The Burrill Report


A lengthy battle between Novartis, India’s patent office, and affordable care advocates is expected to enter its final chapter before the end of March as the Swiss company presents final arguments for why India’s Supreme Court should rule in favor of granting patent protection for its cancer therapy, Glivec.

The U.S. Food and Drug Administration first approved Glivec, sold in the United States as Gleevec, in May 2001. Heralded as a breakthrough cancer treatment, it was quickly copied by Indian drugmakers eager to bring a low-cost generic to market—a goal they accomplished in 2003. Since then, global intellectual property agreements opened the way for Novartis to seek patent protection for the drug in India.

But when it did so, Indian patent authorities rejected the company’s application, suggesting it fell short of novelty and efficacy requirements set forth in Indian patent law. Novartis initiated legal action in 2006 to appeal the rejection and, following a loss in that effort, sought to challenge interpretation of the law.

“The ruling is important for all innovators, national and global, with a presence or wanting to have a presence in India,” Ranjit Shahani, managing director of Novartis India told The Economic Times. “This is about safeguarding incentives for better medicines so that patients' needs would be met in future.”

Winning the case is important for Novartis, which is relying on revenue from emerging markets, such as India, to boost its bottom line. In 2011, India was among six emerging markets that generated approximately $5.8 billion, or about 10 percent of net sales for Novartis.

Patient advocates worry that if Novartis wins the case, access to affordable drugs to treat life-threatening conditions will be at risk. If Novartis wins the case, “patents would be granted in India as broadly as they are in wealthy countries and on new formulations of known medicines already in use. India would no longer be able to supply much of the developing world with quality affordable medicines,” says the international medical humanitarian organization Médecins Sans Frontières. In a February protest, the group called on Novartis shareholders to urge the company to drop its ongoing court case against the Indian government.

Novartis argues that no matter the outcome of the case, drug access programs—such as its own that provides Glivec free to around 15,000 patients in India—and international organizations seeking to expand access to affordable products in developing countries will ensure that patients in need won’t lose access to life-saving drugs.

Nevertheless, the case reflects the growing importance of intellectual property battles in emerging markets that are likely to flare in the future as the importance of emerging markets to drugmakers magnifies.


March 09, 2012
http://www.burrillreport.com/article-novartis_takes_glivec_arguments_to_india%e2%80%99s_supreme_court.html