Supreme Court of India Denies Novartis Patent Application

by Miller Canfield

In a landmark judgment delivered on April 1, 2013, the Supreme Court of India dismissed an appeal by Novartis AG, a Swiss pharmaceutical giant, to win patent protection in India for its cancer drug Glivec. The polarizing decision has been hailed by activists as a step in the right direction for affordable healthcare, and as being detrimental to innovation and investment by the international business community.


Prior to 2005, Indian patent law only provided for process patents. In 2005, the Patents Act, 1970 (the “Act”) was amended retrospectively to allow for product patents so that India could meet its obligations under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (the “TRIPS Agreement”). The Act was welcomed by multinational companies as a measure to curb Indian generic drug companies that were manufacturing low-cost versions of drugs patented by the multinationals.

In 1997, Novartis filed an application for a patent for Glivec - the application was taken into consideration in 2005, under a “mailbox” scheme, after the change in the patent regime. In 2006, the Indian Patent Office ruled that the drug was not substantially different from one for which patents had already been given in the U.S. and Europe and that the active ingredient, imatinib myselate, was a known compound before the development of Glivec, and therefore it did not pass the requisite novelty test to obtain a patent. Novartis contended that it had developed a newer beta-crystalline form of imatinib myselate, which was patentable. On appeal, the decision by the Patent Office to deny Novartis a patent was upheld by the Intellectual Property Appellate Board in 2009. Novartis filed an appeal before the Supreme Court of India.

Factors considered by the Court

In its 112-page judgment, the Court considered a variety of factors that led to its decision, including:

  • The need to strike a balance between promoting research and development in science and technology and keeping private monopoly at a minimum;
  • The particular context in which patent law developed in India, with an aim to minimize the abuse of patent monopoly;
  • A comparison of the high growth rate of the domestic pharmaceutical industry with that of the multinational companies in India, prior to the changes in patent law in 2005;
  • India’s reputation as the “pharmacy of the world” - a low cost producer of high quality bulk drugs;
  • The provisions of the TRIPS Agreement;
  • The Doha Declaration on TRIPS and Public Health of 2001, which took into account the effect of intellectual property protection on prices and public health concerns caused by it and enabled member states to control patent rights for public health reasons;
  • Concerns voiced by the WHO and by the international community on the effect of the TRIPS Agreement on the supply of affordable drugs from India, particularly to countries in Africa and South East Asia;
  • The Parliamentary debate in India over the changes in patent law in 2005;
  • The technical details relating to Glivec, provided by Novartis in its patent application;
  • The labeling on packages of Glivec;
  • The price of the drug marketed by Novartis – Rs. 120,000 (approximately $1,700) and the price of the generic drug in the market (Rs. 5,000 to Rs. 9000, approximately $ 200).

Interpretation of the Act

In deciding Novartis’s appeal, the Court was primarily required to interpret Section 3(d) of the Act, which states that 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 is not an invention for the purposes of the Act. The provision also explains that derivatives of a known substance are to be considered the same substance, unless they differ significantly in properties with regard to efficacy. The Act defines “invention” as a new product or process involving an inventive step and capable of industrial application. “Inventive step” is defined to mean a feature of an invention that involves technical advance as compared to the existing knowledge, or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

Section 3(d) aims at preventing “evergreening”, i.e., prolonging the life of a patent by making minor incremental changes that do not necessarily alter the utility and features of the original patented product. The Court was of the opinion that Section 3(d) applied particularly to pharmaceuticals and that there was a higher requirement for the granting of patents in India; what was patentable in other countries may not be patentable in India.

While discussing the meaning of “efficacy”, the Court laid down that the test of efficacy, in the context of Section 3(d), for a medicine that claims to cure a disease could only be “therapeutic efficacy”, which must be judged strictly and narrowly. It was found that the physico-chemical properties of beta crystalline form of imatinib mesylate that distinguished it from imatinib mesylate had nothing to do with therapeutic efficacy.

The Court also considered whether a patent granted previously in the U.S. (the “Zimmerman Patent”) also included imatinib mesylate, which would make it a known substance. The Court rejected Novartis’s contention that imatinib mesylate was a new product and the outcome of an invention beyond the Zimmermann patent. It held that imatinib mesylate was a known substance from the Zimmermann patent itself, and was therefore not an ‘invention’ for the purposes of the Act. Further, it was held that the beta-crystalline form of imatinib myselate did not have any pharmacological properties that were not possessed in the free base of imatinib, and therefore, both the compounds were known substances with known efficacy.

The Court recognized that the Indian legislature had to balance its obligations under the TRIPS Agreement with its duty to protect and promote public health measures in India. It was clarified that its decision applied narrowly to the case at hand and that Section 3(d) does not bar patent protection for all incremental inventions of chemical and pharmaceutical substances. In dismissing the appeal by Novartis with costs, the Court found that the beta crystalline form of imatinib mesylate, failed in both the tests of invention and patentability as provided under the Act.


The decision of the Supreme Court is likely to have implications for several Western pharmaceutical companies involved in intellectual property cases in India. Many multinational pharmaceutical companies have expressed their frustration at the way the Indian Patent Office and courts have interpreted the Act to restrict patent protection for their drugs in favor of domestic generic drug companies. The decision will raise questions about the ability of multinational companies to obtain patents in India for newer versions of existing drugs and the commitment of the government to attracting foreign investment in the pharmaceutical sector. In 2012, the Indian Patent Office granted a compulsory license to Indian drugmaker, Natco, to manufacture Bayer’s patented cancer drug, Nexavar

The perceived lack of protection for intellectual property rights in India may also have long-term effects on innovation in drug-making. Without patent protection, there will be fewer incentives for multinationals to invest in research and development for new treatments. Novartis has warned that it will be cautious about investing in India, especially over introducing new drugs, and seek patent protection before launching any new products. It will also continue to refrain from research and development activities in the country.

The decision is also a wake-up call to the Indian government to introduce reforms in the healthcare, insurance and drug-pricing sectors in India. India’s health care system is poorly funded and the lack of extensive insurance coverage means that individuals bear the brunt of medical costs. There is a need to introduce negotiated tiered drug-pricing that allows access to expensive medicines. Given the recent slowdown in the Indian economy and the need to attract foreign investment, it is crucial that the Indian government restores confidence in the Indian market among foreign investors.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Miller Canfield | Attorney Advertising

Written by:

Miller Canfield

Miller Canfield on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.