PhotoCure and Wyeth District Court PTE Decisions Appealed to the Federal Circuit; Effects of the PhotoCure Decision are Already Evident

By Kurt R. Karst –      

Recent decisions by the U.S. District Court for the Eastern District of Virginia and the U.S. District Court for the District of Columbia in PhotoCure ASA v. Dudas and Wyeth Holding Corp. v. United States, respectively, concerning certain Patent Term Extension (“PTE”) issues have been appealed to the U.S. Court of Appeals for the Federal Circuit.  The PhotoCure case is of particular interest because the Federal Circuit’s decision will likely have broad implications. 

PhotoCure concerns a PTE request for U.S. Patent No. 6,034,267 (“the ‘267 patent”) covering the human drug product METVIXIA (methyl aminoevulinate hydrochloride), which FDA approved on July 27, 2004 under New Drug Application (“NDA”) No. 21-415.  As we previously reported, the U.S. Patent and Trademark Office (“PTO”) denied a PTE for the ‘267 patent based on an analysis of the “first permitted commercial marketing” criterion in the PTE statute.  (Under 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, among other things, “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.” (emphasis added))  Specifically, the PTO applied an “active moiety” interpretation of the PTE law (rather than an “active ingredient” interpretation) and determined 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 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.  PhotoCure promptly sued the PTO. 

The court in PhotoCure ruled that the PTO’s decision to deny a PTE with respect to ‘267 patent was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law” under the Administrative Procedure Act.  In issuing its decision, the court applied the “active ingredient” interpretation of the PTE law and determined that “the ‘267 patent covering Metvixia satisfies § 156(a)(5)(A) . . . .” 

Wyeth concerns a PTE request for U.S. Patent #4,916,154 (“the ‘154 patent”) covering Wyeth’s new animal drug CYDECTIN (moxidectin) Pour-On.  FDA approved CYDECTIN Pour-On on January 28, 1998 under New Animal Drug Application (“NADA”) No. 141-099.  The NADA was reviewed under FDA’s Phased Data Review Policy and Administrative NADA process (i.e., a process permitting rolling submission and review of marketing application sections).  FDA determined that the date NADA No. 141-099 was “initially submitted” to the agency for PTE purposes was January 13, 1998, when the final NADA component was submitted to the Agency, thus resulting in a 16-day approval period and a short PTE period for the ‘154 patent.  Wyeth sued FDA and contended that a 16-day approval period “is unreasonable,” and argued that the NADA was “initially submitted” to FDA on August 8, 1995 when the company submitted the first technical section to its application.  As we previously reported, the court ultimately ruled in FDA’s favor.

Both the PTO and Wyeth have appealed their respective district court decisions to the U.S. Court of Appeals for the Federal Circuit.  Both cases will be closely watched, and in particular the PhotoCure case.  The district court decision in PhotoCure has already been used to support a PTE request for reconsideration, arguments in a recent PTE case concerning enantiomers, and was cited in a recent FDA docket submission concerning the availability of New Chemical Entity (“NCE”) exclusivity for pro-drugs. 

Specifically, AstraZeneca has argued that the PhotoCure decision supports the company’s efforts to obtain a PTE for U.S. Patent No. 5,817,338 (“the ‘338 patent”) covering PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets.  As we previously reported, the PTO determined that the ‘338 patent is not eligible for a PTE because the PRILOSEC OTC NDA was not the first permitted commercial marketing or use of omeprazole (and also because the PTE application was not timely submitted).  That is, the PTO applied an  “active moiety” interpretation of the PTE statute and 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.”

The PhotoCure decision has also been cited in post-trial communications (here and here) in a case concerning a PTE granted by the PTO with respect to U.S. Patent No. 5,053,407 (“the ‘407 patent”) covering Ortho McNeil-Janssen Pharmaceutical, Inc.’s enantiomer drug product LEVAQUIN (levofloxacin).  As we previously reported, the U.S. District Court for the District of New Jersey ruled last month that the PTE granted with respect to the ‘407 patent is valid.  Lupin challenged the validity of the ‘407 patent PTE on the basis that the “marketing of levofloxacin would not be the ‘first permitted commercial marketing or use’ of the active ingredient (levofloxacin) as either a single entity or in combination with another active ingredient” given FDA’s previous approval of the racemate drug FLOXIN (ofloxacin).  Both parties contend that the PhotoCure decision is consistent with their arguments.  The district court’s decision has been appealed to the Federal Circuit. 

In addition, the PhotoCure decision has been used to support a position that FDA should affirm its decision to grant a period of five-year NCE exclusivity for the pro-drug VYVANSE (lisdexamfetamine dimesylate) Capsules.  As we previously reported (here and here), FDA has been sued over its decision to grant NCE exclusivity for VYVANSE and its refusal to accept an ANDA for a generic version of the drug product.  That litigation has been put on hold while FDA solicits and considers public comment (Docket No. FDA-2009-N-0184) on pro-drug NCE exclusivity issues.  In a recent docket submission, one company argues that the PhotoCure decision “supports FDA’s decision that Vyvanse is entitled to five-year NCE exclusivity.”