The patent owner or its agent, their attorneys or agents, and every other individual who is substantively involved on behalf of the patent owner in a patent term extension proceeding are also subjects to a duty of disclosure in patent term extension proceedings. See 37 C.F.R. § 1.765.See 35 U.S.C. §156(a) and 37 C.F.R. § 1.720(a).See 35 U.S.C. § 156(a)(1) and 37 C.F.R. § 1.720(g). The statute allows the applicant to request an interim patent term extension under 35 U.S.C. § 156(d)(5), if the term of the patent is going to expire prior to product approval.

The USDA argues in its petition, among other things, that the language, structure, and purpose of the PTE statute give the PTO discretion to grant a second subsequent interim PTE outside of the timing window of 35 U.S.C. § 156(d)(5)(C). In particular, the USDA argues that the PTE statute at 35 U.S.C. § 156(a) states that a PTE “shall” be granted provided certain conditions are met, and the USPTO’s implementing regulation at 37 C.F.R. § 1.720(a) uses the word “may.” Thus, according to the USDA, if the word “shall” means “may” to the PTO for purposes of 35 U.S.C. § 156(a), then the word “shall” in 35 U.S.C. § 156(d)(5)(C) should also mean “may,” and the PTO has discretion to grant the USDA’s untimely request for a second subsequent interim PTE for the ‘759 patent.

Such products include human and veterinary pharmaceuticals, food additives, color additives and medical devices. PTE aims to restore a portion of the patent term that is lost while the patent holder is awaiting regulatory approval of the product.The determination as to whether PTE should be granted is made by the U.S. Patent and Trademark Office (PTO), in consultation with the regulatory agency responsible for approval of the product.Requirements for PTE Application Under 35 U.S.C. § 156Deadline for filing is within 60 daysof the mailing date of a marketing approval of the product (37 C.F.R. § 1.720(f)) Approval of New Drug Application (NDA), Biologics License Application (BLA) or Premarketing Approval Application (PMA)The approval date is counted as day 1Saturdays, Sundays and Federal Holidays are countedApplicant is the owner of record or its agent (37 C.F.R. § 1.730(a))Must comply with the requirements provided in 37 C.F.R. § 1.740: Complete identification of the approved product (37 C.F.R § 1.740(a)(1))Complete identification of the Federal statute under which the regulatory review occurredAn identification of the date on which the commercial marketing approval was receivedIn case of a drug product, identification of each active ingredient and a statement that the product has not been previously approvedA statement that the PTE application is submitted within the 60-day period and an identification of the last day the application can be submittedA complete identification of the patent for which extension is soughtA copy of the patentA copy of any terminal disclaimer, certific

710 (2012); 37 C.F.R. §§ 1.775 (calculation of the length of the extension period for a patent directed towards a human drug, an antibiotic drug, or a human biologic); 37 C.F.R. § 1.720 (conditions for PTE); and 37 C.F.R. § 1.740 (2012) (formal requirements for an application for extension of patent term)1.

PhotoCure is currently challenging this PTO interpretation in the context of a PTE denial for METVIXIA (seeJuly 28, 2008 FDA Law Blog post).In October 2004, FDA determined that AstraZeneca’s PTE application for the ‘338 patent covering PRILOSEC OTC was “timely within the meaning of 35 U.S.C. 5 156(d)(l),” and that the PRILOSEC OTC NDA approval “represents the first permitted commercial marketing or use of the product. . . .” Despite this initial determination, an April 2008 letter from the PTO to FDA reverses course and states that “it is the position of the [PTO] that the subject [PTE] was not timely filed based on a plain reading of the statutory language of 35 U.S.C. § 156(d)(1) and the [PTO’s] implementing regulations at 37 C.F.R. § 1.720(f),” and that because of the previous approval of PRILOSEC (omeprazole), PRILOSEC OTC “does not represent the first permitted commercial marketing or use of the ‘product’ . . . .” In May 2008, AstraZeneca petitioned the PTO to have the April 2008 letter withdrawn and to prevent the PTO from retroactively applying “an apparently new method of determining timeliness that has not yet even been announced to the public.”

In 2004, the PTO and FDA determined that the PTE application for the ‘338 patent covering PRILOSEC OTC was “timely within the meaning of 35 U.S.C. 5 156(d)(l).”Despite this initial determination, an April 1, 2008 letter from the PTO to FDA reverses course and states that “it is the position of the [PTO] that the subject [PTE] was not timely filed based on a plain reading of the statutory language of 35 U.S.C. § 156(d)(1) and the [PTO’s] implementing regulations at 37 C.F.R. § 1.720(f).”Clearly unhappy with this turn of events, AstraZeneca petitioned the PTO to have the April 1, 2008 letter withdrawn and to prevent the PTO from retroactively applying “an apparently new method of determining timeliness that has not yet even been announced to the public.”(In January 2008, AstraZeneca filed similar documentation with respect to the ‘860 patent covering SYMBICORT.The PTO denied a PTE for that patent in June 2008.)