FDAnews Drug Daily Bulletin

Court Blocks New Patent Rule

Nov. 2, 2007

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

The U.S. Patent and Trademark Office (PTO) had announced the final rule in August. The rule stipulates 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 also modifies 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 Oct. 9 in the U.S. District Court for the Eastern District of Virginia, asking the court to enjoin the PTO from implementing the rule. In its complaint, GSK argued that the PTO doesn’t have the legal authority to promulgate the rule as Congress has not finished passing the Patent Reform Act, which would give the PTO the ability to issue regulations relating to continuing applications. The House has passed its version of the legislation, H.R. 1908.

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

PhRMA, in its motion for permission to file an amicus brief, 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 Biotechnology Industry Organization (BIO) also submitted a motion for permission to file an amicus brief, noting that “adverse effects of the final rules will nowhere be felt more strongly than in the biotechnology industry.”