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
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.”
On July 5, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Apotex Inc., Fed. Cir. Case No. 2016-1308. [Read full opinion here.]
In many respects, the decision can be viewed as an extension of the Court’s decision from a year ago in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). [See Mintz Levin post re: Amgen v. Sandoz] Both cases involved the 180-day “Notice of Commercial Marketing” provision that the BPCIA introduced into 42 U.S.C. § 262(l)(8)(A), and both asked the question when that notice could effectively be given: at some point before FDA licensure of the biosimilar product, or only after? Continue Reading Fed Circuit’s “Amgen v. Apotex” Decision: Clarification of a BPCIA Riddle (Unless, of course, the Supreme Court Steps In)
Our Biosimilar webinar series continued this month with Tom Wintner’s BPCIA Patent Litigation presentation. Tom discussed the general framework of litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), including the “patent dance” information exchange under 42 U.S.C. §262(l), and three case studies that inform our current understanding of emerging judicial interpretation of BPCIA requirements.
For those who missed the webinar, some of the key takeaways include the following:
- Biosimilar litigation is ultimately about patent litigation, but much of the underlying patent issues have been obscured because current litigation focuses on when and how the BPCIA applies and the BPCIA’s requirements when it does apply.
Yesterday, the FDA’s Arthritis Advisory Committee voted 21-3 to recommend that CT-P13, Celltrion’s proposed biosimilar of Janssen Biotech, Inc.’s Remicade® (infliximab) be approved for all indications — including, among others, Crohn’s disease, ulcerative colitis, rheumatoid arthritis (RA), and ankylosing spondylitis (AS). The Advisory Committee’s vote is notable because Celltrion provided comparative clinical data for CT-P13 only for the RA and AS indications; thus, the other indications would be approved based on extrapolation and the “totality” of Celltrion’s evidence supporting biosimilarity. Continue Reading First Monoclonal Antibody Biosimilar in U.S. Gets One Step Closer to FDA Approval
Mintz Levin’s Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act (“BPCIA”) and its implementation. Some of the key takeaways include:
- overviews of FDA guidance on demonstrating biologic product biosimilarity and “interchangeability” (the latter of which means that the biosimilar may be substituted for the FDA-approved reference product without intervention by the prescribing health care provider);
- FDA’s “stepwise” approach to determining biosimilarity, under which more robust initial comparative evidence may reduce FDA clinical study requirements later on;
- current state of FDA draft product labeling guidance that would require, for example, reference products and biosimilars to share a common core name with unique suffixes; and
- exclusivity periods for original reference and biosimilar products.
For a more detailed write-up of the presentation, see our post on Mintz Levin’s Health Law & Policy Matters blog, here.
Tom Wintner, a member in Mintz Levin’s Intellectual Property group, will present the next webinar in the Biosimilar series – BPCIA Patent Litigation – on Thursday, February 25, 2016. This session will offer practical advice regarding litigating patents under the BPCIA and provide an update on current litigation under the law.
Sign up here to attend Tom’s litigation webinar or the other Biosimilar webinars coming up in March and April.