Section 3(d) of the Indian Patent Act, 1970 is one of the most important sections while prosecuting pharmaceutical patent applications in India. About the Author: Prity Khastgir is a Biotech and Pharma Patent Attorney at Tech Corp Legal LLP, an Indian law firm based in New Delhi. She also serves as Director at Tech Corp International Consultants Pte. Ltd. (Singapore), wherein she advises clients regarding creation and monetization of intangible assets. Academically, Prity is a Goldman Sach 10,000 Women Entrepreneur Scholar certified by Indian School of Business (ISB, Hyderabad).

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Importance of Section 3(d) and Section 8 of the Indian Patent Act, 1970
Section 3(d) of the Indian Patent Act, 1970 is one of the most important sections
while prosecuting pharmaceutical patent applications in India. Section 3(d) intends to
avert evergreening of patents. India in the current scenario has established its
credibility for innovative IP standards by including section 3 which relates to “What
are not inventions” and particularly section 3(d) intents to balance pharmaceutical
patent protection with the need to provide access to affordable medicines and
healthcare services to the common man at large. The real intent of section 3(d) is
that the inventions that are mere "discovery" of a "new form" of a "known substance"
and do not result in “increased efficacy” of that substance are not patentable. The
emphasis here should be given to the word “efficacy” and if the patent applicant can’t
provide substantial information about the “increased efficacy” of the "new form" of a
"known substance" with respect to the known efficacy of the substance concerned it
will fall under section 3(d). This means in the patent regime India will not grant
patents for inventions which are minor modifications and thereby preventing undue
monopoly of the multinational pharma giants during the extended period of patent
protection.

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Particularly, in the Novartis’s Glivec patent, the Supreme Court provides an
explanation on the word “efficacy” as mentioned in Section 3(d) of the Indian Patent
Act, 1970 and consequently, further defines the test of inventiveness and criteria for
patentability for pharmaceutical patents. It found that Novartis’ patent application for
the beta-crystalline form of Imatinib Mesylate (polymorph B) did not fulfil the criteria
and did not pass the test of Section 3(d) as it did not show any enhanced
“therapeutic efficacy” over a previously known substance which in this case is
Imatinib free base. While the known substance is a free base, the patent application
claims a salt of it in specific crystal form.
Although Novartis beta salt had 30% increased bio-availability as compared to the
base, the office did not agree and concluded that bio-availability is not as same as
therapeutic efficacy. Bio-availability is a property of a therapeutic substance which
demonstrates the degree to which the substance becomes available to the target
tissue after administration. The therapeutic effect in case in hand is a cancer curing
effect of Imatinib and is well known from the Zimmerman patent (1993).1
It should be
duly noted, that section 3(d) draws a clear distinction between “ever-greening” and
incremental innovation. By making the "new form" of a "known substance" with
enhanced efficacy patentable, section 3(d) encourages the research and
development of existing products or technologies to facilitate and get the better
therapeutic efficacy pharmaceutical products in the market that address the unmet
needs of the healthcare sector.
Earlier this month, Kolkata Patent office clarified its decision on divisional patent
applications of Roche Holding AG for Herceptin.2
Mainly three divisional patent
applications were filed before the patent office, first 1638/KOLNP/2005 divisional
1
http://www.ipab.tn.nic.in/Orders/100‐2009.htm
2
http://pib.nic.in/newsite/erelease.aspx?relid=97629

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application out of IN/PCT/2000/391/KOL, second 3272/KOLNP/2008 divisional
application out of 1638/KOLNP/2005, and third 3273/KOLNP/2008 divisional
application out of 1638/KOLNP/2005. However, the point to be noted here is second
and third patent applications were divisional to a divisional patent application. As per
the Indian Patents Act, if the patent claims of an application relate to more than one
application, such application can be divided and further applications are called
divisional applications, and can be filed under section 16. A divisional application has
to be filed before the date of grant of the first application. In view of law, filing of
divisional applications 3272/KOLNP/2008 and 3273/KOLNP/2008 was not
permissible. Roche Holding AG had missed the statutory timelines prescribed under
the Indian Patent act or had abandoned due to incorrect filing.
In current scenario, definitely the Indian patent regime is strengthening its patent
ecosystem and invalidating the weak patents being filed by the multi national
companies and thereby preventing “evergreening” of the block buster drugs.
Principle of natural justice has been followed by the Indian Patent Office while
prosecuting the patent applications. In some cases, it was found that the patent
applicants misrepresented facts and withheld information while filing requisite forms
for providing up to date status of the same patent applications filed in other
countries. Recently, the Intellectual Property Appellate Board (IPAB) revoked patents
protecting Ganfort (bimatoprost/ timolol maleate)3
for treatment of ocular
hypertension and Combigan (brimonidine tartrate/timolol maleate)4
for topical
opthalmic use granted to Allergan Inc. Allergan violated section 8 of the Indian
Patent act, and no information was furnished on the prosecution histories of EPO
and USPTO counterpart applications. In light of prior art cited the patent claims were
3
http://www.ipab.tn.nic.in/172‐2013.htm
4
http://www.ipab.tn.nic.in/173‐2013.htm

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obvious, Timolol was the preferred beta blocker that was conventionally employed in
prior art combinations, and it was proved to be obvious to employ the same in
combination with Bimatoprost that has a mechanism of action that is complementary
to that of Timolol. The IPAB has also revoked a patent of Glaxo Group's, breast
cancer drug Tykerb, finding that it was obvious and was hit by Section 3(d), of the
patent act. Recently, Section 3(d) has been cited in number of other cases before
the patent office before the grant of the patent. Over the years, more than 4,000+
patents for pharmaceutical inventions were issued by the Indian Patent Office.5
Moreover, most of the patents are owned by foreign companies in India. The foreign
pharma companies should appreciate this fact and should respect the law of the
land. If we see the percentage of pharmaceutical patents granted in India vs. the
number of pharmaceutical patents revoked, the percentage is hardly 3 to 4 percent
of weak patents which are being revoked by the IPAB and the respective patent
offices in India.
However, I strongly feel that the patent office manual should give better clarity and
define terms such as “increased efficacy” of a "new form" of a "known substance"
under section 3(d). In some cases, the IPAB has cited that the patent did not fulfil the
criteria and did not pass the test of Section 3(d) as it did not show any enhanced
“therapeutic efficacy”. The patent manual of India should include appropriate
illustrations and in-depth examination procedures to be followed while dealing with
pharmaceutical patent applications.
In recent scenario, the Indian generic industry has seen a lot of changes. Due to the
introduction of process patent regime for pharmaceuticals in 2005, there has been
growth in the pharmaceutical sector. Some of the leading pharmaceutical giants in
5
http://ipindia.nic.in/patent_Applications_Filed/patentGranted_Pharma_2010‐11_Jul2013.pdf

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India including Dr. Reddy’s and Ranbaxy have invested a lot in research and
development and subsequently have made them competitive in the international
market scenario.
A About the Author: Prity Khastgir is a Biotech and Pharma
Patent Attorney at Tech Corp Legal LLP, an Indian law
firm based in New Delhi. She also serves as Director at
Tech Corp International Consultants Pte. Ltd.
(Singapore), wherein she advises clients regarding
creation and monetization of intangible assets.
Academically, Prity is a Goldman Sach 10,000 Women Entrepreneur Scholar
certified by Indian School of Business (ISB, Hyderabad).