AZ, BMS get a breather as India yanks CL appeals


Compulsory license applications in India for Sprycel (dasatinib) from Bristol-Myers Squibb ($BMS) and Onglyza (saxagliptin) from AstraZeneca ($AZN) have been quietly withdrawn as firms in the space suggest at least a higher bar has been set.

Reuters reports that two midsized makers of generic drugs, Hyderabad-based Lee Pharma for Onglyza, and BDR Pharmaceuticals from Mumbai for Sprycel, withdrew their license applications, blaming a lack of government support for the effort.

"There is no point in pursuing it anymore," Dharmesh Shah, BDR's managing director, told Reuters, who was echoed by his counterpart at Lee Pharma.

"If the government itself is not inclined then why unnecessarily slog on this issue?" said A. Venkata Reddy, Lee's managing director.

Lee and BDR were in the process of appealing rejections on the initial applications.

The move to halt the applications comes after India's Commerce Ministry in March shot down claims by the U.S.-India Business Council that compulsory licenses for drugs are a thing of the past.

Compulsory license applications under Section 3(d) of the Indian Patent Act (1970) have bedeviled several multinational firms in India, including Bayer HealthCare, which lost a round for Nexavar (sorafenib) in 2012. Those cases prompted complaints that India was unfair in such approvals and that dissuaded larger investments in the country.

Prime Minister Narendra Modi, who came to power in 2014 on a promise of creating manufacturing jobs, has said that getting companies to set up shop in India means protecting intellectual property. But critics from civil society groups have pointed out that in the case of drugs, a wide swath of the population lives in poverty and affordability is a cornerstone of public policy.

Reuters quoted Sujay Shetty, head of the life sciences practice for PwC in India, as suggesting the pathway to a compulsory license remains open in India, but with a higher threshold.

"You can never say never in India because of pressure on prices and access to medicines," Shetty told Reuters.

- here's the story from Reuters