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IP: India, generics and the impact of Novartis’ failed Gleevec claims

A recent India Supreme Court decision may have set a higher patentability bar than that of most other countries

India has earned its reputation as “the world’s pharmacy” because it supplies—primarily in the form of generics—much of the affordable medicine needed by countries in the developing world. The country’s $26 billion generic pharmaceutical industry gained the lion’s share of its growth in the period before 2005, when India started offering patent protection to pharmaceuticals. Since then, courts in India have struggled to balance the international trade commitments that prompted the 2005 creation of India’s patent laws with a desire to continue providing wide-spread access to lower cost generic medicines.

Swiss drug manufacturer Novartis recently found itself on the losing end of that struggle. In April, it failed in an attempt to obtain patent protection for its anti-cancer drug Gleevec (marketed in India and Europe as Glivec). Though the vagaries of timing play a part in the outcome of Novartis’ claims, the decision still has significant implications for originator and generic pharmaceutical manufacturers, particularly in India and the U.S.

But the Supreme Court chose a different, more stringent interpretation of the “efficacy” language of section 3(d). Because the subject matter of the patent under consideration involved a compound of medicinal value, the court said that, before allowing the patenting of a previously known substance, section 3(d) required that the applicant show actual enhanced “therapeutic efficacy.” Here, the court found no evidence that the beta crystalline form of imatinib produced any enhanced or superior therapeutic effect when compared to the prior—and patent-ineligible—version of the drug. That determination means that Novartis has no patent rights for Gleevec in India and that it cannot stop generic manufacture of the drug there.

Section 3(d), evergreening and the future of generics in India

Contributing Author

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Jake Holdreith

Jake Holdreith is a partner at Robins, Kaplan, Miller & Ciresi L.L.P. He counsels clients and tries complex lawsuits including intellectual property, regulatory...

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Contributing Author

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Bryan J. Vogel

Bryan J. Vogel is a trial lawyer and partner with the firm Robins, Kaplan, Miller & Ciresi L.L.P. He is a registered patent attorney with...

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