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Lupin wins Altace US patent challenge

India-headquartered Lupin wins its patent challenge against sanofi-aventis and its US co-marketing partner King Pharmaceuticals for their blood pressure drug Altace

India-headquartered generics company Lupin has won its patent challenge against French pharmaceutical company sanofi-aventis (S-A) and its US co-marketing partner King Pharmaceuticals for Altace (ramipril).

Altace, which controls blood pressure, racked up sales of USD 700m in the US region alone and is one of S-A and King's top-selling products.

A US federal appeals court ruled that the Altace patent for was invalid on grounds of being obvious. The court overturned a lower court ruling that Lupin had infringed the patent by seeking approval to market a generic version of the drug.

Lupin filed a generic drug application with the FDA under paragraph IV certification in March 2005. Normally, the approval process lasts 15 months, so Lupin is expecting generic manufacturing approval for ramipril in the very near future. It remains to be seen if Lupin will be awarded a 180-day exclusivity period though, as it was the second company to challenge the S-A patent.

Canada-based Cobalt was the first to challenge Altace. King filed a patent infringement case against Cobalt, with the two companies reaching an out-of-court settlement. Cobalt was granted non-exclusive rights to market a generic capsule formulation of ramipril, supplied by King.

The 11 September court decision was based on a recent ruling by US Supreme Court in a case between information technology firm KSR and Teleflex. In its judgement, the US Supreme court set out certain conditions for proving non-obviousness (one of the three conditions to the grant of a patent) in an innovation.

According to US legal experts, Lupin's ramapril case was the first time these rules were applied to pharmaceuticals. Consequently, more cases will be ruled in favour of generic companies, with a strong likelihood that recent judgements will also be reversed.

Similarly, Indian generics company Sun Pharmaceutical has received approval to market a generic version of Wyeth's antacid blockbuster drug Protonix (pantoprazole) in the US. Sun will benefit from a 180-day exclusivity period, shared with Israeli-headquartered generics giant Teva.

30th September 2008

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