India raises bar for pharmaceutical patents


India is one of the fastest growing economies in the world and one of the most attractive destinations for foreign investments, particularly for Western pharmaceutical companies.

However, in recent times India has been in the spotlight due to its IP regime.  For example, last year India revoked patents granted to Pfizer Inc’s cancer drug Sutent, Roche Holding AG’s hepatitis C drug Pegasys, and Merck & Co’s asthma treatment aerosol suspension formulation. All were revoked on grounds that included lack of innovation.

Last month, India revoked a patent granted to GlaxoSmithKline Plc for breast cancer drug Tykerb, a decision that follows a landmark India court ruling disallowing patents for incremental innovations that was a big setback for global pharmaceutical firms.

India’s Intellectual Property Appellate Board (IPAB) nevertheless upheld a patent granted on the original compound, or active pharmaceutical ingredient, lapatinib, citing innovative merit.

As a result, a GSK spokesman said its medicine would remain subject to patent protection until 2019. The additional patent on the particular salt of lapatinib used in Tykerb, which has now been revoked, would have extended GSK’s patent protection to 2021.

Fresenius Kabi Oncology, the Indian unit of German healthcare group Fresenius SE, had challenged patents granted for both the original molecule and its marketed salt version, saying both molecules lacked innovation.

Following the decision, shares in GlaxoSmithKline Pharmaceuticals, the UK company’s Indian unit, fell 2.8 percent.

GSK believes in the inventiveness of the lapatinib ditosylate salt and will consider appealing the decision to India’s Supreme Court.

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