Indian Patent Office Grants Compulsory License for Generic Version of Bayer’s Nexavar

On March 12, 2012, India’s Patent Office granted Indian drug manufacturer Natco Pharma a compulsory license to sell a generic version of Bayer AG’s kidney and liver cancer drug Nexavar. It’s the first time an Indian company has been granted a compulsory license under the Indian Patent Act of 2005, the law which allows the government to force patent holders “to grant licenses to third parties” when certain condition are met.

For your reference, here’s a roundup of legal commentary on the finding and its implications for multinational pharmaceutical companies:

Indian Patent Office Grants Compulsory License for Bayer’s Nexavar: Implications for Multinational Drug Companies (White & Case LLP)

“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.” Read the full update»

The Anatomy of a Compulsory License: Natco Pharma Ltd. v. Bayer Corp. – Indian Patent Office (McDonnell Boehnen Hulbert & Berghoff LLP)

“In making his decision, the Controller noted that the term ‘worked in the territory of India’ had not been defined in the Indian Patent Act, and so he needed to construe the term with regard to ‘various International Conventions and Agreements in intellectual property,’ the 1970 Patent Act and the legislative history.  But the Controller seemed more interested in addressing the ‘crucial argument’ of the patentee that the applicant’s construction of the term was incorrect because the phrase ‘default of the patentee to manufacture in India to an adequate extent and supply on reasonable terms the patented article’ was deleted from the Act.” Read the full update»

Compulsory License Granted to Indian Pharmaceutical Company (Miller Canfield)

“Compulsory licenses were provided for under the TRIPS agreement of the WTO and have been used in developing countries like Thailand and Brazil in the pharmaceutical industry. The granting of the compulsory license and a proposed drug-pricing policy by the Indian government has caused concern among multinational pharmaceutical companies that have been trying to strengthen patent protection in India.” Read the full update»

First Compulsory License Granted in India on Bayer’s Patent (Divya Prakash)

“The price of the drug covered by the patent and sold by the licensee shall not exceed Rs. 8880 for a pack of 120 tablets, required for one month’s treatment. Licensee has to give account of sales every quarterly and has to pay 6% royalty to the patentee. Patentee will not be restraint to compete with licensee in any manner and he could enjoy his residual rights. Licensee does not have rights to represent itself in relation to said patent and he cannot outsource the product from elsewhere… And also; licensee has to distribute drug, free of cost to 600 needy and deserving patients per year.” Read the full update»


Additional International IP Law Commentary

Indian Supreme Court to Rule on Gleevec Patent (McDonnell Boehnen Hulbert & Berghoff LLP)

European IP Bulletin — Issue 88, March 2012 (McDermott Will & Emery)

EPO Launches New Machine Translation Tool (McDonnell Boehnen Hulbert & Berghoff LLP)

IP Highlights/March 2012 (Karanovic & Nikolic Law Office)

Divided Patent Infringement in Germany (McDermott Will & Emery)

Hobbit Highlights Character Merchandising Pitfalls (Baldwins)

Quick Guide for US Counsel: Patent Litigation in Germany (McDermott Will & Emery)

Sounds Like a Revolution – Trade-marking Sounds in Canada (Heenan Blaikie LLP)

“Raising the Bar” – Australia’s New Intellectual Property Legislation at a Glance (Baldwins)

Inovia Releases 2012 Report on Global Patent Trends (McDonnell Boehnen Hulbert & Berghoff LLP)

Record Number of PCT Applications Filed in 2011 (McDonnell Boehnen Hulbert & Berghoff LLP)


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