Counting to 60 – A Task that is Perhaps More Difficult than One Might Think; AstraZeneca Cries Foul Over PTE Application Timeliness Calculation Method

July 16, 2008

An interesting issue is percolating at the U.S. Patent and Trademark Office (“PTO”) concerning Patent Term Extensions (“PTEs”).  We hinted at this issue in our recent post concerning the PTO’s decision to deny a PTE with respect to U.S. Patent #5,674,860 (“the ‘860 patent”), which covers AstraZeneca’s SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol.  In that case, the PTO determined that the ‘860 patent is ineligible for a PTE because the SYMBICORT New Drug Application (“NDA”) was not the first permitted commercial marketing or use of either of the active ingredients, and because the PTE application was submitted on the 61st day after the date of NDA approval.  In a similar action, the PTO has determined that U.S. Patent #5,817,338 (“the ‘338 patent”), which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a PTE on the same two statutory bases.  In both cases, AstraZeneca has challenged the PTO’s determination that the PTE applications were untimely because they were submitted to the PTO 61 days after NDA approval (including the date of NDA approval).

Under the PTE statute at 35 U.S.C. § 156, the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, the PTE application is submitted to the PTO by the owner of record within 60 days of NDA approval.  Specifically, § 156(d)(1) states that a PTE application “may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use” (emphasis added).  The 60-day filing period is a hard and fast rule.  (At least unless Congress passes the latest iteration of the “Dog Ate My Homework Act,” which would amend the PTE statute to permit a late filing if there is an inadvertent delay in PTE application submission.)  Indeed, in Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d 1644 (Fed. Cir. 1989), the U.S. Court of Appeals for the Federal Circuit addressed PTE application submission timeliness and observed that “section 156(d)(1) admits of no other meaning than that the sixty-day period begins on the FDA approval date.” Notwithstanding the specific language in 35 U.S.C. § 156(d)(1) and the Federal Circuit’s commentary in the Unimed decision, AstraZeneca asserts with respect to the company’s PTE applications for the ‘860 and ‘338 patents that the PTO recently changed the Office’s method for determining the 60-day filing period, and that both PTE applications should considered timely filed according to the PTO’s original method used for calculating the 60-day period. 

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.) 

According to AstraZeneca, “[f]rom at least 1986 until relatively recently, the PTO had consistently applied to numerous other PTE applications the Original Method for determining timeliness,” under which the 60-day statutory filing deadline was calculated beginning on the date after product approval.  AstraZeneca cites several examples of PTEs allegedly granted since 1986 in which the PTE application for the subject patent was submitted to the PTO based on a 60-day period calculated using the date after product approval as day 1.  AstraZeneca also cites: (1) a 1987 PTO-FDA interagency memorandum of understanding stating that in response to a request for assistance in making a PTE determination FDA will provide a written reply to the PTO “informing the [PTO] whether the [PTE] application was submitted within 60 days after the product was approved” (emphasis added); and (2) FDA’s “Frequently Asked Questions on the Patent Term Restoration Program,” which states, in relevant part, that an “[a]pplication for patent extension must be filed within 60 days of FDA approval of the drug product . . . .” (emphasis added).  AstraZeneca asserts that these publications, “which have not been superseded or withdrawn,” show that “the PTO and FDA interpret the timeliness provision of 35 U.S.C. § 156(d)(1) to mean that a PTE application must be filed within 60 days after FDA approval . . . .” (emphasis in original).

Notwithstanding the alleged inconsistencies in the PTO’s 60-day calculation method, AstraZeneca’s petition does not explain how to square the fact that the PTE statute states that the 60-day period begins “on the date the product” was approved for commercial marketing with the fact that the PTE applications for the ‘860 and ‘338 patents were submitted on day 61 according to such a calculation.  Perhaps more concerning, however, is the possibility that the PTO might have incorrectly granted PTEs based on an application submitted on day 61 according to the statutory calculation.   

By Kurt R. Karst    

Categories: Hatch-Waxman