On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product Eticovo^TM (etanercept-ykro) by Samsung Bioepis.  Eticovo is a biosimilar to Enbrel® (etanercept), which is marketed by Amgen, Inc. (“Amgen”).  Like Enbrel, Eticovo was approved across five eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis.[1]  Eticovo is the 19^th FDA-approved biosimilar and the 2^nd FDA-approved biosimilar to Enbrel.  Sandoz’s Erelzi^TM (etanercept-szzs) was approved by the FDA as a biosimilar to Enbrel on August 30, 2016,[2] but Erelzi has yet to launch in the United States due to pending patent litigation.[3]  Sales of Enbrel in the United States last year amounted to $4.807 billion for Amgen.[4]

Samsung Bioepis describes itself as a “biopharmaceutical company dedicated to unlocking the potential of biosimilar medicines.”[5]  According to Samsung Bioepis, its etanercept biosimilar has been approved outside the United States for marketing in 38 countries, including EU member states (January 2016), Canada (August 2016), Brazil (December 2017), Australia (July 2016), and Korea (September 2015),[6] under names such as Benepali and Brenzys.  In the United States, Eticovo is Samsung Bioepis’ second FDA-approved anti-TNF biosimilar, along with Renflexis (infliximab-abda).[7] 

On April 30, 2019, directly after the FDA approved Eticovo, a lawsuit was filed in the District of New Jersey against Samsung Bioepis by Immunex Corp. (“Immunex”), Amgen Manufacturing, Ltd. (“AML”), and Hoffmann-La Roche Inc. (“Roche”) (collectively, “the Plaintiffs”).[8]  Immunex and AML are wholly-owned subsidiaries of Amgen.  The case involves five asserted patents that the Plaintiffs allege cover etanercept, methods and materials for manufacture of etanercept, and therapeutic uses of etanercept.  The asserted patents are (i) U.S. Patent Nos. 8,063,182 and 8,163,522, owned by Roche and exclusively licensed to Immunex; and (ii) U.S. Patent Nos. 7,915,225, 8,119,605, and 8,722,631, owned by Immunex.  For each of the asserted patents, Immunex has granted AML an exclusive license or exclusive sublicense.  To note, these are the same plaintiffs and same five patents at issue in the litigation referenced above involving Sandoz and its etanercept biosimilar, Erelzi.

The Biologics Price Competition and Innovation Act (“BPCIA”) provides a framework for patent disputes between biosimilar applicants and reference product sponsors, commonly referred to as the “patent dance.”  According to the Plaintiffs’ complaint, Samsung Bioepis failed to participate in the patent dance because it did not tender the information specified in 42 U.S.C. § 262(l)(2), including a copy of its abbreviated biologics license application (“aBLA”) for Eticovo.  Under the Supreme Court’s decision in Sandoz Inc. v. Amgen, Inc., 137 S. Ct. 1664 (2017), Samsung Bioepis is entitled to decline participation in the patent dance.  However, upon such a failure by the biosimilar applicant to provide the aBLA and information under 42 U.S.C. § 262(l)(2) to the reference product sponsor, the filing of the aBLA can constitute an artificial act of infringement under 35 U.S.C. § 271(e)(2)(C)(ii) and the reference product sponsor is entitled under 42 U.S.C. § 262(l)(9)(C) to bring an action “for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”  Accordingly, the Plaintiffs seek a declaratory judgment that Samsung Bioepis infringed the asserted patents under 35 U.S.C. § 271(e)(2)(C)(ii) by submitting its aBLA for the alleged purpose of obtaining FDA approval to engage in the commercial manufacture, use, or sale of Eticovo prior to the expiration of the patents.  The Plaintiffs also seek a declaratory judgment that Samsung Bioepis has infringed or will fringe the asserted patents under 35 U.S.C. § 271(a), (b), and/or (g). 

The complaint also alleges that Samsung Bioepis has not yet provided a notice of commercial marketing pursuant to 42 U.S.C. § 262(l)(8)(A).  That section of the BPCIA states that a biosimilar applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product.”  Unlike the voluntariness of participation in the patent dance of the BPCIA, the Plaintiffs assert that this notice of commercial marketing is a mandatory requirement that “operates to bar [Samsung] Bioepis from commercial marketing pending, at a minimum, such notice, followed by 180 days.”  The complaint thus seeks a preliminary injunction prohibiting Samsung Bioepis from commercial marketing consistent with the notice period provided by the statute.  The complaint also seeks a preliminary injunction to enjoin Samsung Bioepis from commercial marketing of Eticovo pending a final determination as to infringement, validity, and enforceability of the patents and further seeks a temporary restraining order pending the court’s decision on a preliminary injunction. We will continue to keep you updated on further developments.

[1] https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761066Orig1s000ltr.pdf; https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761066s000lbl.pdf

[2] https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761042Orig1s000ltr.pdf

[3] See Immunex Corp. v. Sandoz Inc., 2:16-cv-01118 (D.N.J.)

[4] https://www.amgen.com/media/news-releases/2019/01/amgen-reports-fourth-quarter-and-full-year-2018-financial-results/

[5] https://www.samsungbioepis.com/en/about/about01.do

[6] https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=49&currentPage=1; https://www.samsungbioepis.com/en/product/product01.do

[7] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000lbledt.pdf

[8] Immunex Corp. v. Samsung Bioepis Co., Ltd., 2:19-cv-11755 (D.N.J.)