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BL Research Bureau

With the Washington Court of Appeals saying that a lower court had erred in 2005 by saying that generic Neurontin would not infringe on Pfizer Inc’s patent for its blockbuster anti-convulsant.

Indian companies — both bulk drug makers and generics— might pay a high price for their association with the drug.

Presently, nine companies including the three Indian drug makers have FDA approvals for Gabapentin, the active pharmaceutical ingredient (API) for the drug. Glenmark Pharma, Ranbaxy and Sun Pharma have already launched the drug ‘at-risk’ while bulk drug makers like Hikal and Shasun Chemicals are involved in manufacturing the active pharmaceutical ingredient.

An ‘at-risk launch’ is a high risk-high gain strategy where pharma companies launch a generic version of a drug which is under patent challenge, before the expiry of that patent.

If it ends up losing the case, under US law, the generic maker can be liable for triple the damages incurred by the patent holder.

However, this may not be a concern for Hikal and Shasun Chemicals, as API suppliers.

Shasun Chemicals is a supplier to US based Alpharma Inc, it makes generic prescription products and active pharmaceutical ingredients for exclusive sale by Alpharma, which has an agreement with Teva on gabapentin capsules and tablets. Hikal had entered into an agreement with an unnamed US-based pharmaceutical company to supply gabapentin and has begun selling the API to the US market from May 2005.

As a result of this development, Pfizer Inc will be eligible for full damages if it wins in the patent trial. The patent(s) in question do not expire until 2017.

Gabapentin is best known under the brand name Neurontin, which once had sales of $2 billion annually for Pfizer.

In 2006, sales were at $496 million after cheaper generics entered the market.

As of now, the generic-drug companies can again contest that their versions infringe the patent.

While Indian companies might be reviewing their courses of action, a full trial is likely to be held on the allegations of patent infringement.

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