PTO Sidesteps Patent Term Extension “Regulatory Review Period” Issue in Petition Response

Under the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review period” is composed of a “testing phase” and a “review phase.” For a medical device subject to an approved Premarket Approval Application (“PMA”), the Patent Term Extension (“PTE”) statute at 35 U.S.C. § 156(g)(3)(B) states that the “testing phase” begins on “the date a clinical investigation on humans involving the device was begun and [ends] on the date [a PMA] was initially submitted with respect to the device.” The “review phase” is the period between PMA submission and approval. A patent term may be extended for a period of time that is the sum of one-half of the time in the “testing phase,” plus all the time in the “review phase.” The “regulatory review period” must be reduced by any time that the applicant “did not act with due diligence.” (For complete news click on FDAlawblog)