Novartis AG., Natco Pharma Ltd. and Cancer Patients Aid Association vs. Union of India
[(2013) 6 SCC 1, 2013 SCC OnLine SC 271]
Coram: Division Bench comprising Hon’ble Justice Aftab Alam and Justice Ranjana P. Desai
Forum: Hon’ble Supreme Court of India
Case No.: Civil Appeal Nos. 2706-2716 of 2013 with Nos. 2717-28 of 2013.
Date of Decision: April 1, 2013.

Facts:

  • Novartis( Appellant), a multinational pharmaceutical company headquartered in Switzerland, applied for a patent for the beta-crystalline form of imatinib, a medication used to treat gastrointestinal stromal tumors and chronic myeloid leukaemia.
  • The Indian Patent Office and later the Intellectual Property Appellate Board (IPAB) were the Respondents in the case.
  • Novartis applied for a patent in India for the beta-crystalline form of imatinib, claiming it was an improved drug version. Indian Patent Office and later, the IPAB rejected the application.
  • Novartis challenged these rejections by filing two writ petitions in the Madras High Court. These petitions were later transferred to the IPAB, but the case was later dismissed by the IPAB. Novartis then appealed to the Supreme Court of India.


Background/Procedural History:

  • Novartis AG filed a patent application in India in 1998 for Glivec, based on a Swiss priority date of July 18, 1997.
  • The application was initially subject to the "mailbox procedure" and was later granted exclusive marketing rights (EMR) for the drug.
  • Novartis applied for a patent in India for the beta crystalline form of imatinib, claiming it was an improved version of the drug. However, the Indian Patent Office and later the IPAB rejected the application under Section 3(d) of the Indian Patents Act, citing anticipation, obviousness, and lack of enhanced therapeutic efficacy under section 3(d) of the Patents Act.
  • Novartis challenged these rejections by filing two writ petitions in the Madras High Court, questioning both the rejection of its patent application and the constitutionality of section 3(d) of the Patent Act, 1970. These petitions were later transferred to the IPAB, which also dismissed them.
  • Hence, the appeal was filed before the Supreme Court of India, challenging the IPAB's decision was incorrect and that the drug deserved patent protection.

Main Issues:

  1. Whether the invention complied with Section 3(d) of the Patent Act?
  2. What is the meaning of efficacy under Section 3(d) of the Patent Act, 1970?