Indian Patent Office Grants Compulsory License for Bayer’s Nexavar: Implications for Multinational Drug Companies

more+
less-

The Controller General of Patents Designs and Trademarks of India (“Controller”) recently granted Natco Pharma Limited (“Natco”), an Indian drug manufacturer, a compulsory license for Bayer AG’s (“Bayer”) Nexavar (sorafenib), an oncology drug that extends the patient’s life but does not cure the underlying condition.

The Controller found Nexavar eligible for compulsory licensing under Section 84 of the Indian Patent Act because (1) the drug was not meeting the reasonable requirements of the public, (2) the drug was not reasonably affordable and (3) the patent was not being sufficiently “worked” in India because it was not locally manufactured.

The Controller’s order is subject to appeal. Unless the standards applied by the Controller in the Nexavar case are reversed, there is a significantly increased risk that a number of other patent-protected drug products would be subject to similar compulsory licensing in India.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Published In: Administrative Agency Updates, General Business Updates, Intellectual Property Updates, International Trade Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© White & Case LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »