For our earlier posts on India’s first “Doha” compulsory licensing application, see here. In short, the dispute revolves around a “Doha style” compulsory licensing application filed by Natco who argued that in view of a public health problem in Nepal, it ought to be granted a compulsory license to export generic copies of Pfizer’s patented anti cancer drug, Sutent (and Roche’s patented drug, Tarceva) to Nepal.
In our latest post, we discuss the patent office decision in favour of Pfizer and Roche’s right to be heard and state:
“It is important to note that this is not a decision on the main merits of the dispute. Rather, it is on whether or not the patentee, Pfizer has the right to be be heard. In a well reasoned judgment running into 13 odd pages, the Assistant Controller of Patents, Hardev Karar (who we predicted in our earlier post would render a “well reasoned” decision) ruled that Pfizer has the right to be heard….
From a close reading of the judgment, it appears that part of the reason underlying the patent office decision to grant such a right to be heard stems from the various “deficiencies” in Natco’s application. The decision notes:
“In the instant case, the documents submitted by the applicant are not admissible because of the following reasons:
i) The letter issued by the government of Nepal, said to be permission for importation of patented pharmaceutical product is not in the language as recognised by Indian patent rules. Therefore, this letter cannot be considered as permission for import by Nepal government.
ii) The requirement for the importation of the patented drug from India has not been notified to the TRIPS Council by the Govt of Nepal.
iii) Rule 96 requires the applicant to set out the terms and conditions of the licence which he is willing to accept. The applicant has not complied with this requirement.”
No doubt, the above statements ought to have been made during the final disposal of the case and not at this stage, which was confined to adjudging whether or not the patentee has a right to be heard. However, these statements indicate that the patent office was concerned that the Doha CL process ought not to be abused by generic manufacturers that wished to make a quick buck. Therefore, the best way to ensure this was to hear the other side as well .”
Natco’s decision to withdraw its application may have stemmed from a fear that it would lose on merits.