ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

PharmaceuticalSubscribe to Pharmaceutical

Natco-Bayer Verdict

Bayer has lost its case challenging the grant of India's first-ever compulsory licence to Natco Pharma to manufacture an affordable generic version of an anti-cancer drug, but the celebratory air has to be tempered. The issue of what constitutes "local working" of a patent in India remains, in general, unsettled. This article looks at the legality of local working requirements under the Agreement on Trade-related Aspects of Intellectual Property Rights. It also analyses the interpretations of "working" by the Controller General of Patents, Designs and Trademarks, the Intellectual Property Appellate Board, and the Bombay High Court, and considers their broader implications.

Cleaning Up the Pharma Industry

For over 30 years pharmaceutical companies have been selling fixed-dose combination drugs with scant need to justify their efficacy, safety or rationality for use. The Government of India has finally banned 344 such drugs, though pharma companies have been able to obtain interim judicial stay orders. It is hoped that the courts take into account the serious public health implications of the sale of certain drugs and allow regulatory intervention banning uncertified combination drugs, including codeine-based cough syrups and various cold and flu drugs.
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