As reported earlier, India’s compulsory license against Bayer, for the sale of its drug Sorafenib Tosylate (marketed as Nexavar), brought the possibilities for compulsory license under the spotlight. It also highlighted the complex web of intellectual property, and international trade law rules applicable to the case. Bayer’s application for a stay of that license, with the Intellectual Property Appellate Board was dismissed (link courtesy of SpicyIP), however the Appeal on substance is, I understand, still pending, and other possibilities for review with the courts in ordinary exist, too.
WHO, WTO and WIPO have now issued a rare joint report, in which the intersections between public health, intellectual property and trade are clarified. It does not contain a roadmap for the Indian courts to settle the case at issue, however there are quite a lot of sections in the report which one suspects might be invoked by either side in the various appeals.
India’s ‘Controller of patents’ has granted Natco a ‘compulsory license’ (‘CL’) for Bayer’s Sorafenib Tosylate (marketed as Nexavar). The drug extends the lives of terminal liver and kidney cancer patients. Put differently: the controller has forced Bayer to grant a license to Natco, to produce the drug, specifying inter alia a (low) sales price and royalties to be paid to Bayer. Natco is an Indian pharmaceutical company (no surprise there), with an increasing portfolio in pharmaceutical R&D. In other words reportedly not a typical ‘generics’ company.
The ruling is of course subject to appeal. It is also the subject of intense debate under the WTO, in particular the TRIPS Agreement. TRIPS (Articles 30-31) leaves room for a CL system and prima facie leaves a lot of room for manoeuvre to WTO Members to grants such licenses. However underneath Article 30-31’s surface lies quite a bit more than might be assumed. Moreover, even if one takes Members’ discretion in applying these Articles at face value, the articles must not be applied stand-alone. In other words they do not give carte blanche for introducing requirements leading to CL which might otherwise be WTO inconsistent.
Watch this space: this case is a nugget for, yet again, disciplining regulatory autonomy (see here and here) under the WTO.