The Supreme Court on Monday called for the views of the Solicitor General regarding the petitions for certiorari filed by both parties in Amgen v. Sandoz. The case arose after Sandoz filed an aBLA for Zarxio®, a biosimilar of Amgen’s Neupogen® filgrastim product, and it represents the Federal Circuit’s first and only substantive ruling thus far interpreting the Biologics Price Competition and Innovation Act (“BPCIA”).1 In pertinent part, the Federal Circuit held that (1) the “patent dance” provisions of the BPCIA are not mandatory for subsection (k) applicants, and (2) a biosimilar applicant may not give effective notice of intent to commercially market until after the FDA has licensed the applicant’s biosimilar product. Sandoz’s cert. petition seeks review of the latter holding, arguing that “the Federal Circuit has disrupted the careful balance struck by Congress between competition and innovation” by “delay[ing] access by patients to all biosimilars for six months longer than Congress intended.” Amgen responded by filing both an opposition to Sandoz’s petition and a conditional cross-petition arguing that if the Court decides to hear the case, it should also review the “patent dance” issue.
When deciding whether to review a lower court ruling, the Supreme Court will occasionally invite the Solicitor General to file a brief expressing the views of the United States. An empirical analysis from 2009 revealed that the Supreme Court extends such an invitation (formally called a “call for the views of the Solicitor General” or “CVSG”) approximately 11 times per year. David C. Thompson & Melanie F. Wachtell, An Empirical Analysis of Supreme Court Certiorari Petition Procedures: The Call for Response and the Call for the Views of the Solicitor General, 16 Geo. Mason L. Rev. 237, 245 (2009). The analysis further found that (1) for paid petitions (i.e., those in which the filing party paid the Court’s docketing fee instead of filing in forma pauperis2), the Court grants cert. 42% of the time following a CVSG, which is 47 times more frequently than non-CVSG cases; (2) when the Solicitor General recommends a grant, deny, or grant/vacate/remand, the Court follows this recommendation about 80% of the time; and (3) the Solicitor General takes, on average, about four and a half months to respond to a CVSG. This last statistic is significant because the Court is about to take its summer recess, and the new term will not begin until the first Monday in October. Thus, there will likely be no movement in this case until October at the earliest.
In the meantime, the Federal Circuit’s holdings will remain binding. For co-pending late-stage BPCIA litigation, this means that the courts will be forced to build upon an uncertain foundation. Of note, the Federal Circuit is expected to rule any day now in Amgen v. Apotex (involving a Neulasta® biosimilar) on the related question of whether notice of commercial marketing is also only effective after FDA approval for subsection (k) applicants that choose to engage in the “patent dance” (since the parties in Sandoz had not). If the Federal Circuit answers in the affirmative based on its holding in Amgen v. Sandoz only to have that holding overturned by the Supreme Court, we may see a cert. petition or Rule 60(b) motion from Apotex.
We will continue to monitor this case as it develops and provide updates.
1 The Federal Circuit has also ruled on a jurisdictional issue related to the BPCIA in Sandoz v. Amgen 773 F.3d 1274 (Fed Cir. 2014).
2 In forma pauperis petitions disproportionately pertain to prison litigation and were therefore excluded so as not to skew the statistics.
The opinions expressed are those of the author(s) 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 and is not intended to be and should not be taken as legal advice.
Dr. Jenny Shmuel 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...
Tasha Francis, Ph.D., practices intellectual property litigation with an emphasis on patent litigation. Her clients range from solo inventors and emerging companies in the biotechnology and biopharma industries to established international pharmaceutical companies. She has extensive...
Alex Pechette | Summer Associate
Alex Pechette is a litigation summer associate in the Boston office and currently attends the University of Chicago Law School.