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Biosimilar Law May Head to the Supreme Court

February 17, 2016

Biosimilar Law May Head to the Supreme Court

February 17, 2016

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Sandoz is seeking U.S. Supreme Court review of the Federal Circuit’s first ruling related to biosimilars, interpreting the Biologics Price Competition and Innovation Act (“BPCIA”).

The Federal Circuit’s landmark July 2015 decision interpreted two provisions of the BPCIA.  The Federal Circuit held (1) the “patent dance” provisions of section (l)(2)(A) were not mandatory for subsection (k) applicants, and (2) biosimilar applicants may only give effective notice of intent to commercially market after the FDA has licensed the biosimilar product.  On September 3, 2015, Sandoz began marketing Zarxio®, a biosimilar of Amgen’s Neupogen® filgrastim product.  Both parties’ appeal for en banc review was denied on October 16, 2015.

Before the Federal Circuit Sandoz argued that forcing a biosimilar applicant to wait to obtain an FDA license before providing notice improperly grants the reference product sponsor (“RPS”) an additional six months of exclusivity. Sandoz argued that the product must be licensed  by the FDA only at the time of commercial marketing, not at the time the notice is given to the RPS of the intent to market.

The Federal Circuit disagreed based on its interpretation of the statutory language. In the relevant provision, the BPCIA refers to the product as “the biological product licensed under subsection (k).” The Federal Circuit concluded that by referring to the product as a “licensed product” and not “the biological product that is the subject of” the application, Congress intended that the product be licensed before notice may be given.

In addition, the Federal Circuit reasoned that waiting until after the product is licensed ensures “the existence of a fully crystallized controversy regarding the need for injunctive relief.” For instance, the product, the therapeutic uses, and the manufacturing processes can change during the process of obtaining FDA licensure, if licensure is obtained at all.  Waiting until after licensure would remove ambiguity about the scope of the license and the timing of the biosimilar applicant’s commercial marketing.

Sandoz seeks review of the “notice of commercial marketing” ruling.  In particular, Sandoz petitioned the Supreme Court to determine “whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a stand-alone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.” Sandoz argues “the Federal Circuit has disrupted the careful balance struck by Congress between competition and innovation.  If not reversed, the Federal Circuit’s ruling with delay access by patients to all biosimilars for six months longer than Congress intended.”  Sandoz continues that “[b]y its plain terms, the notice of commercial marketing provision simply calls for 180 days’ notice before a biosimilar is marketed.”

Sandoz has already launched its biosimilar product at issue in this case, but argues that the correct interpretation of the BPCIA’s notice provision is not mooted because Sandoz “has a pipeline of biosimilars across various stages of development….” Sandoz maintains that it therefore has a “reasonable expectation” that is will be subject to the BPCIA’s notice provisions again and again.

Amgen did not seek Supreme Court review of the Federal Circuit “patent dance” ruling as of the January 16, 2016 deadline for filing a petition for certiorari.  Nor did it seek a one-month extension until February 16, 2016 as Sandoz did to file its petition yesterday.  By filing its petition, Sandoz has again opened the door for Amgen to seek Supreme Court review of the “patent dance” ruling. Under Supreme Court Rule 12.5, Amgen now has until March 16, 2016 to seek a conditional cross-petition of Sandoz’s petition.

The Supreme Court will likely decide whether to grant Sandoz’s petition for certiorari this spring.  In the meantime, the parties are engaged in continuing litigation in the Northern District of California, where Amgen accuses Sandoz of infringing U.S. Patent Nos. 6,162,427 and 8,940,878.  We will continue to monitor any new developments in this groundbreaking case.

Authors: Jenny Shmuel, Tasha Francis

The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.

Blog Authors

Jenny Shmuel, Ph.D. | Principal

Jenny Shmuel, Ph.D., represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial. Over the last several...