FDA Law: You’re Invited . . . To a Dance Party! Will You Dance the Amgen Waltz, or the Sandoz Shuffle?

Guest Post By Kurt R. Karst.  Mr. Karst runs the excellent FDA Law Blog and is also a director at Hyman, Phelps & McNamara. The following was originally published on the FDA Law Blog.  

As you enter the Courtroom 402 “dance hall” at the U.S. Court of Appeals for the Federal Circuit on Wednesday, June 3, 2015, you’ll have to decide whether to take an initial right step and join the Amgen Inc. (“Amgen”) crowd, or move to the left and side with the folks from Sandoz Inc. (“Sandoz”) as the two sides battle over the applicability and correct interpretation of various provisions of the the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) in the context of Sandoz’s biosimilar version of Amgen’s NEUPOGEN (filgrastim), ZARXIO (filgrastim-sndz), which FDA licensed on March 6, 2015 under BLA 125553.  You’ll need to RSVP soon, however, because space is filling up fast!  There’s already a lineup of parties who want to be at the “must attend” BPCIA event of the year.

The party at the Federal Circuit was kicked off after Judge Richard Seeborg of the U.S. District Court for the Northern District of California ruled on March 19, 2015 in a 19-page decision that, among other things, the BPCIA’s reticulated information exchange and patent resolution procedures are not mandatory for Section 351(k) biosimilar applicants, and that the plain language of the statute allows for the 180-day notice of commercial marketing to come well before the licensure of a Section 351(k) application (see our previous post here).

The decision was a total victory for Sandoz, and thus, a total defeat for Amgen, which promptly appealed the decision to the Federal Circuit (see our previous posthere).  Meanwhile, back in District Court, Amgen filed a Motion for Injunction Pending Appeal.  But Judge Seeborg denied that motion as well, saying that Amgen’s “tenuous and highly contingent showing of irreparable harm forecloses injunctive relief.”  Undeterred, and facing a possible launch of ZARXIO as early as Monday, May 11, 2015, Amgen is now asking the Federal Circuit for an Injunction Pending Appeal.  Sandoz recently filed its Opposition to Amgen’s motion, saying that “Amgen’s appeal involves no claim of patent infringement,” and instead, “Amgen seeks to enjoin launch of Sandoz’s FDA-approved biosimilar filgrastim product based solely on Sandoz’s purported violations of procedures of the [BPCIA],” which “contains no mechanism for Amgen to preclude Sandoz from launching absent a showing of patent infringement.”

Briefing on Amgen’s appeal is nearly complete.  As we previously reported, Amgen filed its Opening Brief on April 3, 2015 laying out the company’s arguments as to why Judge Seeborg erred in ruling on all fours for Sandoz.  Not long thereafter, Amgen received support from several parties that filed amicus briefs.  (Amgen’s Reply Brief is due on April 28, 2015.)

Janssen Biotech, Inc. (“Janssen”) urges the Federal Circuit in its amicus brief to “clarify that the statutory patent dispute resolution procedures are intended to be followed as written, and are not merely optional choices or empty formalities, as Sandoz contends.”  Janssen is currently challenging, in the U.S. District Court for the District of Massachusetts, Celltrion, Inc.’s (“Celltrion’s”) and Hospira, Inc.’s (“Hospira’s”) decision to exit from the BPCIA’s patent dance procedures in the context of a biosimilar version of Janssen’s REMICADE (infliximab) (see our previous post here).

AbbVie Inc. (“AbbVie”), which markets HUMIRA (adalimumab), among many other products, has not yet had to engage in litigation over the BPCIA’s information exchange and patent resolution provisions, but weighs in for Amgen in an amicus brief.  According to AbbVie, absent a reversal of Judge Seeborg’s decision, biosimilars patent litigation will devolve into chaos:

The outcome of this appeal will have a profound effect on the transparency, efficiency, and fairness of the legal process going forward. If Amgen’s positions are adopted—and Congress’s directives are enforced—parties will enter the litigation process well informed; they will be able to identify the patents truly at issue, engage in good-faith negotiations, narrow their disputes, and litigate only those issues that warrant the courts’ time and attention.  If Sandoz were to prevail, the entire biosimilar litigation process would become a free-for-all, where biosimilar companies would utilize the data and work of innovator companies but refuse to provide basic information about their products, including their compositions, indications, formulations, and manufacturing processes, as well as the timing of their planned launches, leaving innovators to blindly guess as to which patents they should sue on and when.  The first option will lead to more focused cases, more transparency, and more frequent and earlier settlements; the second will burden the courts with inefficient and protracted litigation for years to come.

Finally, the Biotechnology Industry Organization (“BIO”), whose members include both Amgen and Sandoz, says in its amicus brief that “the BPCIA patent dispute resolution process must be interpreted in accordance with its purpose — to provide a significant and real opportunity to resolve patent issues prior to the launch of the biosimilar,” which requires, in turn, “notice to the reference product sponsor of the initial submission of the biosimilar application and notice of potential commercial marketing upon approval.”

Sandoz, in the company’s April 21, 2015 Non-Confidential Brief, does an excellent job of laying out why the waltz preferred by Amgen and its supporters is not the only move on the dance floor, and why a shuffle (or perhaps a side step?) is perfectly reasonable under the BPCIA.  According to Sandoz:

Read in the context of the BPCIA as a whole, the “shall” provision in Section 262(l)(2)(A) is a mandatory condition precedent to engaging in the patent-exchange process, not a mandatory requirement in all circumstances. . . .  This interpretation is consistent with uses of “shall” in other provisions in subsection (l), as well as with uses of “shall” in other statutory schemes.  It also gives full effect to both “shall” and “may” in subsection (l)(2)(A). . . .  Congress carefully balanced the interests between sponsors and applicants, determined what the consequences should be at each step of the process for not completing it, and allowed the parties to weigh the benefits of proceeding against the consequences of not.

With respect to notice, says Sandoz, “[t]he plain terms of the ‘[n]otice of commercial marketing’ provision are satisfied when an applicant provides notice at least 180 days before it commercially markets its product.”  “If, as Amgen argues, a biosimilar must be licensed before notice may be given, that would transform this mere ‘[n]otice’ provision into an automatic, six-month bar against marketing of every licensed biosimilar product. Had that been Congress’s intent, it would have said so.”

Sandoz’s arguments are reinforced in an amicus brief filed by the Generic Pharmaceutical Association (“GPhA”), which recently announced the launch of a new division, called the Biosimilars Council.  According to GPhA:

The question here is whether the BPCIA’s patent dispute resolution provisions should be interpreted according to the statute’s clear structure, which in turn supports Congress’s overarching goals of increased competition and consumer access to affordable biologics.  The answer, as the district court found, is yes.  The contrary readings advanced by Amgen and its amici depend on illogical, context-free interpretations of selected individual words that if read as Amgen suggests would render superfluous important sections of the BPCIA, undercut the statute’s overarching purposes, and produce results that Congress could not possibly have intended.

According to a recent docket entry, Celltrion and Hospira also tendered an amicus brief that has only just been made public and is available here.