Pruning The Evergreen Tree Section 3 (D) of The Indian Patents Act 1970

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E.I.P.R. 2009, 31(3), 135-146
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European Intellectual Property Review
2009
Case Comment
PRUNING THE EVERGREEN TREE: SECTION 3(D) OF THE INDIAN PATENTS ACT 1970
Adarsh Ramanujan.
Rajarshi Sen.
Copyright (c) Sweet & Maxwell Limited and Contributors
Case: Novartis India Ltd, Re Unreported August 6, 2007 (HC (Ind))
Legislation: Agreement on Trade-Related Aspects of Intellectual Property

Rights 1994 (WTO) art.27
Constitution of India 1950 (India) art.14
Patents Act 1970 (India) s.3(d)
Subject: INTELLECTUAL PROPERTY. Other related subjects: Constitutional

law. Health. International trade
Keywords: Constitutional law; Excluded subject matter; India; Interna-

tional trade; Patentability; Pharmaceuticals
Abstract: Comments on the Indian High Court judgment in Re Novartis

India Ltd on a constitutional challenge to the Patents Act 1970
s.3(d) on the exclusion of patentability for the mere discovery of a
new use for a known substance. Discusses whether the Indian court had
jurisdiction to disapply an Indian legal provision if it conflicted
with the World Trade Organisation Agreement on Trade-Related Aspects
of Intellectual Property Rights 1994 (TRIPs). Compares US law against
patents for uses of known processes. Examines the implications of the
Constitution of India 1950 art.14 banning provisions which are ex-
cessively vague and permit arbitrary state action.
*135 This article critically examines the controversial s.3(d) of the Pat-
ents Act 1970 (hereinafter "the Act") in light of the decision of the Madras
High Court in a recent writ petition, filed by Novartis India Ltd, the Indian
subsidiary of a Swiss-based pharmaceutical company challenging the constitu-
tional validity of this provision (Writ Petition No.24759 of 2006, hereinafter
"Novartis Writ Petition", filed in the High Court of Judicature of Madras under
Art.226 of the Constitution of India 1950). On August 6, 2007, the Madras High
Court, by a judgment delivered by His Lordship, R. Balasubramanian J., dis-
missed the writ petition. (See Novartis AG represented by it's Power of Attor-
2009 Thomson Reuters.

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ney Ranjna Mehta Dutt v Union of India through the Secretary, Department of In-
dustry, Ministry of Industry and Commerce and Others, (2007) 4 MLJ 1153: MANU/
TN/1263/2007, hereinafter "Novartis"). This is the first time any provision of
the Act has ever been challenged as unconstitutional. This decision is import-
ant from a patent law perspective, since it discusses the scope, ambit and pur-
pose of s.3(d), the parameters to be applied by the Patent Controller in apply-
ing the provision, and, finally, the issue of India's compliance with the
Agreement On Trade-Related Aspects of Intellectual Property Rights (hereinafter
"RIPs").
In Parts I and II, we provide a basic primer to patent law in India, the
background history and purpose of s.3(d). Part III analyses the Novartis case
briefly while Part IV critically examines s.3(d), its scope and ramifications,
finally concluding with a summary of our analysis of s.3(d)'s validity.
I. Patent law in India
The Patents Act 1970 replaced the colonial patent system in India, [FN1] and
was enacted with the specific object of helping the pharmaceutical industry
grow, and lowering rising product prices. [FN2] With India becoming a member of
the World Trade Organisation (WTO), external political pressure (in the form of
trade penalties and aid losses from international sources) forced India to com-
ply with TRIPs. [FN3] However, due to India's own internal political pressures,
as well as the fact that TRIPs compliance required substantial changes in the
Act (especially as regards pharmaceutical products and process technologies,
which were not then protected), the process of compliance was slow. [FN4] After
a few failed attempts, India established a mailbox provision, [FN5] in an at-
tempt at compliance. Amendments followed in 1999, 2002 and 2005, just within
the 10-year timeframe allowed by TRIPs.
As the Act stands today, s.6 provides that certain persons are entitled to
file an application for a patent for an "invention", a term defined in
s.2(1)(j) of the Act to mean "a new product or a process involving an inventive
step and capable of industrial application". The term "inventive step" was ad-
ded in s.2(1)(ja) in 2002, being defined only as a "feature that makes the in-
vention not obvious to a person skilled in the art." The 2005 Amendment re-
defined "inventive step" as:
"... a feature of an invention that involves technical advance as com-
pared to the existing knowledge or having economic significance or both and
that makes the invention not obvious to a person skilled in the art".
Therefore, apart from proving the non-obviousness requirement, the applicant
must also satisfy the requirement that a feature of the invention involves *136
technical advancement or economic significance or both. The scope of this re-
quirement, however, is still unclear.
An anticipation clause has been added under "new invention", now defined as:
"... any invention or technology which has not been anticipated by pub-
lication 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

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form part of the state of the art". [FN6]

"Pharmaceutical substance", a potentially controversial new term added, incor-
porates "inventive step", and is defined as "any new entity involving one or
more inventive steps". [FN7]
Similar to the general standard prevalent throughout the world, the Act re-
quires the applicant to prove the novelty, non-obviousness and utility require-
ments to obtain a patent. Chapter II of India's Manual of Patent Practice and
Procedure (hereinafter "the Indian MPPP"), [FN8] identifies the main require-
ments for patentable subject matter as novelty, inventive step, and industrial
applicability. Briefly stated, a novel invention is one that has not been dis-
closed or anticipated by prior art, which is described as everything published,
presented, or disclosed to the public, in India or other countries, even if the
document is in a foreign language. [FN9] In determining the invention's non-
obviousness, the Indian MPPP suggests using the following question during exam-
ination: "Would a non-inventive mind have thought of the alleged invention?"
[FN10] This question is answered in the context of a person skilled in the art.
[FN11] The invention is obvious when it follows plainly or logically from the
prior art, or from a combination of prior art if it is obvious to combine them
at the time of the invention. [FN12]
An invention considered to have industrial applicability satisfies three

separate conditions: the product can be made, it can be used in at least one
field of activity, and it can be reproduced with the same characteristics as
many times as necessary. [FN13] The question of usefulness is not dependent on
whether it will have commercial success, and therefore, even if an invention
becomes financially or technologically obsolete before the patent issues, the
application or subsequent patent is not invalidated. [FN14]
Moving further towards the subject matter of our discussion, s.3 of the Act
provides certain exceptions to patentability. It is broader and more compre-
hensive than art.53 of the European Patent Convention 1970 (EPC) or art.27(3)
of TRIPs. A few of these exceptions under s.3 strike at the root of the novelty
ingredient and would not have qualified as an invention in any case. [FN15] We
believe that these exceptions are only illustrative and have been inserted as a
matter of abundant caution to make the law more certain. Some of the other ex-
ceptions are public policy based, [FN16] while the rest are miscellaneous
policy decisions as regards patentability of subject matter. [FN17]
The specific exception under challenge in Novartis was s.3(d), which we

shall now analyse in the next part of the article. As we shall see, s.3(d) be-
longs to the first of the above categories.
II. Section 3(d): history and purpose
II.1. History of s.3(d):
The original unamended s.3(d) of the Patents Act 1970 read:

"The mere discovery of any new property or new use of a known substance
or of the mere use of a known process, machine or apparatus unless such

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known process results in a new product or employs at least one new react-
ant."
Ordinance 7/2004 amended s.3(d) as under:
"The mere discovery of any new property or mere new use of a known sub-
stance or of the mere use of a known process; machine or apparatus unless
such known process results in a new product or employs at least one new re-
actant."
Section 3(d) as amended by the Patents (Amendment) Act 2005 reads:
"The mere discovery of a new form of a known substance which does not
result in the enhancement of the known efficacy of that substance or the
mere discovery of any new property or new use for a known substance or of
the mere use of a known process, machine or apparatus unless such known pro-
cess results in a new product or employs at least one new reactant.
Explanation: For the purposes of this clause, salts, esters, ethers,
polymorphs, metabolites, pure form, particle size isomers, mixtures of iso-
mers, complexes, combinations and other derivatives of known substance shall
be considered to be the same substance, unless they differ significantly in
properties with regard to efficacy."
*137 Therefore, it is clear that s.3(d) consists of three independent exclu-
sions:
1. The mere discovery of a new form of a known substance which does not
result in the enhancement of the known efficacy of that substance;
2. The mere discovery of any new property or new use for a known sub-
stance;
3. The mere use of a known process, machine or apparatus unless such
known process results in a new product or employs at least one new reactant.
II.2. Purpose of s.3(d):
Undisputedly, the sole object and purpose of the provision was to prevent
"evergreening" of patents by pharmaceutical companies, [FN18] a concept we
shall briefly explain in this section.
"Evergreening" refers to the strategy adopted by patentees who seek to ex-

tend their period of patent protection by applying for secondary patents over
related or derivative technologies. [FN19] For example, a patentee may seek
protection for novel uses of a drug, or new methods of administering or produ-
cing it, or reduced dosage regimens, or on new versions of the active compound
or combinations that are more effective or that produce fewer side effects than
the original substance, prior to the expiry of the original substance patent.
Another tactic that may be possible, in the case of those drugs that, when
metabolised by the body, are transformed into another substance which directly
causes the therapeutic effect, is to patent this latter chemical also. [FN20]
The effect is to "reset the clock" on the patentee's protection period, exclud-
ing potential competitors from the marketplace for another full term. [FN21]
Patents in these cases do not operate as actual incentives for research, but
create market power that may distort competition and block innovation. [FN22]
Many claim that strong patent protection in such "cumulative" innovations may
deter as many inventors as it encourages, and also add inefficiency to the

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whole cumulative invention process, and thereby hinder technological progress.

[FN23] Recent attention to the issue of "evergreening" of patents reflects
global concern about the manner in which patent systems are to strike a balance
between the interests of inventors and the general public. In any event, such
patents must not be allowed at the cost of the diluting the requirements for
patentability.
In many jurisdictions, this practice is condemned and has been held to not
satisfy the basic requirements of novelty and non-obviousness. One such recent
case in Australia, is Arrow Pharmaceuticals Ltd v Merck & Co Inc, [FN24]
wherein Gyles J. revoked a patent for not having any new technical effect or
utility, [FN25] observing that they each "relate[d] to the use of a known sub-
stance with known properties for a known purpose in a known manner", [FN26] and
thus, did not constitute an invention or a manner of manufacture. [FN27]
In the United States, such patents may be challenged on the basis of failing
the obviousness analysis. [FN28] For instance, a patent over a tetra-orthoester
fuel composition was held to be obvious on the basis that tri-orthoester fuel
composition with similar compounds as fuel additives (orthoester) that pos-
sessed structural and chemical similarity with the claimed invention was
already known. [FN29]
*138 Evergreening, therefore, seems an anathema to the central tenets of

patent law. Accordingly, the practice has been criticised as effectively en-
abling protection beyond the initial term despite only trivial changes to the
invention itself. Therefore, the primary mode of attack on such patents will be
on the grounds of novelty, inventiveness, utility, and other core requirements
of patentability. With this background, we may now proceed to interpret and un-
derstand the application of s.3(d).
III. The Novartis story: a case comment
III.1. Factual and procedural background
The story of Glivec [FN30] began when researchers identified a genetic muta-
tion in patients with chronic myeloid leukemia (CML). [FN31] When subsequent
research located the specific genetic target, [FN32] a team at Ciba-Geigy, a
Novartis predecessor company, created a compound that could inhibit the relev-
ant tyrosine kinase without showing any significant activity against normal
cells, [FN33] an allegedly important advance over traditional cancer treat-
ments. [FN34]
Novartis' patent application in India started with a mailbox application in

1995. [FN35]
The Chennai Patent Office, relying on s.3(d) of the Patents Act 1970, rejec-
ted Novartis' patent application for the drug sold under the brand-name
Gleevec/Glivec. [FN36] The decision of the Patent Controller held against
granting Novartis's patent application on four grounds: incorrect priority
date, [FN37] anticipation by prior publication, [FN38] obviousness, [FN39] and
because of the bar under s.3(d). [FN40]

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*139 Separate Writ Petitions were filed challenging the constitutional

validity of s.3(d) and the validity and legality of this order on merits, re-
spectively. [FN41] The second Writ Petition, challenging the legality of the
Patent Controller's order on merits, and praying for directions to be issued to
the Patent Controller, was later withdrawn. [FN42] Novartis's appeal against
the rejection of patent application, by the Patent Controller, is currently
pending before the Intellectual Property Appellate Board (IPAB). [FN43]
III.2. Issues framed and decision of the Madras High Court
Therefore, the issues which were to be answered by the High Court were
[FN44]:
a. Assuming that the impugned section is in breach of Article 27 TRIPs,
could the Courts in India have the jurisdiction to test the validity of the
amended section in the back drop of such alleged violation of TRIPs? Or,
even if the impugned section could not be struck down by the Court for viol-
ation of TRIPs, could this Court grant declaratory relief holding that the
impugned section violated art.27 of TRIPs?
b. If the above issue were to be answered in the positive, is the im-
pugned section violative of art.27 of TRIPs?
c. Dehors issues (a) and (b) above, could the impugned section be held to
be violative of art.14 of the Constitution of India on the ground of vague-
ness, arbitrariness and conferring uncanalised powers on the Statutory Au-
thority?
Regarding question (a), very clearly, the issue in itself involved two parts:
Part 1 of issue (a) deals with whether courts in India have the jurisdiction to
test the validity of the impugned section in light of TRIPs.
A little background may help in this regard. In international legal theory,

there is a fundamental distinction between international law and a state's in-
ternal municipal law. [FN45] Although, on the international plane, all states
are bound by their international obligations irrespective of their internal
law, [FN46] the problem of defining the exact role of international law within
systems of municipal law have seen several different complicated approaches but
no specific solution, with different jurisdictions following different ap-
proaches of their own. [FN47]
As a general rule, States are at liberty to define the extent to which in-
ternational law is incorporated into their internal legal order. [FN48]
Indian jurisprudence does not specifically follow the Blackstonian view of

"incorporation" of international treaty obligations/rights into Municipal Law.
[FN49] That is, international treaty obligations do not automatically become
part of Indian municipal law. There are, however, exceptions to this rule, and
international law may be used in the rubric of Indian municipal law, as long as
such use is restricted to merely interpreting domestic law and not extending to
supplanting municipal law itself. [FN50] Therefore, the use of international
law is restricted to the extent that it is not contrary to municipal law.
[FN51] In the absence of enacted domestic law occupying the field, internation-
al conventions, norms and treaty obligations may be read into the municipal law

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when there is no inconsistency between them. [FN52]
*140 However, in case harmonisation is not possible to resolve the incon-

sistency between the municipal law and the international law, [FN53] the courts
will be bound by the latter and not the former, [FN54] until the municipal law
has been suitably modified to accommodate international law and treaty obliga-
tions. [FN55] The actual source of this use of international law, including
treaty obligations, to interpret municipal law, is art.51 (c) of the Constitu-
tion of India, which reads that the state "shall" endeavour to foster respect
for international law and treaty obligations in the dealings of organised
peoples with one another. [FN56]
However, the remedy for breaches of international law is not, in general, to

be found in the law courts of the state, since it does not have the force or
authority of civil law, till implemented through legislation, even if the
agreement has already been entered into. [FN57]
Thus, while Indian patent law must be interpreted in light of India's TRIPs
obligations, for purposes of harmonisation of the two, it would not be possible
for municipal courts to strike down any provision of India's patent laws on the
sole ground of alleged TRIPs violation. [FN58]
Although the Madras High Court came to the same conclusion, it applied a
completely different, and possibly incorrect, principle to justify its de-
cision, completely neglecting the body of case law under Indian jurisprudence
seen above.
Perusing art.64 of TRIPs with art.1 of the Dispute Settlement Understanding

along with the rules and procedures applicable to the WTO dispute settlement
mechanism, [FN59] the Court held that when parties to a treaty had created a
"choice of jurisdiction", the same is to be respected and given effect to,
drawing analogy to the principle as applicable to international contracts under
Indian Private International Law. [FN60]
In other words, the Court compared TRIPs to a private contract and held that
the WTO-TRIPs dispute settlement mechanism amounts to a choice of jurisdiction
clause, which would be respected.
A better process of argumentation could, perhaps, have involved pointing out

how, the WTO Agreements are the subject of public international law rules,
[FN61] and are subject to a "strong" "lex specialis" [FN62] regime. [FN63]
Reading art.23 of the WTO Dispute Settlement Understanding, which obliges mem-
bers to submit (all of) their disputes to theWTO's dispute settlement ma-
chinery, with art.64 of TRIPs which does the same, it would seem obvious to
conclude as regards the primacy of the WTO Dispute Settlement Body on this mat-
ter. [FN64]
*141 As regards the second part of question (a)--issuance of a declaration

that s.3(d) violates art.27 of TRIPS, the Court did concede that it had the
power to provide a declaratory relief when a breach or imminent breach of a
fundamental right was involved. [FN65] However, highlighting on the discretion-

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ary nature of the remedy, the Court concluded that in the case at hand, the pe-
titioner's fundamental right to carry on their profession under art.19 (1)(g)
was not interfered with and that the ends of justice do not require such a de-
claration. Further, citing an unreported decision of the Supreme Court, [FN66]
the Court declined the relief on the reasoning that it would serve no useful
purpose whatsoever. [FN67]
Here again, the Court seems to have completely missed the crux of the mat-
ter. When precedents have specifically held that Indian courts cannot go into
the question of a breach of an international treaty obligation, the nature of
the relief is irrelevant; the case itself would not be entertained and that
would be the conclusion even if the petitioner prayed for a declaratory relief.
Secondly, precedents cited by the Court itself have restricted the use of a de-
claratory relief to cases of fundamental right violation. The preceding analys-
is in this article would have made it amply clear that a violation of an inter-
national treaty obligation does not lead to a violation of one's fundamental
rights. Nonetheless, the Court ultimately gave the correct decision.
Regarding question (b), since the answer to question (a) was in the negat-
ive, issue (b) was automatically declared redundant.
Regarding question (c), in our opinion, this is by far the most important
issue of this case, as well as the one most relevant to our analysis of s.3(d)
in part IV. Hence, we have dealt with it therein. [FN68]
IV. Pruning the evergreen tree? Analysing s.3(d)
We noted previously that s.3(d) of the Patents Act 1970 may be conveniently
divided into three parts. We shall now critically analyse and evaluate the im-
plications of each of them.
At this stage, we must note that the first two parts of s.3(d) start with
the phrase "the mere discovery" of a new form, and of any new property or use.
The use of the word "discovery" indicates that the alleged invention exists not
in creating something; but rather in uncovering something already present, yet
unknown. The implications of this would be analysed specifically for each part.
IV.1. New use of known substance
The second part of s.3(d) declares that the mere discovery of a new use or
property of a known substance would not be patentable. As we noted before in
section II.1 of the article, this part has been present since the original 1970
enactment. Such patents, however, are allowed in Europe by virtue of art.54(5)
EPC and in New Zealand under what is known as a Swiss-type format. [FN69]
Clearly, Swiss-type claims would not be patentable in India. Even the United
States allows patents for new uses of known substances, by defining the term
"process" to include a "new use of a known process, machine, manufacture, com-
position of matter, or material". [FN70] Therefore, at first sight, s.3(d)
seems to be at cross-roads with patent law in the United States. Nonetheless,
in the United States, claiming of a new use, new function or unknown property
which is inherently present in the prior art does not necessarily make the

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claim patentable; in such cases, the claim on the substance or composition

(product claim) based only on the new use or property is considered as inher-
ently anticipated. [FN71] However, through the wordings of 100(b), a claim
drafted in the form of a process claim would be allowed. [FN72]
A similar distinction may be made here. Section 3(d) only declares that the
mere discovery of a new use of a known substance would not amount to an inven-
tion. However, if the claim is drafted such that the "invention" claimed is
that of the process of employing the known compound for the new use, the inven-
tion is a process of making use of the new property of the compound as opposed
to the new use of the compound itself. In order to avoid a s.3(d) rejection,
the applicant may strategically word the claim such that no claim is actually
made on the use of the compound per se.
Secondly, it is important to understand the import and scope of the phrase

"new use". To illustrate the point further, consider the patent in Concrete Ap-
pliances Co v Gomery [FN73]--a claim on the use of spouts and chutes for con-
veying wet concrete, which was a newly invented building material. Although
from a narrow sense, this is indeed a new application or use of a sprout, from
a broader perspective, the new result is the same in character as the original
result--the sprout is doing the exact same function, but just on a different
article. In the United States, such type of inventions that involve merely a
new use that is the same in character as the original use have been struck down
as obvious. [FN74] Clearly, this part of s.3(d) seems to cover such inventions.
This is not to state, however, that s.3(d) is to be applied only to new uses in
the same nature as the old use. Going by the clear wordings of this part of
s.3(d), even if the new *142 use is completely unrelated to the old use, the
same is not allowed. [FN75]
However, one must remember that the word "mere" at the beginning of the sen-
tence qualifies the phrase "new use". Therefore, combination claims that satis-
fy the famous "synergism test"--the combination of known elements has an effect
greater than the sum of the several effects of its elements taken separately
[FN76]--will cross the bar under s.3(d), since the claim here is not on the
mere new use or application of a known substance, but on the net effect of the
combined elements that is greater than the sum of the elements themselves. Thus
although there is a new use of a known substance even in a combination claim,
since the claim is not on the "mere use", it shall not be excluded by s.3(d).
The test that is to be applied to differentiate between the "mere use" of an
element which is not patentable and a valid combination claim, which is pat-
entable, may thus lie in the "synergism test"; if the applicant can establish
that the new application of known elements is such that the net effect is
greater than the mere sum of just the uses of the old element.
The last issue would be the scope of applicability of this part of s.3(d).
Although it is beyond doubt that this provision would apply to chemicals and
drugs, is it restricted to only chemicals and drugs? Or does it apply to a much
broader scope of materials by invoking the dictionary meaning of the term sub-
stance? As per Black's Law Dictionary, the term substance means "any matter".
[FN77] The common dictionary meaning of the term "substance" is anything that

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has mass and occupies space, [FN78] which is obviously much broader than merely
chemical substances. Precedents in the Supreme Court of India have held that
terms in a statute may be defined and understood using their common and ordin-
ary meaning from dictionaries. [FN79] There is nothing in the context of the
section itself that disclaims or restricts its application to merely chemical
substances.
IV.2. Mere use of known process, machine or apparatus
The third part of s.3(d) of the Patents Act 1970 prevents patents on any
known process, machine or apparatus, unless such known process results in a new
product or employs at least one new reactant. At first perusal, the provision
gives the impression of having been poorly drafted. This is due to the fact
that the prohibition is on process, machine or apparatus; but the rider or es-
cape clause is restricted to only processes resulting in a new product or using
a new reactant. However, a known machine or apparatus would anyway be disquali-
fied by the novelty clause; and even if used for a new use or purpose, would be
hit by the second part of s.3(d). Thus, the use of the words "machine or appar-
atus" may seem unnecessary. Probably, the words have been used in abundant cau-
tion, contemplating the use of claim formats wherein the claim is made on an
apparatus or machine, but as a method claim, explaining them as a method or
technique to achieve an end.
There is a further indication that seems to limit the scope of its applicab-
ility to merely chemical processes--the use of the phrase "new reactant" in the
rider. The Parliament could have used a more generalised word such as "sub-
stance", which has been used elsewhere in the same provision. The use of a more
restrictive phrase such as "reactant", which, going by ordinary dictionary
meaning is limited to merely a chemical, would create a presumption that the
entire exclusion in the third part of s.3(d) was meant for merely chemical pro-
cesses. Otherwise, it would result in an absurdity: having the operative exclu-
sion clause applicable to all processes, but making the rider clause to escape
from it restricted to just chemical processes.
This makes the Indian law broader than its American counterpart, where pro-
cess claim for making a novel material using a conventional process is not pat-
entable. [FN80] In the United States, the novelty of the invention for a pro-
cess claim must reside in the process only. Since, under s.3(d), known pro-
cesses with new products are not excluded from patentability, Section 3(d) im-
pliedly allows a claim on a known process; though the new product would have to
be mentioned in the claims as a limitation. The claims, nonetheless, would be
on the process, since otherwise the very prohibition is redundant. This is be-
cause, under normal interpretation of process claims, the novelty and inventive
step resides in the process. The mere fact of making a new product would not
make the process subject to a patent application. But by explicitly making an
exclusion clause in the form of s.3(d) and allowing a rider to it, unless the
Parliament intended the patenting of a process based on novelty of the product,
its presence in s.3(d) was unnecessary. Of course, for patentability, the ap-
plicant must ultimately have to prove that the use of the process to make this
product was non-obvious.

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This would imply that as per s.48 of the Act, one of the rights of the pat-
entee would be the exclusive right to prevent any third party, without their
consent, from the act of using the process (irrespective of the product). Thus,
even though a third party may later possess another patent on the same process
with a novel product, they would still be prohibited from exercising their pat-
ent rights without a licence, as this would infringe upon the exclusive right
of the first patentee *143 since the holding of a patent by the second person
cannot be a defence in an infringement suit. [FN81] Of course, this would also
mean that the first patentee cannot work their patent without the permission of
the second person, since even the second person ultimately has an exclusive
right to prevent others from using the process. Thus, there would be increased
cross-licencing as a result of this provision. [FN82]
IV.3. New form of a known substance
We turn our attention now to the more controversial first part of s.3(d) of
the Patents Act 1970, (which was under challenge in Novartis), which excludes
the patentability of new forms of known substances. If this new form results in
the enhancement of the known efficacy of that substance, then it is outside the
scope of the exclusion and hence patentable subject matter.
The first issue would be the scope of applicability of this provision. The
High Court in Novartis held that this part of s.3(d) is definitely referable
only to the pharmacology field, namely, drugs. [FN83] We are completely in
agreement with this opinion, though it may sound untenable in light of the in-
terpretation we previously accorded to the word "substance" in section IV.1 of
the article earlier. However, as will be shown below, this is not the case. As
was discussed by the High Court in Novartis, the sole object and purpose of the
2005 amendment was to prevent the "evergreening" of patents by pharmaceutical
companies and with the welfare object of making sure that the common man is not
denied access to life saving medicines. [FN84] Under the principles of stat-
utory interpretation in India, no provision in a statute would be interpreted
de hors its object. [FN85] The famous Heydon's rule of construction (also
called the Mischief rule), [FN86] has been applied to hold that the history of
the legislation as regards the defect or mischief in prior law that the present
statute attempts to remedy, is to be considered in interpreting the words of
the statute that are to suppress the mischief. [FN87]
A corollary to this principle is that general words in the operative por-

tions of any provision of the legislation will be interpreted narrowly to
merely suit the suppression of the mischief. [FN88] Thus, although words may
have a broader ordinary meaning, they would still be interpreted in a narrower
sense if the very purpose of the provision was to cure only a particular mis-
chief. Since the sole object of the amendment was aimed at regulating pharma-
ceutical companies, the word "substance", though capable of having a broader
meaning, would be limited to merely the field of pharmacology. This would also
mean that inventions relating to chemical substances, other than drugs, would
not be hit by this exclusion. Nonetheless, we have noted earlier as to how such
patents could anyway be challenged on the requirements of novelty and non-
obviousness.

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Secondly, another issue regarding the scope of application arises due to the
starting phrase--the mere discovery of a new form. Clearly, going by ordinary
and common meaning, this should only contemplate pre-existing forms of the sub-
stance that have been unknown and have been uncovered by the applicant. Thus,
the derivative of the compound that has been created artificially in the labor-
atory and not existing, as such, in nature, would be outside the scope of this
exclusion. But this is not a necessary conclusion. We have already noted how
one may interpret words narrowly or broadly so as to suppress the mischief in-
tended to be remedied by the provision. Thus, the word "discovery" must neces-
sarily be given a broader meaning so as to include even artificially created
forms, as otherwise, the mischief of evergreening of patents would continue un-
abated.
We may now focus on defining and trying to understand the meaning of the
terms used in this part of s.3(d) of the Patents Act 1970. One of the terms
used is "new forms". We shall deal with this phrase along with the analysis of
the explanation to s.3(d) that is provided in s.IV.4 of this article.
The second word used is "efficacy". The High Court in Novartis used Dor-
land's Medical Dictionary in defining the word "efficacy" to mean the ability
of a drug to produce the desired therapeutic effect--healing of disease. [FN89]
But the more troubling part of this provision is the way in which the word
efficacy has been used--"enhancement of the known efficacy". This phrasing
gives rise to two related but distinct questions:
(a) What are the parameters to decide whether there has been enhancement
of efficacy?
(b) When does one consider there to be an enhancement of efficacy for the
purpose of s.3(d)?
In answering question (a), the Court opined that due to the advanced technology
in all fields of science, it is possible to show by giving necessary comparat-
ive details, based on such science, that the discovery of a new form a of known
substance had resulted in the enhancement of the known efficacy. [FN90] This is
definitely correct. In this regard, one needs to look no further than the prac-
tices of the Food and Drug Administration (FDA) in the United States, where the
FDA is required to check for the "bioequivalence" of a generic version of an
approved drug. [FN91] This term is defined in that very same legislation.
[FN92]
In brief, this definition holds that the term a drug shall be considered to
be "bioequivalent" to a listed *144 drug if there is no significant difference
between the rate and extent of absorption. [FN93] Bioequivalence studies may
analyse either the rate and extent of absorption of a drug in the blood or the
extent to which the active ingredient becomes available at the site of drug ac-
tion. Where the absorption of a drug tested is altered by the drug, as in a
controlled release dosage form, the pharmaceutical equivalence may be con-
sidered bioequivalent if the extent to which the active ingredient becomes
available at the site of drug action is not significantly different from the
brand drug. [FN94]

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Therefore, evidence of similar blood levels would indicate that the generic
drugs would be therapeutically equivalent. The FDA in its regulations has also
considered the use of "therapeutic ratio"--ratio of the drug dose which pro-
duces an undesired effect to the dose which causes the desired effects and in-
dicates the selectivity of the drug and consequently its usability. [FN95] Bio-
equivalence tests are not unknown in the scientific world. [FN96]
But question (b) remains unanswered. To understand question (b) better, let
us take a hypothetical example of a drug "X". Later, a new form of this sub-
stance, for instance, an ester form of this substance is found to increase the
drug's effects. But this constitutes only a very minute increase--a 0.0002 per
cent increase--in the therapeutic effect of the drug. Although, literally,
there is an enhancement in the efficacy of the drug, the enhancement is so
minute and insubstantial that it counts for almost nothing. [FN97] And as we
know, the very mischief that was sought to be prevented by s.3(d) of the Pat-
ents Act 1970 was evergreening of patents and the above instance fits squarely
within this objective.
In other words, applying Heydon's rule as stated above, [FN98] the word en-
hancement would have to mean a "substantial enhancement". Of course, the above
illustration may be an extreme one. Whether there has been an enhancement of
the efficacy or not cannot be decided from a common man's angle as we have used
in the illustration above; rather, a technical and scientific basis is re-
quired. Thus the term "significant enhancement" is to be given a scope as un-
derstood by those skilled in the art. But the point still remains that the
scale of enhancement is a slippery slope; there is no bright line dividing a
substantial enhancement from an insubstantial one in practical commercial mat-
ters.
To deviate a little, the contention of the petitioner in Novartis hits the

nail on its head; the petitioner contended that without the Act providing any
guideline to decide as to when there is an enhancement in the known efficacy of
the substance, an unguided discretion is vested with the statutory authority
and therefore the amended section is bad in law. [FN99] A similar contention
was raised regarding the explanation as well, since there was no guidance as to
how to decide as to when the derivatives differ significantly in properties
with regard to efficacy. [FN100]
At this stage, it would, perhaps, be prudent to provide a brief introduction

to Indian constitutional law. Part III of the Constitution of India 1950
(consisting of arts 12-35) contains certain fundamental rights guaranteed to
all persons (and, in some cases, only to citizens) which cannot be abridged by
any law made by the state. [FN101] Article 14 [FN102] guarantees the "right to
equality before the law" and "equal protection of the law." Article 14 thus
combines the English doctrine of the "Rule of Law" as propounded by Professor
Dicey, with the Equal Protection Clause of the 14th Amendment to the US Consti-
tution. [FN103] Equality before the law does not mean mathematical equality;
rather that only equals be treated equally. [FN104] Thus evolved the doctrine
of reasonable classification; it allows the state to make classifications based
on intelligible differentia, having a reasonable nexus with the particular ob-

E.I.P.R. 2009, 31(3), 135-146
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ject to be achieved by such classification. [FN105]
*145 In 1974, the Supreme Court evolved a new doctrine that art.14 is a
guarantee against arbitrary state action as well. [FN106] Equality was held as
a dynamic concept and thus when an act is arbitrary it was held to be impliedly
unequal and therefore violative of art.14. [FN107] A corollary to this is the
principle that when a statute delegates wide, unguided, unbridled and uncanal-
ised powers to an authority, it paves way for arbitrary action by the authority
in the application of law and therefore such delegation of power would be
struck down for violation of art.14 on the grounds of arbitrariness. [FN108]
The High Court held that the Parliament is not required to use words in a
statute with mathematical precision; the state is allowed to restrict itself to
general principles, broad objectives and fundamental issues, instead of tech-
nical or situational intricacies which are better left to better equipped full
time expert executive bodies and specialist public servants. [FN109] The mere
fact that the Parliament had used a general phrase would not suffice to prove a
violation of art.14. Since a statute cannot be struck down by just saying that
it is arbitrary or unreasonable, [FN110] the Court finally declined to declare
s.3(d) along with its explanation as unconstitutional. [FN111]
Despite the validity of the provision, the question still remains open. The
authors wish to provide a reasonable solution to the problem using basic prin-
ciples of evidence law. It is submitted that so long as the applicant can pro-
duce evidence to prove enhancement and unless there is evidence, produced
either by the examiner or oppositionists that this enhancement is considered as
insignificant by those skilled in the art, the patent controller cannot reject
the application. In other words, we suggest a division in the burden to be al-
located. The initial burden of proof would be on the applicant to prove using
scientific parameters, that this new form has enhanced efficacy. The burden
then shifts on those who oppose it to prove that this enhancement is too insig-
nificant under the standards of the relevant art. In other words, to answer the
question directly, once an enhancement is established, the patent is to be
granted unless it can be proved that this enhancement was insignificant.
The above answer is a logical and reasonable one. It cannot be left to the
statutory authority to decide on its own whims and fancies as to when there is
an enhancement. That may lead to arbitrary application of law. Instead, if the
general process were to allow every amount of enhancement, presuming that any
amount of enhancement is significant, leaving it to the examiner or opposition-
al third parties to establish otherwise by scientific standards, the entire
procedure becomes subject to reason. That way, when the decision is under ap-
peal or review, the appellate authority or the reviewing body, as the case may
be, would have a better opportunity of fulfilling its duty.
Fourthly, a very important issue is the relationship between the term "in-
vention" under the Patent Act 1970 [FN112] and the exclusion under s.3(d). Tak-
ing another hypothetical and non-technical example, let us suppose that the ap-
plicant has proved an increase in efficacy by 10 per cent and the controller
holds that this removes the patent from the bar under s.3(d). Can the control-

E.I.P.R. 2009, 31(3), 135-146
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ler still hold that despite crossing the bar under s.3(d), by proving
(significant) enhancement of efficacy, the standards for proving it to be an
"invention" under s.2(1)(j) read with s.2(1)(ja) are higher? Unfortunately, the
Act itself is silent on this inter-relationship. The authors believe that such
an interpretation would be an unreasonable abuse of power, amounting to double
standards that would conceivably place applicants at an unfair, unjust and in-
convenient position. [FN113] Having a higher standard of scrutiny for consider-
ation of "invention" as against the scrutiny under s.3(d) would relegate the
status of the rider of enhancement of efficacy under s.3(d) to redundancy.
[FN114]
However, this is not to state that those alleged inventions that cross the
bar of s.3(d) would automatically satisfy the requirements of patentability.
For instance, despite being a new form and having enhanced efficacy, the drug
could still be rendered obvious by proving that some teaching, suggestion or
motivation, either express or implied, taught those skilled in the art that
this new form of the substance would result in the enhancement of efficacy. In
that case, despite clearing s.3(d), the alleged invention would not succeed. To
use the specific words of the statute, the proof of enhancement of efficacy un-
der s.3(d) would be considered as sufficient to establish the requirement of
novelty and "technical advance or economic efficiency or both" under
s.2(1)(ja)'s "inventive step", but not that of non-obviousness under
s.2(1)(ja).
IV.4 Explanation to s.3(d)
The explanation to s.3(d) creates a legal fiction [FN115] to the effect that
salts, esters, ethers, polymorphs, metabolites, pure form, particle size iso-
mers, mixtures of isomers, complexes, combinations and other derivatives of
known substance shall be considered to be the same substance; the rider is that
the legal fiction is removed by proving that they differ significantly in prop-
erties with regard to efficacy. That is, though one may generally state, for
instance, that a salt and a ester of a drug *146 are different forms of a same
substance, the explanation creates a legal fiction that they will considered as
the same substance and not as a new form of a known substance, unless this new
form differs significantly in properties with regard to efficacy.
In other words, from the perspective of the first part of s.3(d) of the Pat-
ents Act 1970, which deals with new forms of a known substance, in cases where
the new form falls in one of the categories mentioned in the explanation, then
the applicant must first prove that the compound is a new form by establishing
that the variant differs significantly in properties with regard to efficacy,
the word efficacy carrying the same meaning as in the operative part of s.3(d).
Later, of course, to cross the bar of s.3(d), one would have to establish an
enhancement of the efficacy of the substance. However, in the authors' opinion,
as we shall justify below, this is a mere restatement of what is already
provided in s.3(d).
If a new form of a known substance is to have an enhancement of efficacy as

required under s.3(d), unless the new form of the substance does not differ

E.I.P.R. 2009, 31(3), 135-146
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significantly in properties with regard to efficacy, there is no scientific

possibility of an enhancement of efficacy per se. Thus the ingredient that the
new form differs significantly in properties with regard to efficacy is implied
in the first part of s.3(d). The explanation, we believe, has been used as a
tool of abundant caution. Nonetheless, it reiterates the requirement that the
difference between the new form and the known substance be "significant"--a re-
quirement which we established previously in s.III.3 of the article.
The next issue is regarding the scope of applicability of the explanation.

The High Court in Novartis held that the explanation would come in aid only to
understand what is meant by the expression "resulting in the enhancement of a
known efficacy" in the amended section and therefore we have no doubt at all
that the explanation would operate only when discovery is made in the pharmaco-
logy field. [FN116] This statement clearly follows as a logical corollary to
the context and the words used in the operative part of s.3(d). Further, the
explanation and the first part of s.3(d) were brought in together as a "pack-
age" by the 2005 amendment to combat evergreening of patents in the pharmaceut-
ical sector. Thus the explanation was meant to go hand-inhand with only the
first part of s.3(d).
The third issue is with regard to the scope and ambit of the explanation.
After using various particular instances of chemical and physical/structural
forms, the explanation ends with a general term "other derivatives". The ques-
tion now, then, is what is the interpretation to be accorded to this word? Per-
sons skilled in this art opine that the term "derivative" of a substance refers
to compounds that are formed on the basis of one step physical or chemical
changes to a given compound, such that the change also involves one step re-
versibility. [FN117] As we know, in a statute relating to a particular busi-
ness, profession, art or science, words are given their "technical" meaning as
would be understood in that science. [FN118] And in such cases, expert testi-
mony of those involved in that field becomes highly relevant. [FN119]
Conclusion: pruning the evergreen tree
In this article, we have discussed certain issues relating to the new

amended s.3(d) of the Indian Patents Act 1970 in light of the decision of the
Madras High Court in Novartis. By no means are these issues exhaustive. Many
more can and will arise on application of the law.
We conclude that the exclusion under s.3(d) seems to be aimed at those al-
leged inventions that could have anyway not qualified the requirements of nov-
elty and non-obviousness--the fundamental rubric upon which patent law all over
the world have been built. It is for this reason that the authors wish to note,
at the risk of oversimplification, that s.3(d) cannot be claimed to be in viol-
ation of India's obligation under art.27.3 of the TRIPs. [FN120] In our opin-
ion, s.3(d) is only clarifying the scope of the requirements under art.27.3 and
is a bold legislative effort to prevent their dilution in the Indian context.
Whether s.3(d) is successful in pruning the "evergreen" tree in patent law, if
one may use that phrase, will depend on the rigour with which it is applied. It
is hoped that this method of pruning would have a significant positive impact

E.I.P.R. 2009, 31(3), 135-146
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on the health and longevity of patent law in India.
FN Adarsh Ramanujan is a B.Sc. LL.B. (IPR Hons.) student in National Law Uni-
versity, Jodhpur (India); Rajarshi Sen is a B.Sc. LL.B. (International Trade
Hons.) student in National Law University, Jodhpur (India). They may be contac-
ted at adarshramanujan@gmail.com and thementaltraveller@gmail.com.
FN1. Although the patent system in India can be traced back to 1856, formal
patent statutes only originated during the time of British rule, namely the In-
dian Patents and Designs Act 1911. See, Santanu Mukherjee, The Journey of Indi-
an Patent Law Towards TRIPS Compliance (2004) 35 I.I.C. 125, 127-128.
FN2. Although the patent system in India can be traced back to 1856, formal
patent statutes only originated during the time of British rule, namely the In-
dian Patents and Designs Act 1911. See Mukherjee, The Journey of Indian Patent
Law Towards TRIPS Compliance (2004) 35 I.I.C. 125, 127-128.
FN3. An investigation into India's failures to adhere to the Agreement On

Trade-Related Aspects of Intellectual Property Rights (TRIPs) and protect phar-
maceutical patents as required, caused the World Trade Organisation (WTO) to
conclude that India was, in fact, not in compliance and to provide a 1998 dead-
line to amend its patent legislation. See, India --Patent Protection for Phar-
maceutical and Agricultural Chemical Products, WT/DS50/AB/R (December 19,
1997), WT/DS79/R (August 24, 1998). India allowed this deadline to pass without
any new legislation. The US, originator of the investigation, agreed to three
more extensions before India finally used a temporary emergency measure to com-
ply with the mailbox portion by 2000, for implementation from January 1, 2005.
Approximately 30,000 applications were already waiting. See Ronald J.T.
Corbett, Protecting and enforcing intellectual property rights in developing
countries (2001) 35 Int'l. L. 1083, 1097.
FN4. Robert C. Bird, Defending intellectual property rights in the BRIC econom-
ies, (2006) 43 Am. Bus. L.J. 317, 330 at 343; Prabhu Ram, India's New "Trip-
Compliant" Patent Regime between Drug Patents and the Right to Health (2006) 5
Chi.-Kent J. Intell. Prop. 195.
FN5. This was to meet the initial art.70(8) of TRIPs requirement that it
provide inventors an immediate opportunity to file patent applications. See Av-
erie Hason and Jean Shimotake, Recent developments in patent rights for pharma-
ceuticals in China and India (2006) 18 Pace Int'l L. Rev. 303, 313. The applic-
ations would be held for examination until new patent laws were promulgated, at
which time, the applications would be examined in order of deposit date.
FN6. Section 2(1)(l) of the Indian Patents Act 1970.
FN7. Section 2(1)(ta) of the Indian Patents Act 1970.
FN8. Patent Office, India, Manual of Patent Practice and Procedure, (2005); as
available at http://www.patentoffice.nic.in/ipr/patent/manual-2052005.pdf
[Accessed December 15, 2008] (note: This is labeled a "draft" manual).

E.I.P.R. 2009, 31(3), 135-146
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FN9. Patent Office, India, Manual of Patent Practice and Procedure, (2005),
2.2.
2.2.
2.2.
2.2.
2.4.
2.4.
FN15. For instance, s.3(c) of the Indian Patents Act 1970--the mere discovery
of a scientific principle; s.3(e)--a substance obtained by a mere admixture
resulting only in the aggregation of properties; s.3(f)--the mere arrangement
or rearrangement of known devices each functioning independently of one another
in a known way; s.3(m)--a mere scheme of or method of performing a mental act;
s.3(p)--an invention, which, in effect, is traditional knowledge.
FN16. For instance, s.3(a) of the Indian Patents Act 1970--an invention which
is frivolous or contrary to well established natural laws; s.3(b)--an invention
against public order or morality; s.3(j)--any process for medicinal, surgical,
curative, diagnostic, etc. treatment.
FN17. For instance, s.3(l) of the Indian Patents Act 1970--copyrightable works;
s.3(o)--topography of integrated circuits; s.3(h)--a method of agriculture or
horticulture; s.3(i)--plants and animals in whole or in any part other than mi-
croorganisms; s.3(j)--a business method or a computer programme per se.
FN18. In Novartis (2007) 4 M.L.J. 1153, the Madras High Court quoted from the
records of the Parliamentary debates to conclusively establish the same. See
[12] of the case.
FN19. Lara J. Glasgow, "Stretching the Limits of Intellectual Property Rights:

Has the Pharmaceutical Industry Gone Too Far?"(2001) 41 Intell. Prop. L. Rev.
227, 235-37 (2001).
FN20. See C.M. Correa, Trends in Drug Patenting: Case Studies 11-12
(Corregidor, 2001), which provides a list of patenting targets chosen by com-
panies to extend their monopolies on drugs, including use of polymorphs
(crystalline forms of the active compound); pharmaceutical forms (that is, new
ways of administering the active compound); selective inventions (elements se-
lected from a group that were not specifically named in earlier patents claim-
ing the group); analogy processes; combinations of known products; optical iso-
mers; active metabolites; prodrugs (inactive compounds that produce active

E.I.P.R. 2009, 31(3), 135-146
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metabolites when introduced into the body); new salts of known substances;
variants of existing manufacturing processes; and new uses for old products.
FN21. Robert Chalmers, "Evergreen or Deciduous? Australian Trends in Relation

to the 'Evergreening' of Patents" (2006) 30 Melb. U. L. Rev. 29, 31-32.
FN22. Carlos M. Correa, Internationalization Of The Patent System And New Tech-
nologies: Proceedings of the 2002 Conference Access to Medicines in the Devel-
oping World: International Facilitation or Hindrance? Panel #2: TRIPS and Ac-
cess to Medicines, (2002) 20 Wis. Int'l L.J. 523, 549.
FN23. Richard Nelson, "Intellectual Property Protection for Cumulative Systems

Technology" (1994) 94 Colum. L.Rev. 2674, 2676-2677; Clarissa Long, "Patents
and Cumulative Innovation" (2000) 2 Wash. U. J.L. & Pol'y 229, 234-237 (2000).
FN24. Arrow Pharmaceuticals Ltd v Merck & Co Inc (2004) 63 I.P.R. 85.
FN25. Arrow Pharmaceuticals (2004) 63 I.P.R. 85 at 120.
FN28. The Manual of Patent Examining Procedure (MPEP) of the United States
Trademark and Patent Office (USPTO) holds that a prima facie case of obvious-
ness is made when two chemicals have structural similarities and similar util-
ities. See, United States Department of Commerce, United States Patent and
Trademark Office, Manual of Patent Examining Procedure, 8th edn, (2008),
2144.09, as available at http://www.uspto.gov/web/offices/pac/mpep/mpep_e8r6_
2100.pdf [Accessed December 16, 2008] (hereinafter "US MPEP"). See also, In re
Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979); In re Papesch, 315
F.2d 381, 137 USPQ 43 (CCPA 1963). There is a general presumption that com-
pounds of close structural similarity possess similar properties. See, US MPEP,
2144.09.II. See also, In re May, 574 F.2d 1082, 1094, 197 USPQ 601, 611 (CCPA
1978); In re Schechter, 205 F.2d 185, 191, 98 USPQ 144, 150 (CCPA 1953). This
is, of course, a rebuttable presumption. See, US MPEP, 2144.09.V,
2144.09.VI, 2144.09.VII. See also, In re May, 574 F.2d 1082, 197 USPQ 601
(CCPA 1978); In re Schechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953); Ex parte
Blattner, 2 USPQ2d 2047 (Bd. Pat. App. & Inter. 1987); In re Stemniski, 444
F.2d 581, 170 USPQ 343 (CCPA 1971); In re Albrecht, 514 F.2d 1389, 1396, 185
USPQ 585, 590 (CCPA 1975); In re Lalu, 747 F.2d 703, 223 USPQ 1257 (Fed. Cir.
1984); In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963); In re Wiechert,
370 F.2d 927, 152 USPQ 247 (CCPA 1967); In re Dillon, 919 F.2d 688, 16 USPQ2d
1897 (Fed. Cir. 1991).
FN29. In re Dillon, 919 F.2d 688, at 692-93 (Fed. Cir. 1990). See also Schering
Corp v Geneva Pharmaceuticals Inc. et al., 67 USPQ2d 1661 (Fed. Cir. 2003), and
Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1996] R.P.C. 76, where a
patent on the metabolite of a known drug was held to be inherently anticipated
and thus not novel.

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FN30. The current form of Glivec consists of the beta crystal form of imatinib
mesylate, which is used in the treatment of myeloid leukaemia (blood cancer)
and Gastro-Intestinal Stronlal Tumours (GIST). This compound is the subject
matter of the patent application in question, which is entitled "Crystal Modi-
fication of a N-Phenyl-2-Phyrimidineamine Derivative, Processes for its manu-
facture and its use." The beta crystal form is synthesized from a mesylate salt
of imatinib, which was the subject of a 1993 patent issued in Canada, the EU,
the US and elsewhere. Novartis contends that mesylate salt is not suitable for
medicine; rather, only the beta crystal form of imatinib has been used as an
ingredient in Glivec. Novartis invented two forms--Alpha and Beta--of which,
Novartis claims, the Beta form stores better, is less hygroscopic, is easier to
process and guarantees a constant quality of the final drug product. Novartis
also claims that the beta crystalline form of imatinib mesylate results in a
higher bio-availability over the 1993 compound and, hence, differs signific-
antly in properties with regard to efficacy. Novartis has applied for patent
protection for the same in over 50 countries, and had, at the time of institu-
tion of the Writ Petition, been granted approval in 35 countries. See, Novartis
Writ Petition, at [9.1]-[9.11].
FN31. P.C. Nowell and D.A. Hungerford, "A Minute Chromosome in Human Chronic
Granulocytic Leukaemia" (1960) 132 Science, 164-172. The two researchers found
that a section of DNA was missing from chromosome 22. This alteration soon be-
came known as the Philadelphia (Ph) chromosome and could be detected in approx-
imately 95% of patients with chronic myeloid leukemia (CML). The discovery
meant that for the first time ever, scientists had discovered a genetic abnor-
mality linked to a specific kind of cancer. The discovery of the link between
the Ph chromosome and CML set off an explosion of research into the genetic
causes of cancer. See, G A Koretzky, "The Legacy of the Philadelphia Chromo-
some" (2007) 117 Journal of Clinical Investigation 2030.
FN32. T. Mughal and J. Goldman, Understanding Leukaemia and Related Cancers

(Oxford: Blackwell Science Ltd, 1999). Two researchers from the California In-
stitute of Technology, David Baltimore, PhD, and Owen N. Witte, MD, identified
the principal cause of CML. The Ph chromosome produces an enzyme that plays a
central role in aberrant cell growth and division. The enzyme, a fusion protein
(Bcr-Abl) that enhances tyrosine kinase activity, changes the cell's normal ge-
netic instructions. This aberrant enzyme sends out signals through multiple
pathways within the cell, resulting in the overproduction of white blood cells
in the body. The result is that, while a healthy cubic millimetre of blood con-
tains 4,000 to 10,000 white blood cells, blood from a patient with CML contains
10 to 25 times this amount. The massive increase in the number of white blood
cells characterises CML.
FN33. N.B. Lydon, B. Adams, J.F. Poschet et al. "An E. coli Expression System
for the Rapid Purification and Characterization of a v-abl tyrosine protein
kinase" (1990) 5 Oncogene Research, 161-173; J.F. Geissler, J.L. Roesel, T.
Meyer, et al., "Benzopyranones and benzothiopyranones: A class of tyrosine pro-
tein kinase Inhibitors with Selectivity for the v-abl kinase" (1992) 52 Cancer
Research, 4492-4498; B.J. Druker, S. Tamura, E. Buchdunger, et al., "Effects of

E.I.P.R. 2009, 31(3), 135-146
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a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl pos-
itive cells" (1996) 2 Nature Med, 561-566; M.W. Deininger, J.M. Goldman, N. Ly-
don, et al., "The tyrosine kinase inhibitor CGP57148B selectively inhibits the
growth of BCR-ABL-positive cells" (1997) 90 Blood, 3691-3698; C. Gambacorti-Pas-
serini, P. le Coutre, L.Mologni, et al., "Inhibition of the ABL kinase activity
blocks the proliferation of BCR/ABL+ leukemic cells and induces apoptosis"
(1997) 23 Blood Cells Mol Dis, 380-394.
FN34. B.J. Druker and N.B. Lydon, "Lessons learned from the development of an
Abl tyrosine kinase inhibitor for chronic myelogenous leukaemia" (2000) 105 J
Clin Invest, 3-7.
FN35. See, Novartis Writ Petition, at [9.12]-[9.14].
FN36. See Novartis Writ Petition at [3]. See also, Decision of the Assistant
Controller of Patents & Designs, In the matter of an Application for Patent
No.1602/MAS/98 filed on July 17, 1998 AND In the matter of a Representation un-
der Section 25(1) of the Patents Act, 1970 AND In the matter of Rule 55 of the
Patents Rules, 2003 (hereinafter Decision of the Patent Controller) (on file
with the authors).
FN37. Novartis's patent application was filed in India on July 17, 1998 as a
convention application claiming Swiss priority date of July 18, 1997 whereas
Switzerland was not a convention country on that date, and because s.133 of the
Patent Act 1970 (whereby the Central Government has the power to notify a par-
ticular country as a convention country, for the purposes of making patent ap-
plications under the Act), was not retrospective in effect. See, Decision of
the Patent Controller, at 4 (citing Danieli A C Officine Maccaniche SPA v Con-
troller of Patents & Designs (2000)1 CAL LT 7 (HC); MANU/WB/0002/2000).
FN38. Since a 1993 patent granted by the US (US Patent No: 5521184), whose pub-
lication date is prior to the priority date of July 17, 1997, existed, which
claimed a pharmaceutically acceptable salt of the base compound, and since the
patent term extension certificate for the 1993 patent issued by the US Patent
Office specifically mentions imatinib mesylate, anticipation by prior publica-
tion was held to have been proved. See Decision of the Patent Controller at
2-3.
FN39. Since the free base was already disclosed by the 1993 Patent, it was held
to be obvious for a person skilled in the art to prepare corresponding pharma-
ceutically acceptable salts, especially in view of certain disclosures provided
in the 1993 Patent specification. See Decision of the Patent Controller at 3.
FN40. It was found that this patent application claims only a new form of a
known substance (the Opponent had pleaded that the application claims only a
polymorphic form of imatinibmesylate) without having any significant improve-
ment in efficacy (since the specification itself states that imatinib free base
of other salts can also be used). Moreover, it was found that there was no im-
provement in the efficacy of the beta crystal form over the known substances as
the difference in bioavailability of the free base with that of the beta crys-

E.I.P.R. 2009, 31(3), 135-146
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tal form of imatinib mesylate was only 30%, which may have been due to their
different solubilities in water. See Decision of the Patent Controller at 3-4.
FN41. See Novartis Writ Petition at [4].
FN42. Novartis (2007) 4 M.L.J. 1153 at [1].
FN43. This was done pursuant to a notification issued under s.117G of the Pat-
ents Act 1970 (which provided that all pending appeals in the High Court
against rectification of register; against all cases pertaining to revocation
of patent other than on a counter-claim in a suit for infringement; and against
any order or decision of the Patent Controller, were to stand transferred to
the newly constituted Appellate Board). See Ministry of Commerce & Industry,
Notification No.12/15/2006-IPR-III (Regd. No.D.L. 33004/99) at S.O.514(E),
(Gazette of India, April 3, 2007), as available at http:// ipin-
dia.nic.in/ipr/patent/gazetteofindia_apr2007.pdf [Accessed December 16, 2008].
The matter is currently pending before the Intellectual Property Appellate
Board (IPAB).
FN45. Ian Brownlie, Principles of Public International Law, 6th edn (Oxford:
Oxford University Press, 2003), pp.31-36 (exploring the nature of the relation-
ship between International Law and Municipal Law); Louis Henkin, International
Law: Politics and Values (Martinus Nijhoff Publishers, 1995) (stating that the
distinction between International and Municipal Law is implicit in the state
system); J.G. Starke, Introduction to International Law, 11th edn(London: But-
terworths, 1994) (opining that understanding relationship between International
andMunicipal Law is essential to understanding International Legal Theory);
Philip V. Tisne, "The ICJ And Municipal Law: The Precedential Effect Of The
Avena And Lagrand Decisions In U.S. Courts" (2006) 29 Fordham Int'l L.J. 865.
FN46. The 1969 Vienna Convention on the Law of Treaties art.27 (states may not
invoke the provisions of internal law as a justification for failure to perform
international obligations); Articles on the Responsibility of States for Inter-
nationally Wrongful Acts, Int'l Law Comm'n art 3, annexed to G.A. Res. 56/83,
U.N. GAOR, 56th Sess., Supp. No. 10, U.N. Doc. A/56/10 (2001) (hereinafter re-
ferred to as "Articles on State Responsibility"). For an overview of interna-
tional jurisprudence on the principle, see "Commentaries on the Articles on the
Responsibility of States for Internationally Wrongful Acts", Int'l L. Comm'n,
53rd Sess., U.N. GAOR, 56th Sess., Supp. No. 10, U.N. Doc. A/56/10 (2001)
(hereinafter referred to as "ILC Commentary").
FN47. Malcolm N. Shaw, International Law, 5th edn (Cambridge University Press,
2003), p.128.
FN48. Jonkheer H. F. van Panhuys, "Relations and Interactions between Interna-

tional and National Scenes of Law" (1964-II) 112 Receuil Des Cours 7, 78.
FN49. S.K. Verma, "International Law" in S.K. Verma and Kusum, Fifty Years of
the Supreme Court of India: Its Grasp and Reach (New Delhi: The Indian Law In-

E.I.P.R. 2009, 31(3), 135-146
(Cite as: E.I.P.R. 2009, 31(3), 135-146)
stitute, Oxford University Press, 2000). See also, Shaw, International Law
(2003), p.129.
FN50. State of West Bengal v Kesoram Industries Ltd (2004) 10 S.C.C. 201 at
[494]; Vishaka v State of Rajasthan, AIR 1997 SC 3011: (1997) 6 S.C.C. 241;
People's Union of Civil Liberties (PUCL) v Union of India, AIR 1997 SC 568:
(1997) 1 S.C.C. 301 at [23]; Vellore Citizen's Welfare Forum v Union of India
(1996) 5 S.C.C. 647; Jolly George Varghese v Bank of Cochin, AIR 1980 SC 470:
(1980) 2 S.C.C. 360.
FN51. People's Union of Civil Liberties (PUCL) v Union of India AIR 1997 SC
568: (1997) 1 S.C.C. 301 at [23]; Vellore Citizen's Welfare Forum v Union of
India (1996) 5 S.C.C. 647; Gramophone Company of India Ltd v Birendra Bahadur
Pandey, AIR 1984 SC 667: (1984) 2 S.C.C. 534 at [3]-[7]. Tractoroexport, Moscow
v M/s. Tarapore & Co AIR 1971 SC 1: (1969) 3 S.C.C. 562.
FN52. Pratap Singh v State of Jharkhand (2005) 3 S.C.C. 551 at [63]; Transmis-
sion Corporation of Andhra Pradesh v Ch. Prabhakar (2004) 5 S.C.C. 551 at [12];
State of West Bengal v Kesoram Industries Ltd (2004) 10 S.C.C. 201 at
[497]-[498]; Vishaka v State of Rajasthan AIR 1997 SC 3011: (1997) 6 S.C.C. 241
at [14]; People's Union of Civil Liberties (PUCL) v Union of India AIR 1997 SC
568: (1997) 1 S.C.C. 301 at [23]; Jolly George Varghese v Bank of Cochin AIR
1980 SC 470: (1980) 2 S.C.C. 360 at [23].
FN53. For the application of the "Doctrine of Harmonious Construction" between

international and municipal laws, see Mirza Ali Akbar Kashani v United Arab Re-
public AIR 1966 SC 230. See also Raja Harinder Singh v Commissioner of Income
Tax, AIR 1972 SC 202.
FN54. M.V. Al Quamar v Tsavliris Salvage (International) Ltd AIR 2000 SC 2826:
(2000) 8 S.C.C. 278at [37]; Gramophone Company of India Ltd v Birendra Bahadur
Pandey, AIR 1984 SC 667: (1984) 2 S.C.C. 534 at [5].
FN55. M.V. Al Quamar v Tsavliris Salvage (International) Ltd AIR 2000 SC 2826:
(2000) 8 S.C.C. 278 at [37]; Gramophone Company of India Ltd v Birendra Bahadur
Pandey AIR 1984 SC 667: (1984) 2 S.C.C. 534 at [5]; Jolly George Varghese v
Bank of Cochin AIR 1980 SC 470: (1980) 2 S.C.C. 360 at [10]-[12]. See also
Xavier v Cenara Bank Ltd 1969 K.L.T. 927 at 931, 933.
FN56. In the celebrated case of His Holiness Shri Kesavananda Bharathi Sripad-
agalvaru v State of Kerala [1973] Supp. S.C.R. 1, per Sikri C.J., held that it
was the Courts' duty, so far as was possible, to construe legislation so as to
be in conformity with International Law and not in conflict with it. Sripad-
agalvaru v State of Kerala [1973] Supp. S.C.R. 1 at [151], [152] (citing Coro-
craft v Pan American Airways [1969] All E.R. 82 at 87).
FN57. Jolly George Varghese v Bank of Cochin, AIR 1980 SC 470: (1980) 2 S.C.C.
360 at [12]. Indian courts have held that to give effect to treaties, appropri-
ate legislation must be passed so as to make them binding on Indian courts. See
State of Madras v G.G. Menon AIR 1954 SC 517. This is especially true in case
such treaty "modifies or restricts the laws of the State" or "operates to re-

E.I.P.R. 2009, 31(3), 135-146
(Cite as: E.I.P.R. 2009, 31(3), 135-146)
strict the rights of citizens". See Maganbhai Ishwarbhai v Union of India AIR
1969 SC 783 at 807 (per Shah J.).
FN58. This argument was advanced before the Madras High Court. See, Novartis,
at paragraph 7.
FN60. The Madras High Court held that essentially, international covenants,
treaties and agreement are all documents that are essentially in the nature of
a contract. Novartis (2007) 4 M.L.J. 1153 (citing Head Money Cases 112 U.S.
580, 598 (1884)).
FN61. See Joost Pauwelyn, Conflict of Norms in Public International Law: How
WTO Law Relates to Other Rules of International Law (Cambridge, Massachussets:
Cambridge University Press, 2003). Generally, it is not disputed that WTO law
is part of the greater corpus that constitutes public international law. See,
John H. Jackson, TheWorld Trading System 25 (1997);DonaldMcRae, "The WTO in In-
ternational Law: Tradition Continued or New Frontier?" (2000) 3 J. Int'l Econ.
L. 27; Donald McRae, "The Contribution of International Trade Law to the Devel-
opment of International Law" (1996) 260 Recueil Des Cours 111; Ernst-Ulrich
Petersmann, "Dispute Settlement in International Economic Law-Lessons for
Strengthening International Dispute Settlement in Non-Economic Areas" (1999) 2
J. Int'l Econ. L. 189; M. Garcia-Rubio, "Unilateral Measures as a Means of En-
forcement of WTO Recommendations and Decisions" (Geneva: Graduate Institute of
International Studies, 2001) (calling it "difficult ... to envisage any other
possible status for rules emanating from a[] treaty concluded among States un-
der international law, as the WTO Agreement"). For earlier sources confirming
that the General Agreement on Tariffs and Trade (GATT) was no more than a spe-
cialised branch of public international law, see Ignaz Seidl-Hohenveldern, In-
ternational Economic Law (1989); Georg Schwarzenberger, "The Principles and
Standards of International Economic Law" (1996 I) 87 Recueil Des Cours 1. The
possible exception is Judith Bello, "The WTO Dispute Settlement Understanding:
Less IsMore" (1996) 90 AJIL 416, 416-17 (stating that "WTO rules are simply not
'binding' in the traditional sense"). In the case of the WTO, the Appellate
Body has acknowledged that the GATT remains firmly imbedded in general interna-
tional law, stating that the Agreement "is not to be read in clinical isolation
from public international law". See "US - Standards for Reformulated and Con-
ventional Gasoline", Report of the Appellate Body, April 29, 1996, WT/DS2/AB/R
at 17; "US - Import Prohibition of Certain Shrimp and Shrimp Products", Report
of the Appellate Body, 6 Nov. 1998, WT/DS58/AB/R, at 154-157.
FN62. On the application of the maxim lex specialis derogat legi generali, see,
M. Koskenniemi, "Study on the Function and Scope of the lex specialis Rule and
the Question of 'Self-Contained Regimes"', Preliminary Report by the Chairman
of the Study Group submitted for consideration during the 2004 session of the
International Law Commission, Doc. ILC(LVI)SG/FIL/CRD.1 and Add. 1, available
from the Codification Division of the UN Office of Legal Affairs;
Gabc_kovo-Nagymaros Project (Hungary v Slovakia), ICJ Reports (1997),
para.132.

E.I.P.R. 2009, 31(3), 135-146
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FN63. Pieter Kuyper, The Law of GATT as a Special Field of International Law,
XXV Netherlands Yearbook IL 227 (1994), at 252 (noting that the WTO "has moved
decisively in the direction of ... a self-contained regime.").
FN64. G. Arangio-Ruiz, "Fourth Report on State Responsibility" in ILC Yearbook

(1992), Vol.II Pt 1, 357.
FN65. See Charanjit Lal v Union of India MANU/SC/0009/1950. See also K.K. Ko-
chunni v State of MadrasMANU/SC/0018/1959.
FN66. Katakis v Union of India (W.P. No.54/68 dated October 28,1968).
FN68. See Part IV of this article.
FN69. The standard Swiss-type claim format is: "Use of compound A for the manu-
facture of a medicament for the treatment of disease B".
FN70. United States Code 35 USC 100(b).
FN71. In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); In re
Crish 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004); US MPEP
2112.I.
FN72. In re Hack 245 F.2d 246, 248, 114 U.S.P.Q. (BNA) 161, 163 (C.C.P.A.
1957); see also US MPEP 2112.02.
FN73. Concrete Appliances Co v Gomery 269 U.S. 177 (1925).
FN74. Concrete Appliances Co v Gomery 269 U.S. 177 (1925); Cuno Eng'g Corp v
Automatic Devices Corp 314 U.S. 84, 91 (1941); Blake v San Francisco 113 U.S.
679, 683 (1885); See also Graham v John Deere Co 383 U.S. 1 (1966) at 26, 31.
The English case of Harwood v Great Northern Railway Co (1865) 11 H.L.C. 654,
11 Eng. Rep. 1488 is also on the same note.
FN75. We have previously noted how such claims relating to chemicals and drugs
have been held to be inherently anticipated, since the new use is a result of a
property that is deemed to be disclosed to the public along with the disclosure
of the compound itself.
FN76. Anderson's-Black Rock Inc v Pavement Salvage Co 396 U.S. 57, 61 (1969).
FN77. Bryan A. Garner (ed), Black's Law Dictionary, 8th edn (2004).
FN78. The American Heritage Dictionary of the English Language, 4th edn
(Houghton Mifflin Company, 2006).
FN79. Commissioner of Income Tax, West Bengal v Kumar Sahas Roy AIR 1957 SC
768, 875 (per Bhagwathi J.); New Delhi Municipal Committee v Allied Motor Pvt
Ltd (1995) 6 SCALE 37, 40; Bolani Ores Ltd v State of Orissa AIR 1975 SC 17 at
25-26; Union of India v Harjeet Singh Sandhu AIR 2001 SC 1772 at [31]; Naresh
Shridhar Maraikar v State of Maharashtra AIR 1967 SC 1, 16; Urban Improvement

E.I.P.R. 2009, 31(3), 135-146
(Cite as: E.I.P.R. 2009, 31(3), 135-146)
Trust v Gokul Narain AIR 1996 SC 1819 at 1823. The Madras High Court in No-
vartis used dictionaries to define the term "efficacy"--Novartis (2007) 4
M.L.J. 1153 at [13].
FN80. Ex parte MacAdams, Wu, & Joyner, 206 U.S.P.Q. (BNA) 445, 447 (Board of
Patent Appeals and Interferences 1978); In re Maucy 182 U.S.P.Q. (BNA) 303, 306
(C.C.P.A. 1974).
FN81. See Hindustan Lever Ltd v Lalit Wadhwa 2007 (35) PTC 377 (Del.).
FN82. Section 91 of the Patents Act 1970 contains provisions for obtaining com-
pulsory licencing from the Patent Controller of related patents such as the
ones discussed above.
FN85. New India Sugar Mills v CST, Bihar, AIR 1975 SC 2260, p. 2270; K. Veer-
aswamy v Union of India (1991) 3 S.C.C. 655 at 702; Municipal Corporation of
Greater Bombay v Indian Oil Corp., AIR 1991 SC 1289 at 689.
FN86. Heydon's case (1584) 3 Co. Rep. 7a, p. 7b.
FN87. Bengal Immunity Co v State of Bihar AIR 1955 SC 661 at 664; CIT, Patiala
v Shahzada Nand AIR 1966 SC 1342 at 1347.
FN88. RMD Chamarbaugwalla v Union of India AIR 1957 SC 627 at 632; CIT v Sodra
Devi AIR 1957 SC 832 at 839.
FN91. United States Code 21 USC 355(j)(2)(A)(iv) (FDCA 505(j)(2)(A)(iv)).
FN92. United States Code 21 USC 355(j)(8)(B) (FDCA 505(j)(8)(B)).
FN93. "(i) the rate and extent of absorption of the drug do not show a signi-
ficant difference from the rate and extent of absorption of the listed drug
when administered at the same molar dose of the therapeutic ingredient under
similar experimental conditions in either a single dose or multiple doses; or
(ii) the extent of absorption of the drug does not show a significant differ-
ence from the extent of absorption of the listed drug when administered at the
same molar dose of the therapeutic ingredient under similar experimental condi-
tions in either a single dose or multiple doses and the difference form the
listed drug in the rate of absorption of the drug is intentional, is reflected
in its proposed labeling, is not essential to the attainment of effective body
drug concentrations on chronic use, and is considered medically insignificant
for the drug." (21 USC 355(j)(8)(B) (FDCA 505(j)(8)(B))).
FN94. Code of Federal Regulations 21 CFR 320.1(e).

E.I.P.R. 2009, 31(3), 135-146
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FN95. "The Commissioner of Food and Drugs shall consider the following factors,
when supported by well-documented evidence, to identify specific pharmaceutical
equivalents and pharmaceutical alternatives that are not or may not be bioequi-
valent drug products: ... (c)Evidence that the drug products exhibit a narrow
therapeutic ratio, e.g., there is less than a 2-fold difference in median leth-
al dose (LD50) and median effective dose (ED50) values, or have less than a
2-fold difference in the minimum toxic concentrations and minimum effective
concentrations in the blood, and safe and effective use of the drug products
requires careful dosage titration and patient monitoring." (21 C.F.R. 320.33)
FN96. See Justina A. Molzon, "The Generic Drug Approval Process" (1997) 5 J.
Pharmacy & L. 275 (generally describing the process). For a more in-depth ana-
lysis, see Sam H. Haidar, Barbara Davit, Mei-Ling Chen et. al., "Bioequivalence
Approaches for Highly Variable Drugs and Drug Products" (2008) 25(1) Pharma-
ceutical Research; Kenneth C. Lasseter, Jay Gambale, Bo Jin et. al., "Tolerabil-
ity of Fosaprepitant and Bioequivalency to Aprepitant in Healthy Subjects"
(2007) 47 J. Clin. Pharmacol. 834 (bioequivalence study comparing two drugs
used to reduce nausea); Anita A. Mathias, John Hinkle, Mark Menning et. al.,
"Bioequivalence of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate
Single-Tablet Regimen" (2007) 46 J Acquir Immune Defic Syndr 167
(bioequivalence study of three drugs used to treat AIDS).
FN97. Here, we assume that, in pharmacology, this increase would be considered

insignificant.
FN98. Heydon's case (1584) 3 Co. Rep. 7a, p. 7b; Bengal Immunity Co v State of
Bihar AIR 1955 SC 661 at 664; CIT, Patiala v Shahzada Nand AIR 1966 SC 1342 at
1347; RMD Chamarbaugwalla v Union of India AIR 1957 SC 627 at 632; CIT v
SodraDevi AIR 1957 SC 832 at 839; Novartis (2007) 4 M.L.J. 1153 at [13].
FN99. Novartis (2007) 4 M.L.J. 1153 at [3], [10].
FN100. Novartis (2007) 4 M.L.J. 1153 at [10], [11].
FN101. Article 13 of the Constitution of India 1950.
FN102. Equality before law--The State shall not deny to any person equality be-
fore the law or the equal protection of the laws within the territory of India.
FN103. Basheshar Nath v Commissioner of Income Tax (1959) Supp. 1 SCR 528, 551
(per Das C.J.).
FN104. Gauri Shankar v Union of India AIR 1995 SC 55 at 58; Western Uttar Pra-
desh Electric Power and Supply Co Ltd v State of Uttar Pradesh AIR 1970 SC 21,
24.
FN105. Babu Ram v State of Uttar Pradesh (1995) 2 S.C.C. 689 at [37]; Javed v
State of Haryana (2003) 8 S.C.C. 369, 880-381; State of West Bengal v Anwar Ali
Sarkar, AIR 1952 SC 75.
FN106. E.P. Royappa v State of Tamil Nadu (1974) 4 S.C.C. 3.

E.I.P.R. 2009, 31(3), 135-146
(Cite as: E.I.P.R. 2009, 31(3), 135-146)
FN107. E.P. Royappa v State of Tamil Nadu (1974) 4 S.C.C. 3 at 38.
FN108. Kaushal v Union of India AIR 1978 SC 1457 at [60]-[62]; State of West
Bengal v Anwar Ali Sarkar 1952 S.C.R. 284 at 310, 315-316, 355; Avinder Singh v
State of Punjab AIR 1979 SC 321 at [9].
FN109. Registrar of Co-operative Societies v K. Kunjabmu (1980) 1 S.C.C. 340;

Benilal v State of Maharashtra (1995) Supp. 1 S.C.C. 235.
FN110. See State of A.P. v Mc Dowell & Com MANU/SC/0427/1996.
FN111. Novartis (2007) 4 M.L.J. 1153 at [15]-[17].
FN112. See Part I of this article.
FN113. If possible, statutes are to be given a just, reasonable, sensible in-

terpretation that does not result in anomalies. See Nasiruddin v State Trans-
port Appellate Tribunal AIR 1976 SC 331 at 338; Tirath Singh v Bachittar Singh
AIR 1955 SC 830 at 833.
FN114. It is an accepted principle of law in India that if possible, that in-

terpretation which renders a part of the statute devoid of any application is
to be rejected. See Rao Shiv Bahadur Singh v State of UP, AIR 1953 SC 394 at
397; Ghanshyamdas v Regional Asstt. Comm., Sales Tax, AIR 1964 SC 766 at 722.
This very same argument would apply to even to the third part of s.3(d) of the
Patents Act 1970 as was previously stated in s.III.2 of this article.
FN117. This opinion has been sought from Professor Dr. K.K. Banerji, Ph.D.,
D.Sc., Professor (Chemistry), National Law University, Jodhpur.
FN118. See Union of India v Garware Nylons Ltd AIR 1996 SC 3509 at 3512; Indian
Cable Co Ltd v Collector of Central Excise, AIR 1995 SC 64 at 67, 68.
FN119. See Justice G.P. Singh, Principles of Statutory Interpretation, 10th edn
(Nagpur: Wadhwa & Co, 2006), p.107, where the author has cited a few Supreme
Court decisions in India that have considered such expert opinion.
FN120. The High Court of Madras in Novartis (2007) 4 M.L.J. 1153 at [8], [9],
dismissed this claim of the petitioner on the ground that it did not have the
jurisdiction to decide the question of India's compliance of TRIPS.
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Case: Novartis India Ltd, Re Unreported August 6, 2007 (HC (Ind))

Legislation: Agreement on Trade-Related Aspects of Intellectual Property

Constitution of India 1950 (India) art.14

Patents Act 1970 (India) s.3(d)

Subject: INTELLECTUAL PROPERTY. Other related subjects: Constitutional

Keywords: Constitutional law; Excluded subject matter; India; Interna-

Abstract: Comments on the Indian High Court judgment in Re Novartis

2009 Thomson Reuters.

I. Patent law in India

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form part of the state of the art". [FN6]

An invention considered to have industrial applicability satisfies three

The specific exception under challenge in Novartis was s.3(d), which we

II. Section 3(d): history and purpose

II.1. History of s.3(d):

The original unamended s.3(d) of the Patents Act 1970 read:

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II.2. Purpose of s.3(d):

"Evergreening" refers to the strategy adopted by patentees who seek to ex-

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whole cumulative invention process, and thereby hinder technological progress.

*138 Evergreening, therefore, seems an anathema to the central tenets of

III. The Novartis story: a case comment

III.1. Factual and procedural background

Novartis' patent application in India started with a mailbox application in

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*139 Separate Writ Petitions were filed challenging the constitutional

III.2. Issues framed and decision of the Madras High Court

A little background may help in this regard. In international legal theory,

Indian jurisprudence does not specifically follow the Blackstonian view of

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when there is no inconsistency between them. [FN52]

*140 However, in case harmonisation is not possible to resolve the incon-

However, the remedy for breaches of international law is not, in general, to

Perusing art.64 of TRIPs with art.1 of the Dispute Settlement Understanding

A better process of argumentation could, perhaps, have involved pointing out

*141 As regards the second part of question (a)--issuance of a declaration

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IV. Pruning the evergreen tree? Analysing s.3(d)

IV.1. New use of known substance

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claim patentable; in such cases, the claim on the substance or composition

Secondly, it is important to understand the import and scope of the phrase

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IV.2. Mere use of known process, machine or apparatus

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IV.3. New form of a known substance

A corollary to this principle is that general words in the operative por-

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To deviate a little, the contention of the petitioner in Novartis hits the

At this stage, it would, perhaps, be prudent to provide a brief introduction

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ject to be achieved by such classification. [FN105]

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IV.4 Explanation to s.3(d)

If a new form of a known substance is to have an enhancement of efficacy as

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significantly in properties with regard to efficacy, there is no scientific