FDA Law Blog - Amgen Asks the Supreme Court to Reject Challenge to Ruling that Notice of Commercial Marketing is Mandatory, But Asks for Review of Patent Dance Ruling Just in Case

Amgen Asks the Supreme Court to Reject Challenge to Ruling that Notice of Commercial Marketing is Mandatory, But Asks for Review of Patent Dance Ruling Just in Case Posted: 28 Mar 2016 05:11 PM PDT By James C. Shehan – On March 21, 2016, Amgen filed a brief opposing Sandoz’s request that the Supreme Court overturn last year’s Federal Circuit ruling that the Biologics Price Competition and Innovation Act’s ("BPCIA's") notice of commercial marketing provision is mandatory and can only be given after FDA licensure of a biosimilar (see our previous posts here, here and here).  But Amgen also filed a certiorari cross-petition, asking that, should the Court decide to review the commercial marketing ruling, it should also review and overturn the Federal Circuit’s ruling that the patent dance information exchange procedures of the BPCIA are optional. The case involves the first and only approved US biosimilar product, Sandoz’s filgrastim product Zarxio, which referenced Amgen’s filgrastim product Neupogen in order to be approved. Amgen’s reply brief asserts that the Supreme Court should reject the Sandoz certiorari request for three reasons.  First, Amgen argues that the only issue that Sandoz can appeal based on the record was correctly decided below - the Federal Circuit’s unanimous holding that notice of commercial marketing can only be given post-licensure.  Second, Amgen contends that Sandoz’s requests concerning a private right of action and the availability of injunctive relief are moot based on the facts in the case because the issues were not decided by the Federal Circuit.  Third, Amgen posits that Supreme Court review would be premature, noting that BPCIA issues are currently being litigated in seven pending cases, including in a case that the Federal Circuit will hear on April 4, 2016. On the notice of commercial marketing issue, Amgen’s main argument continues to be that the BPCIA’s language is clear (“The subsection (k) 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 licensed under subsection (k)” (emphasis in original)) and that the Federal Circuit correctly applied principles of statutory construction in holding that the notice is mandatory.  Amgen also asserts that the Federal Circuit holding is not in conflict with either the statute or any Supreme Court ruling, and thus is not an appropriate case for review.  Amgen goes on to say that “Sandoz offers a raft of policy arguments for why [mandatory notice] is supposedly a bad or unfair rule, arguments that are wrong on their merits but that in any event cannot overcome the statute’s text.”  Amgen also contends that “requiring that a [biosimilar] be licensed before notice of commercial marketing ensures the existence of a fully crystallized controversy regarding the need for injunctive relief” and “provides a defined statutory window during which the court and the parties can fairly assess the parties’ rights prior to the launch of the biosimilar product.” Amgen devotes a couple of pages of its brief to distinguishing between marketing exclusivity and data exclusivity, saying that the BPCIA does not protect brand name products from competition and pointing to the example of Teva’s filgrastim product Granix, which was approved under a BLA and competes with Amgen’s Neupogen.  In addition, addressing the Sandoz contention that notice after approval makes no sense because approval is public, Amgen points out that commercial marketing cannot be presumed to occur 180 days after approval, and therefore mandatory notice after approval serves a purpose in helping a reference product sponsor determine when and whether to file a lawsuit. Amgen’s second basis for asking the Supreme Court to reject Sandoz’s request is based largely on procedural matters and state law. One major point made by Amgen is that Sandoz did provide Amgen with notice of commercial marketing, so the issue of what might happen if Sandoz had not done so is moot. Regarding the third basis, arguing that the Supreme Court should wait for further lower court decisions before taking a BPCIA appeal, Amgen states that there are seven BPCIA lawsuits pending in the lower courts. Amgen also argues a lack of urgency, given that only one biosimilar (Zarxio) has been approved by FDA and that the 15% discount off of the Neupogen wholesale price that Sandoz is offering demonstrates that waiting will have a minimal impact on consumer costs. In its cross-petition on the patent dance provisions, Amgen asks that, should the Supreme court decide to review the notice of commercial marketing issue, that the Court also take under review the Federal Circuit’s ruling that the patent dance is a voluntary proceeding. Amgen argues that the two issues are “inextricably intertwined” and that the Federal Circuit ruling is incorrect under Supreme Court precedent on statutory interpretation. Regarding the latter point, Amgen’s basic contention is that the word “shall” employed in the patent dance provisions of the BPCIA is a mandatory word, just as it is in the notice of commercial marketing provisions. Sandoz’s response to Amgen’s cross-petition is due on April 22nd. Meanwhile, interest in the case form third parties remains high, including amicus briefs from Hospira, Apotex and the Biosimilars Council.