Biosimilar Litigation: Amgen Sues Samsung Bioepis To Enforce 180-Day Notice Requirement
Executive Summary
Although Samsung has not provided 180-day advance notice of commercialization for Eticovo, its recently approved biosimilar to Enbrel, Amgen seeks a preliminary injunction because it has reason to believe the company is prepared to launch ‘imminently.’
Amgen Inc. has gone to court to prevent the near-term launch of Samsung Bioepis Co. Ltd.'s Eticovo (etanercept-ykro), a biosimilar to Enbrel (etanercept), even though Samsung has not given 180-day advance notice of commercialization.
Amgen, its Immunex Corp. subsidiary and Roche filed a patent infringement lawsuit against Samsung Bioepis on 30 April, five days after the Food and Drug Administration approved Eticovo as the second biosimilar to Amgen’s TNF-inhibitor. (Also see "Keeping Track: A Glut Of Big Approvals While Lartruvo Makes Its Market Exit" - Pink Sheet, 28 Apr, 2019.)
Samsung Bioepis has not engaged in the Biologics Price Competition and Innovation Act’s information-sharing procedures, commonly known as the “patent dance,” according to the complaint. Consequently, it is reasonable to assume that Samsung might not provide the 180-day commercialization notice required under the statute, the lawsuit states.
The complaint seeks temporary and preliminary injunctive relief barring Eticovo’s launch until no less than 180 days after Samsung provides notice of commercial marketing, and a permanent injunction against the biosimilar’s manufacture, sale and importation before expiration of the last of five patents at issue.
Approval Delayed By Complete Response Letter
The FDA’s April 25 approval of Eticovo was a relatively under-the-radar event.
Samsung does not appear to have announced the May 2017 submission of its 351(k) application for Eticovo, the agency’s March 2018 complete response letter, or the October 2018 resubmission. The company announced the agency’s approval action 29 April. Samsung told the Pink Sheet its launch plans remain under review.
Eticovo was approved for all eligible indications on the Enbrel label:
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Rheumatoid arthritis;
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Polyarticular juvenile idiopathic arthritis in patients two years and older;
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Psoriatic arthritis;
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Ankylosing spondylitis; and
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Plaque psoriasis in patients four years and older.
However, in a difference from Enbrel’s labeling, the biosimilar’s use in pediatric psoriasis and JIA is limited to patients who weigh 63 kg or more. As a postapproval requirement, Samsung must develop a presentation that can be used to accurately administer Eticovo to pediatric patients who weigh less than 63 kg, according to the FDA’s approval letter.
Sandoz Inc.’s Erelzi (etanercept-szzs) was approved in August 2016 with all five indications on the Enbrel label. However, the Novartis AG unit subsequently carved out the psoriatic arthritis and plaque psoriasis indications as part of its legal strategy in patent litigation with Amgen. (Also see "Biosimilar Labeling Carve-Out Turned Erelzi's Psoriatic Arthritis, Plaque Psoriasis Uses Into 'Another Indication'" - Pink Sheet, 14 Mar, 2018.)
Erelzi’s launch has been held up by the patent case.
Samsung Chose Not To Dance
Samsung Bioepis did not provide Amgen with a copy of its 351(k) application after the FDA accepted it for review, or a description of the biosimilar’s manufacturing process, pursuant to the BPCIA patent dance provisions, the complaint asserts.
“Such failure removed any limits on Plaintiffs’ ability to bring an action for a declaration of infringement, validity, or enforceability of any patent that claims Bioepis’ biosimilar etanercept or the use thereof,” the complaint states.
“On information and belief, Bioepis is prepared imminently to begin to use, offer for sale, and sell in the United States, and import into the United States, its etanercept biosimilar product.” – Amgen
In addition, 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, but “Bioepis has not yet provided Immunex the notice of commercial marketing” required under this provision, the complaint states.
The US Supreme Court ruled that the BPCIA does not require 351(k) applicants to engage in the patent dance and that biosimilar sponsors may provide the 180-day notice prior to FDA licensure. (Also see "US Supreme Court Permits Earlier Biosimilar Launches; Penalty For Declining Patent Dance Uncertain" - Pink Sheet, 12 Jun, 2017.)
Based on Samsung Bioepis’ failure to provide Amgen with the application and other information “required” under the BPCIA patent dance procedures, “it is reasonable to infer that Bioepis might not provide” 180-day notice of commercial launch for Eticovo, the complaint states. “Bioepis should be prohibited from beginning commercial marketing of its biosimilar product for at least 180 days from the date Bioepis provides such notice to Immunex.”
“On information and belief, Bioepis is prepared imminently to begin to use, offer for sale, and sell in the United States, and import into the United States, its etanercept biosimilar product,” the complaint states. “Immunex/AML and Roche are entitled to injunctive relief preventing Bioepis from commercial marketing consistent with the notice period provided by that statute.”
The lawsuit alleges that Immunex/AML and/or Roche would be irreparably harmed if Samsung Bioepis were not enjoined from manufacturing, selling and importing the biosimilar. “Immunex/AML and Roche do not have an adequate remedy at law and are entitled to injunctive relief preventing Bioepis from such infringement of one or more claims” of the five patents, the complaint states.
Samsung may be waiting to see how Amgen’s etanercept patent case against Sandoz plays out before settling on a launch strategy for Eticovo.
Five Patents At Issue
Amgen’s complaint against Eticovo, filed in US District Court for the District of New Jersey, alleges that Eticovo infringes five patents that cover the TNF-inhibitor, its manufacturing methods and materials, and certain approved uses.
Roches owns two of the patents:
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No. 8,063,182, directed to a fusion protein incorporating a TNF-binding portion of the p75 TNF receptor etanercept; and
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No. 8,163,522, directed to nucleic acids, host cells and methods of using such nucleic acids and host cells to make the p75 TNF receptor fusion protein.
The ‘182 patent expires in November 2028 and the ‘522 patent expires in April 2029, according to court documents in Amgen’s patent litigation with Sandoz related to Erelzi.
In the Sandoz case, a bench trial on validity of certain claims in the ‘182 and ‘522 patents was held in September 2018, and a decision is pending. Sandoz stipulated to infringement of the claims at issue prior to trial.
Immunex, which was acquired by Amgen in 2002, is the exclusive licensee of all commercial rights in the Roche patents. Immunex also owns the other three patents at issue (Nos. 7,915,225; 8,119,605; and 8,722,631). These claim methods of using etanercept to treat psoriasis and/or psoriatic arthritis and expire on 13 August 2019, according to the complaint.
Immunex granted Amgen Manufacturing Limited (AML) exclusive rights to all five patents.
The complaint alleges that Samsung Bioepis infringed the five patents when it submitted its 351(k) application seeking FDA approval to manufacture, use or sell its etanercept biosimilar product before the patents expired.
Furthermore, use of Samsung’s biosimilar for the labeled indications of psoriasis and/or psoriatic arthritis falls within the scope of the protected uses claimed by the Immunex patents, the lawsuit states.