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 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.

Natco_vs_Bayer_Decision_of_Controller_of_Patents_Mumbai_9_Mar_2012

One Response to “Indian Patent Office Grants Compulsory License To Bayer Drug”

  1. Paul Cole says:

    Low royalty rate (6%) for an invention in the pharmaceutical industry where 20-30% would be more normal. Also decision is on the basis of a royalty rather than a fixed sum per kg drug. There are UK decisions dating from the 1960′s and 1970′s which would normally be considered pertinent.

    But the factual background compared to the UK compulsory licence cases may have been different because (according to the decision) Sorifenib was not being sold on a substantial scale in India and the Indian public was (allegedly) being denied access to this anti-cancer drug on reasonable terms.