SUBMITTED BY AKHIN.V.P 2ND M.

SC MICROBIOLOGY PONDICHERRY UNIVERSITY

INTRODUCTION
Patents are a form of intellectual property. Patents provide an exclusive right preventing

others from practicing the invention for the life of the patent. Knowledge about patent rules are important for scientists and engineers. Patent laws are constantly changing to ensure maximum protection and offering coverage for various intellectual rights. The ideas and basic rules of patents were originated from U.S.A

Who may apply for patent

A patent application must file the name of

actual inventor. An application patent can simultaneously file by more persons. Joint inventorsip is not a common practice. It is a very difficult process to identify the person invented specific processes or products. The idea should be novel and new.

The requirements for patentability

The invention must be concrete than an idea,

requiring both conception and reduction to practice. Conception must be mental formulation and disclosure of the completed ideas for invention. Reduction to practice involves actual or constructive. An invention that constitutes statutory subject matter must satisfy several other requirements.

Nonobviousness

Sufficiency of disclosures

The requirements of patentability

Utility

Novelty

Rights obtained after patent

The granting of a patent gives the patentee and his heirs or

assignees the right to exclude others from making,using,offering to sell,selling or importing the patented invention within limited period. The patent gives no right to manufacture,use,or sell anything. Another patentee has the patent to cover the aspect of new patent has the right to encompass new patent.The new patentee has the same right towards other forthcoming patents. The time period for patent is maximum of 20yrs. But in biotechnology field this time period is too inadequate since almost a decade is needed for clearing formalities.

Infringement of a patent
The patentee has the whole right to use his invention. He have the rights to sell his patent to another person or

company. Others using invention without permission from patentee is considering as infringement of patent rules. In biotechnology related inventions patents are applicable to already existing processes. Legal remedies for infringement includes equitable relief,monetary relief damages,and in exceptional cases attorneys fees. For purposes solely and reasonably related to obtaining regulatory approval in the U.S.A patent infringement rules are not applicable.

OBTAINING PATENT PROTECTION

It starts with keeping laboratory records. Records are very much important when two applications

are filing in the same time. In order to pass litigation lab records can be using as a proof. However second inventor can get patent under; a)an earlier date of conception b)reasonable diligence from a time just before the first inventor to reduce the invention to practice entered the field until the second reduction to complete.

APPLYING FOR PATENT PROTECTION

Many steps have to taken before filing applications for

patent. First step is to ensure the novelty of invention from an authentic sources like PTO, or chemical structure searches or even searches performed by the European Patent Office. All the details should keep confidential. Documents should labeled as CONFIDENTIAL.

Going with patenting invention.

Before filing patent patent agent or patent attorney should

approve the invention. A patentee should have a clear idea of that he want to claim;ie-a compound,method or both. He should explain possible alternatives for his invention to the agent. Should submit the notebooks to the agent. Do not disclose confidential informations to anyone. Should not include the names of technicians and others dont have direct involvement with that invention.

Types of patent applications

Provisional

Regular

Parts of patent application

Tittle of the invention Reserved section

Cross reference to related applications on file; if any

Brief summary of the invention Brief description of drawings or figures.

Detailed description of the invention

Claim or claims. Abstract of the disclosure.

Signed oath or declaration.

Patent prosecution
Patent prosecution is the back and forth that takes place

with the PTO after it is filed and before it issued a patentee. PTO and examiners will raise a number of questions to check the novelty of invention. For biotechnology inventions too much time is taking to clear patent. After all legal battles application will either rejected or accepted. Under certain conditions applications can be refiled.

CHALLENGES OF BIOTECHNOLOGY PATENT LAW AND PROCEDURES

Utility requirements-Many worthy

biotechnology inventions are rejected under the name of utility.eg:human genome project, therapeutics. Biotechnology related inventions are judged by the same standards of other inventions.In biology when a natural prodct is made to exist in a form other than one in which it exists in nature,it is considered for patentability. For nonobvious they changed rules for BT.

Non obviousness in biotechnology

Cell fusion procedures yielding a cell line that express a specific protein eg:a monoclonal antibody
A method of using a product produced by a process defined by A or B.

A process of genetically altering or otherwise inducing a single or multicellular organism to;

Inhibit,eliminate,argume nt or alter expression of an endogenous nucleotide sequence Express a specific physiologic characteristic not naturally associated with said organism Express an exogenous nucleotide

CONCLUSION
The patent laws are formulated from U.S.A are constantly

changing by new discoveries. Present laws are inappropriate to afford protection for biotechnology innovations. Patent protection is a time taking process. Many of the traditional valuables of other nations are looting by patent protection.to keep sufficient records. In order to patent an invention it is very important to keep sufficient records.

Thank you