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GSK loses patent on Tykerb in India

Cuts period of exclusivity by two years

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GlaxoSmithKline (GSK) became the latest pharma company to suffer an intellectual property (IP) setback in India after a patent on its breast cancer drug Tykerb was revoked.

A bid to overturn the patent - filed by New Delhi-based Fresenius Kabi Oncology Ltd - was upheld by India's Intellectual Property Appellate Board (IPAB) last week, opening the door to low-cost competition to Tykerb (lapatinib), which had worldwide sales of $160m in the first half of this year.

A basic substance patent covering the active pharmaceutical ingredient (API) lapatinib (IN221017) was upheld by the Board on the grounds that the petitioner was unable to show a known compound with equivalent therapeutic efficacy.

A second (IN221171) covering the crystalline form used in GSK's Tykerb formulation (lapatinib ditosylate) was, however, dismissed on the grounds that it was an obvious variation and involved no inventive step, citing the controversial section 3(d) clause of India's patent regime.

As the first patent was upheld GSK retains patent protection until 2019, but has lost a couple of years of exclusivity with the demise of the second patent, which was due to expire in 2021.

GSK has been selling Tykerb in India for four years and said: "we already offer significantly discounted prices for Tykerb in India", referring to its decision to reduce its cost by around a third.

The company added that it will "continue to take steps to ensure that Tykerb is available to women … in India who need it".

The drugmaker got off fairly lightly in comparison with other pharma companies over the last few months, however, which prompted assertions in the Indian press that the ruling undermines accusations that India's patent regime is geared toward undermining the IP of overseas corporations, not just in pharma but also IT and renewable energies.

This year has already seen IP setbacks in India for Novartis' leukaemia drug Glivec (imatinib), Merck & Co's Januvia (sitagliptin) diabetes franchise and Singulair (montelukast), Roche's Pegasys (peginterferon alfa-2a), Gilead Sciences' Viread (tenofovir), Pfizer's Sutent (sunitinib) and Bayer's Nexavar (sorafenib tosylate).

5th August 2013

From: Sales, Regulatory



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