On March 19, 2015, U.S. District Judge Seeborg of the Northern District of California denied a motion for a preliminary injunction filed by Amgen to prevent the imminent launch by Sandoz of a biosimilar version of NEUPOGEN^® (filgrastrim).  In so doing, the Court ruled that the disclosure and notice provisions of the Biologics Price Competition and Innovation Act ("BPCIA") were not mandatory.  The Court entered final judgment on March 25, and two days later Amgen filed an appeal with the U.S. Court of Appeals for the Federal Circuit.  According to a subsequent order in the District Court, the Federal Circuit granted an unopposed motion filed by Amgen to expedite briefing, and the parties have requested that the Appeals Court hear the matter in June.

As this case is one of first impression for the interpretation of the relevant provisions of the BPCIA, the Biotechnology Industry Organization ("BIO") filed an amicus brief last week at the Federal Circuit.  In addition, two other briefs were filed by Janssen Biotech, Inc., owner of the BLA for Remicade® (infliximab), and Abbvie Inc., owner of the BLA for Humira®.  It is unclear, however, whether Abbvie's corrected brief was actually properly filed.  In this post, we review the amicus brief filed by BIO.

BIO began by highlighting the fact that it represents more than 1,100 member companies and research organizations, from start-ups to Fortune 500 companies.  Not surprising, therefore, the brief focused on the balance struck during the establishment of the statutory pathway found in the BPCIA, which was meant to balance the interests of the biosimilar applicants and the reference product sponsors.  Indeed, after noting that BIO played a leading role in the efforts to establish the BPCIA, it focused much attention on the desire of both biosimilar applicants and reference product sponsors to handle any litigation surrounding relevant patents in an expeditious manner.  Because it is essentially of first impression, BIO urged the Court to not only consider the impact on this case, but on all "the circumstances to which this statute must be applied for the coming decades."

BIO first explained that in developing the BPCIA, the Hatch-Waxman Act was used as a guide, even if all of the provisions were not copied.  One place of commonality was the creation of a "scheme to provide a meaningful opportunity to resolve patent disputes before product launch" (emphasis in original).  This includes an artificial act of infringement prior to actual sales, and a required notification that an ANDA or biosimilar application has been filed.  The acts differ, of course, in that the BPCIA adds a series of patent exchanges (the so-called "patent dance").  In addition, the reference product is entitled to 12 years of data exclusivity to preserve the incentives for biomedical research.

BIO's main argument was that "the BPCIA's notice procedure (a first notice upon acceptance and second notice prior to commercial marketing) balance the interest of biologic reference product sponsors and biosimilars to address the needs of both for a significant and real opportunity to resolve patent issues prior to the launch of the biosimilar."  In fact, in the other biosimilar actions to date (relating to Amgen's Enbrel® (etanercept) product and Remicade®), both the biosimilar applicants and reference product sponsors cited the desire for "a prompt, real opportunity to resolve patent disputes before launch of the biosimilar."  In the Enbrel action, Sandoz filed a declaratory judgment ("DJ"), because it allegedly sought a final district court judgement before commercial marketing in order to avoid a potential billion dollar damages claim.  However, as we reported, the Federal Circuit upheld the dismissal of the action for lack of subject matter jurisdiction.  Similar DJ actions were filed in the matters involving Remicade®, with similar results (one voluntary dismissal, and two motions to dismiss granted by the District court, reported here).  Nevertheless, one of those DJ plaintiffs, Celltrion, had argued that the BPCIA provides a mechanism to ensure the expeditious resolution of the patent issues.  In case it was not clear, the interests of both the reference product sponsor and the biosimilar applicant were encompassed within the statutory scheme of the BPCIA because it provides an expeditious pathway to resolve any potential patent infringement issues.

In an attempt to paint a similar picture that both parties to the instant action also valued the balance of the BPCIA, BIO pointed to statements by Sandoz highlighting Congress's stated goal of allowing for the resolution of "potential patent disputes prior to the launch of the biosimilar product . . . " (emphasis in original).  Nevertheless, no matter the language used, it is clear that Sandoz was satisfied with circumventing these procedures notwithstanding the lack of patent certainty that would result.  Indeed, Sandoz has only agreed to refrain from launching its biosimilar product until May 11, 2015, even though the Federal Circuit will certainly have not decided this case by that time.

Interestingly, BIO refers to both the disclosure provisions and the commercial marketing provisions as "notices" -- "(1) notice upon application and (2) notice of commercial marketing."  Therefore, in a way, Sandoz satisfied both "notice" aspects by informing Amgen via letter that its biosimilar application had been accepted and that it intended to market upon FDA approval.  However, BIO did not suggest that Sandoz had satisfied the statutory requirement, because the only form in which notice of application can be provided is through the disclosure of the application and other essential information.  Otherwise, as BIO explained, if the biosimilar applicant withholds its application and does not otherwise provide notice, the reference product sponsor may never learn that such an application was filed.  "It makes little sense for Congress to devise a carefully orchestrated process for exchanging information, and identifying and enforcing patents that might only begin if the reference product sponsor serendipitously discovered from public sources that a biosimilar application has been filed."

Moreover, the 180-day notice of commercial marketing, under the BPCIA, "effectuates litigation on patents that were listed but not part of the early stage litigation" (emphasis in original).  As such, the statute specifies that this notice must occur at the end of the patent dance, not before it has even begun.  BIO also pointed to the statute's requirement that this "notice" be with regard to the "licensed" product, not simply with any biosimilar application that has been filed with the FDA.  To be a licensed product, it must have FDA approval.

Finally, in response to the arguments below that the 180-day notice period amounts to a de facto extension of the data exclusivity, BIO asserted that this is simply not true.  Instead, the patent disputes were meant to be resolved during the final 8 years of data exclusivity -- which should be plenty of time for a decision on the merits.  In other words, the 180-day notice should normally be provided well before exclusivity expires.  Just because scenarios exist where the 180-day notice cannot be provided with sufficient time does not make the statute unfair.  "The biosimilar applicants' choice of when to file the application or to defer the litigation over listed patents until 'late stage' preliminary injunction litigation comes with timing consequences."  For biologics such as in this case, where the drug has been on the market so long that there is no data exclusivity remaining, "a notice of commercial marketing would provide a modest 6-month respite before commercial launch of the approved biosimilar product to resolve patent disputes before biosimilar launch . . . ."  That this timing might not be optimal for all applicants is of no moment.

We will continue to monitor this case and report on the briefing of other parties in subsequent posts.