Friday, February 29, 2008

Litmus Test: Natco's Applications for Compulsory License

Indian Patent Office has finally started proceedings over Natco’s applications for Compulsory License for anti-cancer drugs Tarceva and Sutent to be exported to Nepal under statutory provisions of section 92A of the Patents Act, 1970, also referred as “Doha-style provision.” Natco even reported to offer a five percent royalty to Roche for the generic Tarceva exported to Nepal. Interestingly, the Delhi Patent Office allowed hearing Roche and Pfizer over the issue, which prompted Natco to file an interlocutory petition saying that Roche/Pfizer should not be privy to the compulsory license hearing that takes place between the Patent Office and Natco. No idea which provision allowed Natco to make such an objection?

Reading section 92A, there is nothing explicitly mentioned about hearing will be allowed to patentee or not, but that even does not mean to exclude the possibility for hearing. This can further be supported by the rule 97(1) of the Patents Rules, 2003 which reads as –

If, upon consideration of the evidence, the Controller is satisfied that a prima facie case has not been made out for the making of an order under any of the sections referred to in rule 96, he shall notify the applicant accordingly, and unless the applicant requests to be heard in the matter, within one month from the date of such notification, the Controller shall refuse the application.

The rule clearly allows the Controller to consider evidence to judge a prima case for making an order under section 92A. Now the question is, how the Controller will decide is there a prima case for compulsory license or not? Only by hearing Natco (and may be doing some additional search over Google)? Obviously that will be unfair enough to do that, particularly when Nepal, till date, has made no notification to WTO Council about the importation of Tarceva under Doha-style provision from India. Having an import license from Nepal Drug Authority is not sufficient enough to establish a prima case for making an order for compulsory license under section 92A. In fact, the Controller has made fair and just decision to allow hearing Pfizer/Roche, which will build a transparency and creditability in Indian Patent System.

It would be interesting to know, who approached whom? Whether Nepal Drug Authority approached Natco for supplying the generic Tarceva in Nepal or Natco suggested Nepal Drug Authority to trigger Doha-style provision?

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