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US patent ruling setback for drug firms

A US federal appeals court has upheld controversial, new patent office rules, rejecting a GlaxoSmithKline challenge and overturning a 2007 judgement

A US federal appeals court has upheld controversial, new patent office rules, rejecting a GlaxoSmithKline challenge and overturning a 2007 judgement.

Pharma and biotech users of the US patent system suffered a potential setback on Friday a US federal appeals court revived measures aimed at curbing abuse of the US patent system and reducing the backlog of applications. 

UK chartered patent attorney, Gordon Wright, who specialises in pharma patent applications, said: "Although the US ruling has no direct effect on the patent systems in either the UK or in Europe, these US rules will further increase the cost and complexity for all users of the US patent system, including of course European pharma companies wishing to get patent protection in the US."

The ruling upheld some of the rule changes adopted by the US Patent and Trademark Office in 2007. At the time GlaxoSmithKline (GSK) said the rules would undermine patent rights that encourage firms to take financial risks in developing new drugs. One of the changes upheld is a rule that would require an inventor who makes a large number of claims about what a patent covers to provide detailed information on why the invention is eligible for patent protection.

Backed by other drug makers, including Elan Corporation, GSK and an independent inventor challenged the rules before they went into effect, arguing that the patent office didn't have the authority to make the changes. 

In 2007 a federal trial judge in Virginia sided with GSK and invalidated the rules, but the US Court of Appeals for the Federal Circuit on March 20 overturned much of the trial judge's decision and sent the case back to the trial judge for further study.

The court, however, dismissed a patent office rule that would limit the number of times an inventor can file a patent "continuation", the process used to amend an application.

According to the patent office, new rules would stop opportunistic patent applicants from flooding and abusing the system. An array of consumer groups and law professors supported the patent office in the case, saying the current system creates uncertainty in the marketplace and makes it all too likely that dubious patents will eventually be approved.

Bradley Wright, a Washington patent attorney with Banner & Witcoff, said the ruling could have a significant negative impact on pharma, biotech and chemical companies, which frequently file patent applications that contain a large number of claims. He also said that the cost of filing for new patients would rise.

GSK is reviewing the decision and assessing its options.

24th March 2009

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