INDIAN generic pharma companies may now find it easier to challenge
patents in the US. In a new twist in the battle between innovators and
generic companies, the US Supreme Court has written new rules that will
make it harder to obtain and defend patents in the US. Ruling
unanimously in a case that could affect billion of dollars worth of US
patents, the court has set a higher threshold for obtaining patent
protection and sent a clear signal that it feels excessive patent
rights are stifling innovation in the US.
This could represent a significant opportunity for Indian generic companies, which are adopting increasingly aggressive strategies in the US to capture a chunk of the rapidly growing pharma market, challenging productâ€™s patent to prepone their entrance in the market.
â€œThis is a very positive move for the Indian pharma industry,â€ said Dilip G Shah, secretary general, Indian Pharma Alliance (IPA). â€œThe decision may make it harder to obtain a United States patent, and existing United States patents will be subject to an immediate enhanced threat by re-examination.â€ In its judgement, the US Supreme court defined non-obviousness â€”one of the three conditions to the grant of a patentâ€” in a more narrow and rigid way. This move will affect primarily patents for incremental innovations, new forms of existing drugs, often considered as â€˜weak patentsâ€™, and challenged by the generic industry. Itâ€™s the case of Astra Zenecaâ€™s patent on Nexium, which has been challenged by generic pharma companies, including Indiaâ€™s Ranbaxy and Dr Reddyâ€™s Lab. Facing the loss of patent protection and competition from generic manufacturers, the UK drug giant developed a new version of its blockbuster ulcer drug, claiming enhanced efficacy over the off-patent old version of the drug. With $3.44 billion sales in the US, Nexium was the second best selling drug in 2005, after Pfizerâ€™s Lipitor.
â€œThe US Court judgement determined the grounds for non-obviousness by assessing the predictability of the results,â€ said Gopakumar G Nair, an industry expert on patents. In the case of Nexium, the results from adding an excipient to the old molecule, was known, argue generic companies.
If AstraZenecaâ€™s patent is invalidated by the US Court, the generic company which was the first to file a patent challenge will stand to benefit from a 180-day exclusivity period in the US market. This means a windfall of revenues. For instance, Ranbaxy Labâ€™s generic version of Glaxo-SmithKlineâ€™s antibiotic drug Ceftin, launched with exclusivity in March 2002, had garnered around $100 million in 2002, according to Ranbaxy.
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