June 18, 2009 - 12:15am
USPTO Appeals EDVA Order Holding That Two Federal Circuit Decisions on Patent-Term Extension Are in Conflict Posted by: Administrator

 

The PTO is appealing a decision by the Eastern District of Virginia overturning the PTO’s denial of patent-term extension for a pharmaceutical patent. PhotoCure ASA v. Dudas, No 1:08cv718-LO-JFA, 2009 U.S. Dist. LEXIS 27543 (E.D. Va. Mar. 31, 2009), appeal docketed, No. 2009-1393 (Fed. Cir. June 11, 2009). In its ruling, the Eastern District of Virginia determined that a 1990 decision from the Federal Circuit interpreting the patent-term extension statute conflicted with a later panel decision. The Court held that the earlier decision is controlling and compels extension of the patent’s term.

Plaintiff PhotoCure ASA (“PhotoCure”) filed an application with the PTO to extend the term of a patent it holds on its drug product Metvixia™. PhotoCure based its application for additional patent term on the loss of marketing opportunities due to the regulatory-approval process for the drug. PhotoCure did not obtain approval until more than four years after the issuance of its patent, and believed it was entitled to a term extension under 35 U.S.C. § 156.

The PTO denied the application, however, because it determined that Metvixia was not the “first permitted commercial marketing or use of the product,” 35 U.S.C. § 156(a)(5)(A), covered by the patent. This determination was reached this because an earlier drug, Levulan™, has a key ingredient having the same “active moiety” as that of Metvixia’s key ingredient.

 

   

 Key Ingredient in Metvixia

 Key Ingredient in Levulan

 Common Active Moiety

The PTO relied on 35 U.S.C. § 156(f)(1)(A), which defines “product” to be a “drug product,” defined by 35 U.S.C. § 156(f)(2) to mean “the active ingredient of a new drug...including any salt or ester of the active ingredient.” Taking the position that the active moiety is the “active ingredient” of both Metvixia and Levulan, the PTO decided that extending the term of PhotoCure’s patent would be improper. Photocure challenged the PTO’s decision by suing in the Eastern District of Virginia and moved for summary judgment.

In deciding the motion, the Court compared Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392 (Fed. Cir. 1990), and Pfizer, Inc. v. Dr. Reddy’s Laboratories, Ltd., 359 F.3d 1361 (Fed. Cir. 2004). The Court determined that the Pfizer panel had adopted an “active moiety approach” that the Glaxo panel had previously determined was not consistent with the plain language of the statute. Finding Pfizer and Glaxo to be “clearly in conflict,” the Court applied Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 765 (Fed. Cir. 1988), to follow Glaxo and grant summary judgment in favor of PhotoCure. The PTO’s appeal will give the Federal Circuit an opportunity to analyze Pfizer and Glaxo and determine whether they are indeed in conflict and, if so, how that conflict should be resolved.