The patent dispute over bird flu drug Tamiflu does not seem to settle down. Gilead Sciences, the manufacturer of the drug, is set to appeal the verdict of the Delhi patent office which rejected the patent application for Tamiflu (oseltamivir phosphate) while considering the pre-grant opposition of Mumbai-based Cipla last week. The patent office had recently rejected Gilead?s patent application owing to lack of inventiveness in the drug.
In a mail to FE, Cara Miller, spokesperson, Gilead Sciences, said, ?We believe Tamiflu represents an important scientific innovation and remain confident in the strength of our intellectual property. We plan to vigorously defend the patent and the scientific innovation on which it is based.?
Swiss drug major Roche Scientific has the marketing rights for Tamiflu in the country. The company had sub-licensed its production and marketing rights to Hyderabad-based Hetero in India and other developing countries following Cipla?s decision to launch the generic version of Tamiflu in India in 2005.
?We are disappointed by the patent office?s decision regarding Cipla?s pre-grant opposition. However, we remain committed to ensuring access to Tamiflu in India. This is not the final step in the patent application process. It is typical in this process for a rejection to be issued and for the applicant to appeal and present arguments and data in support of the application,? the Gilead spokesperson said.
According to Varun Chhonkar, CEO, IP Feathers, a Mumbai-based IP consultancy firm, Gilead may still challenge the order of the Indian patent office which refused to grant patent for oseltamivir by filing a writ petition similar to Novartis beta-crystalline imatinib (Glivec) case. Novartis had appealed at the Madras High Court against Chennai patent office?s decision to reject its patent application for the cancer drug, Glivec (imatinib mesylate), on the ground that Glivec is not an innovative drug. He said, ?The rejection of patent application can be challenged at the appellate board. But, provision for pre-grant opposition under section 25(1) is not appealable under the patent law. However, Gilead has an option of approaching the court with filing a writ petition against the patent office verdict.?
?In recent years, Gilead has worked closely with the Indian government to ensure the supply of and access to both Tamiflu and to our antiretrovirals. We look forward to continuing positive discussions with the government to ensure continued, broad access to Tamiflu,? the Gilead spokesperson added. Cipla, the leading AIDS drugs manufacturer, had filed a pre-grant opposition with the Indian patent office against Viread, the much sought-after second line AIDS drug manufactured by Gilead, arguing that the grant of the patent in India will make the HIV drug unaffordable to patients worldwide.