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8 October 2019PatentsRory O'Neill

USPTO amends patent term adjustment after Supernus

The US Patent and Trademark Office (USPTO) has amended its rules on patent term adjustment (PTA) to bring them in line with the US Court of Appeals for the Federal Circuit’s ruling in  Supernus Pharma v Iancu in January this year.

In a Federal Register notice published on Friday, October 4, the office said that the Federal Circuit had ruled that a “reduction of patent term adjustment must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application”.

“The office is proposing to revise the provisions pertaining to reduction of PTA for alignment with the Federal Circuit decision in Supernus,” the notice said.

In Supernus, the Federal Circuit concluded that the USPTO had miscalculated the correct PTA for the pharma company’s patent covering an “osmotic drug delivery system” (US number 8,747,897).

The USPTO had attributed a total of 646 days worth of delay in examining the patent to Supernus.

The company accepted responsibility for 100 of these days, but argued there was nothing it could have done to advance the examination process during the remaining 546 days.

The delay related to an opposition filed at the European Patent Office (EPO) by Sandoz.

In its judgment, the Federal Circuit concluded that there was “no action Supernus could have taken to advance prosecution of the patent during the 546-day period, particularly because the EPO notice of opposition did not yet exist”.

The court added: “Congress intended that the PTA statute not adversely impact applicants like Supernus who could have done nothing to advance prosecution.”

The USPTO has now updated its rules in light of the decision to ensure that applicants are not penalised for delays during which they could not have done anything to advance prosecution of a patent.

The new rules will not impose “any additional requirements or fees on applicants”, nor will they “change the circumstances defined as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application,” the USPTO said.

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