In the second lawsuit in as many months, the Patent and Trademark Office (“PTO”) has been sued over a decision to deny a Patent Term Extension (“PTE”). As we previously reported, Wyeth sued the PTO and FDA in June 2008 concerning the appropriate PTE regulatory review period determination for a patent covering the company’s new animal drug CYDECTIN (moxidectin) Pour-On.
On July 11, 2008, PhotoCure ASA (“PhotoCure”) sued the PTO after the Office denied the company’s PTE application for U.S. Patent No. 6,034,267 (“the ‘267 patent”) covering the human drug product METVIXIA (methyl aminoevulinate hydrochloride). FDA approved METVIXIA on July 27, 2004 under New Drug Application (“NDA”) #21-415 for the treatment of actinic keratoses of the face and scalp in certain patients and granted PhotoCure a period of 3-year exclusivity for a “new ester or salt of an active ingredient.” The PTO’s decision to deny a PTE for the ‘267 patent was based on an analysis of the “first permitted commercial marketing” criterion in the PTE statute at 35 U.S.C. § 156(a). PhotoCure’s lawsuit comes on the heels of several recent PTO decisions denying a PTE based on the “first permitted commercial marketing” criterion.
Under the PTE statute at 35 U.S.C. § 156(a)(5)(A), the term of a patent claiming a drug shall be extended from the original expiration date of the patent 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 “active ingredient” (i.e., the active moiety in a drug product, including any salt, ester, or other non-covalent derivative).
With respect to PhotoCure’s PTE request for the ‘267 patent covering METVIXIA, the PTO issued a final decision in May 2008 stating that METVIXIA does not represent the first permitted commercial marketing or use of the product because of FDA’s December 1999 approval of an NDA for Dusa Pharmaceuticals Inc.’s LEVULAN KERASTICK (aminolevulinic acid HCl) Topical Solution, which contains the active moiety aminolevulinic acid (“ALA”). Thus, according to the PTO, METVIXIA does not represent the first permitted commercial marketing or use of ALA and the ‘267 patent is ineligible for a PTE.
Dissatisfied with the PTO’s decision, PhotoCure filed a complaint in the U.S. District Court for the Eastern District of Virginia (Alexandria Division) seeking declaratory relief. Specifically, PhotoCure requests that the court declare that the PTO acted unlawfully in denying PhotoCure’s PTE application, declare that the company’s PTE application satisfies the statutory PTE criteria, and grant further relief as necessary. PhotoCure alleges that the PTO’s interpretation of the “first permitted commercial marketing” PTE criterion should be rejected because it is “contrary to law and will frustrate the overriding purpose of [the 1984 Hatch-Waxman Amendments], which is to encourage research and innovation, including the development of new active ingredients.”
Over the past several months, the PTO has denied several PTE applications based on the failure to meet the “first permitted commercial marketing” criterion using analyses similar to those used to deny PhotoCure’s PTE application. Examples include decisions on patents covering SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol, PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, and EXELON (rivastigmine) Patch . Presumably those applicants will be closely following the outcome of the PhotoCure litigation.
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