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August 13, 2007
Volume 85, Number 33
p. 14


India Patent Law Decision

Court upholds stipulation that new forms of a drug cannot be patented unless they improve efficacy

Ann Thayer

The High Court in Chennai, India, has dismissed a petition filed by Novartis challenging the constitutionality and World Trade Organization compliance of India's patent law. The Swiss drug company took exception to a stipulation that new forms of a drug cannot be patented unless they offer improved efficacy. On these grounds, India's patent office, contrary to those in nearly 40 other countries, refused to patent Novartis' anticancer drug Gleevec in 2006.

Although Novartis is unlikely to appeal, the company believes the High Court's decision will have long-term negative consequences for R&D by eliminating incentives for companies to invest in India. "Medical progress occurs through incremental innovation," said Paul Herrling, Novartis' head of corporate research, after the ruling. "If Indian patent law does not recognize these important advances, patients will be denied new and better medicines."

While the court dismissed one challenge, it left WTO itself to determine whether Indian patent law complies with the WTO agreement on trade-related aspects of intellectual property rights. Novartis also awaits a decision by a new Indian intellectual property review board on the firm's request for reconsideration of its Gleevec patent application.

Meanwhile, generic drugmakers in India can still make generic versions of Gleevec. Humanitarian organizations that rely heavily on Indian suppliers consider the court's decision a major victory for patient access to affordable medicines in developing countries. Novartis points out, however, that it already provides Gleevec free to 99% of patients in India to whom the medicine has been prescribed.

Chemical & Engineering News
ISSN 0009-2347
Copyright © 2011 American Chemical Society

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