Licences

by Morag Peberdy and Christina Helden

On 19 March 2013 the India’s Intellectual Property Appellate Board (IPAB) released its written judgment upholding the Controller of the Indian Patent Office’s decision to grant Natco Pharma Ltd a compulsory licence under Bayer A.G.’s patent for its anti-cancer drug Nexavar.  Section 84(1)(a)–(c) of the Indian Patents Act 1970 sets out three conditions for the grant of a compulsory licence.  The IPAB confirmed that although any one of these is sufficient, all three requirements were in fact met in this case, namely Bayer had not: (a) satisfied the reasonable requirements of the public; (b) made the patented invention available at a reasonably affordable price; or (c) worked the patented invention in India.

Although the IPAB was not as rigid in its views on local working as the Controller, this aspect of the judgment is most likely to raise concern internationally, and has implications across all industry sectors.  The Controller took the stance that for a patent to be worked locally, product must be manufactured in India.  The IPAB held that the local working requirement needs to be considered on a case-by-case basis.  However, if product is merely imported, the onus is on the patentee to show why its product could not be manufactured locally.  As Bayer did not manufacture Nexavar in India nor provide evidence as to why it could not manufacture this particular drug in India, it failed the local working requirement.  The IPAB considered WTO’s Trade Related Aspects of Intellectual Property Rights Agreement (TRIPs) but found no inconsistency.  Others are likely to disagree, and to view the IPAB’s interpretation of s84(1)(c) as being protectionist and incompatible with the fundamental principle of non-discrimination that underpins TRIPs. 
Continue Reading India Upholds its First Compulsory Licence