New India patent chief means Lee Pharma's saxagliptin CL app on hold for now

The appointment of a new Controller-General for Patents, Designs and Trademarks in India has delayed the compulsory license application by Lee Pharma, which wants to produce the diabetes drug saxagliptin developed and patented by London-based AstraZeneca ($AZN), according to a report by The Hindu.

The newspaper quoted an official from the Department of Industrial Policy & Promotion as saying that there should be a "fresh hearing" on the application because of the appointment and follows the August rejection of its earlier application, the report said.

The license, if granted, would allow Lee Pharma to produce the drug without the permission of AstraZeneca in response to a health crisis. To date, India has only granted once such license that allowed generics maker Natco in 2012 to produce a generic version of Bayer's Nexavar, which treats kidney and liver cancers, according to The Hindu.

"We are not at all apologetic about the CL (license) issued to Natco, as it was well deserved," the industrial policy official told The Hindu, "… but at the same time we are very careful while scrutinizing CL applications to ensure that it is issued only when it meets the established criteria of inaccessibility or public health crisis in spirit."

Lee Pharma said in its license application that AstraZeneca "has not taken steps to manufacture the drug" in India and that the cost was too high for most Indian patients.

The Hindu reported that the patent office rejected the application originally because there was a number of alternative drugs available in India and Lee Pharma "was not able to convincingly establish that patients were suffering" because of AstraZeneca's actions.

- here's the story from The Hindu

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