Biogen MA, Inc. v. Japanese Foundation for Cancer Research (Fed. Cir. 2015)

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Biogen IdecThe Federal Circuit affirmed a decision by the U.S. District Court for the District of Massachusetts that it lacked subject matter jurisdiction under 35 U.S.C. § 146 pursuant to changes in the statute provided by the Leahy-Smith America Invents Act, in Biogen MA, Inc. v. Japanese Foundation for Cancer Research.  Biogen brought suit after receiving an unfavorable PTAB determination in an interference, a proceeding eliminated by other changes in the AIA for patents having an earliest effective filing date after March 15, 2013.  At issue here was whether these AIA changes in the scope of appeals applied to interferences instituted after September 15, 2012 under circumstances wherein each party had an earliest effective filing date prior to the effective date of the change from the "first to invent" to "first inventor to file" standard.

This interference (No. 105,939) is one in a line with long provenance in biotechnology patent law, being related to the three-way interference that resulted in the Federal Circuit decision in Fiers v. Revel (v. Sugano, the latter inventor having been granted priority to claims for isolated human β-interferon DNA). That case stands for the proposition that conception of an invention comprising an isolated nucleic acid molecule requires that the molecule actually be isolated.  It is a decision that directly supports the further development of the Federal Circuit's written description jurisprudence, from Regents of the University of California v. Eli Lilly & Co. through Ariad v. Eli Lilly.

In the case at bar the PTAB held that one of the inventors, Walter Fiers, was estopped by losses in two earlier interferences "covering the same subject matter" (the opinion notes that the '939 interference was directed to β-interferon protein).  The district court determined that the AIA eliminated district court jurisdiction for appeals of PTAB decisions in interferences, and transferred the case to the Federal Circuit (which undoubtedly has jurisdiction under 35 U.S.C. § 141).  The Federal Circuit panel affirmed the district court on the procedural question and the PTAB on the substantive question regarding interference estoppel, in a decision by Judge Dyk joined by Judges Schall and Chen.

Regarding the procedural issue, the panel decided the "threshold issue" of whether the Federal Circuit had jurisdiction to decide whether the district court had properly decided that it did not have jurisdiction (a decision that the Japanese Foundation contended was not reviewable).  The Federal Circuit held that the district court's decision was reviewable, citing In re Teles AG Informationstechnologien, 747 F.3d 1357 (Fed. Cir. 2014).  That case was one "virtually indistinguishable" from this one, but there the Court did not "explicitly discuss the basis for adjudicating the district court's jurisdiction" so the panel set forth its grounds in this opinion.  The opinion relied on its own "'inherent jurisdiction to determine [is] own jurisdiction,'" citing  C.R. Bard, Inc. v. Schwartz, 716 F.2d 874, 877 (Fed. Cir. 1983) (citing United States v. United Mine Workers of Am., 330 U.S. 258 (1947)) and noted that Congress had "provided two mutually exclusive avenues of review [of adverse interference decisions] under § 146 and § 141."  This proposition finds support not only in the Court's own jurisprudence (including  AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759 F.3d 1285, 1296 (Fed. Cir. 2014)) but more importantly under controlling Supreme Court precedent. Hoover Co. v. Coe, 325 U.S. 79, 84-85 (1945)(regarding an earlier version of the Patent Act having similar alternate provisions, wherein the Court "thoroughly reviewed the legislative history of the patent acts since 1836, which revealed continued maintenance of alternative paths of review").  The opinion notes that these procedural alternatives have been upheld "uniform[ly]" by appellate courts and that choosing one option constitutes an "irrevocable election."    In such an "either/or" situation, the question of whether the Court can properly exercise jurisdiction depends on whether the district court was correct in determining that it did not have jurisdiction, contrary to the Foundation's position.

The panel determined that the AIA stripped district courts of their jurisdiction over adverse interference decisions.  In reaching its decision that Court reviewed the provisions of the AIA to understand whether the new law changed availability of  § 146 challenge of patent decisions for interferences declared after September 15, 2012 (one year after enactment of the law and the time when changes in other provisions of the law, such as the change from inter partes re-examination to inter partes review became effective).  The opinion does not rely solely on the AIA, however, but also considered revisions to the AIA enacted by the Leahy-Smith America Invents Technical Corrections Act, Pub. L. No. 112– 274, 126 Stat. 2456 (2013).  In part this was necessary because the panel found the "effective date" provisions to be "far from a model of clarity," containing a "hodgepodge" of "express" and "implicit reservations" of pre-AIA provisions "and sometimes simply silence."  With this backdrop, the opinion focuses on the parties' contentions regarding the meaning of § 3(n)(1) of the AIA:

(1) IN GENERAL.—Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18- month period beginning on the date of the enactment of this Act [i.e., March 16, 2013], and shall apply to any application for patent, and to any pa- tent issuing thereon, that contains or contained at any time—
    (A) a claim to a claimed invention that has an effective filing date as defined in section 100(i) of title 35, United States Code, that is on or after  the effective date described in this paragraph; or
    (B) a specific reference under section 120, 121, or 365(c) of title 35, United States Code, to any patent or application that contains or contained at any time such a claim.

which the opinion admits is "silent" regarding interferences.  Biogen relied upon this silence to support its position that pre-AIA provisions of the Patent Act, including the alternative choices for forum of appeals from adverse interference decisions, remain effective for interferences declared after September 15, 2012.  The panel disagrees and found that "Congress specifically addressed the manner of judicial review of Board decisions in continuing interference proceedings" and that these provisions control.  Specifically, the opinion cites §6(f)(3)(C), which provides:

(C) APPEALS.—The authorization to appeal or have remedy from derivation proceedings in sections 141(d) and 146 of title 35, United States Code, as amended by this Act, and the jurisdiction to entertain appeals from derivation proceedings in section 1295(a)(4)(A) of title 28, United States Code, as amended by this Act, shall be deemed to extend to any final decision in an interference that is commenced before the effective date set forth in paragraph (2)(A) of this subsection [i.e., September 16, 2012] and that is not dismissed pursuant to this paragraph.

The opinion recognized that this section did not address appeals in interferences declared after September 15, 2012 but asserted that Congress "corrected [its] omission" in § 1(k)(3) of the (AIA) Technical Corrections Act:

(3) REVIEW OF INTERFERENCE DECISIONS.—The provisions of sections 6 and 141 of title 35, United States Code, and section 1295(a)(4)(A) of title 28, United States Code, as in effect on September 15, 2012, shall apply to interference proceedings that are declared after September 15, 2012, under section 135 of title 35, United States Code, as in effect before the effective date under section 3(n) of the Leahy-Smith America Invents Act. The Patent Trial and Appeal Board may be deemed to be the Board of Patent Appeals and Interferences for purposes of such interference proceedings.

The Federal Circuit found express provisions regarding appellate review under § 141 for interferences declared after September 16, 2012; the absence of any corresponding provisions for review under § 146 was enough for the Court to conclude that no such provision survived the changes in U.S. patent law wrought by the AIA.  Taking this silence in combination with the provisions of §6(f)(3)(C) of the AIA, the panel concluded that "pre-AIA § 146 review was eliminated for interference proceedings declared after September 15, 2012."

The basis for this conclusion bears some consideration from the Court, which asserted in the opinion that the panel relied on the "basic tenet of statutory interpretation that the specific governs the general."  This tenet is illustrated in the opinion by Supreme Court precedent including RadLAX Gateway Hotel, LLC v. Amalgamated Bank, 132 S. Ct. 2065 (2012) and Gozlon-Peretz v. United States, 498 U.S. 395 (1991).  In the instant case, the opinion states that "even if the general effective date provision in § 3(n)(1) suggests that in general Congress preserved pre- AIA provisions for pre-March 16, 2013, patent applications, it does not follow that we should myopically apply § 3(n)(1) independently of the specific provisions in AIA § 6(f)(3)(C) and § 1(k)(3)."  The opinion discerns that Congress intended to target "'deliberately targeted specific problems with specific solutions,'" citing RadLAX that the Court "cannot ignore."   The panel decided that it "must accordingly follow the express provisions in the statute" (forgetting, it would seem, the lack of clarity the Court noted earlier in its opinion) and characterized Biogen's arguments to the contrary to be "convoluted."

Turning to the merits, the panel agreed with the PTAB that "estoppel by judgment" applies here, defined as situations where "'a losing party in a previous interference between the same parties'" tries to patent a claim 'not patentably distinct from the counts in issue in that [prior] interference,'" citing Woods v. Tsuchiya, 754 F.2d 1571, 1579 (Fed. Cir. 1985).  "Claims that are not patentably distinct from lost counts were already adjudicated in the prior interference and are thus conclusive," said the Court and agreed with the Foundation that "Fiers failed to meet his burden to show patentable distinctness to avoid interference estoppel by judgment."  The Court also relied upon the Board's reasoning that "'[i]n light of [the fact] that DNA and the known genetic code indicating which DNA sequences encode each amino acid, those of skill in the art would have considered the polypeptide Fiers now claims to have been obvious.'"  Included in the litany of failures was Biogen's assertion of a Restriction Requirement in Biogen's application at issue in the interference, with the Court holding that issuing this paper is not determinative of patentable distinctness but as being limited to "evidence that the examiner thought that there were 'two or more independent and distinct inventions' claimed in a single application," citing 35 U.S.C. § 121; 37 C.F.R. § 1.142; MPEP § 802.01.  The panel characterizes restriction requirements as being "primarily for administrative convenience" and as "not represent[ing] a final determination that the relevant claims are patentably distinct," citing Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563, 1568 (Fed. Cir. 1996).  The panel showed similar disregard for similar arguments regarding the Office declaring separate interferences, also emphasizing the "discretionary" nature of these decisions.

The panel decision cannot properly be contested as being "wrong" per se, but it can be recognized that it is based on the absence of express provisions regarding district court review of interferences declared after September 15, 2012.  As such, it should be a simple matter for Congress to restore the status quo ante (the AIA) the next time it considers "technical amendments" to the AIA or other revisions to the Patent Act.

Biogen MA, Inc. v. Japanese Foundation for Cancer Research (Fed. Cir. 2015)
Panel: Circuit Judges Dyk, Schall, and Chen
Opinion by Circuit Judge Dyk

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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