The Hindu Business Line : Pfizer gets relief on epilepsy drug as US court reverses ruling

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Pfizer gets relief on epilepsy drug as US court reverses ruling

Competitors now not allowed to market generic versions

Impact
The drug was a prominent feature on the radar of domestic generic companies such as Ranbaxy, Sun Pharma, Shasun, Glenmark and Hikal.
Sun Pharma, Ranbaxy may face reduced impact, but Hikal, Shasun may take a hit.

P.T. Jyothi Datta

Mumbai, Sept. 24 Domestic drug companies looking for a slice of Pfizer’s ‘gabapentin’ market, an epilepsy medicine grossing over $2 billion in revenues, may be in for a setback in the US.

A US court has reversed an earlier ruling that allowed companies to market the generic copies of ‘Neurontin’, Pfizer’s brand name for ‘gabapentin’.

Indian drug companies such as Glenmark, Sun Pharma and Ranbaxy, among others, that Business Line spoke to maintain that they have not infringed on Pfizer’s patent on gabapentin.

But there is still more litigation to go before a final resolution of the case. And adding to the worries of companies on the generic gabapentin bandwagon is whether they may have to pay for Pfizer’s loss of revenue, if the final decision is not in their favour, say analysts. Particularly, since generic copies of gabapentin have already been launched in the US.

Gabapentin was a prominent feature on the radar of not just domestic generic companies such as Ranbaxy, Sun Pharma, Shasun, Glenmark and Hikal, but also overseas generic majors such as Teva/Ivax, Apotex and Eon.

Pfizer, however, sought to protect its patent on the drug and the race for gabapentin ran into litigation.

But some generic companies, with a risk for appetite, nevertheless launched the drug in the US after they received regulatory approval from the Food and Drug Administration.

Ruling reversed

But the late Friday ruling queered that pitch. The Court of Appeals for the Federal Circuit reversed a 2005 district court ruling granting summary judgment of non-infringement to several generic drug companies who sought to market generic versions of Pfizer’s gabapentin, said an overseas media report.

The district court had ruled on summary judgment that generic versions of Neurontin made by Teva, IVAX, and Eon did not infringe Pfizer’s US Patent No. 6,054,482, which covers a process for the preparation of, and compositions containing, gabapentin, the report said.

A summary judgment is given after assessing the documentary evidence and statements made by the different parties involved in the case, without going into a trial and with no jury, explained an intellectual property expert.

Gabapentin accounts for about 20 per cent of Glenmark’s US sales, five per cent of Sun Pharma’s sales in the region and about two per cent of Ranbaxy’s US sales, an industry-watcher said.

The Indian drug majors did not comment on the development.

Analysts maintain that Sun Pharma and Ranbaxy had non-infringing process patents on the drug and so may face only a reduced impact.

Companies like Hikal or Shasun, that supply bulk gabapentin to the multinational generic majors, may be in for the rough ride. In fact, Hikal had felt the heat of the litigation and generic competition in the past, and company top-brass had admitted that it had hurt Hikal’s bottomline.

Ranbaxy’s shares on the BSE were up close to 3 per cent on the BSE, at Rs 416.90; Glenmark shares were up more than 3 per cent at Rs 389.40; Sun Pharma was however down by 3 per cent at Rs 949.55; Hikal was up over one per cent at Rs 485.25 and Shasun was marginally down at Rs 92.25.

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