W: www.techcorplegal.com 
W. www.biocorplegal.com 
 
Importance of Section 3(d) and Section 8 of the Indian Patent Act, 19...
W: www.techcorplegal.com 
W. www.biocorplegal.com 
 
Particularly, in the Novartis’s Glivec patent, the Supreme Court prov...
W: www.techcorplegal.com 
W. www.biocorplegal.com 
 
application out of IN/PCT/2000/391/KOL, second 3272/KOLNP/2008 divisi...
W: www.techcorplegal.com 
W. www.biocorplegal.com 
 
obvious, Timolol was the preferred beta blocker that was conventional...
W: www.techcorplegal.com 
W. www.biocorplegal.com 
 
India including Dr. Reddy’s and Ranbaxy have invested a lot in resear...
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Section 3d of the Indian Patent Act and Section 8 of the Indian Patent Act are the most important patent sections while Prosecuting Pharmaceutical Patent Applications in India

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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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Section 3d of the Indian Patent Act and Section 8 of the Indian Patent Act are the most important patent sections while Prosecuting Pharmaceutical Patent Applications in India

  1. 1. W: www.techcorplegal.com  W. www.biocorplegal.com    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.
  2. 2. W: www.techcorplegal.com  W. www.biocorplegal.com    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 
  3. 3. W: www.techcorplegal.com  W. www.biocorplegal.com    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 
  4. 4. W: www.techcorplegal.com  W. www.biocorplegal.com    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 
  5. 5. W: www.techcorplegal.com  W. www.biocorplegal.com    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).

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