United States: AIA Eliminates District Court's § 146 Review Of Interferences Declared After September 15, 2012

Biogen MA, Inc. v. Japanese Foundation for Cancer Research, No. 2014-1525, 2015 U.S. App. LEXIS 7520 (Fed. Cir. May 7, 2015) (Dyk, J.). Click Here for a copy of the opinion.

Since 1983, a series of interferences were declared between applicants Fiers and Sugano. The first interference was related to the parties' applications (06/201,359 and 06/250,609) directing to DNA sequences coding for hFIF proteins. Fiers moved to add counts directed to the hFIF proteins, which the Board denied. The Board then awarded priority to Sugano.

In 2009, a second interference was declared between Sugano U.S. Pat. Nos. 5,236,859 and 5,514,567 and Fiers application no. 08/471,646. The count was directed to the DNA sequence encoding the mature hFIF protein. The Board ordered Fiers to "show cause why the interference should continue given that its subject matter was the same as in the first interference." The Board concluded that Fiers failed to meet its burden and entered judgment in favor of Sugano. Fiers did not appeal this decision.

In July 2013, a third interference was declared between Sugano application no. 08/463,575 and Fiers application no. 08/253,843. The counts were directed to precursor and mature hFIF proteins. The Board again ordered Fiers to "show cause as to why Fiers should not be estopped from proceeding" given the outcome of the first two interferences. Fiers argued that estoppel did not apply because claims to hFIF proteins "are patentably distinct" from claims to the DNA sequences encoding these proteins. In addition, estoppel should not apply because Fiers previously moved in the first interference to add counts for the hFIF proteins but was barred by the Board. The Board nevertheless concluded that Fiers is estopped by the two earlier interferences and that Fiers failed to show patentable distinctness.

Subsequently, Biogen, owner of the Fiers '646 application, filed suit in the district court under pre-AIA 35 U.S.C. § 146 to set aside the Board's determination. JFC, owner of the Sugano '575 application, moved to dismiss the case for lack of subject matter jurisdiction. The district court granted JFC's motion and transferred the case to the Federal Circuit. Biogen requested a retransfer, back to the district court.

The Federal Circuit first concluded that it has jurisdiction to review the district court's conclusion that it (the district court) lacks subject matter jurisdiction to consider Biogen's case under pre-AIA 35 U.S.C. § 146. Next, the Federal Circuit explained that the district court's jurisdiction under § 146 and the Federal Circuit's jurisdiction under § 141 are mutually exclusive avenues of review for pre-AIA interference decisions by the Board. If a party elects to have the Board's decision reviewed by the Federal Circuit under § 141, it has irrevocably waived district court review under § 146. Likewise, an election of § 146 review would deprive the Federal Circuit of jurisdiction. However, this is only true if § 146 review is available to the party seeking review.

Under the AIA, § 146 has been amended to authorize review only of derivative proceedings. In addition, AIA § 3(n)(1) generally states that the new AIA provisions only apply to applications with an effective filing date on or after March 16, 2013. However, this provision is silent as to judicial review of interference proceedings. Biogen argued that this silence "implicitly preserves interference proceedings and judicial review provisions concerning interference proceedings for patent applications filed before March 16, 2013." The Federal Circuit rejected Biogen's argument and found support in specific provisions of the AIA (§ 6(f)(3)(C) and § 1(k)(3)).

AIA § 6(f)(3)(C) provides that amended § 146 "shall be 'deemed' to provide review of interferences declared before September 16, 2012." In addition, § 1(k)(3) explicitly authorizes pre-AIA § 141 review but does not authorize § 146 review. Taking the two provisions together and applying the "basic tenet of statutory interpretation that the specific governs the general," the Federal Circuit concluded that the AIA eliminated pre-AIA § 146 review for interference proceedings declared after September 15, 2012. The Court affirmed the district court's lack of subject matter jurisdiction. Because pre-AIA § 146 review is not available, the Court concluded that it has jurisdiction under § 141.

The Court also affirmed the Board's conclusions on the merits. Fiers is estopped from continuing with the interference. Fiers failed to meet his burden to show patentable distinctness. Rejecting Fiers' evidence, the Court concluded that (1) "[r]estricting requirements are discretionary decisions, primarily for administrative convenience, and do not represent a final determination that the relevant claims are patentably distinct"; (2) a "discretionary decision to declare separate interferences in another proceeding is not necessarily a determination, let alone a final one, of patentable distinctness"; (3) the Board's reversal on the examiner's determination that the protein claims were unpatentable as anticipated over the DNA claims was evidentiary and not for "patentably distinct" reasons; and (4) Fiers' expert addressed only written description issues and not "how Fiers' hFIF protein claims were not obvious over the lost counts directed to the DNA sequences."

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