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July 09, 2020

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Indian Patent Office Grants Compulsory License To Bayer Drug

Finding that Bayer had failed the requirement to “work” the invention in India, e.g., manufacture and sell at a reasonable price, the Indian Patent Office granted Natco Pharma, an Indian company, a “compulsory license” to make, use and sell  a generic version of the anti-cancer drug Sorifenib. (A copy of this decision can be found here.)

If your client/company/institution has an Indian patent on a drug, don’t forget to fill out the working forms that your associate should remember to send to you. However, this decision does not answer the question of whether or not an Indian company could seek approval to market a drug not yet approved by your client or its licensee in, say, the US or the EU, if the Indian company went through the NDA process in India. I know this sounds unlikely but, at the least, this decision should remind us all to take “working requirements” seriously, particularly for drugs that are moving through the approval processes outside of India.

© 2020 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.National Law Review, Volume II, Number 81


About this Author

Warren Woessner, Registered Patent Attorney, Schwegman Lundberg Law firm

Warren Woessner is a registered patent attorney and a founding shareholder of Schwegman, Lundberg & Woessner. His practice focuses on chemical patent law, including biotechnology, pharmaceuticals, vaccines, medical treatments, diagnostics, and biofuels and agricultural chemistry, including related opinion and licensing matters.

Warren received his B.A. in chemistry (1966) from Cornell University, his Ph.D. (organic chemistry, 1971) and his law degree (J.D., cum laude, 1981) from the University of Wisconsin...