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US District Court blocks new patent rule

A district court judge has granted UK-based pharma giant GlaxoSmithKline's (GSK) motion for a preliminary injunction to prevent a new rule on patent claims and continuations from going into effect.

A district court judge has granted UK-based pharma giant GlaxoSmithKline's (GSK) motion for a preliminary injunction to prevent a new rule on patent claims and continuations from going into effect.

The US Patent and Trademark Office (PTO) announced the final rule in August 2007, which said that if a patent application contains more than five independent claims or more than 25 total claims, the applicant must provide an examination-support document to the PTO.

The new rule would have also modified how many continuing applications parties are allowed to file after submitting an initial application. Under the final rule, any third or subsequent continuation or continuation-in-part application, as well as any second or subsequent request for continued examination, must contain justification of why the new evidence was not submitted previously.

GSK sued the PTO on 9 October in the US. The District Court for the Eastern District of Virginia asked the court to enjoin the PTO from implementing the rule.

In its complaint, GSK argued that the PTO did not have the legal right to push through the rule as Congress had not finished passing the Patent Reform Act, which would give the PTO the ability to issue regulations relating to continuing applications. The House of Representatives has already passed its version of the legislation.

GSK also argued that the limit on the number of claims was unjust because companies are specifically permitted to file one or more claims under law. The company added that the examination-support document requirement was vague and burdensome.

The Pharmaceutical Research and Manufacturers of America (PhRMA) argued that the final rule would "impermissibly undercut long-held rights relating to the filing of patent applications that are important to pharmaceutical and biotechnology companies".

The US-based Biotechnology Industry Organisation (BIO) also submitted a motion, noting that "adverse effects of the final rules will nowhere be felt more strongly than in the biotechnology industry".

30th September 2008

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