Since our prior article on the litigation between Amgen and Hospira over Hospira’s proposed biosimilar to Amgen’s Epogen®, there have been several developments, including those that occurred after the Supreme Court’s recent Amgen v. Sandoz decision.
The last major development we previously discussed was a motion for a preliminary injunction filed by Amgen seeking “to enjoin [Hospira] from launching a biosimilar version of Amgen’s EPOGEN® (epoetin alfa) product until Hospira has complied with the [notice of commercial marketing] requirement of 42 U.S.C. § 262(l)(8)(A).” Since then, the brief supporting the motion, which was initially sealed, was filed in redacted form on June 5, 2017.
In its original supporting brief, Amgen relied heavily on the Federal Circuit’s earlier holding in Amgen v. Sandoz to support its position that the notice of commercial marketing was required to be given after FDA approval. Amgen also cited to this holding in support of its arguments with respect to Hospira’s alleged failure to disclose manufacturing information. While compelling such disclosure was not a direct point of this motion (as this exact point is currently pending before the Federal Circuit in an interlocutory review), Amgen used this alleged failure of disclosure as a factor in support of the preliminary injunction, citing to a Federal Circuit statement that a party in Amgen’s position can “access the required [manufacturing] information through discovery” in a patent-infringement action.
Then, on June 12, 2017, the Supreme Court issued its decision reversing the portion of the Federal Circuit’s Amgen v. Sandoz decision regarding notice of commercial marketing on which Amgen had relied. Specifically, the Supreme Court held that the notice of commercial marketing may be provided before a biosimilar applicant obtains a license (e.g. FDA approval).
The Supreme Court also emphasized that federal law does not provide the right to an injunction to force compliance with the disclosure requirements of section (l)(2)(A) of the BPCIA. However, the Court left open the issue of whether state laws may provide an alternative avenue for injunctive relief, as discussed in this article.
On June 12, 2017, the parties in the Epogen® litigation stipulated to an extension of time regarding the motion for a preliminary injunction to allow the parties to consider and address the impact of the Supreme Court decision. A week later on June 19, 2017, Amgen moved to file an amended brief in view of the decision, and following grant of the motion, a sealed amended brief was filed on June 20, 2017. Hospira’s sealed opposition brief was filed June 26, 2017.
Amgen’s amended brief (as seen in its redacted form filed on June 29, 2017) seems to focus on the argument that notice of commercial marketing is mandatory and that Hospira’s notice is ineffective. While much of the rationale as to why the notice was allegedly ineffective is currently redacted, the argument appears to be based on an assertion that because Hospira had received a complete response letter from the FDA requiring resubmission of its application, any notice provided prior to such resubmission was no longer effective. Amgen’s position on the discovery of manufacturing information remained largely the same as in its original brief.
Hospira’s amended opposition brief (as seen in its redacted form filed on July 6, 2017) noted that there is no requirement for additional notice following receipt of and response to a complete response letter. Hospira characterized Amgen’s argument as “a repackaged version of its argument in Sandoz, which was explicitly rejected by the Supreme Court” and argued that “Amgen now links its argument to the submission of additional data and information to the FDA, rather than the date of FDA approval.” Hospira did not address Amgen’s points regarding disclosure of manufacturing information and the pending interlocutory review.
The district court held oral argument on several motions, including the motion for preliminary injunction, on June 28, 2017. Amgen requested and received an extended deadline to submit a reply in response to Hospira’s amended opposition brief. Then, on July 12, 2017, Amgen filed a notice of withdrawal of its preliminary injunction motion. Not only has there been a change in the law, as discussed above, but the pertinent facts have also changed since the filing of the motion seeking a preliminary injunction. When At the time the motion initially filed, the FDA’s Oncologic Drugs Advisory Committee had recommended approval of Hospira’s Epogen® biosimilar. Amgen cited this recommendation in support of its claim of imminent harm absent an injunction. However, as we previously discussed in this post, Pfizer/Hospira announced in late June that its pending application had received another complete response letter, thus delaying any approval. Such delay would make it more difficult to establish imminent irreparable harm for purposes of a preliminary injunction, and this may have also impacted Amgen’s decision.
Unfortunately, for those looking to the limited number of biosimilar litigations for guidance, this case has presented additional questions but has not yet provided an answer to the question of what exactly is required to provide sufficient notice of commercial marketing. Perhaps the pending appeal will provide further answers regarding the disclosure of manufacturing information.
On July 20, 2017, the parties filed a joint stipulation regarding the case schedule. The pretrial order is currently due on August 31, 2017, and a five day jury trial remains scheduled to begin on September 18, 2017.