Last summer, the Federal Circuit decided two questions under Biologics Price Control and Innovation Act (BPCIA) in Amgen v. Sandoz. The first was whether the law required a biosimilar applicant (BA) to disclose its biosimilar application (aBLA) and other information to the reference product sponsor (RPS), with the court deciding disclosure is not mandatory. The second question was whether the 180-day notice provisions of the statute permits a BA to give notice prior to FDA approval of the aBLA; according to the Federal Circuit’s decision, the BA cannot provide such “early” notice. Both parties petitioned for Supreme Court review, and the court asked the Solicitor General (SG) for the government’s views on whether or not to grant these petitions. Last week, tha nation’s acting solicitor general, Ian Heath Gershengorn, provided those views.
The SG recommended that the court grant both petitions, counseling that the court should overturn the Federal Circuit’s determination that a BA cannot provide notice of commercial marketing under the statute prior to FDA approval, but should affirm the Federal Circuit’s decision that the disclosure provisions of the statute are not mandatory.
The SG’s brief argues that the Federal Circuit erred in deciding that a BA could not give the statutory notice of commercial marketing before the FDA had approved the biosimilar, but was correct in deciding that the disclosure requirements are not mandatory. The SG’s analysis is drawn to the text of the statute, and frames the notice provisions as a gatekeeper for initiation of a second round of patent infringement litigation after a first round based on the BA’s disclosure of its aBLA to the RPS. The SG advocates for an interpretation of the law that permits, but does not require, the BA to give “advance notice” (i.e., more than 180 days prior to marketing), as Sandoz did in this case.
The SG advocates that the statute provides that the RPS “may seek a preliminary injunction to enjoin such marketing “[a]fter receiving the notice ... and before [the] date of the first commercial marketing.” In practice, however, should the BA (as Sandoz did in this case) give the required notice when the FDA accepts the aBLA for review, the RPS can either suit immediately (as in this case, in the absence of anything other than the notice upon which to base its motion), or risk waiting for the FDA to approve the biosimilar (burdening the RPS with a surveillance responsibility not recited in the statute).
Importantly, not only does the SG argue that notice of commercial can be given before FDA approval, but the brief argues that injunctive relief is not available as a remedy after such notice is given. This is based on the principle that the right to an injunction must be conferred by statute, and the BPCIA does not (supposedly this proscription does not apply to a preliminary injunction motion in the anticipated second round of litigation provided by the statute).
Under the SG’s view of the proper interpretation of the law, a BA should be able to market immediately upon approval, and the only recourse for an RPS is to file suit and apply for a temporary restraining order—because unlike under the Hatch-Waxman Act there is no automatic stay upon filing suit under the provisions of the BPCIA. Alternatively, if as in this case the notice is given at the same time that the FDA accepts the aBLA for review, the RPS would need to initiate both Phase 1 and Phase 2 of the litigation at the same time.
With regard to the disclosure requirements, the SG states that while Federal Circuit construed the statute incorrectly, it arrived at the correct conclusion. The remedy, contained in the statute, for BA non-compliance with the disclosure provisions are for the RPS to file a lawsuit. Under these circumstances, the government believes that a RPS can file an infringement suit that will provide discovery regarding the aBLA and any other information relevant to infringement.
The Supreme Court should grant review in this case, according to the SG, because “proper interpretation of those provisions has a significant impact on the operation of the BPCIA and the ability of aBLA applicants promptly to bring their biosimilars to the public.” Also, these provisions of the law are “integrally related” and thus it would be beneficial to have the court consider them together.
These recommendations are expressly policy-driven; the SG states that the reason the court should hear the parties is based on the importance of biologic drugs and their cost. The overarching concern expressed by the brief is delay in getting biosimilar drugs to market, particularly under circumstances where biosimilar market entry could be delayed even if there was no basis for a delay, i.e., that the RPS did not have a patent that would preclude marketing.
These recommendations are significant, because the Supreme Court asks the government for its views under those circumstances inter alia where there are important policy considerations at stake. What these recommendations have in common is a reading of the statute that materially disadvantages the RPS in favor of the BA. According to the government, the BA can “opt out” of the patent dance at any time, and the statutory remedy is immediate suit. But depending on the timing of the BA’s opt-out, the RPS may have but a brief time to decide whether and where to bring suit, and on what basis. At this stage of the process the balance of information is firmly in favor of the BA; the BA has all the information (from regulatory filings and patent disclosures) the RPS may use against her. On the other hand, the RPS may know little about how the BA will produce its biosimilar and the similarities and differences (structural, pharmacological, etc.) between the biosimilar and the reference product, considerations important in making these decisions regarding suit against the BA.
The Court’s decision to grant either or both petition for review should come down some time in the next month or so.
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.