On December 19, 2017, an expanded panel of the Patent Trial and Appeal Board (PTAB) ruled that the state of Minnesota waived its Eleventh Amendment immunity to challenges to patent validity by inter partes review (IPR) by filing suit in federal court alleging infringement of the same patent being challenged by IPR. In Ericsson Inc. and Telefonaktiebolaget LM Ericsson v. Regents of the University of Minnesota (IPR2017-01186; IPR2017-01197; IPR2017-01200; IPR2017-01213; IPR2017-01214; IPR2017-01219), Petitioner Ericsson Inc. filed IPR petitions against five University of Minnesota patents covering wireless communications technology. In response, the University filed a motion to dismiss, arguing its Eleventh Amendment sovereign immunity exempted the patents from IPR challenge.
Thomas Wintner is a Member in the firm and is based in our Boston office. He focuses on complex litigation, at both the trial and appellate levels, for clients in a wide range of industries. He has successfully tried cases in both state and federal courts, and has guided others through mediation and arbitration. In IP matters, Tom draws on his experience as a research chemist. He represents life sciences companies in patent litigation and other IP disputes, and has particular experience in matters involving pharmaceuticals, biotech, the Hatch-Waxman Act (for small molecule drugs), and the Biologics Price Competition and Innovation Act (for large-molecule biologics).
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 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.
Yesterday, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010. The BPCIA created a new, abbreviated pathway for highly similar biological products to enter the U.S. market by following in the footsteps of a reference biological product. The Court’s decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.
To read our full alert on the oral argument, please click here.
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.
Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to commercialize a biosimilar version of Genentech’s cancer drug, Avastin®.
Pursuant to 42 U.S.C. § 262(l)(2), a key provision of the BPCIA, upon FDA acceptance of a biosimilar application for review, an applicant has twenty days to submit the application and “such other information that describes the process or processes used to manufacture the biological product that is the subject of such application” to the reference product sponsor (“RPS”). According to Genentech’s complaint, Amgen produced the application for its proposed Avastin® biosimilar, but declined to provide manufacturing information. Genentech also alleged that this “obstructed Genentech’s ability to perform an infringement analysis of its patent portfolio by withholding ‘confidential information’ highly relevant to that analysis,” and further, that Amgen “unreasonably with[held] its permission for any of Genentech’s expert consultants to review the limited information…Amgen has provided.” Continue Reading BPCIA Helps Amgen Gain Dismissal of Genentech Complaint
Nondisclosure or confidentiality agreements (NDAs) are among the most common documents attorneys draft and review for clients. They are so common, in fact, that where a client needs to execute a large number of facially distinct but substantively similar NDAs, it may make sense for the client to draft and review these documents itself. To assist the client in doing so, we typically provide it with an informal and non-exhaustive list of considerations, of the kind recreated below, to bear in mind when thinking about each specific NDA.
On September 9, 2016, Apotex Inc. filed a petition for writ of certiorari in the U.S. Supreme Court seeking review of the Federal Circuit’s decision in Amgen Inc. v. Apotex Inc., Case No. 2016-1308. This case involves Apotex’s proposed filgrastim product, which is a biosimilar version of Amgen’s Neulasta®. At issue is whether the 180-day “Notice of Commercial Marketing” period provided by 42 U.S.C. § 262(l)(8)(A) of the BPCIA is always mandatory, and whether the Federal Circuit’s decision improperly extended the 12-year exclusivity period for reference product sponsors from 12 to 12 ½ years by holding that a biosimilar applicant cannot give effective Notice of Commercial Marketing for its biosimilar product until after it receives FDA license approval.
As previously discussed on this blog, the Federal Circuit held in Amgen Inc. v. Apotex Inc. that even though Apotex participated in the “information exchange” (a.k.a. the “patent dance”) envisioned by § 262(l) of the BPCIA, the statute’s “requirement of 180 days’ post-licensure notice before commercial marketing … is a mandatory one enforceable by injunction.”