Big Pharma Fights Drug Rulings In India

Landmark drug patent protection cases involving Bayer, Roche, and Novartis are advancing in India this month. Together, they will help determine how friendly the country is to Western pharmaceutical makers.

On Sept. 3, Bayer filed an appeal with the Intellectual Property Appellate Board in Chennai over a compulsory license order entitling the Indian firm Natco Pharma to produce a generic version of the Bayer kidney and liver cancer drug Nexavar. Issued in the spring, the license let Natco onto the market by paying Bayer a modest 6% royalty on sales of the generic drug. The order marks the first time that a foreign branded drug has been subject to compulsory licensing in India.

On Sept. 7, Roche lost a case in the High Court of Delhi, where it had argued that the Indian drug producer Cipla was infringing on its patents by selling a generic version of the lung cancer drug Tarceva. In a 275-page ruling, the court sided with Cipla’s contention that Tarceva is based on a different polymorph of the active ingredient erlotinib than the one Roche patented in India. Roche had attempted to patent the different polymorph, but India rejected it as too similar to the patented one.

“We are strongly considering an appeal,” Roche says. “Many of the cheap generic drugs today used in India were once patent-protected and are only available to society because companies such as Roche were willing to take a risk by investing in new innovative drugs.”

Meanwhile, on Sept. 11, Novartis began contesting in India’s Supreme Court key features of the pharmaceutical patent regime that the country instituted in 2005. The Novartis challenge follows India’s repeated refusal to grant patent protection to the cancer drug Gleevec on the grounds that it is nothing more than a new crystal form of an older compound. Gleevec enjoys patent protection in most major markets around the world.

“Novartis challenged the decision not to grant a patent to our life-saving medicine Gleevec because we strongly believe safeguarding incentives for innovation through the granting of patents leads to better medicines for patients,” the company says.

Although each case involves its own complex scientific and legal circumstances, drugmakers and patient activists are watching the disputes for the tone they collectively will set about intellectual property protection in India. Some observers see India as a model for the developing world.

Legal and medical scholars Peter Roderick and Allyson M. Pollock, at Queen Mary, University of London, argue that India’s system of intellectual property protection “should help rather than hinder” access to drugs in India. “The Bayer and Novartis cases are seeking to undermine public health considerations aimed at improving access and therapeutic advantage,” they write (Lancet, DOI: 10.1016/S0140-6736(12)61513-X).