As we previously reported, Amgen commercially launched two biosimilars in the United States earlier this month: KANJINTI (trastuzumab-anns), a biosimilar to Herceptin®; and MVASI® (bevacizumab-awwb), a biosimilar to Avastin®. Amgen’s launch announcement on July 18, 2019 came shortly after a Delaware federal district court denied Genentech’s requests for a temporary restraining order (TRO) and/or preliminary injunction (PI) in each of the trastuzumab and bevacizumab BPCIA litigations. These disputes have since advanced to the U.S. Court of Appeals for the Federal Circuit.
In the trastuzumab litigation, as previously reported, the district court denied Genentech’s motions for a TRO and PI against Amgen primarily on the ground that Genentech had failed to establish that it would suffer irreparable harm if the injunction did not issue, including due to Genentech’s delay in seeking injunctive relief.
In the bevacizumab litigation, Genentech filed a motion to enforce the BPCIA’s statutory prohibition on commercial marketing and a corresponding motion for a TRO. Genentech argued that Amgen’s October 2017 notice of commercial marketing (NCM) was legally ineffective under subsection (l)(8)(A) because Amgen later filed, and the FDA approved, supplements to Amgen’s already approved aBLA with additional manufacturing and labeling information, so the biosimilar that Amgen was seeking to launch was a different “biological product” under the BPCIA. Accordingly, Genentech sought to enjoin Amgen’s launch until 180 days after Amgen provided a new NCM. The district court, however, denied Genentech’s motions, finding that Amgen’s October 2017 NCM satisfied the requirements of subsection (l)(8)(A). The district court determined that “under the express terms of the BPCIA, the same biologic product can be the subject of an application and supplements to the application” and that “the BPCIA’s language makes clear that a biologic product is not defined by its manufacturing facilities or labeling.” “Thus,” the court found, “the fact that Mvasi was the subject of the original application approved by the FDA in September 2017 does not make it a different biological product than the Mvasi that was the subject of the supplements to the application approved by the FDA in December 2018 and June 2019.”
On July 19, 2019, Genentech appealed these adverse decisions to the Federal Circuit and simultaneously filed emergency motions with both the Federal Circuit and the district court to seek injunctions against Amgen, pending resolution of the appeals.
While the district court denied Genentech’s motions for injunctions pending appeal on the very same day they were filed, the parties are engaged in briefing before the Federal Circuit. In the trastuzumab appeal, Genentech asserts that it “will undisputedly suffer irreparable price erosion and lost market share due to Amgen’s infringement” and responds to the district court’s findings in its order denying entry of a preliminary injunction. First, Genentech argues that it did not delay in seeking injunctive relief because, when it received Amgen’s NCM KANJINTI® was not yet approved, and in fact did not obtain approval for more than a year after the NCM. Therefore, according to Genentech, at the time of the NCM there was no immediate threat of launch and the matter was not yet ripe to warrant injunctive relief. Second, Genentech argues that the district court erred in finding a lack of irreparable harm because Genentech had licensed its patents to other biosimilar manufacturers in the settlement of litigation, as none of Genentech’s licensees are currently authorized to launch in the United States.
In the bevacizumab appeal, Genentech argues that the plain text of the BPCIA compels a biosimilar applicant to provide an NCM for each new biological product licensed under subsection (k) and that Amgen’s interpretation contradicts the purpose of NCM to “fairly assess the parties’ rights prior to the launch of the biosimilar product.” Genentech further asserts that “an unlawful launch of Mvasi would inflict severe injury in the form of price erosion, loss of market share, and lost goodwill.”
On July 29, Amgen filed its oppositions to Genentech’s motions for injunctions pending appeal. With regard to the trastuzumab appeal, Amgen argues, among other things, that Genentech’s “unreasonable delay and its pattern of licensing each demonstrated a lack of irreparable harm” and that enjoining the launch of Amgen’s product would harm the public interest by precluding non-infringing uses. With regard to the bevacizumab appeal, Amgen argues that it provided the notice required under subsection (l)(8)(A) and that “Genentech’s contention that the Mvasi product now is somehow a ‘different biological product’ from the product referenced in Amgen’s 2017 notice is contradicted by the record, the statutory text, the case law, and common sense.” Genentech filed reply briefs in support of their motions in the trastuzumab and bevacizumab appeals on August 1.
In the meantime, on July 26, Genentech filed its opening brief on the merits of its appeal in the trastuzumab appeal, asserting that the district court committed legal errors and abused its discretion in denying Genentech’s motion for a preliminary injunction to enjoin Amgen’s commercial marketing of KANJINTI in the United States.
Stay tuned to Big Molecule Watch for further developments.