On 12 March 2012 the Controller General of Patents,Designs & Trademarks of India issued an order granting a compulsory license under Section 84 of the Patents Act (1970) to Natco in patent number 215758 granted to Bayer covering the anti-drug sorafenib toslyate. KEI filed an affidavit in this compulsory licensing dispute involving Natco and Bayer. Following the issuance of a compulsory license, Bayer requested the Intellectual Property Appellate Board (IPAB) to issue a stay on the compulsory license.
On Friday, 14 September 2012, IPAB issued Order (No. 223 of 2012) in the case between Bayer Corporation versus the Union of India, The Controller of Patents, and Natco Pharma Limited dismissing Bayer’s request for a stay on the compulsory license granted to Natco.
Please find the statement of Knowledge Ecology International on the order issued by the IPAB.
Statement of James Love, Knowledge Ecology International
The decision of the Intellectual Property Appellate Board, rejecting a stay of the compulsory license of a Bayer patent on Nexavar to Natco, is a welcome and strong statement about the India requirement that patent holders make drugs available at “reasonably affordable” prices to people living in India. Bayer sought to make the India statute meaningless by arguing that undocumented and largely irrelevant claims about the putative Nexavar R&D outlays would make any price for Nexavar “reasonably affordable,” even one of more than $5,000 per month, in India. The decision said the “words reasonably affordable’ can only be understood in the context of the purchasing power of the public,” and the R&D costs would have only “some relevance when the Controller General is fixing the percentage of royalty.” The decision also noted that “The appellant cannot ride piggyback on CIPLA’s sale, particularly when the appellant is fighting CIPLA before another forum regarding the same invention and the same drug.”
It is possible and indeed likely that Bayer will continue to litigate this issue, which will soon be scheduled for another hearing on its merits, now that the stay has been rejected. It is important that the U.S. and German governments, and the European Commission, resist the temptation to interfere with the India legal system while this matter is litigated. What is at stake is nothing less than the right to live. The decision is also a test of the 2001 WTO Doha Declaration on TRIPS and Public Health, which says that WTO Members should implement their patent laws “in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.” Access to medicines for all cannot be achieved without addressing squarely the issue of the affordability of products.
News coverage, blogs and statements
18 September 2012, Patralekha Chatterjee in Intellectual Property Watch, India: Balancing Public And Private Interests In The Intellectual Property Regime.
17 September 2012, Economic Times, Bayer says it will defend its intellectual property rights on cancer drug.
17 September 2012, By Rumman Ahmed and Dhanya Ann Thoppil in Dow Jones Newswires, India Appeals Body Rejects Bayer’s Plea to Suspend Sales of Generic Nexavar.
17 September 2012, Kaustubh Kulkarni in Reuters, UPDATE 1-Bayer’s plea for stay on Nexavar generic in India dismissed.
17 September 2012, Tracy Staton in Fierce Pharma, Indian board nixes Bayer’s bid to stop generic Nexavar.
17 September 2012, MSF, MSF statement on India’s dismissal of Bayer’s request for a stay on compulsory licence.
16 September 2012, Divya Rajagopal in The Economic Times, Bayer petition against Natco over manufacture of Nexavar dismissed.
16 September 2012, R. Sivaraman in The Hindu, Bayer plea against Natco on cancer drug dismissed.