(CN) - Tardiness will stop Merck from securing an adjustment of its patent term for a chemical used in diabetes treatments, a federal judge ruled.
Merck Sharp & Dohme, the pharmaceutical company known as Merck & Co. in the U.S. and Canada, is the assignee of the 7,326,708 patent, which is used for diabetes treatments, effective for 17 years from the date of filing.
Because delays by the U.S. Patent and Trademark Office (PTO) in finalizing a patent may significantly cut into the overall patent term, the patent office offers adjustments to account for administrative delays.
The PTO does not dispute that Merck was entitled to an 883-day adjustment but was awarded only 657 days.
Since Merck did not challenge the adjustment within 180 days, however, the PTO claimed that the drugmaker is now ineligible to dispute the adjustment.
U.S. District Judge Beryl Howell in Washington granted Merck summary judgment on Nov. 6, saying its challenge qualifies for equitable tolling of the limitations period.
"At the status hearing, the court asked whether the defendant's position was properly understood to be that the plaintiff met 'the factual predicate for equitable tolling,' but that equitable tolling was not available as a matter of law," Howell said. "After taking time to confer with other counsel, counsel for the defendant responded: 'I think that's right, your Honor.' As a result of this concession, the plaintiff was denied the opportunity to further develop facts in support of its equitable tolling argument. The defendant will not be permitted to now escape from this concession."
As the government presented no evidence against the presumption of equitable tolling, the judge found Merck's action to be timely filed.
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