PTO Denies PTE for PRILOSEC OTC; SYMBICORT PTE Decision Likely to Follow Suit; Litigation Seems a Likely Possibility

January 4, 2009

By Kurt R. Karst

We previously reported on the Patent and Trademark Office’s (“PTO’s”) determination 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 Patent term Extension (“PTE”) because the PRILOSEC OTC New Drug Application (“NDA”) was not the first permitted commercial marketing or use of omeprazole, and because the PTE application was not timely submitted.  (The PTE application was submitted on the 61st day after the date of NDA approval).  The PTO finalized that determination in a decision issued last month. 

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, the statute 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)), and if “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.”   In recent PTE memoranda, the PTO has heavily relied on decisions by the U.S. Court of Appeals for the Federal Circuit in Fisons v. Quigg, 8 U.S.P.Q.2d 1491 (D.D.C.1988), aff’d 876 F.2d 99 U.S.P.Q.2d 1869 (Fed.Cir.1989), Pfizer Inc. v. Dr. Reddy’s Labs., 359 F.3d 1361 (Fed. Cir. 2004), and Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990) to support the Office’s interpretation of the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” (i.e., the molecule in a drug product responsible for pharmacological action, excluding any salt, ester, or other non-covalent derivative) rather than the entire molecule (i.e., the active moiety in a drug product, including any salt, ester, or other non-covalent derivative).  FDA has apparently accepted this interpretation.  PhotoCure is currently challenging this PTO interpretation in the context of a PTE denial for METVIXIA (see July 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.”  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.  In October 2008, FDA issued a letter retracting the Agency’s October 2004 determination.  AstraZeneca has criticized FDA’s retraction decision.

On December 16, 2008, the PTO issued a denial of a PTE for the ‘338 patent.  With respect to the first permitted commercial marketing or use PTE criterion, the Office concluded that PRILOSEC OTC is not the first permitted commercial marketing or use of the product, because the term “product” in the PTE statute ultimately means “the underlying molecule or ion (excluding those appended portions of the molecule that cause it to be a salt or ester) responsible for the physiological or pharmacological action of the drug.”  And because FDA previously approved PRILOSEC, which contains omeprazole, PRILOSEC OTC, which contains omeprazole magnesium, does not represent the first permitted commercial marketing or use of omeprazole. 

With respect to the 60-day PTE application submission criterion and AstraZeneca’s May 2008 petition alleging application of a new counting method, the PTO acknowledges a change in the Office’s counting methodology, but nevertheless denies the PTE application as untimely.  The PTO states that AstraZeneca:

is correct that the USPTO has changed the way in which it makes the timeliness count between 2004 and 2008.  The agency has done so because it realized that it was erroneously beginning the sixty-day count on the wrong day.  By not counting the date of FDA approval as one of the sixty days included in the time period for filing a PTE application, the USPTO was failing to comply with section 156 and case law. . . .  If the USPTO treated [AstraZeneca’s] late filed PTE application as timely filed, as [AstraZeneca] requests, the agency would perpetuate an erroneous application of section 156(d)(1); the USPTO cannot do so.

The PTO’s PRILOSEC OTC decision also has implications on a PTE request concerning another AstraZeneca drug product; namely a PTE application for U.S. Patent No. 5,674,860 (“the ‘860 patent”), which covers the drug product SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol.  As we previously reported, in June 2008, the PTO denied a PTE for the ‘860 patent because the SYMBICORT NDA was not the first permitted commercial use of budesonide or formoterol fumarate dihydrate, and also because the PTE application was not submitted within the 60-day statutory period.  On December 16, 2008 (the same day the PTO issued its PTE denial for PRILOSEC OTC), AstraZeneca submitted a request for reconsideration of the PTO’s June 2008 decision.  Presumably the PTO will deny the request, perhaps using reasoning similar to that in the PRILOSEC OTC decision.  Litigation over the PRILOSEC OTC and/or the SYMBICORT PTE decisions seems a likely possibility given the importance of the drug products to AstraZeneca.  And indeed, the PTO seems to have set itself up for litigation.  Typically the PTO provides an opportunity for an applicant to submit a request for reconsideration of a final determination of PTE ineligibility.  The PTO’s PRILOSEC OTC decision, however, makes no such offer and notes that the December 16, 2008 decision “IS CONSIDERED A FINAL AGENCY DECISION.”

Categories: Hatch-Waxman