On April 16, 2018 in a precedential opinion, the United States Court of Appeals for the Federal Circuit, Sumitomo Dainippon Pharma v. Emcure Pharms., Nos. 2017-1798, -1799, -1800, affirmed the United States District Court for the District of New Jersey by construing the claimed chemical structure diagram to encompass at least the specific enantiomer depicted, refusing to limit the claim to only cover a racemic mixture of the (+) and (–) enantiomers, absent clear indication that the depicted enantiomer should be excluded from the claim.
Joseph Rutkowski is an Associate and is based in the firm’s Boston office. His practice focuses on a variety of civil litigation matters, including patent litigation, trade secret disputes, and complex commercial litigation. Joseph’s primary focus is intellectual property litigation, including matters involving pharmaceuticals and the Hatch-Waxman Act, and he is experienced in all stages of litigation.
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize biosimilars applicants who fail to disclose information about their abbreviated Biologics License Applications (“aBLAs”) or manufacturing processes as required by 42 U.S.C. § 262(l)(2)(A).
Amgen’s State Law Claims
This is the latest in a line of BPCIA decisions arising out of Sandoz’s application to market a biosimilar version of Amgen’s Neupogen (filgrastim) biologic. (For more complete coverage of the facts and prior proceedings, see our prior coverage, including the Supreme Court and Federal Circuit opinions.) In relevant part, after filing its aBLA, Sandoz refused to provide Amgen with a copy of its aBLA and manufacturing information as required by § 262(l)(2)(A). Amgen then filed suit, asserting both patent infringement under the BPCIA as well as state law claims under California law, including a claim for unfair competition. Sandoz asserted, among its many defenses, an affirmative defense that Amgen’s state law claims are preempted by the federal BPCIA. However, neither the district court nor the Federal Circuit addressed preemption on the merits. On June 12, 2017, the Supreme Court ruled that the BPCIA’s “patent dance” information exchange provisions are optional and that an aBLA applicant may refuse to provide a reference product sponsor with a copy of the aBLA and manufacturing information required by § 262(l)(2)(A). The Court, however, remanded to the Federal Circuit for a determination of whether the BPCIA preempts Amgen’s state law claims.
In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for biosimilar versions of Neulasta® and Neupogen® did not infringe an Amgen protein folding patent. The Federal Circuit affirmed the non-infringement finding despite statements made in Apotex’s pre-litigation letters sent during the parties’ information exchange (i.e., the “patent dance”), which the district court found were controverted by evidence presented by Apotex at trial.
Amgen makes the biologic drugs Neulasta® (pegfilgrastim) and Neupogen® (filgrastim). Apotex submitted aBLAs (“abbreviated Biologics License Applications”) to the FDA seeking approval of biosimilar versions of both drugs under the BPCIA (“Biologics Price Competition and Innovation Act”) framework. The parties engaged in the BPCIA’s “patent dance” information exchange process, whereby Apotex provided Amgen with copies of Apotex’s aBLAs. Amgen ultimately brought suit under 35 U.S.C. § 271(e)(2)(C), (a) and (g), asserting that Apotex’s proposed manufacturing processes would infringe, among others, Amgen’s U.S. Patent. No. 8,952,138 (the ‘138 patent).
The ‘138 patent covers a method of refolding misfolded proteins. This process purportedly allows for large-scale protein refolding using lower reagent volumes than was previously possible. The district court construed (and the Federal Circuit did not reverse) asserted claim 1 of the ‘138 patent to require “refold mixture” protein concentrations above 1.0 g/L. Continue Reading Federal Circuit Evaluates Import of Factual Statements Made During BPCIA Pre-litigation Patent Dance
In a precedential opinion issued on October 11, 2017, the United States Court of Appeals for the Federal Circuit reversed the Patent Trial and Appeals Board’s (“PTAB”) finding of non-obviousness where the prior art taught away from some, but not all, of the embodiments covered by the challenged claims. In Owens Corning v. Fast Felt Corp., No. 2016-2613 (Fed. Cir. Oct. 11, 2017), the panel held that the PTAB had applied an unreasonably narrow construction to the exclusion of embodiments that were not taught away from by prior combinations disclosing all of the claim elements.
PTAB’s Improper Claim Construction
Fast Felt owns U.S. Patent No. 8,137,757 (“the ‘757 patent”), which it asserted against Owens Corning in the U.S. District Court for the Northern District of Ohio. In turn, Owens Corning petitioned for inter partes review of the claims of ‘757 patent, and the PTAB instituted trial. Owens Corning contended that the challenged claims were rendered obvious by prior art combinations disclosing all elements of the independent claims. However, in its final written decision, the Board determined that Owens Corning failed to provide a motivation to combine and upheld the patentability of the challenged claims. Owens Corning timely appealed.
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court ruling that claims of a patent directed to the Velcade® cancer treatment drug compound were invalid as obvious. The Court held that the District of Delaware clearly erred by finding U.S. Patent No. 6,713,446 (the ‘446 patent) prima facie obvious to one of skill in the art, and by misapplying the secondary indicia of unexpected success and long-unmet need.
In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195 (U.S. June 12, 2017). The Court’s decision grants more flexibility to biosimilar companies and filers of abbreviated Biologics License Applications (“aBLAs”), holding that (1) a reference product sponsor is not entitled to injunctive relief under federal law for an applicant’s refusal to provide a copy of its aBLA and manufacturing information during the information exchange period contemplated by the BPCIA, and (2) an applicant may provide statutory 180-day pre-launch notice of commercial marketing before its proposed biosimilar product is licensed by FDA. An overview of the parties’ oral arguments before the Court on these issues can be found here.
On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S. Patent No. 8,273,707 (the “’707 patent”) by filing an abbreviated Biologic License Application (“aBLA”) for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) product. Amgen asserted that the biosimilar manufacturing process disclosed in the Coherus aBLA will infringe the ’707 patent’s claimed protein purification process.
On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price Competition and Innovation Act (“BPCIA”) “patent dance” information exchange process may expose the biosimilar maker to eventual infringement damages in the form of lost profits, and preclude limiting damages to a reasonable royalty. Janssen Biotech, Inc. et al v. Celltrion Healthcare Co., Ltd. et al, 1:15-cv-10698 (D. Mass, 2017).
Janssen sued Celltrion for patent infringement under the BPCIA following the FDA’s acceptance of Celltrion’s abbreviated Biologics License Application (“aBLA”) for a biosimilar version of Janssen’s Remicade (infliximab). In the course of litigation, Celltrion moved to dismiss the complaint for lack of standing based on Janssen’s alleged failure to add a necessary party. To guide the parties’ settlement negotiations, the court sought to clarify whether, in the event the action was dismissed and Janssen was forced to refile the complaint with the proper plaintiffs, Janssen would be prevented from seeking lost profits damages under the BPCIA.
On March 3, 2017, the United States Court of Appeals for the Federal Circuit reaffirmed, in a precedential opinion, that prosecution disclaimers may only limit the scope of a claim where the disclaimer is “both clear and unmistakable to one of ordinary skill in the art.” In Technology Properties Ltd. v. Huawei Technologies Co., Ltd., the Federal Circuit made clear that statements made during patent prosecution will not constitute a disclaimer of claim scope where the statements are “ambiguous or amenable to multiple reasonable interpretations,” but that a disclaimer based on unambiguous statements during prosecution may serve to surrender more claim scope than was necessary to overcome a rejection. Continue Reading Federal Circuit Reiterates That Patent Prosecution Disclaimers Must Be “Clear and Unmistakable”
On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.