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INDIA’S Lupin has won its patent challenge against King Pharmaceuticals and Sanofi-Aventis for blood pressure drug Altace, which has sales of $700 million in the US alone. A US federal appeals court has ruled that the patent for Altace, chemically known as ramipril, was invalid on grounds of being obvious. Thus, 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 had filed in March 2005, a generic drug application with the US Food and Drug Administration, using the paragraph IV certification pertaining to generics launches for patented drugs. It typically takes up to 15 months for approval and with this latest legal victory, the company is expecting the approval for ramipril any time.

“We should be able to know within a few days as to when we’ll be able to launch the drug in the US,” a top company official said. It remains unclear whether Lupin will gain 180-day exclusivity for the drug in the US.

This judgement is very significant for Indian pharma companies like Ranbaxy Lab, Dr Reddy’s Lab, Sun Pharma, Glenmark Pharma or Cadila, which are adopting increasingly aggressive strategies in the US generics market.

Canada’s Cobalt Pharmaceuticals was the first company to challenge Sanofi-Aventis’ patent for Altace, which is marketed in the US by King Pharmaceuticals. Though King filed a patent infringement case against Cobalt initially, the two companies reached an out-of-court settlement, under which Cobalt was granted a non-exclusive right to market a generic capsule formulation of ramipril, supplied by King. Lupin was the second firm to challenge the patent.

The Federal Circuit’s decision was based partly 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 had set out certain conditions for proving non-obviousness — one of the three conditions to the grant of a patent — in an innovation.

“This is the first time that these rules are applied to pharmaceuticals,” said Gopakumar Nair, a legal expert. “Going forward, more cases will be ruled in favour of generic companies and chances are that recent judgements will be reversed as well.”

As the US generic drug market continues to reel under ever-rising pricing pressure and competition, manufacturers are challenging pharma companies’ patents, in an attempt to accelerate their entry into the market.

“This is a positive development of the Indian generic industry. This judgement will assist domestic pharma companies prosecuting similar applications in the US,” said Anoop Narayanan, partner of Majmudar & Co, a leading law firm in Mumbai.
In a similar development, Sun Pharmaceutical Industries announced that it had received approval to market a generic version of Wyeth’s heart burn and anti-ulcer drug Protonix in the US, prior to the expiry of Wyeth’s patents for the drug. As the ‘first-to-file’ firm, Sun Pharma stands to benefit from a 180-day exclusivity period to marketing the US. The Mumbaibased company shares this exclusivity period with Israel generic drug maker Teva, which had received approval to market the drug on August 2.

However, if Sun Pharma launches Protonix in the US now, it will run the risk to have to pay damages to Wyeth, in case the latter’s patent for Protonix is upheld in court. “The company is currently evaluating its launch options,” stated the company’s release.

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