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Polsinelli Polsinelli - Hatch-Waxman Litigation and Opinion

July 2015


Federal Circuit Delays Sandoz Biosimilar Launch


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In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's obligation to disclose information related to its application, and whether Sandoz could effectively provide notice of commercial marketing before FDA approval. The Federal Circuit decided that certain information-sharing requirements of the BPCIA are optional, because Amgen, the reference product sponsor (RPS) in this case, can obtain such information through discovery following suit for patent infringement, and that is the sole remedy contemplated by the BPCIA. The Federal Circuit also concluded that the biosimilar applicant, Sandoz, may only provide effective notice of commercial marketing after grant of FDA licensure, even though this may, in some situations, result in an additional 180 days of exclusivity in excess of the twelve years of exclusivity provided in the BPCIA. The Federal Circuit's conclusions impact biosimilar applicants by providing additional business options for companies to examine.

In the present legal dispute, Sandoz obtained the first biosimilar approval for Zarxio under the BPCIA in March 2015, for which Amgen was the RPS for Neopogen (filgrastim). Amgen sued Sandoz in October 2014 for, among other things, Sandoz's failure to provide information it argued was required under BPCIA Section 262(l)(8)(A), and for premature and ineffective notice of commercial marketing, which was provided before licensure, as well as through a "further notice" in March 2015, following grant of FDA licensure. The district court interpreted the BPCIA as giving a biosimilar applicant the option to share its application and manufacturing information subject to the consequences of Section 262(l)(9)(C), and that the biosimilar applicant may provide notice of commercial marketing before FDA approval. The Federal Circuit affirmed the district court regarding the information-sharing provisions, but reversed on the commercial marketing notice requirements. The Federal Circuit also found that Sandoz's further notice to Amgen in March 2015, immediately after FDA licensure, was sufficient to meet the commercial marketing notice requirements, preventing Sandoz from marketing its filgrastim product for 180 days, until September 2015.

The Federal Circuit's conclusion that the information-sharing requirements of Section 262(l)(1)-(2) are effectively optional is good for biosimilar applicants by providing additional business options to consider. Unfortunately, however, the Federal Circuit's assessment that a biosimilar applicant may only provide effective notice after FDA licensure is potentially bad precedent for biosimilar applicants, as it may provide up to 180 days of additional exclusivity for the RPS. In the present situation, Sandoz may not market Zarxio until 180 days after March 6, 2015 (i.e., until September 2, 2015), which extends Amgen's market exclusivity for months and prevents competition until that later date. Whether Sandoz seeks rehearing or appeals the Federal Circuit panel's decision remains to be seen, but it is possible that full Federal Circuit or the Supreme Court may not review the panel decision and/or that the legal dispute will no longer be ripe by that time. To the extent Sandoz or another biosimilar applicant wishes to challenge the Federal Circuit panel's interpretation of the 180-day notice provision, Judge Chen's dissent-in-part may provide a legal rationale for doing so, as it states that the additional 180-days of exclusivity may be unnecessary. As the decision stands, the Federal Circuit has determined that all remedies for the RPS are patent-oriented and are sufficiently crystallized for a declaratory judgment action if the biosimilar applicant fails to participate in the very first information-sharing requirement. Here, it seems peculiar that the 180-day notice provision, as currently construed by the Federal Circuit, may significantly delay the legal resolution process. After all, Amgen was clearly on notice since July 8, 2014, when Sandoz notified Amgen that it had filed a biosimilar application referencing Neupogen and that it intended to launch immediately upon FDA approval. Instead, because Zarxio was not actually approved until March 2015, Sandoz now cannot launch until September 2015.

Biosimilar Background

Biosimilars, or "generic biologics," are a rapidly emerging area of the pharmaceutical industry. The BPCIA, enacted in 2009, is somewhat similar to the Hatch-Waxman Act in its goals of balancing innovation and consumer interests. The biosimilar applicant may rely in part on the approved license of a reference product if it can show that its product is "highly similar." To provide reference products some protection, the BPCIA provides for twelve years of exclusivity for the reference drug from the date of reference product licensure, even upon loss of patent protection. Additionally, biosimilar applicants must give reference product sponsors notice of commercial marketing 180 days prior to marketing their products to allow those sponsors to seek a preliminary injunction.

The BPCIA also provides at Section 262(l)(1)-(2) a procedure for the biosimilar applicant to provide its biosimilar application and biosimilar manufacturing information to the reference product sponsor no later than 20 days after the FDA accepts the application for review. The BPCIA also provides for a procedure for exchanging information on the patents that could reasonably be asserted regarding the biosimilar application, which may be used to determine grounds for an infringement action by the reference product sponsor. Section 262(l)(9)(C) provides that a reference drug sponsor may bring a declaratory judgment action upon the biosimilar applicant's failure to provide this information.

For More Information

If you have questions regarding the Federal Circuit's interpretation of the BPCIA or how it may impact your business, please contact your Polsinelli attorney or the author



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