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GSK lawsuit tries to halt new US patent rules

GSK launches a lawsuit to try and stop changes to existing US patent laws from coming into effect at the beginning of November 2007

GlaxoSmithkline (GSK) has launched a lawsuit to try and stop changes to existing US patent laws from coming into effect at the beginning of November 2007.

According to Drugresearcher.com, the UK pharmaceutical company is seeking an injunction against the US Patent and Trademark Office (PTO) to stop them from bringing into effect new rules as of 1 November. GSK says the new law will stifle innovation.

Currently in the US, companies submit their patent applications to protect their intellectual property when they discover a potential new drug candidate. The original applications are generally very broad, with companies "fine-tuning" the applications as more information about the molecule is discovered. The claim and any continuations must be then reviewed by the PTO. The existing US law imposes no limit onto the number of continuations and claims made by pharmaceutical companies.

The new laws, which were proposed by the PTO in August 2007, state that companies can only file up to two continuation applications, with up to 25 claims in total. SIf a company wants to exceed this quota, they will have to ask PTO for permission. The PTO will grant permission if the company can prove that "the amendment, argument or evidence sought to be entered could not have been submitted during the prosecution of the prior-filed application". The company will also have to pay additional fees to the PTO.

The PTO says it proposed the changes as more and more continuation applications and claims are being made by pharmaceutical companies as the competition from generic copies increases. The PTO says that the review process takes too long, with a typical timescale of around 32 months. The PTO adds that a backlog of 760,000 applications continues to increase.

If the law is passed, the PTO says it will apply it retrospectively to all pending patent applications. GSK has over 100 such filings pending and another 30 filings planned that will be affected, hence the lawsuit.

30th September 2008

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