Thursday, November 17, 2011
Compulsory licensing: Is presumptive evidence sufficient?
Sometime back, we posted on compulsory license triggered by Natco Pharma with respect to IN215758 claiming anti-cancer drug Nexavar, generically sorafenib tosylate marketed by Bayer. The Application for compulsory license (FORM 17) was filed on July 28, 2011 along with the details of documentary evidence as mandated under S. 84 (3) of the Act. Natco argument for issuance of compulsory license mainly relied upon on the issues that:
  • patented product (sorafenib tosylate) not been manufactured in India. In other words, patented invention not worked within the territory of India.
  • circulation of patented product limited to certain hospitals and metro cities. In other words, patented invention not worked to the fullest extent.
  • unaffordable to 99% of patients. In other words, patented product not available at affordable price.
  • requirement of patented product is far higher than what is available in Indian market. In other words, reasonable requirements of the public with respect to the patented product not been satisfied.
  • patented product is found expensive in UK and US. In other words, Natco possibly trying to say anything that is expensive in UK and US will automatically be expensive in India.

Natco further provided details including regulatory approval, proposed manufacturing capacity (6,00,00,000 tablets per day) and proposed market price to a patient (INR 8,800 per month). Natco also proposed to provide free to patients who cannot afford even the proposed price. Interestingly, Natco’s application completely lacked factual evidence/data to support most of its argument rather Natco relied primarily on secondary sources collected from Mayo Clinic and Harward Center for Cancer Prevention. 

As per Indian patent practice, the Controller may either publish the application in the Official Journal (see S. 87 (1) of the Act) when a prima facie case is made by the Applicant or reject the application. In this case, the Controller found prima facie case and published the application is Issue No. 32/2011 dated August 12, 2011. 

Later Bayer petitioned for an extension to file notice of opposition and subsequently in November filed a writ petition with the Mumbai High Court challenging the Controller decision to publish the application. However, the Court refused to look into the merits of the case and disposed of the petition citing that the proper jurisdiction to file the petition would be the Delhi High Court. The Court also extended time to file opposition till November 18, 2011. 

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