Open Access Research Article
CRITIQUE OF THE NOVARTIS CASE: BROADENING THE HORIZON OF SECTION 3(D) (By-Richik Dadhich)
Published Paper
Article Details
Authored
By-Richik Dadhich
Introduction
2005 marked the beginning
of an extraordinary new frontier for India's generic drug industry and
drug-hungry population. For the first time in India's history, India recognized
that pharmaceuticals, foods, and chemicals were patent-eligible and entitled to
protection from infringers.[1]
Thus, Section 3(d) of the Indian Patent Act introduced a new threshold of
patent eligibility for pharmaceutical innovation that requires applicants to
demonstrate enhanced efficacy of their products.
In 2006, the Indian
patent office rejected a patent application covering Glivec. The rejection
stemmed, inter alia, from a unique section in the Indian patent regime that
prohibits the patenting of new forms of existing pharmaceutical substances that
do not demonstrate significantly enhanced "efficacy". Failing to
satisfy this Section 3(d) threshold, first at the Patent Office and later
before the Madras High Court on appeal, Novartis' suit arrived at the Indian
Supreme Court.
The judgment given by
the two-judge bench of the Hon'ble Supreme Court of India in the case of
Novartis AG V. Union of India[2]
(hereafter “the Novartis case”) is one the landmark judgments in India.
In this case Novartis challenged the rejection of its patent application for
Beta crystalline form of "Imatinib mesylate" wherein such challenge
was rejected by the Supreme Court of India on the ground that the said drug did
not produce an enhanced or superior therapeutic efficacy as compared to the
known substance i.e., Imatinib mesylate means that the said drug did not
involve an inventive step. One of the major reasons for rejecting the patent
application of Novartis was to avoid ever-greening of already patented products
by introducing minor changes.
Now, this project will
critically examine Section 3(d) of the Patent Act which would be followed by a
critique of Novartis case in the context of protection of intellectual property
of pharmaceutical companies. This is followed by concluding remarks which
focuses on why the Indian legislature needs to draw a balance between social
justice, intellectual property rights and scientific innovation.
It must be noted that
much before the 2013 decision by the Indian Supreme Court, Section 3(d) had
already been subjected to a mixed review.[3] Pharmaceutical companies
condemned its higher threshold of patentability for fear of losing their
extended market exclusivity. Scholars lauded its mechanism for preventing
pharmaceutical companies from extending their market exclusivity strategies.[4]
Evergreening is a term
for corporate manoeuvring where a product manufacturer continues to extract
patent protection on an originally patented product for successive designated
periods on more than one attribute, even though such attributes can be linked
to a single product.[5]
Section 3(d) was
designed to prevent this, as the following discussion of the text and
explanation of the statute would reveal. Section 3(d) reads as follows:[6]
“(d) 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 process 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 isomers, 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.”
Thus, Section 3(d)
establishes an extra layer of deterministic criteria in the patent eligibility framework.
This specific layer stipulates that, only those pharmaceutical derivatives that
can be demonstrated to exhibit significantly enhanced efficacy are eligible for
patent protection. This added layer would be a step towards real innovation as
opposed to claiming innovation on minor enhancement. Therefore, this extra
layer requiring enhanced efficacy would help in preventing fraudulent or superfluous
patent applications that are routinely sought through evergreening or patent
layering.
As each subsequent
variant of a compound is structurally equivalent to the original, either in
their naturally existing forms, or as known pharmaceutical substances, it is
more likely than not that these structurally similar substances are
functionally equivalent.[7]
Therefore, Section 3(d)'s requirement of enhanced efficacy of the derivative is
more effectively shown by observing its chemical interaction with other
chemical compounds that offer the most significant reactivity.[8]
The statute for
section 3(d) calls for a patent eligible product to be
"efficacious," or have the
attribute of enhanced efficacy over a prior known form, regardless of whether
the invention is incremental or groundbreaking. It could be said that Section
3(d) creates a "floor" in demonstrating "efficacy," while
charting a layered patentability framework for pharmaceutical products.[9]
Therefore, in order to claim patent, the onus of proving enhancement-that of
improved and enhanced functionality-would fall on the patent applicant. 100
Thus, imposition of this simple demonstrability barrier for claiming a patent
should be recognized as a process or instrumentality of bringing improved
chemical compounds to the market to make significant contributions as
pharmaceutical agents. This efficacy step certainly can distinguish between
patent applicants that arrive via evergreening and those that contain a
rigorous inventive step. Therefore, by making it mandatory for derivatives of
known substances to exhibit added efficacy, 3(d) encourages sequential
development of improved products to address significant public health needs.
The core arguments of
initial Novartis' challenge were centered on Section 3(d)'s lack of
constitutionality and TRIPS incompatibility. TRIPS incompatibility has garnered
significant coverage, an area on which the Madras High Court has refrained from
ruling, citing jurisdictional grounds.
The Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS) framework sought
to align global patentability regimes in line with predominantly U.S.
standards, and the feasibility of achieving this was recognized early on. The
resulting framework did not clearly define patentability criteria, nor did it
articulate a bright line of distinction between invention and patentability. In
many ways, the TRIPS agreement created a multi-layer exception paradigm that
has taken into account the different starting points from which member States
began their journey towards industrialization.[10]
Therefore, the only
hurdle Section 3(d) might face is if under a broader WTO panel evaluation the
efficacy barrier is eventually found to be in direct contravention of TRIPS.[11]
Here, the deterministic benchmark would be to evaluate whether a required
demonstration of efficacy invites one of the two outcomes-either imposing an
undue burden on the innovator, or the patentability framework in the target
jurisdiction is subject to arbitrary determination.
However, various
scholars point out that given its clear articulation, well established
legislative history, associated due diligence in its crafting, and a highly
nuanced judicial deterministic paradigm, Indian patent regime's efficacy
framework can no longer be recognized as narrowly construed for TRIPS
violation.[12]
Rather, it is of significant value to trace the flexibility guidelines provided
within TRIPS in formulation of 3(d).
Article 27 of TRIPS
endows a member State with the option to exclude certain inventions from
patentability, if their commercial exploitation is contrary to the national
interest or inconsistent with the settled law of the land. This exception
allows flexibility to member States in crafting their patentability framework to
be in line with their own interests. Moreover, members are also allowed to
exclude various method patents that are consistent with providing essential
health and human
services to its citizens.[13]
Thus, the TRIPS agreement embodies a commitment to public health and societal
welfare.
In evaluating TRIPS
compatibility of a member State's legal jurisdiction, we must bear in mind the
fundamental precept-a member State has flexibility to create an individual
paradigm that is resonant with its internal aspirations.[14] The TRIPS agreement has
empowered its member States to craft their own patentability regimes that
reflect their diverging starting points from an agrarian way of life towards
industrialization. Thus, while TRIPS ensures that innovators have commercial
impetus, nowhere in the agreements does it advocate the granting of unfettered
right of evergreening to pharmaceutical companies.[15]
Under the emerging
rubric of Section 3(d), pharmaceuticals can no longer shape the market
exclusivity in their favor, nor, can they subsume broader public interest
within the predatory property rights framework. This is consistent with the
various flexibilities offered to the member States by the Articles 7, 8, and 27
of the TRIPS agreement.[16]
Thus, India is within its rights under the TRIPS agreement to adjust its
patentability criteria and set higher standards for patent protection. And it
is therefore TRIPS compliant.
On 1 April 2013 the
Indian Supreme Court delivered the landmark judgment of Novartis AG v Union of
India[17] in
an appeal that had been brought to it by Novartis, a Swiss-based pharmaceutical
company with a business presence in India, against rejection by the Indian
Patent Office of a product patent application for a specific compound, the beta
crystalline form of Imatinib Mesylate. Novartis lost the case because the
Supreme Court ruled that the beta crystalline form of Imatinib Mesylate failed
both the tests of invention and patentability.
Factual Matrix And Context Of The Case
The crux of the matter
was whether or not the appellant was entitled to a patent for the beta
crystalline form of the compound Imatinib Mesylate, which is a therapeutic drug
for chronic myeloid leukaemia and certain kinds of tumours and is marketed
under the name "Glivec".
The basis for
Novartis' patent application for the beta crystalline form of Imatinib in India
was an alleged inventive step that materialised when a two-stage invention
process involving the introduction of a specified amount of beta crystals into
the base form of Imatinib was embarked upon.[18] Very specifically, the
claims in the patent application alleged the following about the Beta
crystalline form of Imatinib:
(a) it had more
beneficial flow properties;
(b) it had better
thermodynamic stability; and
(c) it had lower
hydroscopicity than the alpha crystalline form of Imatinib.
It was alleged that these properties made the
beta crystalline form of Imatinib "new" and superior due to its
ability to store better, be processed more easily, and its having "better
processability of the methanesulfonic acid addition of a compound formula I"
coupled with the advantage of storing and processing.[19]
Two important
developments occurred before the patent application was considered by the
Chennai Patents Office. Firstly, the Patents Act was amended and section 3(d)40
was introduced. Secondly, before the patent application was considered, it had
attracted five pre-grant oppositions.41 The most vocal oppositions came from
rival pharmaceutical companies and patient groups, basing their opposition
mainly on the fact that the alleged invention had been anticipated, was
obvious, and ran afoul of section 3(d) of the Patents Act.
The matter relating to
the patentability of the beta crystalline form of Imatinib was heard by the
Assistant Controller of Patents and Designs and the application was rejected.42
The Assistant Controller of Patents and Designs rejected the application on the
basis that the invention had
been anticipated by
reason of prior publication,43 its lack of novelty and its not meeting the acid
test of section 3(d).[20]
Novartis appealed the
decision of the Assistant Controller of Patents and Designs to the High Court
in Madras, in addition to asking for an order that section 3(d) was
unconstitutional and also fell afoul of the TRIPS Agreement. At that time the
Intellectual Property Appellate Body (hereinafter “IPAB”) had not yet
been formed. After the IPAB had been formed the matter was remitted to it by
the Madras High Court. Despite ruling in favour of Novartis by reversing the
findings of the Assistant Controller on novelty and non-obviousness, the IPAB
ruled that the patent could not be granted in the light of the provisions of section
3(d) of the Act, which, according to the IPAB, introduces a higher standard of
inventiveness and provides that what is patentable in other countries will not
necessarily be patentable in India.46 The IPAB went a step further and observed
that the specific section was particularly targeted at drugs/pharmaceutical
substances.[21]
Further, the IPAB
referred to the pricing policy of Novartis, which had exclusive marketing
rights over Glivec, which sold at 120 000 Indian Rupees per month48 per
required dose, and concluded that the patentability of the subject product
would fall foul of section 3(b) of the Act, which prohibits the granting of
patents on certain inventions the exploitation of which could cause public
disorder, among other social ills.[22]
Novartis then appealed
the decision of the IPAB to the Supreme Court of India, which was initially
reluctant to hear the appeal but was swayed by the public interest in the
matter50 and the delays that had accompanied the finalisation of the matter.
Judgment was delivered on 1 April 2013.
The key question to
answer in the opinion of the Court was "does the product which Novartis
claims as a patent qualify as a new product?" 52 As a corollary to the
question, it was crucial to enquire into whether the product in question had a
characteristic feature that involves a
technical advance over
existing knowledge that makes the invention not obvious to a person skilled in
the art.[23]
After affirming that
the meaning of an invention is delimited by clauses (j) and (ja) of section
2(1) of the Patents Act, the Court went further and asked the rhetorical
question of whether or not a product qualifying as an invention under the
relevant clauses of section 2(1) could have its patentability status questioned
under section 3(d).
Clauses (j) and (ja)
had deleted section 5 of the previous Patents Act, which prohibited product
patents in India, and at the same time, amendments were effected to section 3,
introducing section 3(d). The Court expressed the opinion that in order to
understand the purport and objects of the amendments it was important to
identify the mischief parliament wanted to check. The object which section 3(d)
sought to achieve was to prevent evergreening, provide easy access to life-saving
drugs to citizens, and realise the constitutional obligation to provide good
health care to citizens.
After a detailed
exposition of India's legislative history relating to intellectual property
generally and patents in particular, the Supreme Court concluded that the law
had been passed in order to protect India's policy space to afford good health
to its citizens while complying with the basic prescripts of the TRIPS
Agreement. The Court believed that the patent protection of pharmaceutical and
agricultural chemical products might have the effect of putting life-saving
medicines beyond the reach of a very large section of the population,60 and
that the amendments were therefore justified.[24]
Further, it was
submitted on behalf of Novartis that section 3(d) was not an exception to
patentability. Hence, once a substance satisfies the requirements in section
2(1)(j) and (ja), it satisfies the requirements of patentability. Consequently,
section 3(d) did not apply to the Novartis case. With specific reference to
public health and the use of TRIPS flexibilities, Novartis argued that the best
route was to make use of compulsory licences,[25] revocation proceedings and
multiple stages of patent opposition procedures rather than to make use of
section 3(d).[26]
The Supreme Court
dismissed the above submissions on a number of grounds:
Firstly, the Court held that
section 3(d) is not a provision ex majorie cautela (out of abundant
caution), as was submitted on behalf of Novartis, when taking into account the
totality of the historical development that led to the enactment of the
provision.
Secondly, the Court cautioned
that the relevant provision was enacted to deal with chemical patents and
pharmaceuticals by setting additional qualifications for the patentability of
such products.
Thirdly, and very
importantly, the Court clarified the position by stating that the door was wide
open for true inventions but closed by Section 3(d) for repetitive patenting or
the extension of patent terms on spurious grounds. In coming to the conclusion
that section 3(d) applied to the case, the Court emphasised that different
standards are set for things of different classes to qualify as inventions; and
for medical drugs and other chemical substances, the invention threshold is set
higher.[27]
Now, with specific
reference to the beta crystalline form of Imatinib, it was submitted on behalf
of Novartis that section 3(d) applies if a substance is a new form of a known
product having known efficacy, and that “known” in the specific context meant
proven and well established while “known efficacy” meant “efficacy
established empirically and proven beyond doubt”.
Citing with approval
the case of Monsanto Company v Caramandel Indag Products (P) Ltd,[28] the
Supreme Court disagreed and rejected the submission on the basis that it was
wrong in both fact and law. The court sealed the dismissal of the submission
with the powerful observation that the beta crystalline form of Imatinib
Mesylate is a new form of a known substance, namely, Imatinib Mesylate, with
well-known efficacy.90 Therefore, the fact that the beta form of Imatinib was a
product that claimed to enhance the form of its old counterpart triggered the
application of section 3(d).[29]
Very specifically, the
Court observed that in its application for a patent, Novartis averred that all
the therapeutic qualities of the beta crystalline form of Imatinib Mesylate
were also possessed by Imatinib in a free base form.
This, therefore, raised the question of
whether an enhanced efficacy over a known substance as demanded by section 3(d)
existed. The Court held that the correct "efficacy" to consider in
section 3(d) is "therapeutic efficacy" in the specific context of
medicines. The Court further noted that the test for enhanced therapeutic
efficacy must be applied strictly.[30]
The Court, therefore,
held that the chemical properties of beta crystalline Imatinib Mesylate may be
beneficial but do not add anything to therapeutic efficacy. On the contention
submitted on behalf of Novartis that the beta crystalline form of Imatinib had
increased bioavailability, the Court held that an increased bioavailability, in
the absence of compelling proof, may not necessarily lead to an enhancement of
therapeutic efficacy, hence Novartis' bid for a patent for the beta crystalline
form of Imatinib Mesylate had to fail.[31]
To conclude, the Court
ruled that the impugned form of Imatinib failed the test of invention as provided
for in section 2(1) clauses (j) and (ja) and section 3(d), that it did not have
enhanced therapeutic efficacy, and that Novartis' appeal had inevitably to
fail.
Post-Novartis Regime: Overview Of Recent Judgements On
Section 3(D)
The Supreme Court’s
decision was warmly welcomed by access to medicines activists and patient
organisations in India and beyond. It thus established a significant precedent
and various High Court judgements have cited the Novartis case with approval.
Interestingly, all of
the cases after the Novartis judgment have given a strict interpretation to
Section 3(d) and various drug product patents have been denied by the patent
office and by the Intellectual Property Appellate Board. These include
enantiomer for Tofacitinib (Sep 2015); Enzalutamide, a derivative (Nov 2016);
Epothilone B a polymorph (Dec 2018); Tiotropium bromide, a polymorph (July
2015) at the patent office; and Valganciclovir, a prodrug (July 2015) and
Lapatinib ditosylate salt (August 2013) by the IPAB. Recently, multiple
oppositions against Bedaquiline fumarate salt, had been filed in 2020.
Some of the
significant judgements have been discussed below.
In this case, the
Controller refused Indian patent application entitled “Isotopically Substituted
Pantoprazole” owned by Takeda GmBH (Takeda) for falling under the purview of
Section 3(d) of the Act.[32]
Takeda’s application
discloses and claims isotopically substituted (deuterated) pantoprazole and
enantiomers thereof that can be used to inhibit acid secretion in subjects
suffering from a gastrointestinal disorder. According to the specification, the
claimed deuterated compounds exhibit a decreased metabolization rate compared
to the corresponding non-deuterated compounds and thus have an improved
half-life. The specification also contained data demonstrating that 5
deuterated compounds exhibited higher metabolic stability and intrinsic
clearance values compared to their equivalent non-deuterated (pantoprazole)
compounds. Takeda argued that this data demonstrated that the claimed compounds
exhibited higher efficacy than pantoprazole.
The closest prior art
was European Patent Application 0 005 129 (D1) which disclosed non-deuterated
pantoprazole derivatives for the same use and U.S. Patent 6,818,200 (D2) which
taught that deuterated compounds have enhanced efficiency and thus are less
susceptible to the typical metabolic pathways, thereby resulting in an increase
in half-life. In view of this prior art, the Examiner rejected the claims as
being obvious and for failing to qualify as an invention under Section 3(d).
The Controller noted
that when examining whether or not a claimed invention violates Section 3(d),
the following analysis must be performed:[33]
1. Compare the claimed invention with the
closest compound known in the prior art (in this case the closest prior art
compound was pantoprazole); and
2. Determine whether Applicant has provided
sufficient evidence (such as through arguments and experimental evidence) to
demonstrate that the claimed compounds demonstrate significantly improved
therapeutic efficacy when compared to the closest prior art compound.
The Controller found
that the only experimental evidence provided related to metabolic stability and
intrinsic clearance values. According to the Controller, this data demonstrated
how the system acted on the claimed compounds. However, evidence of therapeutic
efficacy requires demonstrating how the drug acts upon the system. Because such
evidence was missing, the Controller affirmed the Examiner’s rejection under
Section 3(d).
Another major decision
which outlines Section 3(d) is the Roche case.[34] The dispute commenced over
anti-cancer drug between Roche and Cipla. Roche sold Erlotinib drug with brand
name 'Tarceva' which was introduced by Roche in the Indian market in 2006.
Cipla planned to launch the generic version of this drug in 2007.
In 2015, the division
bench of Delhi High Court finally stated that there was no infringement as the
patent which was in question was a mixture of Polymorphs A and B, whereas the
drug Tarceva drug consisted of only Polymorph B. The point here to be noted was
that Roche had applied for patent of Polymorph B but was denied by the Indian
Patent office as it did not satisfy the criteria of Section 3(d) and the test
of patentability was not satisfied. Moreover, the court considered the intent
of the legislature in enacting Section 3(d) and anti-evergreening laws and held
public interest above everything.
The Court analysed
Sections 2(1)(j), 2(1)(ja), 2(1)(l), 2(1)(ta) and Section 3(d) and held:
“Section 3 of the Act lays down a threshold
for patent eligibility and is not an exception to Section 2(1)(j) as urged by
learned Senior counsel for Cipla. Section 2(1)(j) provides a theoretical
definition of an invention while Section 3 illustratively outlines what are not
inventions. In other words, for subject matter that falls outside the scope of
Section 3, a qualitative analysis needs to be employed to ascertain whether it
satisfies the conditions of Section 2(1)(j), while for subject matter that
falls within the scope of Section 3, an analysis under Section 2(1)(j) need not
be employed as it will be rejected at the threshold.”[35]
It must be noted that
the Supreme Court in Novartis case[36] did not decide whether
Section 3(d) was a patent eligibility or patentability standard since this
question did not impact its determination on validity in the facts of that
case. Here, Delhi High Court negatived the proposition that Section 3(d) is a
patentability standard.
The Court further
clarified that the deeming fiction in Section 3(d) implies that when a patent
application for a substance is rejected by Section 3(d) because it is a
derivative of known substance, that substance would automatically be deemed to
be covered and disclosed by the prior art on the basis of which the application
was rejected, i.e., the known substance if under patent.
Thus, what Section
3(d) does impact, apart from the prosecution of a patent application, is the
construction of claims of the patent of the known substance whose ‘salts,
esters, ethers, polymorphs, metabolites, pure form, particle size, isomers,
mixtures of isomers, complexes, combinations and other derivatives of known
substance’ is sought to be patented independently, but fails because of Section
3(d).
Abraxis Biosciences
Drug Abraxane Case
Another patent that
has been refused by the patent office is for the anti-cancer drug Abraxane sold
by the US firm Abraxis BioSciences which was claimed to be a combination of new
form of a known substance Paclitaxel and anti-SPARC antibody.[37]
The patent application
on the Abraxane formulation was refused by the Controller of Patents on the
basis of lack of inventive step and Section 3(d) violation as the new form of a
known substance is patentable only when it exhibits enhanced efficacy. It paved
way for generic companies to launch affordable versions in the domestic market.
Boehringer Ingelheim
Drug Spiriva Case
Boehringer Ingelheim
filed a patent application (558/DELNP/2003) for crystalline tiotropium bromide
monohydrate in Patent Office, Delhi on 16th April, 2003. Indian Patent office
issued an order in March 2015 to revoke Boehringer’s patent covering
crystalline tiotropium bromide monohydrate.[38]
In its decision, the Patent
office ordered,
“The physical stability of the compound during
formulation cannot be considered as a sole factor for improvement of
therapeutic efficacy of the drug under as required under section 3 (d) of the
Indian Patent Act, adding the compound is “a product of mere trial and error”
and does not “involve any inventive skill”[39]
Further, in consonance
with the Novartis case, it was affirmed that Section 3(d) was incorporated in
the amended Patent Act with the objective of blocking the pharmaceutical companies’
attempt to claim the patent rights for incremental innovation involving new
forms of a known molecule with no significantly enhanced efficacy.
Hoff-Man La- Roche
Drug Valganciclovir case
Here, the patent
related to Valganciclovir[40]
drug used against active cytomegalovirus retinis infection affecting the eye of the patients
living with HIV, was rejected. The drug showed improved bioavailability when
administered orally but the Controller of Patents ruled that improved
bioavailability cannot be correlated with the efficacy and hence was rejected
on Section 3(d) grounds.
On 15 January 2020, the Delhi High Court adjudicated upon interim
injunction applications in two suits filed by AstraZeneca against Emcure
Pharmaceuticals Limited and MSN Laboratories Limited respectively.[41]
AstraZeneca had asserted three types of patents in the law suits: a species
patent (IN'209907), a crystalline patent (IN'247984) and a formulation patent
(IN'272674).
Rejecting each of the defendants' contention, the Hon'ble Court held
that the species patent IN'907 was not anticipated by the genus patent IN'229;
that the pleadings on record showed that the species patent IN'907 had enhanced
efficacy over IN'229 and that while the invention claimed in IN'907 (i.e., the
compound Ticagrelor) was covered within the Markush Structure of the genus
patent and IN'229 did not specifically disclose Ticagrelor.
With regards to Section 3(d), the Hon'ble Court held that in view of
the plaintiffs' specific pleadings stating the compound Ticagrelor claimed by
IN'907 was of high potency, high metabolic stability and demonstrated
bioavailability, it could not be said that IN'907 did not result in an
invention with enhanced efficacy.
In the recent 2021
case, the plaintiff in this case held two patents covering the product and
process to make Chlorantraniliprole (“CTPR”), an insecticide.[42] The
patents were species patents that were claimed in markush claims of an expired
patent that covered several species along with the patents in question. When
the plaintiff filed this suit for patent infringement of its CTPR patents, the
defendant countered that the patents are invalid because they were covered in a
prior patent. In response, the plaintiff argued that though the species were
covered, they did not form part of the patent disclosure.
The plaintiff also argued that the decision of the Supreme Court in
the Novartis would not advance the case of the Defendants, in the first place,
because the case deals with the patentability of the invention specifically in
the light of Section 3(d) of the Act. However, the issue in the present case is
on the vulnerability of the granted patent, and the onus is on Defendants to
show that the patent is vulnerable to challenge.
Rejecting this argument, the Hon'ble Court held that despite a
proceeding that was instituted by the defendants for declaration of
non-infringement prior to the institution of the suit for patent infringement,
the suit for patent infringement would continue.
In this context, the
Delhi High Court discussed Novartis elaborately and held the position of law
laid down by it as “something which is specifically claimed or covered by
the specific claim cannot be disowned by asserting that it was not disclosed.”
The Court stated that the Supreme Court’s
judgment in Novartis does not state that disclosure is equal to claim coverage,
but simply points out that there cannot be a large gap between the two. The
Court also observed that disclosure of a compound in a markush claim does not
necessarily make the species patent susceptible to anticipation, prior
claiming, obviousness or Section 3(d) challenge.
Understanding
The Threshold: Is There A Need For A Broader Scope?
A peripheral analysis of the Novartis case and the subsequent
judgements, as discussed in the previous sections, makes it clear that the
Indian courts have given higher importance to social justice instead of the
intellectual property rights of the pharmaceutical companies.
As depicted in the
previous section, the fear and confusion have only been exacerbated by
subsequent decisions by Indian courts rejecting patents for a series of
pharmaceutical substances. Most of these decisions centred on section 3(d) of
the Indian Patent Act.
In addition to this,
while Section 3(d) aims to prevent trivial patents, incremental inventions can
often include a considerable innovation.[43] In particular, in the
pharmaceutical industry, patents rarely involve new chemical entities but
rather incremental improvements over prior inventions. If the nonobviousness
standard is set so high that it effectively bars patentability of most
incremental pharmaceutical innovations, that rule may contravene TRIPS and be
detrimental to the Indian pharmaceutical industry by failing to provide proper
incentives for research and development for the long term.[44]
The interpretation of section 3(d) by the patent office, IPAB, and
Indian courts has primarily focused on direct evidence for the enhancement of
known efficacy of the drugs - indirect evidence in terms of improved bioavailability
has not been taken into consideration. These patent applications did not have
direct evidence in support of enhanced known efficacy, and therefore, the
patent offices and courts have not ventured to examine the other terms of
section 3(d).[45]
Now, the
“explanation” appended to section 3(d) was essentially taken from the
definition of “generic substances” given in the Directive 2001/83/EC of the
European Parliament[46].
Therefore, a proper interpretation of section 3(d) requires an understanding of
the scope and intent of the European Directive. The lack of understanding
around the scope and intent of the Directive is responsible for the existing
debate and controversy concerning section 3(d).
Part II, Annex 1 to
Directive 2001/83/EC states that generic substances must also contain the same
therapeutic moiety as the innovative substance.[47] If that is not the case,
the substance shall be considered a new active substance.
The scope of the
Directive is to regard derivatives as generic substances and thus, derivatives
differing in therapeutic moiety, possessing unknown efficacy, or either
significant differences in enhanced or reduced known efficacy, are not
considered generic substances under the Directive.
Further, European
Union’s Medicine Agency[48] lists
what might constitute significant differences in safety and/or efficacy to
justify a product as a new active substance. They include significant changes
to the dosing frequency; meaningful changes to the overall efficacy; meaningful
and clinically relevant changes that allow the product to be used in a wider
patient population; or previously excluded sub-groups. Such circumstances could
include shortened time for pain relief, decreased mortality etc.
Thus, the controversy and confusion can be removed by interpreting
section 3(d) in light of the European Directive and its allied guidance
documents. Such an interpretation would greatly enhance the scope of new
physical forms and new derivatives of existing pharmaceutical substances
outside the purview of section 3(d), would help remove the ambiguity, and would
lead to proper interpretation of section 3(d).
Balancing Innovation And Country’s Needs: Need To
Lower The Efficiency Requirement
From the outcomes of
the legal battles between the generics industry and Pfizer, Bayer, Hoffman-La
Roche, and Boehringer Ingelheim, it is clear that the Courts are inclined
towards protecting domestic generics industry. Pharmaceutical MNCs have yet to
win a decisive battle in patenting their drug innovations. The Indian legal
system has given no indication that it will provide MNCs with any sort of
relief. Although the Indian government's intent to secure low-cost life-saving
drugs to its population is laudable, scholars believe that this is an extremely
limited view.[49]
According to Forbes, “it
really does cost billions of dollars to invent new medicines for heart disease,
cancer, or diabetes. The reality is that the pharmaceutical business is in the
grip of rising failure rates and rising costs.”[50] As a result, without some
sort of patent protection, pharmaceutical companies are rarely willing to
develop drugs.[51]
These high costs, in
conjunction with the recent string of legal disincentives, could very well and
stifle innovation and drive pharmaceutical MNCs permanently away from the
Indian market. Factoring in rigorous competition from generics manufacturers,
pharmaceutical companies are unable to recover R&D costs.[52]
Thus, to achieve
India's goal of providing low-cost, accessible drugs to its people while also
maintaining some semblance of certainty for MNCs and protection to new drugs
they seek to patent, India should expand the categories covered under the
“efficacy” requirement of Section 3(d) of the Patents Act rather than limit it
to products that have a “therapeutic effect in healing a disease.” Other
provisions in the Patents Act, such as the "inventive step" provision
in Section 2(1)(j) and compulsory licensing in Section 92A, already provide
sufficient protection to the Patents Act to keep frivolous patents from issuing.
Conclusion
“Wherever the art of
Medicine is loved, there is also a love of Humanity.”
-
Hippocrates 400 BC
The Supreme Court in
its Novartis judgement made clear that India is a developing country and the
availability of medicines at a cheaper rate is necessary for the lives of 1
billion people. However, the Court's decision to adopt a narrow interpretation
of Section 3(d) is problematic. Although a narrow interpretation of Section
3(d) would provide drug manufacturers with notice that any drug must
specifically have an increased healing effect on the body, such an
interpretation does not serve the policies of India's patent system, nor does
it promote innovation.
This restrictive
interpretation excludes too many possible improvements on a drug. For example,
increased bioavailability, enhanced lipid solubility, increased heat stability
of the chemical drug inside the body, increased shelf life of the drug,
improved drug delivery systems, drugs targeting protein kinases as therapeutic
targets, and reduction of microbial growth would all likely fall outside the
court's narrow interpretation of "therapeutic efficacy."
These classes of drug
improvements may lead to increased efficiency by allowing patients to take
smaller doses of drugs, take fewer combinations of drugs, and prolong the
maximal potency of the drugs. Such improvements also increase the chances that
the drug will fulfil its desired purpose. But because these improvements do not
result in an increased "healing effect" on the body, they do not meet
Section 3(d)'s "efficacy" threshold.
A broader
interpretation of Section 3(d) will bring a stronger balance to the Patents Act
and protect the kinds of drugs that will lead to future pharmaceutical
breakthroughs. Companies such as Novartis must collaborate and cooperate with
developing countries like India to promote access to their life-saving drugs.
But, a patent system like India's, with weak protections and provisions that
stifle innovation, is not the answer. Although foreign pharmaceutical companies
seem to be the likely beneficiaries of a less restrictive Section 3(d) in the
short-term, in the long-term, that interpretation will encourage an
already-vibrant Indian generics industry to innovate and become leaders in
scientific advancement.
Article Information
CRITIQUE OF THE NOVARTIS CASE: BROADENING THE HORIZON OF SECTION 3(D) (By-Richik Dadhich)
Authors: Richik Dadhich
- Journal IJLRA
- ISSN 2582-6433
- Published 2022/07/20
- Volume 2
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
- Access Open Access
- License CC 4.0
All research articles published in International Journal for Legal Research and Analysis are open access and available to read, download and share, subject to proper citation of the original work.
Disclaimer: The opinions expressed in this publication are those of the authors and do not necessarily reflect the views of International Journal for Legal Research and Analysis.