VA District Court Grants PhotoCure’s Summary Judgment Motion Challenging PTO’s “First Permitted Commercial Marketing” Interpretation for METVIXIA PTE

By Kurt R. Karst –      

We previously reported on a lawsuit filed in July 2008 by PhotoCure ASA (“PhotoCure”) against the U.S. Patent and Trademark Office (“PTO”) after the PTO denied PhotoCure’s application for a Patent Term Extension (“PTE”) 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.  In a decision issued earlier this week, the U.S. District Court for the Eastern District of Virginia granted PhotoCure’s Motion for Summary Judgment and denied the PTO’s Motion for Summary Judgment.  The decision, which struck down the PTO's interpretation of “product” in the PTE statute, could have significant implications on previous PTE decisions if the decision is appealed and affirmed by the Federal Circuit.

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.  Specifically, 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).  In recent PTE determinations, 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), and Pfizer Inc. v. Dr. Reddy’s Labs., 359 F.3d 1361 (Fed. Cir. 2004) (“Pfizer II”), 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, regardless of whether the active moiety is formulated as a salt, ester, or other non-covalent derivative) rather than “active ingredient” (i.e., the active ingredient physically found in the drug product, which would include any salt, ester, or other non-covalent derivative of the active ingredient physically found in the drug product).  In contrast, the Federal Circuit’s 1990 decision in Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990) (“Glaxo II”), construed the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active ingredient.”

Applying the active moiety interpretation of the law, the PTO determined in May 2008 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. 

In reaching its decision that the PTO’s decision to deny a PTE with respect to ‘267 patent covering METVIXIA was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law” under the Administrative Procedure Act, the court explained that it must determine whether it is required to follow the Federal Circuit’s ruling in Glaxo II or Pfizer II.  The court stated that “[i]mportantly, Pfizer II postdated Glaxo II and was a panel decision that the Federal Circuit declined to hear en banc.  ‘[The Federal Curcuit] has adopted the rule that prior decisions of a panel of the court are binding precedent on subsequent panels unless and until overturned in banc.  Where there is a direct conflict, the precedential decision is the first’” (internal citation omitted).   As a result, the court applied the “active ingredient” interpretation adopted in Glaxo II and determined that “the ‘267 patent covering Metvixia satisfies § 156(a)(5)(A), and that the USPTO’s decision to apply the active moiety interpretation and deny PhotoCute a [PTE] under this provision was contrary to the plain meaning of the statute and thus not in accordance with the law.”  The court also stated:

To adopt the active moiety approach would entail construing the term “active ingredient” in such a manner that permits compounds to qualify as ingredients of drugs even when those compounds are not actually present in the drug.  To adopt such a construction would be permissible, in this Court’s view, only if there was support in the legislative history.  But the Court could find no legitimate support for the active moiety approach in the § 156 legislative history.  Therefore, the Court will not construe the “active ingredient” term against its plain meaning by adopting a construction that permits compounds not present in the drug to qualify as the “active ingredient.”

Also worth emphasizing is that the term “active moiety” was indisputably well-known at the time Congress drafted the statute.  If Congress desired to infuse the “active moiety” concept into §§ 156(a) and (f), it could have done so easily by including the term somewhere in either of those two provisions.

The district court’s decision comes on the heels of several recent PTO decisions denying PTEs based on the “first permitted commercial marketing” criterion applying the active moiety interpretation of the statute – see our previous post here.  As such, it seems likely that the PTO will appeal the case to the Federal Circuit.  A Federal Circuit decision affirming the district court’s decision could call into question previous PTE denials using the active moiety interpretation of the statute.