India’s patent fights have intensified further. A recent ruling by India’s Intellectual Property Appellate Board has revoked a patent belonging to GlaxoSmithKline for its breast cancer drug Tykerb, the salt form of lapatinib compound that is sold in India. However, the Board has upheld the patent granted on the original API, lapatinib, citing innovative merit.
In April, India’s Supreme Court had set a precedent by rejecting a patent for Novartis’s cancer drug Glivec. The court had held that Glivec was an amended version of a known molecule, imatinib.
Upholding GSK’s patent on the original compound lapatinib has, however, been termed a victory for multinationals operating in India. GSK said it was pleased that the Board had upheld its basic patent for the API, which is valid until January 2019, but the revoking of the patent for the lapatinib ditosyate salt was termed a ‘mixed bag’ by the multinational.
Interestingly, for the first time, the Board acted on a complaint filed by another international pharmaceutical firm rather a local Indian company. The challenge to GSK’s patent was launched by an Indian subsidiary of German health group Fresenius.
It had disputed the patents both for the original molecule and Tykerb. GSK, which had cut prices of Tykerb by a third in India as part of a flexible pricing programme, said it would continue to take steps to ensure that Tykerb is available to women with breast cancer.
In a bid to keep exclusive patents on its list, Pfizer has sued yet another Indian generic drug major in the US courts. The company is taking action against two units of Wockhardt, alleging its planned generic version of overactive-bladder medication, Toviaz, infringes a handful of patents covering the drug.
According to Pfizer, Wockhardt’s US unit plans to make fesoterodine fumarate extended release tablets; it alleges that this infringes five patents covering the active ingredient, which is exclusively licensed to Pfizer by UCB Pharma.
Earlier this year Pfizer sued Wockhardt and two other Indian companies to prevent them from securing approval to sell a generic version of its neuropathic painkiller, Lyrica, on the US market.
That patent battles are heating up can be witnessed by the spate of cases recently filed. Merck Sharp & Dohme has moved in the Delhi High Court against Ahmedabad-based Aprica Pharma to prevent it from launching its own generic version of the blockbuster diabetes drug Sitagliptin. And Bristol-Myers Squibb has sued Hyderabad-based Natco at the Delhi High Court for patent infringement of its cancer drug Dasatanib (Sprycel). The company has also launched a patent suit against Ranbaxy Labs in the case of Entecavir (Baraclude).