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 and also at the end of this post.) 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.
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This blog, Patents4Life, does not contain legal advice and is for informational purposes only. Its publication does not create an attorney-client relationship nor is it a solicitation for business. This is the personal blog of Warren Woessner and does not reflect the views of Schwegman Lundberg & Woessner, or any of its attorneys or staff. To the best of his ability, the Author provides current and accurate information at the time of each post, however, readers should check for current information and accuracy.