Indian Compulsory License Debate Enters New Phase With Push From Local Pharma Natco
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - In a move that could have far-reaching impact in determining India's approach to compulsory licensing, Natco Pharma - the local oncology and anti-HIV drugs specialist - has written to German drugs-to-agrochemicals giant Bayer to provide it with a "voluntary license" to manufacture and market its anti-cancer drug brand Nexavar (sorafenib)
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MUMBAI - In a move that could have far-reaching impact in determining India's approach to compulsory licensing, Natco Pharma - the local oncology and anti-HIV drugs specialist - has written to German drugs-to-agrochemicals giant Bayer to provide it with a "voluntary license" to manufacture and market its anti-cancer drug brand Nexavar (sorafenib). According to a top source from the legal fraternity, the Indian company in its note to Bayer pleaded that the life-saving cancer medicine be made available to needy patients at around $218 per month (10,000 Indian rupees per month) compared to $6,123 per month (2.8 million Indian rupees per month) charged by Bayer in other markets including developed markets. Nexavar Hit By A Saga Of Court Battles When queried by PharmAsia News, Natco declined to comment on the news development. Bayer India spokesman Aloke Pradhan confirmed that Bayer received a request Dec. 6 from Natco for a voluntary license to manufacture sorafenib in India. Interestingly, another Indian generic major Cipla is fighting a protracted battle with Bayer at the Delhi High Court for alleged infringement of patent rights for the same drug, but has gone ahead and launched at risk a sorafenib version last year. Cipla, which has consistently retained the largest market share among its Indian peers like Sun Pharma, Cadila and Lupin, priced its sorafenib brand at $612 per month (Rs. 28,000 per month) and is said to be doing exceedingly well in terms of revenues due to a formidable distribution chain and reach to doctors. "As a research-and-development-focused company, Bayer relies strongly on recouping its research expenses during the limited period of patent protection," Bayer's Pradhan said in an emailed response. "Only then can Bayer ensure continued investment for further research and innovation." The Bayer spokesman also said that Natco had not been able to make its case for the grant of a voluntary license, and "we have therefore rejected Natco's request." Earlier in December, Bayer suffered a major setback in its efforts to secure exclusive rights for its brand after India's highest legal authority - the Supreme Court - rejected its petition to disallow the Drug Controller General of India from proceeding with the registration of generic products that could infringe Bayer patents (Also see "Bayer Suffers Nexavar Setback As India's Supreme Court Dismisses Linkage of Patent With Generic Marketing Approval" - Scrip, 2 Dec, 2010.). Termed "patent linkage," a few India-based patient advocacy groups like Lawyers Collective and generic companies like Cipla have battled against Bayer's claims to establish a link in India between the drug approval process and the patent status of a drug. Testing Times For Compulsory License Earlier in December, Natco had also sought a voluntary license for ViiV Healthcare's anti-HIV brand Celsentri (maraviroc). ViiV is a joint venture of Pfizer and GSK dedicated to the development and marketing of anti-AIDS medicines ('Natco Seeks To Trigger India CL Law By Asking Pfizer To OK HIV Copy,' PharmAsia News, Jan. 6, 2011). ViiV Healthcare spokeswoman Rebecca Hunt told The Economic Times last week that it is evaluating local partnerships to launch its patented HIV medicine maraviroc in India and is open to a deal with Natco Pharma to make a low-cost version of the drug. Natco's aggressive moves have not surprised patent experts. Speaking to PharmAsia News, Gopa Kumar Nair one of India's well-known patent experts said, "Indian companies are legally entitled to enter negotiations for a voluntary license if the patent holder is uninterested in launching life-saving medicines in India at an affordable treatment cost. Nair runs Patent Gurukul, an institution that provides education on the Indian patenting system while also representing Indian firms in patent cases. Natco's latest moves to seek voluntary licenses is seen as a test case on how India approaches the issue of compulsory licensing. While many believe that multinational companies will be less open to granting voluntary licenses or an arrangement to allow generic companies to produce lower-priced versions of their patented brands, Natco is seen as building its case to ultimately ask for a compulsory license from the Indian government. Will India Follow Thailand's Example? Unlike India, which has adopted a cautious approach on compulsory licensing, countries like Brazil and Thailand have been more open in granting compulsory licenses to local companies for anti-HIV drugs like Sustiva and Kaletra ('Thailand Extends Compulsory License For Pair Of U.S. HIV/AIDS Drugs,' PharmAsia News, Aug. 5, 2010). In August, a discussion paper floated by India's Department of Industrial Policy and Promotion under the Commerce Ministry highlighted perceived threats to compulsory licensing and availability of low-cost medicines in India and invited comments from various stakeholders to help construct a more robust policy (Also see "Indian Firms Must Be In Indian Hands, Says Government Paper; Highlights Threats to Compulsory Licensing And Drug Pricing" - Scrip, 25 Aug, 2010.). - Vikas Dandekar ([email protected]) |