Innovation, Economic Development, and Intellectual Property in India and China by Kung-Chung Liu & Uday S. Racherla

Author:Kung-Chung Liu & Uday S. Racherla
Language: eng
Format: epub, pdf
ISBN: 9789811381027
Publisher: Springer Singapore

2.4 Interpretation of Patentable Subject Matter

The flexibility to interpret patentable subject matter creates opportunities for the domestic generic drug companies to challenge a pharmaceutical patent in India. Given that the term “invention” is not defined in the TRIPS Agreement, there is flexibility to interpret patentable subject matter. The Indian Patents (Amendment) Act of 2005 excludes any new form of a known substance from patentable subject matter, if the new form does not result in enhancement in efficacy. This amendment would make it easier to challenge a pharmaceutical patent in India.

In the Novartis v. Union of India case, the patent application on Gleevec was rejected by the Controller, which rejection was upheld by the IPAB and eventually by the Supreme Court on the ground that the patent failed to meet the requirements of section 3(d) of the Patents (Amendment) Act of 2005. According to section 3(d), a modification of a known drug is only patentable when it enhances therapeutic efficacy. The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug imatinib, which was disclosed in the 1993 patent application. However, Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib.44 The rejection was considered an effective practice to prevent evergreening of pharmaceutical patents and create opportunities for local generic drug companies.45 Novartis case was a benchmark for preventing the evergreening of pharmaceuticals. After 2013, every pharmaceutical patent has to pass the standards set by the Supreme Court in the Novartis case. Meanwhile, in 2014, the Controller framed a new set of guidelines for examining pharmaceutical applications, which incorporates the findings in the Novartis case.46

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