So, intellectual property assets in the field of biotechnology can be

categorized in many ways:

• a new method of isolating a pharmaceutically active compound from a

plant;
• a new compound created by employing a microbiological process method
to synthesize an organic dye, (such as indigo previously only available
from eukaryotic plants);
• a database of information, for example on growth characteristics of maize
varieties in Sub-Saharan Africa;
• plant or animal varieties produced as a result of biotechnology;
• secondary information: products, compositions, applied methods,
databases, techniques, scientific articles, scientific know-how,
manufacturing methods, computer programs for annotating sequences,
field trial data, clinical trial data, geographical names associated with
particular products that result from biotechnology processes.

BASIC INSTRUMENTS TO PROTECT BIOTECHNOLOGY IP ASSETS

The instruments most often associated with the protection of biotechnology associated
intellectual assets are:

• Patents (utility, design, innovation/petty);

• Trade secret;
• Copyright;
• Trademark;
• Plant patent;
• Plant breeder’s right; and
• Geographic indication.

If the asset is an invention then it would be very routine to file for patent
protection for this asset in almost any country (or most countries or a
selection of countries) in the world. Then after making sure that your
application meets the legal requirements in the country(-ies) where you have
filed, and after an examination of the claims, you will be granted a patent.
This enables you to prevent others (for the term of the grant) from making,
using or selling your invention in the country where the patent is issued,
unless they obtain a license from you.

But, because you must disclose the best mode of practicing your invention,
at the time the patent application is filed, people can then read about, look
at, and handle your invention. That is, your invention can be inspected,
perhaps even literally touched. For example, if your invention had been a
plasmid or a seed, it may be possible for others to germinate and grow the
invention, without a license, as long as the invention is not used or made in
the way it is protected in the patent claims. You may not wish this to happen
as it could give ideas to potential competitors.

Hence, alternatively you could choose to keep the invention a trade secret,
by not telling anyone (unless they had signed a confidentiality or non-
disclosure agreement). You could also license this type of trade secret, under
the conditions of a confidentiality agreement. With the trade secret route
there is no public disclosure, unless you choose to do so or someone violates
a contract.

Your records, written down during your experiments can be copyrighted

and the copyright can also be registered. Registration is not necessary to
obtain copyright protection, but registration may make it easier to enforce
your copyright. Then you might also choose to name your invention and
trademark the name.

Sometimes it can be more problematical to protect your asset. This can be

due to an inherent characteristic of your asset, such as trying to protect
know-how to something more recognizable than know-how but that still
presents difficulties. An example of this would be a variation in the legal
standard of what constitutes patentable subject matter, due to a difference
in the laws or regulations between countries.

Protection of databases presents a good example of legal differences in regulations. Under U.S.
law and in many other places, with the exception of the European Union (EU), databases are
generally protected by copyright, as compilations; a compilation being the collection and
assembling of data or other materials into a fixed mode.

Now there has been variation in the past with regard to a test as to the
amount of creativity that has gone into the construction of the database that
has to be satisfied before formal protection can be obtained. Creativity is
related to the way in which the data has been selected and arranged. The
only protection you may be able to provide your database that fails this
creativity test is to keep the information confidential as a trade secret.

Even in situations where a database is protected by copyright, the

underlying data is not automatically granted copyright protection in its own
right. However, the underlying data itself may already be protected by
copyright, e.g. in a database that is a compilation of video images of cell
reaction in response to a particular treatment, the images themselves may
be protected by copyright.

The limited protection available to databases in some countries has

prompted owners of these types of assets to seek additional protection for
databases and for the use of the data contained in the database, by making
databases available only under contract or a license agreement. An
enforceable contract could prohibit the end user from making data extracted
from the database available to third parties or from incorporating such data
into another database.

However, in some European countries, all databases are immediately

protected by database rights as soon as they are fixed or the data are set
down. Laws enacted in response to the European Database directive set out
two types of protection; 1) protection that is similar to copyright protection
regarding the particular selection or arrangement of the contents, and 2) a
sui generis protection against the extraction or reuse of substantial portions
of the database contents. All countries that are members of the EU have now
enacted such legislation.

Living materials present another set of issues in relation to biotechnology

and intellectual property. Protection of an intellectual property asset as
represented by living plant material has always been a complex issue.
Farmers have always saved seed and traded their supplies in barter or
money for goods, if the demand was there. Domesticated hybrid maize has
long been protected by keeping information about the parental lines as a
trade secret. This is clearly an important issue for plant breeders.
Initially plant breeders in the United States of America turned to the U.S. Patent Office for
protection and indeed the Patent Office collected information on agriculture and even distributed
seeds as early as 1836. This was apparently burdensome and confusing to patent examiners
accustomed to looking at the novelty and utility of farm machinery or gearboxes. In 1930, the
U.S. created a special form of protection (that exists to this day in the U.S. and other countries
such as the Republic of Korea), called a plant patent. This created a special form of protection
that is usually limited to asexually reproduced varieties of plants. (Curiously, and depending
upon the regulations for a particular country, such patents cannot be granted to new varieties of
plants that form edible tubers such as potato plants and Jerusalem artichokes).

Interestingly, this type of patent contains only one claim, in which the patent
owner claims the plant, based on a new characteristic that the plant exhibits.
This claim is substantiated by a drawing, a photograph or information that
clearly illustrates the new characteristic. The plant is not grown in trials, nor
is there a requirement for enablement associated with this type of patent.

Another type of protection that can be formally sought for plants is a plant
breeder’s right (PBR). Historically, the Netherlands granted a very limited
exclusive right for breeders of agriculturally important species to market the
first generation of certified seed, and also an exclusive right to market
propagating material of other species, in the Breeders’ Ordinance of 1941.
Also in Germany, after many years of limited protection for breeders based
upon seed certification, the Law on the Protection of Varieties and the Seeds
of Cultivated Plants of 1953 gave breeders the exclusive right to produce
seed of their varieties for the purposes of the seed trade and to offer for sale
and market such seed. Some patents were granted in some German states
but the likelihood of securing patent protection for plant varieties was not
generally considered to be sufficient to constitute an effective incentive for
plant breeders.

PBR is usually obtained in accordance with plant variety protection

regulations that involve growing the plant for which protection is sought to
see if the plant is distinct from existing varieties of the same species. Tests
also involve propagation of the variety to ensure that the variety is uniform
when multiplied and that with propagation the varietal plants exhibit a
stability that is inherited. As you may have realized from these requirements
obtaining a PBR can often take quite a long period of time, due to the
verification process that involves growing and multiplying the material in
question. You have already learnt in the last Unit that the International Union
for the Protection of New Varieties of Plants (UPOV) is an intergovernmental
organization with headquarters in Geneva (Switzerland) that administers the
International Convention for the Protection of New Varieties of Plants, with
the objective to protect new varieties of plants by PBR. In a limited number
of countries, such as Japan and the U.S., new varieties of plants or animals
can also be protected by seeking a utility patent. In these situations the
examiners make decisions about the patentability of 25 a plant variety
invention using the same procedures as with other categories of utility
patent applications. The basis for allowance of claims is utility, novelty, and
non-obviousness. The plant material itself is not tested, nor is it handled in
any way. However, a deposit of material at a certified biological material
depository may be a legal requirement.

A name, associated with a biotechnology intellectual property asset can

receive trademark protection. The legal requirements for this type of
protection are usually not subject to a great deal of interpretation. Often this
type of protection will prove to be an excellent marketing tool that may meet
the desired goal of protection in a more timely manner than seeking patent
protection or a plant breeder’s certificate. By trade marking the name of a
new plant variety, you can prevent others from using that name in the same
way; an example is the Madeleine® strawberry. Other trademarks found in
association with biotechnology assets can be names of laboratory machinery
for example, SNPstream™, a system used for identifying single nucleotide
polymorphisms (SNP’s) in genomic DNAs harvested from organisms. A
trademark thus has the quality of establishing intellectual property rights
associated with this type of name or logo asset.

The filing of a design patent can be an option to consider for the protection
of a biotechnology asset where the design, for a piece of equipment such as
a tractor, a DNA analyzer or a DNA chip, be it either ornamental or functional
is unique. The acceptable format for this type of application is usually quite
formalized and applicants are advised to follow Patent Office instructions to
the letter to avoid rejection problems.
In some countries, such as Australia, an inventor can apply for a patent
called an innovation patent. With this type of application there is no formal
examination of the claims, unless it is requested by the applicant or
contested after the patent has issued. In addition, the term of the patent is
much shorter, 8 years as compared to the usual 20-year coverage period for
utility applications. In Thailand and some other countries it is possible to get
protection for an invention using the petty patent system. Under this
system, the inventive step or the uniqueness associated with an invention is
not examined. The time period that such a patent is in force is also reduced.

Geographic indication is a category of intellectual property asset

protection that is seeing increasing use in the agricultural and food industry
sectors of the life sciences industry. Currently, this type of protection is
sought for particular varieties that have a strong association with a particular
geographical region and allow producers in that region to exert a type of
quality control over their asset. A famous example is the term, champagne,
which is registered as a geographic indicator for the type of fermented
beverage made using a certain type of grape that is grown in a certain
region of France. The unique flavour of this wine is associated both with the
grape species, the fermenting micro-organisms, and with the conditions
under which the grapes are grown.

A particular category of biotechnological inventions, concerning micro-

organisms (either the processes for obtaining a micro-organism or the micro-
organism itself, or the particular use of a micro-organism) is governed by
special provisions. We will discuss about these in the next section.

Trademark law
The Trade Marks Act, 1999 replaces the Trade and Merchandise Marks Act,
1958. The Act is a consolidated effort to bring the law at par with
international practices. These changes were envisaged by India well before it
signed the General Agreement on Trade and Tariff (GATT) and the Trade
Related Intellectual Property Rights (TRIPS).

For the first time the new Act will protect service marks, and the scope of
other terms has been expanded in tune with international practices. A brief
analysis of the expanded terms is mentioned herein. The service sector,
including information technology, BPO services, hotels, hospitals, airlines and
advertisement agencies, can now protect their marks as service marks.

Well-known trademarks without registration or use are now protected in

India. India recently made certain changes to its trademarks law to
harmonise it with the requirements of TRIPS. To fulfil its obligations under
TRIPS, India enacted a new trademarks law — the Trade Marks Act, 1999,
which differentiates between well-known trademarks and trademarks
generally. Special treatment and rights are envisaged for well-known
trademarks under the 1999 Act.

An important feature of the 1999 Act is the recognition and protection of

well-known trademarks. The 1999 Act deals elaborately with facts to be
considered and methods to be adopted by the Registrar of Trade Marks
(Registrar) in protecting a well-known trademark against copying of such
marks by others, whether the proprietor is an Indian or a foreign company,
and at the same time protecting the interests of bona fide proprietors.

The provisions of the 1999 Act are not to be seen as totally new as similar
results are achieved under existing law — the Trade and Merchandise Marks
Act, 1958, and the practice followed by Indian courts in various decided
cases. The determination of a well-known trademark should be based on the
knowledge or recognition of that trademark in the relevant section of the
public, including knowledge in India obtained as a result of promotion of the
trademark.
The question of whether a trademark is known to or recognised by the
relevant section of the public is to be determined after taking into
consideration the following facts:

the number of actual or potential consumers of the goods or services;

the number of persons involved in the channels of distribution of the goods

or services;

the business circle dealing with the goods or services, to which that mark
applies.

Where a trademark is determined to be well-known in at least one relevant

section of the public in India by any court or Registrar, the Registrar would
consider that trademark as a well-known trademark for registration under
the 1999 Act.

the duration, extent and geographical area of any use of that trademark;

the duration, extent and geographical area of any promotion of the

trademark, including advertising or publicity and presentation, at fairs or
exhibitions of the goods or services to which the trademark applies;

the duration and geographical area of any registration of or any publication

for registration of that trademark under the 1999 Act to the extent they
reflect the use or recognition of the trademark; and

the record of successful enforcement of rights in that trademark, in particular

the extent to which the trademark has been recognised as a well-known
trademark by any court or registrar under that record.

The above list is not exhaustive and any other relevant fact in determining
whether the trademark in question has become well-known is to be taken
into account.
It will also be seen that it is not a single factor but the totality of the
circumstances that establish and determine whether or not a particular
trademark is well-known.

There are new provisions of additional remedy against criminal offence,

which has now been made a cognisable offence.

An Intellectual Property Appellate Board has now been constituted to hear

appeals on the decisions of the Registrar.

The authority to register a certification trademark now vests with the

Registrar under the new Act and the validity of Registration has been
increased from seven years to 10 years. The concept of collective trademark
has been introduced. Collective trademark means trademark distinguishing
the goods or services of members of an association of persons (not being a
partnership) as proprietorship from those of others. The scope of
infringement has been widened.

Intellectual property is probably an entity's most valuable asset and it is

important to clearly identify it. It may be a name on your front door, a
graphic design, or invention.

Failure to protect it, or to do so early enough, may put your business at risk.
Identify and value your IP assets and ensure they are itemised in your
business plan.

Copyright Law

Copyright Law in India is governed by the Copyright Act, which was

enacted in 1957. Under copyright Act, Copyright is proprietary right although
vests in the author of the work. On the creation of the work, the author
receives exclusive right, use or exploit the work as well as prevent the
authors from using or exploit the work. Specifically, the copyright lists the
following as protected work: -

1. Literary work

2. Musical work

3. Dramatic work

4. Artistic work

5. Cinematographer work

6. Audio Tape; and

7. Computer Software

The Copyright Amendment (Amendment Act) passed in the year 1984

defines and permit computer program "as literary work that includes tables,
compilation and program that is to say programs record on any discs, tape,
perforated media or other. The information storage device which is if fed into
or located in computer, any information. The originality of the work is to be
proved by the author since the author of the work must be able to prove that
the work was first published or displayed or performed. The Copyright act
defines infringement as in the Act permitted only by the author of the work
which is done by the person without permission of the author. Yes, Software
in India can be protected against piracy. The Act provides for registration of
the work but various pronouncements by various courts have held that the
registration under the Copyright Act is not mandatory. Piracy of the
Copyright has been protected under Section 51 of the Act. That it is desirable
that the Software registration is made with the Registrar of Copyright New
Delhi. For obtaining registration of the Software one as statutory right which
can be protected and enforced through Police or Courts which has been
effective enforcement by the Police by raiding the premises of the infringers.
The next query asked by you is-how can one enforce licensing its software in
India. The statute permits licensing of the work as that of assignment
provision of the Copyright Act, the author is permitted to license one or more
rights or interest in work In the statute contains a list or different type of
licensing including the following: -

1. Exclusive license
2. 2. Non-exclusive License
3. 3. License from a Joint Owner
4. License without consideration; and
5. Implied License.
Only restriction placed in that creation of the license is that the agreement
of license has to be in writing and has to be executed by the Licensee
(owner of the work). In addition to allowing the author of the work to take
action to permit his or moral rights in the work. There are three types of
remedies for infringement of the work by any authorized persons in India: -

1. Owner Assignee
2. . Exclusive Licensee or legatees of the work may initiate a lawsuit
claiming infringement of the copyright.
3. The Plaintiff in such suit may name Defendant, the person to copyright
infringement act, the person to permit a place to be used to infringe the
copyright and persons who sells or offers to soil any product which
infringes copyright. The lawsuit can be filed in any District or High Court
but to be filed within years from the date of infringement. Monetary
damages can be recovered. Delivery has been all infringing copyright
work and injunctive reliefs are appropriate. Form of remedy for
infringement provided by the Copyright Act is imprisonment of criminal
fines and sanction including a term of imprisonment for any person that
infringes a protected work.
COPYRIGHTS IN INDIA

Under Indian law, registration or any other formality is not required either for acquiring
copyright or for enforcing it in an infringement action. In other words, registration is not a
prerequisite or a condition precedent for securing copyright protection in India. It only has
evidentiary value in showing that the person mentioned in the Register is the actual
author/owner. India is a signatory to the Universal Copyright Convention and the Berne
Convention

LEGISLATION

India's copyright law, laid down in the Indian Copyright Act, 1957, fully reflects the Berne
Convention on Copyrights, to which Indian is a party. Additionally, India is party to the Geneva
Convention for the Protection of Rights of Producers of Phonograms and to the Universal
Copyright Convention. India is also an active member of the World Intellectual Property
Organization (WIPO), Geneva and UNESCO.

The copyright law has been amended periodically to keep pace with changing requirements. The
latest amendment to the copyright law which came into force in May 1995, has ushered in
comprehensive changes and brought the copyright law in line with new developments in satellite
broadcasting, computer software and digital technology. The amended law has made provisions
for the first time, to protect performers' rights as envisaged in the Rome Convention.

Several measures have been adopted to strengthen and streamline the enforcement of copyrights.
These include the setting up of a Copyright Enforcement Advisory Council, training programs
for enforcement officers and setting up special police cells to deal with cases relating to
infringement of copyrights.

Copyright (Amendment) Act, 1994

Since we last reported, developments have taken place in the field of copyright law. The
Copyright (Amendment) Act, 1994 came into force with effect from May 10, 1995 and some of
the salient features thereof are listed below:

(i) A comprehensive definition for "computer programme" (absent in the previous Act) reading
as follows has been introduced :

"computer programme" means a set of instructions expressed in words, codes, schemes or in any
other form, including a machine readable medium capable of causing a computer to perform a
particular task or achieve a particular result"
As under the earlier Act, computer programmes continue to be treated as "literary works". The
definition of "literary works" under the new Act includes "computer programmes, tables and
compilations including computer data bases".

(ii) In relation to any literary, dramatic, musical or artistic work which is computer-generated,
the person who causes the work to be created is the "author".

(iii) A new offence has been added in the Act for knowing use of infringing copy of computer
programme prescribing imprisonment for a term which shall not be less than 7 days but which
may extend to 3 years and with fine ranging from Rs 50,000 (US $ 1,500 approx.) to Rs 200,000
(US $ 6,000 approx.) However, where the computer programme has not been used for gain or in
the course of trade or business the court may not impose any sentence of imprisonment and may
instead only impose a fine up to US $ 1,500.

(iv) The definition of "communication to the public" has been amplified -

"communication to the public" means making any work available for being seen or heard or
otherwise enjoyed by the public directly or by any means of display or diffusion other than by
issuing copies of such work regardless of whether any member of the public actually sees, hears
or otherwise enjoys the work so made available."

In an explanation to this definition, it has been clarified that communication through satellite or
cable or any other means of simultaneous communication to more than one household or place of
residence including residential rooms of any hotel or hostel shall be deemed to be
communication to the public.

(v) Every "broadcasting organisation" has been conferred with a special right known as
"broadcast reproduction right" which shall subsist until 25 years from the beginning of the
calendar year next following the year in which the broadcast is made. The Act stipulates that
certain acts, which when done without the licence of the owner of such right, shall be deemed to
have infringed such right.

(vi) The Act specifies certain acts which do not constitute infringement of copyright the
important one being "the making of copies or adaptation of a computer programme by the lawful
possessor of a copy of such computer programme, from such copy (i) in order to utilise the
computer programme for the purpose for which it was supplied; or (ii) to make back-up copies
purely as a temporary protection against loss, destruction or damage in order only to utilise the
computer programme for the purpose for which it was supplied".

Copyright (Amendment) Act, 1999

An amendment to the Copyright Act, 1957, the Copyright (Amendment) Act, 1999 has recently
come into force. In compliance with Article 14 of TRIPS it extends copyright protection to
performers from the present twenty-five years to at least fifty years computed from the end of the
calendar year in which the performance took place. It further empowers the Government to
extend the provisions of the Copyright Act to broadcasts and performances made in other
countries provided those countries extend similar protection to broadcasts and performances
made in India.

In terms of the International Copyright Order, 1991 (promulgated by the Indian Government)
"foreign works" first published in a country which is a member of either of the
Conventions would be accorded the same copyright protection in India as Indian works
without undergoing any formalities. This is on the assumption that the home country
accords "national treatment" to Indian works, i.e., recognises the criterion of reciprocity.
This has led to a somewhat peculiar situation in the Indian Copyright Registry. If an
application for registration of copyright is filed by an applicant who is a member of either
of the Conventions, the Registry is inclined to return the application on the ground that
since copyright protection would be afforded to the applicant automatically, there is no
need for registration therefore. It appears that in the process the Registry is trying to
reduce its paper work. Thus, in case of infringement, the applicant can rely on the
copyright registration certificate issued by his home country and on the basis thereof
enforce his rights in India through the International Copyright Order, 1991.

TRIPS: STANDARDS CONCERNING TRADEMARKS

Part II of the TRIPS Agreement provides minimum standards concerning the

availability, scope and use of intellectual property rights. This Part contains
eight sections relating, respectively, to copyright and related rights,
trademarks, geographical indications, industrial designs, patents, layout
designs (topographies) of integrated circuits, protection of undisclosed
information and control of anti-competitive practices in contractual licenses
(the latter subject is not contained in the definition of intellectual property of
Article 1.2).
Trademarks

The essential elements of the standards concerning the availability, scope

and use of trademark rights include the following:

• any sign capable of distinguishing the goods or services of one

undertaking from those of other undertakings (thus including service
marks) shall be eligible for registration as a trademark (Article 15.1);
• registrability may be conditional upon visual perceptibility and, for signs
which are not inherently distinctive, on distinctiveness acquired through
use (Article 15.1);
• registrability may be conditional upon use (Article 15.2), but use may not
be a condition for filing and an application may not be refused solely on
the ground that intended use has not taken place within three years of
the filing date (Article 15.3);
• the nature of the goods or services to which a trademark is to be applied
may not be an obstacle to the registration of the mark (Article 15.4);
• Members shall publish each trademark and afford a reasonable
opportunity for petitions to cancel the registration, and may afford an
opportunity to oppose the registration (Article 15.5);
• the rights conferred by registration shall include the exclusive right to
prevent third parties from using identical or similar signs for identical or
similar goods or services, where such use would result in a likelihood of
confusion, the latter to be presumed where the goods or services are
identical (Article 16.1), subject to certain allowable exceptions such as the
fair use of descriptive terms (Article 17);
• certain rights are provided for the owners of well-known trademarks and
service marks (Article 16.2 and 16.3);
• the term of initial registration and renewals shall be no less than seven
years, renewable indefinitely (Article 18);
• if a showing of use is required for the maintenance of a registration, the
registration may be cancelled only after an uninterrupted period of at
least three years of non-use, unless valid reasons for non-use are shown
(Article 19.1);
• certain restrictions on use are not permitted (Article 20);
• compulsory licensing of trademarks is not permitted (Article 21);
• trademarks may be assigned with or without the transfer of the business
to which the trademark belongs (Article 21).
Geographical Indications

The essential elements of the standards concerning the availability, scope

and use of rights involving geographical indications include the following:

• geographical indications are defined as indications which identify a

product as originating in the territory of a Member, or a region or locality
in that territory, where a given quality, reputation or other characteristic
of the product is essentially attributable to its geographical origin (Article
22.1);
• Members must provide the legal means for interested parties to prevent
the use of indications that misleadingly indicate or suggest that a good
originates in a geographical area other than the true place of origin
(Article 22.2(a));
• Members shall refuse or invalidate the registration of a trademark which
consists of a misleading indication (Article 22.3), and provide means to
prevent any use which constitutes an act of unfair competition within the
meaning of Article 10bis of the Paris Convention (Article 22.2(b));
• protection shall be applicable against a geographical indication which is
literally true but misleading (Article 22.4) and, in the case of wines or
spirits, even where the true origin of the goods is indicated or the
geographical indication is used in translation or accompanied by
expressions such as kind, type, style, imitation or the like (Article 23.1);
• protection is not required in respect of a geographical indication of
another Member which is identical with the common name for goods or
services, or, for products of the vine, which is identical with the customary
name of a grape variety existing in the territory of that Member as of the
date of entry into force of the WTO Agreement (Article 24.6);
• there is no obligation to protect geographical indications which are not or
cease to be protected in their country of origin, or which have fallen into
disuse in that country (Article 24.9);
• guidelines are provided for additional protection for geographical
indications for wines and spirits (Article 23), including concurrent
protection of homonymous geographical indications for wines (Article
23.3), certain exceptions to substantive rights such as prior rights (Article
24.4) and the right to use personal names (Article 24.8), and time limits
for registration in certain cases (Article 24.7);
• in order to facilitate the protection of geographical indications for wines,
negotiations are to be undertaken in the TRIPS Council, concerning the
establishment of a multilateral system of notification and registration of
 geographical indications for wines, which would be effective for those
Members participating in the system (Article 23.4).
For provisions relating to enforcement of intellectual property rights and
maintenance and dispute settlement under TRIPS, you may refer back to
section 6.5 and 6.6 of Unit 6, Module 2.

• Paris Convention signed in 1883, came into effect on July 7, 1884. It was
subsequently revised in 1900 at Brussels, in 1911 at Washington, in 1925
at the Hague, in 1934 at London, in 1958 at Lisbon and in 1967 at
Stockholm.

• The convention touches on the issue of the use of marks in Article 5C (1),
(2) and (3).

• Article 6 at the convention establishes the important principle of the

independence of trademarks in the different countries of the Union.

• The convention obliges a member country to refuse or cancel the

registration and to prohibit the use of a trademark that is liable to create
confusion with another trademark already well-known in that member
country.

• The convention also makes provisions for collective marks, industrial

designs, trade names, appellation of origin and unfair competition.

• TRIPS agreement covers Copyrights and Related Rights, Trademarks,

Geographical Indications, Industrial Designs, Patents, Layout Designs of
ICs and Undisclosed Information under IPR subject matter. It also
provides for control of anti-competitive practices in contractual
agreements.

The TRIPS agreement is built on the principles of Paris and Bern Conventions

U NIT 3 INTELLECTUAL PROPERTY RIGHTS − THE INDIAN SCENARIO

INTRODUCTION

The tradition of scholarship and intellectual creativity in India goes back to a

few millennia. Yet the concept of Intellectual Property Rights in the modern
sense is rather new and would appear to have no cultural moorings or
sanction in our country. The history of intellectual property rights in India
backed by enforceable legal provisions scarcely goes back to 150 years.

Objectives

After studying this unit you will:

• know the history of IP legislation in India;

• have an overview of the IP Law in India;
• know IP Laws enacted by India; and
• know International IP Treaties where India is a member.

HISTORY OF IP LEGISLATION

Patents

The first Indian statute on patents was passed in 1856 granting some
exclusive rights to inventors for 14 years. It had to be re-enacted with some
modification as the Act of 1859. It granted to inventors of ‘new manufacture’
exclusive rights to make, sell and use the invention in India, or to authorise
some one to do so. Its scope was expanded to include designs, under ‘the
new manufacture’ in the Patents and Designs Protection Act 1872. Then
came the Inventions and Designs Act of 1888, and later the Indian Patents
and Designs Act 1911, (which was modelled largely on the British Patents
and Designs Act 1907). After independence in 1947, the Government felt
the need for a more effective patent legislation. The existing situation with
regard to patents was reviewed by two expert committees: one, headed by
Justice Rajagopal Iyengar, and another headed by Bakshi Tek Chand. It was
revealed that the MNCs, who owned 90% of all patents in India, had misused
patents largely to ensure a protected market in India for their products,
denying availability of many essential goods to people at competitive prices.
The Patents Bill following the reports of these Committees was debated for a
decade when finally the Indian Patents Act 1970 was enacted. It was highly
acclaimed by, amongst others, UNCTAD, as a most progressive patent law
and inspired similar legislation in many developing countries. It clearly
codified inventions that could not be patented, permitted patenting of only
process, not products, of manufacture in the fields of food, drugs and
medicines and substances produced by chemical processes. The term of
patent was in the case of process relating to food, medicines and drug, 5
years from the sealing of the patent or 7 years from the date of patent
whichever was earlier; in case of other process patents, it was 14 years; it
had provision for ‘licences of right’ and compulsory licensing in some
circumstances; it provided for use of inventions for government purposes,
acquisition of invention by Central Government and revocation of patents in
public interest.

Following India’s membership of the WTO and her obligations under the
TRIPS Agreement, the Indian Patents Act 1970, was amended by Patents
(Amendment) Act 1999 and Patents (Amendment) Act 2002, which came into
force on May 2, 2003. The Provisions of the present Act are in line with the
TRIPS Agreement.

Trademarks

No specific legislation existed on trademark before 1940. However,

remedies for violation of trademark were available under the Indian Penal
Code 1860 and Specific Relief Act, 1877. The Trade Marks Act, 1940 was
replaced by the Trade and Merchandise Marks Act, 1958, which has now
been repealed and replaced by the Trade Marks Act, 1999.

Designs

Designs continued to be governed by the provisions of the Indian Patents

and Designs Act, 1911, until the Designs Act, 2000 was passed.

Copyright

In matters of Copyright the English Copyright Act, 1842 was deemed

applicable to India, though it was never expressly declared to be so. The
application of the Copyright Act, 1911 of England was extended to India as a
British dominion. The Indian Copyright Act, 1914 introduced criminal
sanctions for infringement and continued till the copyright act 1957 came
into force on 21.1.1958. This was necessitated as much by the changed
status of India as an independent nation as by the advancement of
technology of reproduction and communication. The Act had several original
features; registration of copyright was voluntary; an administrative
machinery for registration of copyright was established; the government was
empowered to protect copyright of citizens from other countries. It has been
amended since then in 1983, 1992, 1994, and 1999 – the last one, after India
ratified the TRIPS Agreement as a member of the WTO.

Besides these four principal fields for intellectual property protection,

namely, patents, trademarks, industrial designs and copyright, India has
enacted the IP laws for geographical indications of goods, protection of plant
varieties and farmers’ rights, semiconductor IC layout designs, information
technology, and biodiversity.

OVERVIEW OF IP LAW IN INDIA

The Indian Law to grant and regulate protection of intellectual property in

various fields of IP has now been aligned to the requirements and provisions
as visualised under the TRIPS Agreement of the WTO.

You will study the details of the individual Acts dealing with specific IP
instruments – patents, copyright, trademarks, industrial designs etc. – in
relevant Units. Here we will refer to some general features, specially those
pertaining to the administration and enforcement of IPRs in India, that define
IP Laws in India.

3.3.1 The Indian Patent Law

The law relating to patents is laid down in the Indian Patents Act (1970) as
amended by Patents (Amendment) Act, 1999 and Patents (Amendment) Act,
2002. Some of the more significant changes introduced by these
amendments in the original Act of 1970 are as follows:

• There is no restriction now on Indians applying for patents abroad.

• The definition of term ‘invention’ is fully consistent with the TRIPS
Agreement, and includes both products and processes in all fields of
technology. Before amendment only methods or processes of
manufacture relating to food, medicines and drugs were patentable.
• The list of items that are not to count as inventions for grant of patents
has been modified to include exclusions permitted by the TRIPS
Agreement. Earlier an invention was not patentable if its primary or
intended use would be ‘contrary to law or morality or injurious to public
health.’ Now it will not be considered an invention if its ‘primary or
intended use or commercial exploitation’ could be ‘contrary to public
order or morality or which causes serious prejudice to human, animal or
plant life or health or to the environment. Also ‘discovery of any living
thing or non-living substance occurring in nature’ is not regarded as an
invention under the amended Act.
• The rights of the patentee have been brought in line with the provisions of
the TRIPS Agreement, as necessitated by changes permitting product
patents.
• Reversal of burden of proof when infringement of a process patent occurs
has been included in accordance with the TRIPS Agreement. It is now for
the defendant to prove that the process being used by him is different
from the patented process alleged to be infringed.
• The term of patent is now uniform 20 years as required by the TRIPS.
Earlier, for a process patent, relating to an item of food, medicine or drug
it was five years from the date of sealing of the patent or seven years
from the date of application whichever period was shorter, and fourteen
years from the date of patent in respect of any other invention.
• The provision of licenses of right has been omitted and compulsory
licensing brought in line with TRIPS.
• Provisions for exclusive marketing rights have been included.
• Provisions for parallel import of patented products have been included.
• Protection of biodiversity and traditional knowledge, under ‘inventions not
patentable’ category.
The Act makes the Controller General of Patents, Designs and Trade marks
appointed under the Trade Marks Act, 1999 as the controller of Patents with
powers of a civil court.

Indian Copyright Law

The Copyright Act, 1957, as amended in 1999 governs the copyright law in
India. It came into force on January 15, 2000. It has established a copyright
office, under the immediate control of the Registrar of Copyrights, to
facilitate registration of copyright. It has also established a Copyright Board
(CB) with Registrar of copyrights as its Secretary. The CB is meant to hear
and settle certain kinds of disputes arising under the Act.

The Act defines various categories of works in which copyright subsists, and
has inter alia, provisions for determination of first ownership of copyright, the
scope of rights conferred; assignment and licensing of copyright; compulsory
licensing and the circumstances in which it could be granted; performing
rights of societies; broadcasting rights; authors special rights; international
copyrights. The Act sets out in detail what constitutes infringement and
what does not; civil and criminal remedies against infringement and
remedies against threat of legal proceedings without any ground.

The Indian copyright law is in conformity with the provisions of the TRIPS
Agreement of the WTO. It is also in line with the provisions of the Berne
Convention for the Protection of Literary and Artistic Works (Brussel Text,
1948), and the Universal Copyright Convention (1952); India is a member of
both conventions.

Indian Trade Mark Law

The Trade Marks Act, 1999 lays down the law governing trade marks in India.

It extends the scope of protection by registration of trade marks to services,

besides goods. It provides for a single register and simplifies the procedure
for registration. It recognises well known marks as a distinct category, and
provides for registration of collective marks, owned by an association of
persons. It firmly discourages persons tempted to exploit other persons
good name in business through false or misleading means.

The Controller-General of Patents, Designs and Trade Marks is the Registrar

of Trade Marks. The act establishes an appellate board with the same
powers as are vested in a civil court; any proceedings before the Board are
deemed as judicial proceedings.

Several measures have been taken to simplify trade mark law and
procedure, offer better protection and make enforcement more effective,
e.g. a single application for registration in more than one class; increasing
the term of protection from 7 years to 10 years; enhancing punishment to
bring it at par with the copyright law; making trade mark offences
cognisable.

Indian Designs Law

The Designs Act 2000 lays down the law for protection of industrial designs
in India. The Controller-General of Patents, Designs and Trade Marks is the
Controller of Designs.

The Act inter alia defines ‘original’ and enlarges the scope of definitions of
‘article’ and ‘design’; it spells out what designs shall not be registered, brings
in the internationally followed system of classification in place of the Indian
system, provides for restoration of lapsed designs and maintaining the
register of designs on computer; the two year period of secrecy of a
registered design is revoked and any document for transfer of right in a
registered design is required to be compulsorily registered. More grounds
have been added for cancellation of registration and cancellation
proceedings are to be initiated before the Controller of Designs instead of a
High Court. Infringement attracts heavier penalties; the initial period of
registration is enhanced from 5 years to 10 years, extendable by a further
period of 5 years. It provides for control of anti-competitive practices in
contractual licences. Appeal against an order of the control lies to the High
Court.

Appeal Mechanism

In keeping with its status as a major, vibrant economy, and as an active

contributor in the realm of knowledge and creativity, India, though a
relatively late comer in the IP game, has strong IP Laws and effective
enforcement of IPRs. All the Acts dealing with IP in its various forms are
aligned to the TRIPS Agreement making appropriate use of flexibilities
available under the TRIPS. They are fully alive to the role of IPRs in growth
and development consistent with societal and environmental concerns.

All the IP Laws provide for (i) a fully empowered administrative machinery to
grant and register claims for IPRs in a fair and transparent manner, (ii) a
mechanism for appeal against administrative decisions if necessary, and (iii)
a procedure for legal enforcement of IPRs.

Patents and industrial designs are required to be registered under the

relevant Acts to claim any legal protection of IPRs. However, copyright and
trademarks (in India) have no such requirement. Their registration is
voluntary, but in case of legal disputes, registration carries distinct
advantages. As copying, counterfeiting and forgery have become easy and
rampant and economic consequences of infringing a copyright or using a
brand name (trademark) in an unfair way may be huge, it is advisable to get
the copyright and trademark duly registered.

The provision of appeal against a decision/order of the highest controlling

authority is only fair and necessary under a sound legal system. The appeal
earlier used to lie with a High Court of appropriate jurisdiction. However, the
domain of IP being highly specialised, which was often unfamiliar to a High
Court judge, the need of a specialist member on the reviewing bench was
always felt. Further the disposal of an appeal in a High Court was time-
consuming and involved high cost of litigation.

Having regard to these considerations, the Trade Marks Act, 1999,

established an Appellate Board (AB) having advocates who have been active
in the field of Trade Marks for 10 years. A bench of the Appellate Board will
consist of a Judicial Member and a Technical Member. The bench will sit at a
place decided by the Central Government.
The Appellate Board for trade marks is also the appellate authority under the
Patents Act, 1970, as amended by the Patents (Amendment) Act, 2002. It is
also the Appellate Board for geographical indications. The Technical Member
of the AB for patents cases is a person experienced in patent law to consider
appeals against the decision of Controller. He is a person who has been
Controller, or has exercised his functions, for 5 years, or he should be an
Advocate practising law relating to patents and designs for 10 years. A
bench of the Appellate Board consists of one judicial member and one
technical member.

The Appellate Board sits in the following cities: Ahmedabad, Chennai, Delhi,
Mumbai, Kolkata. The Board fixes its own procedure, place and time of
sittings.

Pursuing a case before a trade mark Appellate Board or the Copyright Board
(which can also have sittings all over India) can be frustrating and difficult
experience.

The procedure for appeal in the case of copyright is different. The appeal
against a decision of the Registrar of Copyrights lies with the Copyright
Board. The Copyright Board, constituted by the Central Government,
consists of a Chairman who is or has been or has the qualifications to be a
judge of High Court, and two to fourteen members. The Registrar of
Copyrights is the secretary of the Board. A further appeal against the
decision of the Copyright Board lies with the High Court of appropriate
jurisdiction.

Under the Designs Act, 2000, the appeal against a decision of the Controller
of Designs lies with the High Court. The Semiconductor Integrated Circuits
Lay-out Designs Act, 2000, provides for a Layout Design Appellate Board,
and an appeal against its decision lies with the High Court. The appellate
authority under the Protection of Plant Varieties and Farmers’ Rights Act
2001, is the Plant Varieties Protection Appellate Tribunal. The Biological
Diversity Act 2002 provides for a appeal against the orders of the national
biodiversity authority or a state biodiversity board, to the High Court. The
Information Technology Act provides for appeal to a cyber Appellate Tribunal
against one order of the Controller of Certifying Authority or an adjucating
officer.

Thus, the situation in respect of appeal related to various kinds of IPRs may
do with some streamlining.
The diversity of appellate authorities and procedures for different IPRs seems
unnecessary. There could be a case to have only one Intellectual Property
Appellate Tribunal to hear appeals cases of all category of IPRs. The Tribunal
and its benches may also shed the roving character and have fixed places
for hearings to make it easy, convenient and less costly for litigants to
pursue their cases.

IP ACTS ENACTED BY INDIA

India has enacted the following IP Acts:

1. The Patents Act, 1970, as amended by the Patents (Amendment) Act,

1999, and the Patents (Amendment) Act, 2002
2. The Copyright Act, 1957 as amended in 1999
3. The Trade marks Act, 1999
4. The Designs Act, 2000
5. The Geographical Indications of Goods (Registration and Protection) Act,
1999
6. The Protection of Plant Varieties and Farmers Rights Act, 2001
7. Integrated Circuit Layout Designs Act, 2000
8. The Biological Diversity Act, 2002

3.5 MAJOR INTERNATIONAL TREATIES SIGNED BY INDIA

1. The Convention Establishing the World Intellectual Property Organisation

2. The Paris Convention for the Protection of Industrial Property
3. The Berne Convention for the Protection of Literary and Artistic works
4. The Patent Cooperation Treaty
5. The Geneva Convention for the Protection of Producers of Phonograms
Against Unauthorised Duplication of their Phonograms.
6. The Budapest Treaty on the International Recognition of the Deposit of
Micro organisms for the Purposes of Patent Procedure
7. The Universal Convention of Copyrights

A brief history of IP legislation in India is given. An overview of the current IP

Law in four principal kinds of IP viz. patents, copyrights, trade marks and
designs, is given pointing to some salient features that make the IP
provisions in India tougher and in conformity with its international
obligations. Existing Acts giving IP laws in various categories of IP have been
listed, as also major international treaties which India has signed.

Unit 2

What are patents? What are the requirements of patentability?

Can software be patented?

A. Background:

A patent is a form of industrial property which may be broadly described as a monopoly right
conferred by the state to an inventor to industrially and commercially exploit his invention at the
cost of making a complete disclosure of the details of his invention. A patent is thus a statutory
privilege granted by the Government to an inventor, and to other persons deriving their rights
from the inventor, for a fixed period of years, to exclude other persons from manufacturing,
using or selling a patented product, or from utilising a patented method or process. At the
expiration of the period of the patent, the patented invention is available to the general public or
as it is sometimes put, falls into the public domain.

B. Object of Patent Law:

In the case of Bishawanath Prasad Radhey Shyam v. Hindustan Metal Industries1, the apex court
outlined the objectives of patent law as under:
1
Bishwanath
‘[T]he object of patent law is to encourage scientific research, new technology and industrial
progress. Grant of exclusive privilege to own, use or sell the method or the product patented for
a limited period stimulates mew inventions of commercial utility. The price of the grant of
monopoly is the disclosure of the invention at the Patent Office, which after expiry of the fixed
period of monopoly, passes into the public domain.’

C. Requirements of Patentability:

A patent confers a statutory privilege on an inventor i.e. that there is no common law of patents.2
As seen above, India became a signatory to the TRIPS Agreement in 1995 and as such was
bound to embody the principles contained therein into its domestic intellectual property
legislation.

Keeping in mind its obligations under TRIPS, the Patents Act, 1970 came to substantially
amended in 2002 and again in 2005. In light of the TRIPS Agreement, the Patent Act, 1970
prescribes that an invention must satisfy the trinity requirements of novelty, innovativeness and
usefulness in order to receive a patent under the Act.

i. Test 1: Trinity requirements:

As stated above, India as a signatory to TRIPS, has adopted the trinity requirements as specified
therein in order to ascertain the patentability of an invention. Before considering these
requirements in detail and whether the invention satisfies these requirements, let us consider
some pertinent definitions under the Act.

patent: patent means a patent for any invention granted under this Act2

invention: invention means a new product or process involving an inventive step and capable of
industrial application3

2
Section 2(1) (m) of the Act.
3
inventive step: a feature of an invention that involves technical advance as compared to the
existing knowledge or having economic significance or both and that makes the invention not
obvious to a person skilled in the art4

capable of industrial application: capable of being made or used in an industry5

new invention: any invention or technology which has not been anticipated by publication in any
document or used in the country or elsewhere in the world before the date of filing of patent
application with complete specification, i.e. the subject matter has not fallen in public domain or
that it does not form part of the state of the art6

Therefore, the criteria for an invention to be patentable are,

(1) novelty

(2) inventive step

(3) utility

1. Novelty:

The first ingredient for an invention is that it must be new product or a new process. Novelty
means what is new and original, never seen or done before. An invention is taken to be new if it
does not form a part of the state-of-the-art. In order to be patentable, the new subject must
involve invention over what is old. It is not essential that the invention should be anything
complex or complicated. It must merely be of such nature that it involves a technical advance as

4
.
5
6
compared to the existing knowledge. As observed by Cotton LJ in Blakey & Co. v. Lathem &
Co.7

‘To be new in the patent sense, the novelty must be shown in the invention. It is not enough that
the purpose is new or that there is novelty in the application, so that the article produced is in
that sense new. There must be novelty in the mode of application.’

In view of this principle, the Court of Appeal in England in Fomento v Mentomore8 denied patent
rights to a designer of an improved design of a ball-point pen, on the grounds that the inventor
himself had published a description of making ball point pens and had made two pens
embodying the invention available to the members of the public before filing the patent
application.

2. Inventive step:

As seen above, an ‘inventive step’ is one which makes the invention ‘non-obvious to a person
skilled in the art’. In other words, if the invention is obvious to the person skilled in the art, it
cannot be said to involve an inventive step. After the Amendment in 2005, the definition of
inventive step has been enlarged to include economic significance of the invention as well.

The test to ascertain whether an invention involves an inventive step is expressed in Halsbury
Laws of England as: ‘was it for practical purposes obvious to the skilled worker, in the field
concerned, in the state of knowledge existing at the date of the patent to be found in the
literature then available to him, that he should or would make the invention the subject of the
claim concerned.’ In other words, the question to be answered in determining inventive step is
‘Would a non-inventive mind have thought of the alleged invention?’ If the answer is ‘no’, then
the invention is non-obvious. If the patent claimed merely includes the development of some
existing trade, in the sense that it is a development as would suggest itself to an ordinary person
skilled in the art, it would fail the test of non-obviousness.

7
8
In order to ascertain whether an invention subscribes to the requirements of an ‘inventive step’, a
two pronged approach may be adopted. Firstly, ascertaining what was the state of the art before
the relevant date of the complete specification filed pursuant to an application for a patent, and
secondly having regard to the state of the art, ascertaining whether the alleged inventive step
would have been obvious to a person skilled in the art.9

i. State of Prior Art

For an invention to be judged as novel, the disclosed information should not be available in the
‘prior art’. This means that there should not be any prior disclosure of any information contained
in the application for patent (anywhere in the public domain, either written or in any other form,
or in any language) before the date on which the application is first filed i.e. the ‘priority date’.
Although the term ‘prior art’ has not been defined under the Indian Patents Act, it shall be
determined by the provisions of section 13 read with the provisions of sections 29 to 34 of the
Act.

The following has been indicated as ‘prior art’ vide the Act10:

(a) anticipation by publication before the date of the filing of the application in any of the
specification filed in pursuance of application for patent in India on or after the 1st day of
January 1912;

(b) anticipation by publication made before the date of filing of the application in any of the
documents in any country;

(c) claim in any claim of any other complete specification filed in India which is filed before
the application but published after said application;

(d) anticipation having regard to the knowledge, oral or otherwise, available within any local
or indigenous community in India or elsewhere.

9
Molnlycke A.B. v Procter and Gamble 1994 RPC 49; Hoechst Celanese Corp. v B.P Chemicals 1997 FSR 547,
562.
10
From the above it is clear that in order for an invention to be anticipated by virtue of a patent, the
patent must have been granted in India alone.11 Thus, a patent granted in any other country would
not constitute ‘prior art’ for the purposes of the Act.12 However, if the patent is anticipated by
publication, it is irrelevant whether the publication occurred in India or elsewhere.

An invention is not considered ‘new’ if the claimed invention is publicly known or publicly used
in India before the priority date.13 As observed by the Supreme Court in Monsanto:

‘Publicly known does not mean that it must be published in a document, although not found in a
book, it may form a part of the common knowledge among the public concerned. It also does not
mean that it should be widely used to the knowledge of the consumer. It is sufficient if it is known
to persons who are engaged in the pursuit of knowledge of the patented product or process,
either as men of science or men of commerce or as consumers.’14

The Supreme Court in Bishwanath Prasad’s case observed that prior public knowledge of the
alleged invention would disqualify the grant of a patent. Publications concerning the invention
whether through word of mouth or through books or media would, therefore nullify any
subsequent attempt to secure a patent.

ii. Obviousness to a person skilled in the art:

A skilled person would be a person who ‘has experience of the field in question and he may be
one who have available assistants who would carry out tests’.15 In order to pass the test of
obviousness, the prior art referred above must be of such nature as to inform the skilled person as
to how the invention derived from the prior art is to be performed. In other words, the person
11

12

13

14

15
skilled in the art must have the necessary information (through the prior art) to take the inventive
step in question.16

In determining whether an invention involves an ‘inventive step’ and is ‘non-obvious’, the

supervening policy of patent law viz. to reward and encourage invention without inhibiting
improvements of existing technologies by others must be kept in mind. Although no absolutely
uniform test for determination of inventive step can be formulated, certain broad criteria can be
indicated, whether the invention was publicly known, used or practiced before or at the date of
the patent? If the answer is positive, it shall negate inventive step.

A structured approach to determine obviousness consisting of four steps was expounded in

Windsurfing International v Tabur Marine17:

a. Identify the inventive concept in the suit

b. Keep in mind a normally skilled, but unimaginative person having common general
knowledge of the concerned art as at the priority date will be the date from which the
objector to the patent would allege inventive step was obvious

c. Through the spectacles of the aforesaid skilled person identify differences, if any,
between the matter cited as being known or used and the alleged invention;

d. Finally, without considering the alleged invention, consider whether the differences
would see to the aforesaid skilled person such as leading obviously to the alleged
invention or that a degree of invention would be necessary to obtain the invention.

16

17
In Bishwanth Prasad’s case, the apex court reiterated the above test and suggested three
alternative conceptions of the same:

a. Whether the alleged invention lies so much out of the track of what was known before as
not natural to suggest itself to a person thinking on the subject, it must not be the obvious
or natural suggestion of what was previously known;

b. Had the document been placed in the hands of a competent draftsman, or engineer, (as
distinguished from a mere artisan), endowed with the common general knowledge at the
‘priority date’, who was faced with the problem solved by the patentee, but without
knowledge of the patented invention, would he have said, this gives me what I want?

c. Was it for practical purposes obvious to a skilled worker n the field concerned, in the
state of knowledge existing at the date of the patent, to find in literature then available to
him; that he would or should make the invention the subject of the claim concerned.

3. Utility:

It is pertinent to note that utility was not a requirement for patentability under the Patents and
Designs Act, 1911. In Bishwanath Prasad’s case, the Supreme Court recognised utility as one of
the grounds on which a patent can be revoked. The usefulness of an alleged invention depends
not on whether by following the directions in the complete specification all the results not
necessary for commercial success can be obtained, but on whether by such directions the effects
that the application/patentee professed to produce could be obtained. The usefulness of the
invention is to be judged, by the reference to the state of things at the date of filing of the patent
application, if the invention was then useful, the fact that subsequent improvement have replaced
the patented invention render it obsolete and commercially of no value, does not invalidate the
patent.
Thus, novelty, non-obviousness, industrial applicability and utility form the essential
requirements of patentability. These conditions have been universally accepted as the essential
prerequisites of patentability.

D. Patentability of Computer Software:

It is a well-established proposition that computer programs18 are copyrightable subject-matter,

just like any other literary work.19 Loading a program into computer memory, saving the
program or running it without authority may infringe copyright. Making an arrangement or
altered version of the program or converting it into or out of one computer language or code into
a different computer language or code is also an infringement. Article 10 of the Trade Related
Intellectual Property Rights Agreement (TRIPs) expressly provides that computer programs,
whether in source code or object code shall be protected as literary works under the Berne
Convention, 1971.

Despite protection afforded to computer software through copyright law, it is submitted that
copyright protection is not always ideal. Problems arise when, in a particular invention, software
and hardware co-exist. Would, in such circumstances, copyright protection extend to the
invention itself? That seems unlikely, as copyrights being restricted to literary and artistic works
cannot be held to extend to machines. Hence, some amount of protection is conferred

Section 3 of the Act contains a list of ‘what are not inventions’.4 If the ‘invention’ for which the
patent is sought falls within the provisions of Section 3, no patent would be granted, even if it
otherwise satisfies the requirements of patentability outlined above.

Section 3(k) of the Act prescribes:

‘mathematical or business method or a computer program per se algorithms;’

Section 3 (k) of the Act thus clearly lays down that computer programmes are not patentable.20
However, this was not always the case. The provisions concerning patentability of software have

18

19

20
been amended a number of times. The original unamended Act did not exclude explicitly patents
for computer related inventions, as computer technology at that point of time was relatively
unknown, but the definition of the term ‘invention’6 itself excluded patents for computer
programmes.

A major amendment was introduced in Section 3 with respect to the patentability of computer
programs through the Patents (Amendment) Ordinance on December 27, 2004. The Ordinance
split the sub-section 3k into two- sub-section 3(k) and 3(ka). The excluded subject matters as
originally contained in Sub-section 3(k) were provided in the new Sub-section 3(ka). They
included ‘a mathematical method or a business method or algorithms’. The amended Section
3(k) read as follows:

‘(k) a computer programme per se other than its technical application to industry or a
combination with hardware.’

The key expressions contained in the above amendment are ‘technical application to industry’
and ‘combination with hardware’. The legislative intent behind these words was clear. If an
invention is directed at computer software having technical application to industry or coupled to
hardware – then it is patentable.7 The law as it stands now however reverts to the original
position of excluding computer program per se from patentability.

From the above discussion it follows that if a patent is sought only for the software tools21 i.e. a
patent is sought only for a computer program per se, then a patent would not be available for the
invention, as it would be hit by the provisions of Section 3 (k) elucidated above. However, if the
patent is sought for a combination of software and hardware, then it would not be a computer
application per se, and hence might be patentable.22 As observed in Gales’ case:

‘Although those instructions are not patentable as such, that is not the end of the matter.
Computer instructions may represent, for instance, a technical process. What is recorded in the
instructions may be the means for carrying out a technical process with the aid of a computer. In
such a case the process is not barred from patentability by reason of the use of a computer as a
medium by which it is carried out.’8

21
22
Analogy may also be drawn to the Diamond v. Diehr9, where the US Supreme Court granted a
patent for a rubber curing process controlled by software as the patent was for the ‘rubber curing
process and not the computer software per se.’

From the above, it may be concluded that in ascertaining the patentability of an invention, the
invention must be looked at a whole. A claim directed to a technical process which process is
carried out under the control of a program (whether by means of hardware or software), cannot
be regarded as relating to a computer program per se. An invention consisting of a combination
of hardware and software may be considered patentable, if it satisfies the other requirements
prescribed by the Act.

Unit 3

INTRODUCTION

The remedies in cases of infringement of intellectual property rights are

available through action in three channels: civil procedure, criminal
procedure and administrative procedure. In addition to these there are
always technological measures that the owner of IP can employ to minimise,
if not eliminate, the possibilities of infringement of his IPRs, and detect the
incidence of infringement. The TRIPS Agreement, Part III (Article 41 to 61)
deals with the enforcement of intellectual property rights. Members of the
WTO have the general obligation to provide under their law enforcement
procedures to permit effective action against any act of infringement of IPRs.
The remedies should be expeditious and deterrent to further infringements.
The procedures should not create barriers to legitimate trade and provide for
safeguards against their abuse; they should be fair and equitable and not
unduly costly or complex; there should be no unreasonable time limits or
undue delays. The last two qualifications are important because the
effectiveness of the IPR depends on whether they could be speedily enforced
and with low cost. The TRIPS also lays down other requirements for
enforcement process: right to be heard and give evidence; right to have a
prompt, reasoned, written decision; judicial review, written notice of claims,
legal representation; protection of confidential information; discovery of
information held by the other party; and indemnification against abuse of
enforcement procedure.

Objectives
After studying this unit, you should be able to:
• understand the action-options available to an owner of IPR aggrieved by
infringement;
• know some special evidential aspects in cases of infringement of patents
and trademarks; and
• know the remedies available under different options.

CIVIL PROCEEDINGS

The three issues that need to be considered are:

• Who could initiate proceedings in a case of infringement of industrial

property (the plaintiff)?
• Against whom the proceedings can be initiated (the defendant)?
• Which court will have the jurisdiction to try the case (the Court)?
Who can Initiate Proceedings?

Clearly the owner of the IPR is the aggrieved party if infringement of his IPR
takes place and he is to initiate the proceedings as the plaintiff. If the IP is a
patent or a trademark an exclusive licensee also can initiate proceedings.

The Defendant

You have read in the previous Unit what constitutes infringement in the case
of a specific category of IP. A person who commits an act of infringement
becomes the ‘defendant’, if the plaintiff brings infringement proceedings for
such an act of infringement. Additionally, anyone else who may join the
infringer in a common design to perpetrate the act of infringement will also
be jointly liable to be sued. The liability is, however, to be judged in relation
to the territorial jurisdiction. If a person, outside the jurisdiction of a
country’s courts, supplies a protected article to a party again outside the
jurisdiction, he is not guilty of infringement. But if he is working in a common
design with a person who resides within the jurisdiction and commits the
infringing act, the first person in this case jointly shows the liability with the
infringer.

If an employee attracts tortuous liability, his employer is also vicariously

liable for torts. However, a person, commissioning work from an independent
contractor does not carry such vicarious liability.

The Court
National laws clearly specify, the court which will be competent and have
jurisdiction in relation to a case of infringement. The issue of jurisdiction
becomes complex in cases involving international aspects in a case of
infringement.

An interesting question relating to enforcement of IPR in the context of

global commerce pertains to the legal jurisdiction of a court where the case
for a violation of IPR should be initiated. The difficulty arises when the
parties to litigation belong to different countries. Such situations are
becoming quite common as technological capabilities advance, globalisation
becomes universal and e-commerce becomes common. Different countries
have different laws. The course, outcome and costs of litigation may
significantly depend on where the case is contested. Novell, a US computer
software firm, sued its distributor in South Korea, in a court in Utah, USA for
infringement of copyright and trademark though the cause of action arose in
the Republic of Korea.

Besides IP laws, redressal can in certain cases be available under common law liability for
economic torts, particularly passing off and injurious falsehoods.

Civil Procedure

A Civil Court can provide a wide range of relief in a case of infringement of

property. The relief can be in the form of an injunction, or damages or
account of profits, or otherwise (other relief).

Injunction is a prohibitory relief to stop the infringement. The court may

direct the defendant not to do certain acts. Such direction may come at the
end of a trial in which the complaint of the owner of the IP that his rights
have been violated has been upheld. In such case the injunction is called
final. However, in a civil action, there can also be an interim, interlocutory
injunction, which is meant not to enforce an established right but to maintain
the status quo till the proceedings are complete. Interlocutory injunction
makes the IPR regime very effective.

Damages are meant to compensate the owner of the IP for the loss in money
terms suffered by him due to infringement of the IPR.

‘Accounts’ relates to the account of net profits earned by the defendant

(infringer) due to infringement. If there are no profits, there is no award of
‘Accounts of Profit’ as relief. The account of profit is not a punishment, it
only aims to deny the infringer unjust enrichment at the cost of the owner (or
licensee) of the IPR. Damages and Accounts are alternative remedies; the
plaintiff can choose only one of them, not both.

Civil action can offer remedies also for acts which are themselves not
infringement but may be preparatory for completing the infringing act e.g.
supplying part for illegally making a patented invention, or consequential to
an illegal act e.g. importing or marketing infringing goods. In such
‘secondary’ acts the liability is dependent to a great degree on whether the
defendant knew that infringing goods were involved.

‘Otherwise’ as a remedy is a general provision which authorises the court to

grant such other reliefs as it may deem necessary for complete redressal of
the complaint.

‘Delivery up’ is a provision to make injunction effective. The court ordering

injunction may in its discretion order delivery up of infringing
articles/documents for destruction by the defendant. If the case pertains to
the infringement of a trademark the equivalent order may require erasure of
trademark. In the case of a copyright work or an unregistered design, the
order may extend both to infringing copies and to the apparatus that is
specifically designed to make them.

Recourse to civil proceedings in cases of IP infringements is on the rise. In

many cases, civil courts have awarded substantial damages. For example,
the award in the Polaroid vs. Eastman Kodak case was US $873 million, and
in the Smith International vs. Hughes Tools, US $204 million.

The civil procedure may come to the help of the owner of the IPR in securing
evidence of infringement through what is generally known as Anton Piller
Order and Mareva injunction. These have already been discussed in Unit 1,
Section 1.5. An Anton Piller Order from a competent Court authorises a
plaintiff, after a hearing in camera for pre-trial relief in the form of a search
order of the defendant’s premises, with some safeguards for liberties and
prevention of abuse, for discovery of incrementing material or documents.
The Mareva injunction directs the defendant to retain the infringing material.

The experience with the enforcement of patent rights shows wide variation
from country to country in terms of complexity of the proceedings, duration
of a case in courts and the cost of litigation.

The patent infringement cases are full of technical complexities and receive
divergent interpretations at different courts. The USA has established in
1982 the United States Court of Appeals for the Federal Circuit to deal with
the issue of complexity in an attempt to provide uniform interpretation of
patent claims.

The present efforts seek a negotiated resolution of the international

jurisdictional issue by adopting the Hague Convention on Jurisdiction and
Foreign Judgments in Civil and Commercial Matters.

CRIMINAL PROCEEDINGS

The penalties for infringement in a criminal case are tougher than in civil
proceedings. Criminal penalties involve a real prospect of imprisonment for
a substantial term. Thus recourse to criminal proceedings, in a case of
infringement of IP, can be more effective and have more of a ‘deterrent
value’ than a case under civil proceedings. However, the standards to prove
a liability in a criminal action are more stringent than in a civil suit.

But a criminal suit has no immediate, pre-trial, or interlocutory remedies like

injunction or even remedies like permanent injunction and damages. The
remedial action has to wait for the outcome of criminal proceedings. The
civil remedies have a greater appeal in business community than
punishment by state as in a criminal action.

The legal framework and guidelines provided under the TRIPS Agreement
aim at making enforcement of IP in criminal proceedings more effective.
Recourse to criminal proceedings in cases of violation of IPR is becoming
more popular. Several countries have made criminal proceedings more
effective and pursue infringement of IPRs with seriousness. In Malaysia,
Business Software Alliance assists the government in fighting software
piracy. Penalties include imprisonment up to 5 years, China, Hong Kong,
Singapore, India are all on hot pursuit of counterfeiters and pirates.
Establishments raided include largely those producing auto-parts, fake
medicines, music CDs/cassettes, books etc. and large stocks of counterfeit
and pirated goods have been seized. An interesting development in the
administration of law pertaining to the violation of IPRs is seen in Thailand.
As the IPR law is highly complex and requires specific knowledge for
competent interpretation, needing specially qualified judges, Thailand has
set up a Central Intellectual Property and International Trade Court with
exclusive jurisdiction in both Civil and Criminal matters relating to
enforcement of IPRs.

Criminal proceedings can be initiated by officers of the State.

ADMINISTRATIVE PROCEDURE

Apart from court, administrative agencies can and do take effective steps in
case of violation of IPRs. Such action may include seizing infringing goods at
the borders by customs authorities; confiscation of offending goods by excise
authorities; action by appropriate authorities to test quality and standards
etc. Administrative actions to stop infringement have high visibility.

Customs authorities play a notable role in administrative enforcement of IPRs

at national borders by seizing infringing goods if the owner of the IPR notifies
the Commissioner of Customs and Excise that an incoming consignment is
violative of his IPR, usually a copyright or a trademark, and needs to be
confiscated to uphold his legal right. In 2001, 95 million counterfeit articles
were seized at the EU borders. Administrative enforcement through seizure
at borders faces difficulty in several countries as customs authorities are
generally ill-equipped to handle IP matters; such matters may often not be
receiving high priority in customs policy. Absence of reliable data-bases to
support legal enforcement of IPRs, particularly in trademarks, is an
impediment for quick action.

EVIDENTIAL ASPECTS

Some evidential aspects relating to infringement of a patent and a trade

mark need to be noted.

Patent – Infringement

If it is a product patent, the burden of proof lies on the plaintiff. He has to

furnish evidence to convince the court that on a balance of probabilities the
defendant has infringed the patent.

If it is a process patent for obtaining a product it is for the defendant to

prove the process he has been using to obtain an identical product is
different from the patented process.
It may be necessary, in view of the technical complexities involved in an
invention and the technical language used in specification and claims to call
experts, to give evidence, as to the state of art in a field or the meaning of a
technical term, and whether in his opinion a skilled worker can carry out the
invention as described in the specification. However, it is not for the expert
to say what the specification means or whether a particular step is obvious.

Trademark Infringement

• If a challenge to a trademark has been mounted on the ground of non-

use, or if the owner claims that the trademark has acquired
distinctiveness through use, the burden of proof lies with the proprietor of
the trademark.
• Registration of a trademark is prima facie evidence of its validity, as
regards its ownership.
• Evidence may come from people in the trade (wholesalers, retailers),
experts, and even market surveys though they may not carry much
weight.
•

REMEDIES FOR INFRINGEMENT IN SPECIFIC IP INSTRUMENTS

Patents

Remedies available are: injunction (interlocutory as well as final), damages

or account of profits, an order of delivery up, declaration of validity of patent
and the fact of its infringement by the defendant.

Trademarks

Remedies are: injunctions, damages or accounts, or otherwise; as order of

delivery up which may be subject to limitation of time.

Industrial Designs

Remedies are normally injunctions and damages. However, damages may

not be awarded if the defendant succeeds in showing that he was not aware,
and had no reasonable ground for supposing that the design was registered.

It may be noted that national laws may contain remedies against groundless
threats of infringement proceedings from the owner of the design by means
of advertisements, or publication of views, or circulars, or otherwise.
Semiconductor Layout-Design and Geographical Indicator

Infringement attracts punishment with fine or imprisonment or both.

TECHNOLOGICAL MEASURES TO PREVENT AND DETECT

INFRINGEMENT

Besides the remedies and mechanism of IP enforcement considered so far –

Civil and Criminal Proceedings and Administrative Procedures – which
envisaged active role of the government in enacting enabling legislation and
rules and regulations and in putting in place an effective institutional
infrastructure, the concerned owner can always devise or use technological
means to make counterfeiting and copying difficult. This serves the owner of
the IPR by protecting his economic interest. It also tends to save the
customer from buying ‘fake’ goods (and pirated copies of books, films, music
cassettes, software programmes etc.). Since technology places a powerful
tool in the hands of counterfeiters and copiers, it can also be an apt means
to counter these efforts. In any case, it could create measures to counter
the evil with speed as effecting change in national legislation, or developing
international understanding, is a slow and tedious process.

Technological means to counter infringement of IPRs have acquired

particular importance since the advent and growth of internet, and in its
wake, of e-commerce. To fight piracy in cyber-space, it is necessary to
develop technologies that make copying difficult and easy of detection.
Technological means should increase the risks of the infringers: it should be
difficult for them not to get caught and punishment should be heavy, that
should serve as an effective deterrent.

Governments can help technological enforcement by providing legal

protection and effective remedies if someone tries to circumvent
technological measures which a right-holder employs for protection of IP and
enforcement of IPRs.

The more common technological methods deployed for IPR enforcement are
based on optical technology and electronic technology. They are briefly
discussed. Some measures based on biotechnology and chemical technology
have also made their appearance.
Holograms are the most widely used optical measures. A hologram is a two-
or three-dimensional device which reflects an image, sometimes associated
with some movement. Copying a hologram is very difficult and costly.

Several electronic devices are available e.g. the magnetic strip as the one on
a credit card which stores a large amount of coded data, readable with a
scanner; the smart card, incorporating a computer chip which can carry a
large amount of data upon access; encryption, where electronic signal is
scrambled, but is readable through an authorised key.

Unit 4

The Budapest Treaty on the International Recognition of the Deposit

of Microorganisms for the Purposes of Patent Procedure, or
Budapest Treaty, is an international treaty signed in Budapest, Hungary,
on April 28, 1977. It entered into force on August 9, 1980, and was later
amended on September 26, 1980. The treaty is administered by the World
Intellectual Property Organization (WIPO).

As of December 2008, 72 countries were party to the Budapest Treaty. [1] The
accession to the Treaty is open to States party to the Paris Convention for
the Protection of Industrial Property of 1883. The African Regional Industrial
Property Organization (ARIPO), the Eurasian Patent Organization (EAPO) and
the European Patent Organisation (EPO) have filed a declaration of
acceptance under Article 9(1)(a) [2] of the Treaty.

The treaty allows "deposits of microorganisms at an international depositary

authority to be recognized for the purposes of patent procedure". [3] Usually,
in order to meet the legal requirement of sufficiency of disclosure, patent
applications and patents must disclose in their description the subject-matter
of the invention in a manner sufficiently clear and complete to be carried out
by the person skilled in the art (see also: reduction to practice). When an
invention involves a microorganism, completely describing said invention in
the description to enable third parties to carry it out is usually impossible.
This is why, in the particular case of inventions involving microorganisms, a
deposit of biological material must be made in a recognised institution. The
Budapest Treaty ensures that an applicant, i.e. a person who applies for a
patent, needs not to deposit the biological material in all countries where
he/she wants to obtain a patent. The applicant needs only to deposit the
biological material at one recognised institution, and this deposit will be
recognised in all countries party to the Budapest Treaty.

PATENTING OF MICRO-ORGANISMS

In view of the fact that it is often difficult, if not impossible, to sufficiently

describe a new micro-organism in a patent application, a system for
depositing micro-organisms has been established. Thus, under the national
law of many countries, patentees are required to deposit with a recognized
depositary institution a sample of the new micro-organism, together with a
written description of the micro-organism in the patent application.

The system of deposit of micro-organisms is the subject of the Budapest

Treaty on the International Recognition of the Deposit of Micro-organisms for
the Purposes of Patent Procedure, which provides for the setting up of
international depositary authorities with which micro-organisms can be
deposited. This treaty is a special agreement under the Paris Convention,
and it entered into force on August 19, 1980. The treaty is regulated by the
rules spelt out in the Regulations accompanying it. The complete text of the
Budapest Treaty is given in Appendix A.

Background to the Budapest Treaty

Disclosure of the invention is a generally recognized requirement for the

grant of patents. Normally, an invention is disclosed by means of a written
description. Where an invention involves a micro-organism, or the use of a
micro-organism, which is not available to the public, such a description is not
always sufficient for disclosure. That is why in the patent procedure of an
increasing number of countries it is necessary not only to file a written
description but also to deposit, with a specialized institution, a sample of the
micro-organism. Patent offices are not equipped to handle micro-organisms,
whose preservation requires special expertise and equipment to keep them
viable, to protect them from contamination and to protect health or the
environment from contamination. Such preservation is costly. The furnishing
of samples also requires specialized expertise and equipment.

When protection is sought in several countries for an invention involving a

micro-organism or the use of a micro-organism, the complex and costly
procedures of the deposit of the micro-organism might have to be repeated
in each of those countries. In order to eliminate or reduce such
multiplication, and to enable one deposit to serve the purpose of all the
deposits which would otherwise be necessary, the Budapest Treaty was
concluded.

Important Features of the Budapest Treaty

The main provision of the Treaty is that a Contracting State which allows or
requires the deposit of micro-organisms for the purposes of patent procedure
must recognize, for such purposes, the deposit of a micro-organism with any
international depositary authority (Article 3(1) (a)), irrespective of whether
such authority is on or outside the territory of the said State. In other words,
one deposit, with one international depositary authority, will suffice for the
purposes of patent procedure before the national patent offices of all of the
Contracting States and before any regional patent office (e.g., the European
Patent Office).

What the Treaty calls an international depositary authority is a scientific

institution, which is capable of storing micro-organisms. This is typically a so
called culture collection. Such an institution acquires the status of
international depositary authority through the furnishing, by one of the
Contracting States on the territory of which it is located, of assurances to the
Director General of WIPO to the effect that the said institution complies, and
will continue to comply, with certain requirements (Article 6(1)) including,
that

• it will be available, for the purposes of the deposit of micro-organisms, to

any depositor (person, firm, etc.) under the same conditions;
• it will accept and store the deposited micro-organisms; and
• it will furnish samples thereof to anyone entitled to such samples but to
no one else.

The said assurances may be furnished also by certain intergovernmental

industrial property organizations (Article 9(1) (a)).

The Regulations contain detailed provisions on who is entitled, and when, to

receive samples of the deposited micro-organism. The depositor himself has
a right to a sample at any time. He may authorize any third party (authority,
natural person, legal entity) to ask for a sample and such a third party will
receive a sample upon producing such an authorization. Any interested
industrial property office to which the Treaty applies may ask for a sample
and will receive one; an industrial property office will mainly be regarded as
interested where the micro-organism is needed for the purposes of patent
procedure before the said office. Any other party may obtain a sample if, an
industrial property office to which the Treaty applies certifies that, under the
applicable law, such a party has the right to a sample of the given micro-
organism; the elements of the certification are provided in detail to ensure
that the maximum extent of caution will be exercised by the industrial
property office before it issues a certification.

The Treaty and the Regulations contain provisions for:

• a new deposit where no samples of the originally deposited micro-

organism can be furnished (Article 4);
• for the termination or limitation of the status of international depositary
authority at the will of the Contracting States where the said authority
does not, or does not fully, comply with its assumed duties (Article 8),
• transfer of all micro-organisms deposited with an international depository
authority to another such authority if the former is about to cease
functioning as such;
• the content of the receipt that each international depositary authority is
required to give to the depositor for the deposited micro-organism;
• the testing of the viability of the deposited micro-organisms and the
issuance of viability statements;
• the international depositary authority to charge a fee for each deposit, the
fee covering the minimum 30 years during which the deposited micro-
organism must be stored; and
• for a special status and a special role for certain intergovernmental
organizations.

Main Advantages of the Budapest Treaty

The Budapest Treaty is primarily advantageous to the depositors who are

seeking patent protection in several countries. It will save them money
because, instead of depositing the micro-organism in each and every country
in which they file the patent application referring to that micro-organism,
they can deposit it only once, with one depositary, with the consequence
that in all but one of the countries in which the protection is sought, the
costs pertaining to deposit are saved. In most cases, there will be at least
one international depositary authority in the country of the depositors, which
means that they will deal with an authority which is close to them, can deal
in their own language, can pay the fees in their own currency and they may
even know the depository from personal experience.

The security of the depositor is increased by the fact that, for an institution
to become an international depositary authority, solemn assurances as to
the seriousness and continued existence of that institution must be given.
Such assurances must be given by a State or by an intergovernmental
organization and they are addressed to all the member States of the
Budapest Union. Consequently, it may be expected that the assurances will
be strictly respected, all the more so since, if they are not so respected, the
member States may take away from the defaulting institution the status of
international depositary authority.

Please remember that adherence to the Treaty entails no financial burden or

obligation for any Government.

Let us now summarize the points discussed in this unit.

Unit -5

Biosafety: prevention of large-scale loss of biological integrity, focusing

both on ecology and human health[citation needed].

Biosafety is related to several fields

• in ecology (referring to imported life forms from beyond ecoregion borders),

• in agriculture (reducing the risk of alien viral or transgenic genes, or prions
such as BSE/"MadCow", reducing the risk of food bacterial contamination)
• in medicine (referring to organs or tissues from biological origin, or genetic
therapy products, virus; levels of lab containment protocols measured as 1,
2, 3, 4 in rising order of danger),
• in chemistry (i.e., nitrates in water, PCB levels affecting fertility) and
• in exobiology (i.e., NASA's policy for containing alien microbes that may exist
on space samples - sometimes called "biosafety level 5").

The international Biosafety Protocol deals primarily with the agricultural

definition but many advocacy groups seek to expand it to include post-
genetic threats: new molecules, artificial life forms, and even robots which
may compete directly in the natural food chain.

Biosafety in agriculture, chemistry, medicine, exobiology and beyond will

likely require application of the precautionary principle, and a new definition
focused on the biological nature of the threatened organism rather than the
nature of the threat.
When biological warfare or new, currently hypothetical, threats (i.e., robots,
new artificial bacteria) are considered, biosafety precautions are generally
not sufficient. The new field of biosecurity addresses these complex threats.

Biosafety level refers to the stringency of biocontainment precautions

deemed necessary by the Centers for Disease Control and Prevention (CDC)
for laboratory work with infectious materials.

Biocontainment

The concept of biocontainment, also called laboratory biosafety,

pertains to microbiology laboratories in which the physical containment of
highly pathogenic organisms (bacteria) or agents (viruses) is required,
usually by isolation in environmentally and biologically secure cabinets or
rooms, to prevent accidental infection of workers or release into the
surrounding community during scientific research. The term
"biocontainment" was coined in 1985[1], but the concept stretches back at
least to the 1940s.

Primary containment is the protection of personnel and the immediate

laboratory environment from exposure to infectious agents and is provided
by good microbiological technique and the use of appropriate safety
equipment, such as biological safety cabinets. Secondary containment is the
protection of the environment external to the laboratory from exposure to
infectious materials and is provided by a combination of facility design and
operational practices.

Biological safety cabinets (BSC) are fairly common devices designed to

provide effective primary biocontainment in laboratories working with highly
infectious agents. Three general levels and types have been devised (Class I,
Class II, and Class III).

Biosafety suites are suites of laboratory rooms which are essentially

equivalent to large Class III cabinets in which positive pressure personnel
suits ("space suits") serve as the "outside" environment for workers.
Examples include the biosafety suites at USAMRIID at Fort Detrick, Maryland
and the Maximum Containment Facility (MCF) of the CDC in Atlanta, Georgia.

Biosafety level
A biosafety level is the level of the biocontainment precautions required to
isolate dangerous biological agents in an enclosed facility. The levels of
containment range from the lowest biosafety level 1 to the highest at level 4.
In the United States, the Centers for Disease Control and Prevention (CDC)
have specified these levels.[1] In the European Union, the same biosafety
levels are defined in a directive.[2]

History

The first prototype Class III cabinet was fashioned in 1943 by Hubert Kaempf,
then a U.S. Army soldier, under the direction of Dr. Arnold G. Wedum,
Director (1944–69) of Industrial Health and Safety at the United States Army
Biological Warfare Laboratories, Fort Detrick, Maryland. Kaempf was tired of
his MP duties at Detrick and was able to transfer to the sheet metal
department working with the contractor, the H.K. Ferguson Co.[3]

On 18 April 1955, fourteen representatives met in Camp Detrick in Frederick,

Maryland. The meeting was to share knowledge and experiences regarding
biosafety, chemical, radiological, and industrial safety issues that were
common to the operations at the three principal biological warfare (BW)
laboratories of the U.S. Army[4][5] Because of the potential implication of the
work conducted at biological warfare laboratories, the conferences was
restricted to top level security clearances. Begininning in 1957, these
conferences were planned to include non-classified sessions as well classified
sessions to enable broader sharing of biological safety information. It was not
until 1964, however, that conferences were held in a government installation
not associated with a biological warfare program.[6]

Over the first ten years, the biological safety conferences grew to include
representatives from all federal agencies that sponsored or conducted
research with pathogenic microorganisms. By 1966 it grew to include
representatives from universities, private laboratories, hospitals, and
industrial complexes. Throughout the 1970s participations in the conferences
continued to grow, and by 1983 discussions began considering the creation
of a formal organization.[6]

The American Biological Safety Association (ABSA) was officially established

in 1984, and a constitution and bylaws were drafted in 1984. As of 2008,
ABSA has grown to include 1,600 members in its professional association.[6]
Rationale

Biocontainment can be classified by the relative danger to the surrounding

environment as biological safety levels (BSL). As of 2006, there are four
safety levels. These are called BSL1 through BSL4, with one anomalous level
BSL3-ag for agricultural hazards between BSL3 and BSL4. Higher numbers
indicate a greater risk to the external environment. See biological hazard.

At the lowest level of biocontainment, the containment zone may only be a

chemical fume hood. At the highest level the containment involves isolation
of the organism by means of building systems, sealed rooms, sealed
containers, personal isolation equipment commonly referred to as "space
suits" and elaborate procedures for entering the room, and decontamination
procedures for leaving the room. In most cases this also includes high levels
of security for access to the facility, ensuring that only authorized personnel
may be admitted to any area that may have some effect on the quality of
the containment zone. This is considered a hot zone.

Levels

Biosafety level 1

This level is suitable for work involving well-characterized agents not known
to consistently cause disease in healthy adult humans, and of minimal
potential hazard to laboratory personnel and the environment (CDC,1997).[7]

It includes several kinds of bacteria and viruses including canine hepatitis,

non-pathogenic Escherichia coli, as well as some cell cultures and non-
infectious bacteria. At this level precautions against the biohazardous
materials in question are minimal, most likely involving gloves and some sort
of facial protection. The laboratory is not necessarily separated from the
general traffic patterns in the building. Work is generally conducted on open
bench tops using standard microbiological practices. Usually, contaminated
materials are left in open (but separately indicated) rubbish receptacles.
Decontamination procedures for this level are similar in most respects to
modern precautions against everyday microorganisms (i.e., washing one's
hands with anti-bacterial soap, washing all exposed surfaces of the lab with
disinfectants, etc.). In a lab environment all materials used for cell and/or
bacteria cultures are decontaminated via autoclave. Laboratory personnel
have specific training in the procedures conducted in the laboratory and are
supervised by a scientist with general training in microbiology or a related
science.
Biosafety level 2

This level is similar to Biosafety Level 1 and is suitable for work involving
agents of moderate potential hazard to personnel and the environment.[7] It
includes various bacteria and viruses that cause only mild disease to
humans, or are difficult to contract via aerosol in a lab setting, such as C.
difficile, hepatitis A, B, and C, influenza A, Lyme disease, dengue fever,
Salmonella, mumps, measles, HIV,[8] scrapie, MRSA, and VRSA. Genetically
modified organisms have also been classified as level 2 organisms, even if
they pose no direct threat to humans. This designation is used to limit the
release of modified organisms into the environment. Approval by the FDA is
required to release these organisms. An example is genetically modified food
crops. BSL-2 differs from BSL-1 in that:

1. laboratory personnel have specific training in handling pathogenic agents and

are directed by scientists with advanced training;
2. access to the laboratory is limited when work is being conducted;
3. extreme precautions are taken with contaminated sharp items; and
4. certain procedures in which infectious aerosols or splashes may be created
are conducted in biological safety cabinets or other physical containment
equipment.

Biosafety level 3

This level is applicable to clinical, diagnostic, teaching, research, or

production facilities in which work is done with indigenous or exotic agents
which may cause serious or potentially lethal disease after inhalation.[7] It
includes various bacteria and viruses that can cause severe to fatal disease
in humans, but for which vaccines or other treatment exist, such as
Mycobacterium tuberculosis, Bacillus anthracis, West Nile virus, Venezuelan
equine encephalitis virus, Eastern equine encephalitis virus, Hendra virus,
SARS coronavirus, Salmonella typhi, Coxiella burnetii, Rift Valley fever virus,
Rickettsia rickettsii, and yellow fever virus.

Laboratory personnel have specific training in handling pathogenic and

potentially lethal agents, and are supervised by competent scientists who
are experienced in working with these agents. This is considered a neutral or
warm zone.

All procedures involving the manipulation of infectious materials are

conducted within biological safety cabinets or other physical containment
devices, or by personnel wearing appropriate personal protective clothing
and equipment. The laboratory has special engineering and design features.

It is recognized, however, that some existing facilities may not have all the
facility features recommended for Biosafety Level 3 (i.e., double-door access
zone and sealed penetrations). In this circumstance, an acceptable level of
safety for the conduct of routine procedures, (e.g., diagnostic procedures
involving the propagation of an agent for identification, typing, susceptibility
testing, etc.), may be achieved in a biosafety level 2 facility, providing

1. the filtered exhaust air from the laboratory room is discharged to the
outdoors,
2. the ventilation to the laboratory is balanced to provide directional airflow into
the room,
3. access to the laboratory is restricted when work is in progress, and
4. the recommended Standard Microbiological Practices, Special Practices, and
Safety Equipment for Biosafety Level 3 are rigorously followed.

The decision to implement this modification of biosafety level 3

recommendations is made only by the laboratory director.

Biosafety level 4

The Galveston National Laboratory BSL-4 lab on the Campus of the University of
Texas Medical Branch

This level is required for work with dangerous and exotic agents that pose a
high individual risk of aerosol-transmitted laboratory infections, agents which
cause severe to fatal disease in humans for which vaccines or other
treatments are not available, such as Bolivian and Argentine hemorrhagic
fevers, Marburg virus, Ebola virus, Lassa fever, Crimean-Congo hemorrhagic
fever, Smallpox, and other various hemorrhagic diseases. When dealing with
biological hazards at this level the use of a Hazmat suit and a self-contained
oxygen supply is mandatory. The entrance and exit of a Level Four biolab will
contain multiple showers, a vacuum room, an ultraviolet light room, and
other safety precautions designed to destroy all traces of the biohazard.
Multiple airlocks are employed and are electronically secured to prevent both
doors opening at the same time. All air and water service going to and
coming from a biosafety level 4 lab will undergo similar decontamination
procedures to eliminate the possibility of an accidental release.
Agents with a close or identical antigenic relationship to Biosafety Level 4
agents are handled at this level until sufficient data is obtained either to
confirm continued work at this level, or to work with them at a lower level.

Members of the laboratory staff have specific and thorough training in

handling extremely hazardous infectious agents and they understand the
primary and secondary containment functions of the standard and special
practices, the containment equipment, and the laboratory design
characteristics. They are supervised by qualified scientists who are trained
and experienced in working with these agents. Access to the laboratory is
strictly controlled by the laboratory director.

The facility is either in a separate building or in a controlled area within a

building, which is completely isolated from all other areas of the building. A
specific facility operations manual is prepared or adopted. Building protocols
for preventing contamination often use negatively pressurized facilities,
which, if compromised, would severely inhibit the containment of an
outbreak of aerosol pathogens.

Within work areas of the facility, all activities are confined to Class III
biological safety cabinets, or Class II biological safety cabinets used with one-
piece positive pressure personnel suits ventilated by a life support system.
The Biosafety Level 4 laboratory has special engineering and design features
to prevent microorganisms from being disseminated into the environment.
The laboratory is kept at negative air pressure, so that air flows into the
room if the barrier is penetrated or breached. Furthermore, an airlock is used
during personnel entry and exit.

ist of biosafety facilities

Level Establishe Discontinue

Name Location Description
d d

Virology Laboratory Australia,

of the Queensland Queensland,
4
Department of Coopers
Health Plains

Australia,
Australian Animal
Victoria, 4
Health Laboratory
Geelong

Infectious Diseases India, 3

Unit, St.John's
Research Institute Bangalore

One of the
premier
research
institute &
conducts
studies on
All India Institute of India, New major
1-4 1993
Medical Sciences Delhi pathogenic
organisms.
Has been
contributed in
discovering
novel strains
& vaccines.

This facility
National JALMA
deals with the
Institute for
Mycobacterial
Leprosy & Other
India, Agra 3 2002 strains & their
Mycobacterial
pathogenicity
Diseases
&
(NCJILOMD), Agra
epidemiology.

National High
Security
Laboratory
Operates
Australia,
under the
National High Victoria,
4 auspice of the
Security Laboratory North
Victoria
Melbourne
Infectious
Diseases
Reference
Laboratory.

Australia,
Curtin University of Western
3
Technology Australia,
Bentley

Fundação Oswaldo Brazil, Rio 3 It is unclear

Cruz de Janeiro whether this
 facility
operates as a
BSL-4. Brazil
doesn't have
any BSL-4
facilities[citation
needed]

It is unclear
whether this
facility
operates as a
University of São Brazil, São
3 BSL-4. Brazil
Paulo Paulo
doesn't have
any BSL-4
facilities[citation
needed]

Instituto Adolf Lutz Brazil 3

Instituto Butantan Brazil 3

The British
Columbia
Centre for
British Columbia Canada, Disease
Centre for Disease British 3 Control,
Control Columbia operates
three
biosafety
level 3 labs.

National Canada, 4 Located at

Microbiology Manitoba, the Canadian
Laboratory Winnipeg Science
Centre for
Human and
Animal
Health, it is
jointly
operated by
the Public
Health
Agency of
 Canada and
the Canadian
Food
Inspection
Agency.

Located at
Centre National de Canada, the Institut
Biologie Quebec, 3 national de la
Expérimentale Laval recherche
scientifique.

University of
Saskatchewan
's Vaccine and
Infectious
Disease
Organization
is a pre-
eminent
research
institute
investigating
the
Canada,
Vaccine and pathogenesis
Saskatchew
Infectious Disease 2 1975 N/A of infectious
an,
Organization (VIDO) diseases and
Saskatoon
the
development
of effective
therapeutic
and
prophylactic
methods to
control
infectious
diseases of
humans and
animals.

Canada, 4 This facility

Ontario, never opened
Toronto due to
 community
opposition in
the 1990s.

Located at
the Centrum
biologické
Center of Biological Czech ochrany
4
Protection Republic Těchonín
(Center of
Biological
Protection)[9]

Document
from National
National Institute Finland, Institute for
for Health and Hermanni, 3 Health and
Welfare Helsinki Welfare that
mentios the
facility.[10]

Document
from National
National Institute Finland, Institute for
for Health and Tilkanmäki, 3 Health and
Welfare Helsinki Welfare that
mentios the
facility.[10]

Jean Mérieux
laboratory is a
co-operation
between the
Pasteur
France, Institute and
Laboratoire P4 Jean
Rhône- 4 1999-03-05 INSERM. Note
Mérieux
Alpes, Lyon that in
France, it is
P4 for
Pathogen or
Protection
level 4.[11]
 This facility is
operated by a
research
organization
Centre International
supported by
de Recherches
Gabon 4 the French
Médicales de
government,
Franceville
operates
West Africa's
only BSL-4
lab.[12]

The facility
was licenced
for
Robert Koch Germany, construction
4
Institute Berlin by City of
Berlin on
November 30,
2008.

Bernhard Nocht
Germany,
Institute for 4
Hamburg
Tropical Medicine

The facility is
licenced to
Philipps University Germany, work with
4 2008
of Marburg Marburg genetically
modified
organisms

Wehrwissenschaftli
Germany,
ches Institut für 3
Munster
Schutztechnologien

Friedrich Loeffler Deals

Germany,
Institute on Island 4 2010 especially
Island Riems
Riems with virology

Greece,
Evangelismos 3 2003
Athens

Crete University, Greece, 3 2003

Pagne hospital,
Clinical Heraklion
bacteriology lab

This facility
deals
especially to
High Security zoonotic
India,
Animal Disease 4 1998 organisms
Bhopal
Laboratory (HSADL) and emerging
infectious
disease
threats.

Operated by
Institute of
Tropical
Indonesia, Disease -
Institute of Tropical
East Java, 3 2008 Airlangga
Disease (ITD)
Surabaya University,
Build
Cooperation
with Japan.

A university
hospital in
Polo
Azienda Universitario;
Italy,
Ospedaliera it contains
Lombardy, 4
Ospedale Luigi two special
Milano
Sacco vehicles for
transporting
infectious
persons.

Istituto Nazionale Italy, Rome, 4 This facility,

Malattie Infettive Rome (trans.)
National
Institute of
Infectious
Diseases,
operates
within the
 Lazzaro
Spallanzani
Hospital.

This facility is
able to
conduct
research and
Institute for Medical Malaysia, tests on
Research (IMR), Kuala 3 acarology,
Ministry of Health Lumpur bacteriology,
medical
entomology,
parasitology
and virology.

Located at
National
Institute for
Infectious
Diseases,
Department
of Virology I;
this lab has
the potential
National Institute Japan,
of operating
for Infectious Kantō, 3
as a BSL-4,
Diseases Tokyo
however it is
limited to
perform work
on only BSL-3
agents due to
opposition
from local
residents and
communities.

Institute of Physical Japan, This is a non-

and Chemical Kantō, operating
Research Tsukuba BSL-4 facility.

Netherlands Netherlands, 3 - 4 2009 Currently

National Institute under
 construction,
it is planned
to be finished
for Public Health by the end of
and the Bilthoven 2009. It is
Environment (RIVM) planned to
operate as a
BSL 3 and a
BSL 4 facility.

Wuhan
Institute of
Virology
already hosts
a BSL-3
laboratory. A
distinct BSL-4
facility is
currently
People's being built
Wuhan Institute of
Republic of based on P4
Virology of the
China, 3-4 2010 (P4) standards,
Chinese Academy
Hubei, the original
of Sciences
Wuhan technology for
confinement
developed by
France.[13][14] It
will be the
first at level 4
in China,
under the
direction of
Shi Zhengli.[15]

State Research Russia, 1-4 It is one of

Center of Virology Novosibirsk two facilities
and Biotechnology Oblast, in the world
VECTOR Koltsovo that officially
hold
smallpox. The
other Russian
BSL-4
 facilities have
been
dismantled.

Defence
Science
Organization
goal is to
conduct
autopsies
during a
potential
deadly
Defence Science epidemic
Singapore 4
Organization (DSO) outbreak.
Singapore
also has a
mobile BSL-4
autopsy
facility,
perhaps the
only one of its
kind in the
world.[16]

National
Institute for
Communicabl
e Diseases of
Special
National Institute South Africa, Pathogens
for Communicable Johannesbur 4 Unit is one of
Diseases g only two BSL-
4 facilities in
Africa but the
only suit
laboratory on
the continent.

National Public Malaysia, 3 The NPHL is

Health Laboratory Sungai established to
(NPHL), Ministry of Buloh, develop
Health Selangor laboratory-
 based
surveillance
systems for
infectious
diseases of
epidemic and
pandemic
potential as
part of an
early warning
system and
response
strategies for
outbreaks of
infectious
diseases.

Swedish
Institute for
Swedish Institute Infectious
Sweden,
for Infectious 4 Disease
Solna
Disease Control Control is
Scandinavia's
P4 facility.

This facility
only deals
with animal
diseases
Institute of Virology which do not
Switzerland,
and transmit to
Mittelhäuser 4 2007-02-01
Immunoprophylaxis humans, and
n
(IVI) is the only P4
facility where
complete
isolation suits
are not used.

High Containment Switzerland, 4 Under

Laboratory DDPS Spiez construction,
(SiLab) it will start
operations in
2010. This
 laboratory will
comply with
BSL-4
standards.

Preventive Medical
Republic of
Institute of ROC
China 4
Ministry of National
(Taiwan)
Defense

Part of the
Kwen-yang
Republic of Department
Laboratory (昆陽實
China 4 of Health
驗室) Center of
(Taiwan) Republic of
Disease Control
China.

Health Protection United Located in the

Agency's Centre for Kingdom, 4 Viral Zoonosis
Infections Colindale unit.

National Institute United

for Medical Kingdom, 4
Research London

Defence Science United

and Technology Kingdom, 4
Laboratory Porton Down

United Under
4
Kingdom construction.

Currently
operates in
United
two buildings.
Centers for Disease States of
One of two
Control and America, 4
facilities in
Prevention Georgia,
the world that
Atlanta
officially hold
smallpox.

George Mason United 3 This facility is

University States of currently
Biomedical America, under
Research Virginia, construction
Laboratory Manassas on a 10-acre
 site adjacent
to George
Mason
University's
Prince William
Campus. It is
scheduled to
be fully
operational in
the Spring of
2010.

United
Is an older
States of
Georgia State design
America, 4
University "glovebox"
Georgia,
facility.
Atlanta

Under
construction.
This facility
will be
operated by
National
United
Institute of
States of
Integrated Allergy and
America, 4
Research Facility Infectious
Maryland,
Diseases
Fort Detrick
(NIAID), it is
planned to
begin
operating at
2009 at the
earliest.

National Biodefense United 4 Under

Analysis and States of construction,
Countermeasures America, it will be
Center (NBACC) Maryland, operated for
Fort Detrick the
Department
of Homeland
 Security.

Located on
United
the NIH
States of
National Institutes Campus, it
America, 4
of Health (NIH) currently only
Maryland,
operates with
Bethesda
BSL-3 agents.

US Army Medical United

Research Institute States of
of Infectious America, 4 Old building
Diseases Maryland,
(USAMRIID) Fort Detrick

US Army Medical United

New building,
Research Institute States of
currently
of Infectious America, 4
under design
Diseases Maryland,
construction
(USAMRIID) Fort Detrick

Under
construction
by Boston
United
University,
National Emerging States of
building and
Infectious Diseases America, 4
staff training
Laboratory (NEIDL) Massachuset
complete,
ts, Boston
waiting for
regulatory
approval.

Under
United construction,
NIAID Rocky States of it is planned
Mountain America, 4 to begin
Laboratories Montana, operation in
Hamilton 2009 at the
earliest.

Stony Brook United 3 1999 Operated by

University Centers States of State
for Molecular America, University of
Medicine Center for New York, New York at
 Stony Brook,
a BSL-3
facility
studying
Borrelia
burgdorferi
(Lyme
Infectious Diseases Stony Brook
Disease),
Yersinia pestis
(Bubonic
plague) and
Francisella
tularensis
(Rabbit fever)

United University of
States of Cincinnati
University of
America, 3 Medical
Cincinnati
Ohio, Sciences
Cincinnati Building

United
States of
Battelle Memorial
America, 3
Institute
Ohio, West
Jefferson

Opened in
Galveston National United 2008, facility
Laboratory, States of is operated by
National America, 4 the University
Biocontainment Texas, of Texas
Facility Galveston Medical
Branch.[17]

Operated by
United
the University
States of
of Texas
Shope Laboratory America, 4
Medical
Texas,
Branch
Galveston
(UTMB).

Southwest United 4 The only

Foundation for States of privately-
 America,
Biomedical owned BSL-4
Texas, San
Research lab in the US.
Antonio

This facility is
part of the
Department
United of General
Division of States of Services of
Consolidated America, 4 the
Laboratory Services Virginia, Commonwealt
Richmond h of Virginia.
It is so called
"surge" BSL-4
capacity.

Facility to be
operated by
the
United Department
States of of Homeland
America, Security, and
National Bio and
Kansas replace the
Agro-Defense 4
State Plum Island
Facility (NBAF)
University, Animal
Manhattan, Disease
Kansas Center.
Planned to be
operational by
2014.

Plum Island Animal United 3-ag Facility

Disease Center States of scheduled to
America, be replaced
New York, by the
Plum Island National Bio
and Agro-
Defense
Facility.
Researches
zoonotic
pathogens
 only.

Saint Louis
University's
United new center
Saint Louis States of for biomedical
University Doisy America, 3 research.
Research Building Missouri, St. Monkeypox is
Louis the primary
BSL-3 agent
studied.

The UC
Berkeley BSL3
Facility is
currently
housed in a
United
single location
States of
University of but will be
America, 3
California, Berkeley expanded in
California,
2011 to
Berkeley
include a
second site
(in a building
under
construction).

United
University of
States,
California, Los 3
California,
Angeles
Los Angeles

Instituto Nacional Argentina,

Instituto de
de Tecnologia Buenos
3-A Virologia
Agropecuaria, Aires,
(CICVyA)
Buenos Aires Castelar

Veterinary Malaysia, 3 This facility

Research Institute Ipoh, Perak created a
(VRI), Department breakthrough
of Veterinary in identifying
Services the Nipah
virus, which is
classified
 internationall
y as a BSL-4
agent.

Popular culture

The beginning of the movie Outbreak (1995) walks the audience through
each biosafety level, giving examples of diseases in each category;
unfortunately, the diseases used are often incorrectly categorized, and
numerous egregious violations of biosafety level protocol are witnessed. The
introduction to the book The Hot Zone is similar to the beginning of
Outbreak.

A fictitious Biosafety Level 5 is referenced in the video game Pariah, which

takes place in the year 2520. It is described by the protagonist Jack Mason—
a doctor with military training who works for a government organization
called the Transgenic Control Commission—as a biosafety protocol which
calls for the release of nuclear weapons in order to sterilize a location where
it is believed that a hopelessly catastrophic disease outbreak is imminent.
The novel by Michael Crichton called The Andromeda Strain references a
functionally identical biosafety protocol under the name of "Directive 7-12".