Monday, February 18, 2008

US patent reform to benefit Indian firms [India]

Indian pharmaceutical firms, which make most of their revenues and profits from the manufacture of off-patent, or generic, drugs, are set to play a larger role in the US, the world’s biggest drug market.

That is, if a US plan to reform patent laws by including provisions for what is called post-grant opposition to patents and limiting avenues for extending patent protection for medicine companies becomes law.

The immediate impact of the law change will be to ease challenges on drug patents and also lower legal costs in such challenges.
The changes anticipated in the Patent Reforms Act, which has already been passed by the US House of Representatives in February, would allow opposing a patent after its grant in the US, as is possible in countries such as the UK, Germany and India, along with a general tightening of patentability rules in the US.
It would also, to a large extent, halt the tactics of research-based drug giants in the US to include all possible claims in the patent application by modifying it several times during the life of a patent through what is known as “ever-greening”.
With the reforms, the US patent office sought to limit the number of times to two that a patent applicant can file “continuations” of patents. Currently, there is no limit on the number of times that a patent holder can keep updating its patent claims through such filings. The draft law is now under consideration of the US Senate.
The patent reforms in the US are aimed at eliminating frivolous patents as also invalidating several existing patents that have received such protection through “continuation” filings based on simple modifications. This would help generic players to enter the market with more products as the legal expenses will go down.
Patent experts said that the reforms that the US has initiated are an attempt to harmonize its patent law with the rest of the world, which follows a comparatively higher threshold for patentability.
The new rules, for instance, will replace the current US system that grants patents to applicant who can prove “first-to-invent” status with a “first-to-file” regime in force in others countries.
With the provision of post-grant opposition, generics companies will get a new opportunity to argue against the unsubstantiated claims made by the patent holder without going to court of law or infringing the patent—both expensive options.

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