Amgen v. Sandoz on appeal: new developments and perspectives from other interested parties

Amgen appealed the district court order on March 25, 2015, and sought an expedited briefing schedule and an injunction to delay the launch of Sandoz’s Zarxio product while the Court considers Amgen’s appeal. The Federal Circuit granted the motion for an expedited schedule, and set oral argument for June 3, 2015. Although the district court denied Amgen’s motion for an injunction pending appeal, the Federal Circuit granted the requested injunction on May 5, 2015.

Further development of the parties’ arguments on appeal: 

On appeal, Amgen argues that Sandoz’s interpretation of the patent dance would render the BPCIA unduly one-sided in favor of biosimilar applicants, because it would mean that applicants can dictate whether the patent dance takes place, depending solely on which option offers the applicant greater advantages. Amgen argues that this interpretation is contrary to Congress’s intent, which was to “achieve a balance between competing interests” and “not to let the Applicant control that balance to its favor and as it chooses.”

Sandoz emphasizes on appeal that when crafting the BPCIA, the balance Congress struck between biosimilar applicants and biologic innovators was this: the BPCIA allows biosimilar applicants to seek approval via an abbreviated pathway; “[i]n return, sponsors of approved biological products receive a full 12 years of market exclusivity – regardless of whether they have any valid patent claims.” With the balance thus struck between an abbreviated pathway and a longer period of exclusivity, Congress went on to provide a separate, optional patent resolution process “to resolve any patent disputes as early as possible, preferably before FDA approval of the biosimilar.” The patent dance steps, Sandoz argues, are just one aspect of this optional resolution scheme: “[e]ach step has benefits and burdens for both the sponsor and the applicant. Critically, none of those steps is an end unto itself.  Instead, each is simply a procedural means to a substantive goal: resolving patent disputes so that non-infringing biosimilars can be available to patients as expeditiously as possible.” 

Perspectives from other interested parties: amicus briefs 

Several parties filed amicus briefs to express their views on the case. In support of Amgen were: Janssen Biotech, Inc. (“Janssen”), AbbVie Inc. (“AbbVie”), and Biotechnology Industry Organization (“BIO”). In support of Sandoz were: Hospira, Inc. (“Hospira”) and Celltrion Healthcare Co., Ltd. (“Celltrion”), and the Generic Pharmaceutical Association (“GPhA”).

The amicus briefs filed by Janssen (in support of Amgen) and Hospira and Celltrion (in support of Sandoz) are particularly noteworthy because they are the parties in a second major action concerning the BPCIA: on March 6, 2015, Janssen filed a complaint in the District of Massachusetts, alleging that Celltrion and Hospira had violated the BPCIA by (1) consenting to immediate litigation on all patents listed by Janssen and thereby prematurely cutting off the patent dance, and (2) providing untimely notice of commercial marketing (before FDA approval of the defendants’ proposed biosimilar product referencing Janssen’s Remicade® (infliximab)).

Unlike Amgen, which sought judicial relief based on California state law, Janssen alleged in its complaint that the BPCIA itself creates a private right of action to enforce the provisions of the patent dance, which means that parties can directly enforce the patent dance provisions without resorting to other laws that provide a right to relief connected in some way to a “violation” of the BPCIA.

Janssen also offered a slightly different take on why notice of commercial marketing should not be allowed until after a biosimilar product has been licensed by FDA. According to Janssen, the statutory scheme of the BPCIA makes it clear that the function of the notice provision is to provide “a trigger for a preliminary injunction motion”: a preliminary injunction is unavailable unless commercial launch is imminent, so the notice provision is there to “ensure[] the imminence necessary to vindicate the right to move for a preliminary injunction.” Moreover, Janssen argued, Amgen’s interpretation of the notice provision would not automatically extend protection for the reference product, because for more recently approved reference biologics, the 180-day period and 12-year exclusivity period would run concurrently, and thus the 180-day period would not be tacked on to the end of the 12 years, but would instead be subsumed within the existing 12-year period.

Hospira and Celltrion argued in their amicus brief that the BPCIA’s notice provision “merely allows the sponsor to ‘seek’ an injunction based on…non-listed patents,” (i.e. patents that the reference product sponsor identified during the patent dance, but was not able to assert in immediate litigation) whereas Amgen’s proposed interpretation would effectively grant an automatic injunction regardless of whether the sponsor has any patents to assert.

According to Celltrion and Hospira, for situations in which all listed patents have been agreed upon for immediate litigation (as in Janssen’s case), or where there are otherwise no patents that have not been litigated or agreed upon for litigation, the BPCIA’s notice provision is a nullity; it serves no purpose because it is meant only to lift the restriction on the sponsor’s ability to bring an infringement action on non-listed patents.

Other amici offered further arguments on the proper interpretation of the BPCIA from a policy perspective.

BIO argued in support of Amgen that the BPCIA patent dispute resolution process is structured “to provide a significant and real opportunity to resolve patent issues prior to the launch of the biosimilar.” This scheme cannot work, BIO agues, without the reference product sponsor being notified that a biosimilar application referencing its product has been submitted to FDA, and the only way to ensure that such notice is provided is the patent dance’s mandatory requirement that a biosimilar applicant provide its application to the reference product sponsor within 20 days of FDA’s acceptance of the application.

BIO also argued that requiring compliance with the patent dance, and requiring FDA approval before giving 180 days’ notice of commercial marketing, “correlates to the regulatory process.” Exchanges leading up to the first wave of litigation would take at most about 8 months, BIO reasoned, which lines up with FDA’s commitment to reviewing most biosimilar applications within 8-10 months of acceptance. After these early exchanges, and after FDA approval—both of which would theoretically occur within 8-10 months of FDA acceptance of the application—the biosimilar applicant can provide notice that it will launch its product in not fewer than 180 days.

On the other side, GPhA argued in support of Sandoz that Congress provided a “flexible, multi-layered approach” in order to “advanc[e] the overall objective of the BPCIA of expediting access to affordable medicines.”  An applicant can opt to share its (k) application and thereby secure a “safe harbor” from immediate litigation, or choose not to share its application, which creates an act of infringement under 35 U.S.C. § 271(e)(2)(C)(ii) subjecting the applicant to immediate infringement litigation.

GPhA also denounced the argument that the BPCIA provides a private right of action. Its amicus brief argued that the patent dance provisions “provide a procedural mechanism designed to advance the statute’s general pro-competition purposes by allowing for the efficient resolution of patent disputes.  They are not in and of themselves intended to confer new rights on sponsors to balance the benefits afforded applicants under the statute.”