India drug IP laws in spotlight again in local Fresenius Kabi-Pfizer case

India's policy regarding intellectual property protection has bounced back once again to deny a Big Pharma patent challenged by a local drugmaker. This one was filed by the local unit of Fresenius Kabi Oncology against a Pfizer ($PFE) patent.

The nation's IP policy on drugs has seen flip-flops by offering decisions that could be read as easing the minds of foreign pharma, then denying a patent and causing angst once again.

Fresenius challenged Torisel (temsirolimus), an injectable for treating renal cancer which was developed by Wyeth, now owned by Pfizer.

The patent office sided with a Fresenius claim that temsirolimus already was known in India before Wyeth claimed to have invented it.

The assistant controller of patents and designs went further when he said, "efficacy is related to therapeutic efficacy and is not related to stability of the compound."

The patent official also said Wyeth submitted two mixtures even though they "only separately exist" and no data on their efficacy when combined.

Fresenius Kabi is a wholly owned subsidiary of Germany-based Fresenius SE.

- here's the story from the Financial Express

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