A Biologic Innovator's Pursuit to Uphold Patents

With the FDA approval of the first biosimilar in the U.S., Novartis’ Zarxio (Amgen’s Neupogen), back in March, drug maker Amgen is now fighting to uphold its patent. On September 2, the Federal Circuit issued its decision denying request for a temporary restraining order in Amgen v. Sandoz, an important biosimilars litigation that could have an impact on the industry for years to come.
 
Elaine Blais, partner in Goodwin Procter’s Litigation Department, opens our eyes to some of the legal nuances behind the biosimilar litigation, including commercial marketing issues, the “patent dance”, patent infringement disputes and the commercial launch of biosimilars, as well as “interchangeable” designation by FDA, which may be vital to the long-term market success of biosimilars in the U.S. –KB
 
Contract Pharma: What are some of the main talking points in biosimilar litigation?

        1. Whether a biosimilar applicant may “opt out” of the series of information exchanges and patent identifications spelled out in the BPCIA, often called the “patent dance,” by not disclosing its abbreviated biologic licensing application (“aBLA”) under 42 U.S.C. § 262(l)(2)(A), “subject only to the consequences set forth in § 262(l)(9)(C).” (This is the “patent dance” question).
 
        2. Whether a biosimilar applicant that opts out of the patent dance must give 180 days’ notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A), and if it must, whether it may do so before the FDA licenses the biosimilar product (This is the “notice of commercial marketing” question.)
 
Sandoz won the “patent dance” issue:  An applicant can choose to disclose its aBLA and initiate the patent dance, or to not disclose the aBLA and face an immediate infringement action from the reference (i.e., brand) product sponsor (“RPS”).  Amgen won the notice of commercial marketing issue:  If an applicant opts out of the patent dance, it must provide 180 days’ notice of commercial marketing after the FDA approves the biosimilar product.
 
Both Amgen and Sandoz seek en banc review of the panel’s split decision on these two issues. 
 
Beyond Amgen v. Sandoz, three other pending litigations raise related issues. In Janssen v. Celltrion, 1:15-cv-10698-MLW (D. Mass.), Amgen v. Apotex, 0:15-cv-61631-JIC (S.D. Fla.) and Amgen v. Hospira, 1:15-cv-00839 (D. Del.), the parties are litigating the issue of whether 180 days’ notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) is required under other circumstances, for example when an applicant decides to participate in the patent dance.