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Amgen and Genentech Break New Ground in Avastin Biosimilar Dispute

Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab).  On October 6, in a complaint filed in the Central District of California, Amgen brought an action seeking a declaratory judgment that 27 of Genentech’s patents are not infringed, invalid, and unenforceable.  Amgen’s suit appears to be the first post-approval declaratory judgment action brought by a biosimilar applicant under the young U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA). Shortly after Amgen filed its declaratory judgment action, Genentech filed its own suit in the District of Delaware, alleging that Amgen had failed to honor promises made during the pre-suit BPCIA process and infringed Genentech’s patents.  Amgen then promptly moved to transfer the Delaware case to California. Genentech then filed another complaint in the District of Delaware, followed by another Amgen motion to transfer.

The recent complaints are not the first to arise out of Amgen’s efforts to market a biosimilar of Avastin, a blockbuster biologic used in the treatment of a number of different cancers. Soon after the FDA accepted Amgen’s biosimilar application for review, Amgen and Genentech began exchanging information as part of the BPCIA’s “patent dance.” Before long, the parties fell into a dispute over whether Amgen had provided all of the manufacturing information called for by 42 U.S.C. §262(l)(2)(A), leading Genentech to file suit alleging violations of the BPCIA. Genentech’s suit was dismissed, though the order permitted Genentech to refile the suit to allege patent infringement within 45 days.

As Amgen’s complaint describes, Genentech did not file a patent infringement action within 45 days after its BPCIA suit was dismissed.  Instead, the parties continued with the BPCIA patent dance. Pursuant to the statutory process, Genentech provided Amgen with a list of 27 patents that it believed could reasonably be asserted against Mvasi, and Amgen responded with a detailed statement explaining why it believed the patents were not infringed or were invalid.  But, according to Amgen, when Genentech responded to Amgen’s contentions with its own detailed statement, Genentech failed to include all of the information required by the statute. Specifically, Amgen alleges that Genentech provided no response to Amgen’s contentions for certain patents, and provided no factual or legal basis to support a claim of infringement for several others, relying instead on its position that Amgen had failed to provide all the necessary manufacturing information.  Amgen says that it demanded that Genentech withdraw claims related to those patents, but that Genentech refused. In September, Amgen alleges, the parties met to negotiate which patents would be the subject of an infringement action during the BPCIA’s (l)(6) immediate litigation phase, but were unable to agree.

Amgen’s declaratory judgment complaint presents a first-of-its-kind procedural scenario. On the day that it filed the action, Amgen provided Genentech with notice of commercial marketing for Mvasi pursuant to 42 U.S.C. §262(l)(8). Immediately after serving the notice of commercial marketing, Amgen filed suit in the Central District of California, seeking a declaration that the 27 patents identified by Genentech—which cover a variety of compositions and methods relating to production of and treatment by monoclonal antibodies—are invalid and not infringed. Although some biosimilar makers have tried (unsuccessfully) to bring declaratory judgment actions before the BPCIA process unfolded, Amgen’s suit appears to be the first time that a biosimilar maker has brought a declaratory judgment action after participating in the BPCIA procedures.

Amgen’s ability to file a declaratory judgment action is likely to be disputed.  Although the BPCIA allows biosimilar makers to file declaratory judgment actions so long as they participated in the patent dance and carried it through to completion, a provision of the statute (42 U.S.C. § 262(l)(9)) expressly bars declaratory judgment actions by the biosimilar applicant if it either fails to provide its original application and manufacturing information or fails to complete the patent dance.  Section (l)(9)’s limitation on declaratory judgment actions was an important part of the Supreme Court’s rationale in its recent decision that participation in the patent dance is not enforceable under federal law—it reasoned that § 262(l)(9) provided statutory consequences for a biosimilar applicant that refuses to participate in the statutory patent dance. Based on the allegations in Genentech’s complaint (discussed below), Genentech is likely to argue that Amgen failed to fully participate in the patent dance and is therefore barred from filing a declaratory judgment action.

Shortly after Amgen filed suit, Genentech fired back by filing a lawsuit in Delaware, where Amgen is incorporated.  Genentech filed its complaint on October 7, the day after Amgen brought its suit in California (in fact, according to Amgen, Genentech’s suit was filed “[s]hortly after midnight” on October 7, just hours after Amgen’s).  Not surprisingly, Genentech’s complaint presents a different point of view about the parties’ BPCIA exchanges.  As it had done in its earlier procedural lawsuit that was dismissed, Genentech alleges that Amgen failed to provide sufficient manufacturing information about its biosimilar Mvasi, and that this failure prevented Genentech from fully assessing which patents were infringed. According to Genentech, Amgen justified its refusal to provide manufacturing information by arguing that its manufacturing activities were protected from infringement by the 35 U.S.C. § 271(e)(1), the safe harbor for regulatory activities.

Genentech also alleges that Amgen failed to negotiate the scope of patent litigation in good faith “despite the requirements of 42 U.S.C. § 262(l)(4).” According to Genentech, Amgen initially refused to negotiate pursuant to § 262(l)(4), but then later agreed to an in-person meeting, which was inconclusive.  Following the meeting, Genentech alleges, Amgen suggested it would provide a counterproposal concerning the scope of the litigation. Genentech says, however, that no counterproposal arrived before Amgen sent a letter stating that the 15-day period for § 262(l)(4) negotiations had elapsed. Genentech alleges that on October 6, the day Amgen filed its declaratory judgment action in California, Amgen sent Genentech another letter inquiring about § 262(l)(5) negotiations—but that the letter “did not mention that [Amgen] had also purported to serve Genentech with a notice pursuant to § 262(l)(8) that it intended to begin commercial marketing. Nor did Amgen’s letter indicate that it had, just hours earlier, filed a lawsuit against Genentech in the Central District of California, seeking a declaratory judgment with respect to all of the patents listed in Genentech’s § 262(l)(3)(A) list of patents.”

According to Genentech, Amgen’s behavior “deprived Genentech of its plain right under the BPCIA to thoroughly evaluate potential infringement before Amgen’s proposed copy of Avastin comes to market and it seeks to deprive Genentech of its right to select the forum for litigation pursuant to the BPCIA.” Redacted sections of the complaint also make reference to an alleged promise made by Amgen that Genentech believes Amgen breached, apparently related to the conduct of the parties’ BPCIA exchanges. 

On October 18th, Genentech filed another complaint in the District of Delaware, bringing the current tally of Mvasi actions to three. Genentech’s second complaint is currently under seal.

Amgen responded to both of Genentech’s complaints with motions to transfer, arguing that the District of Delaware is not the proper venue.  In its motions, Amgen points out that in addition to being the location where the first lawsuit was filed, California is also the home state of both Amgen and Genentech.  Amgen’s motions seek a transfer to the Central District of California—the same district where Amgen filed its own suit immediately after providing notice of commercial marketing.  Among other issues, Amgen’s motions to transfer raise the question whether the BPCIA grants reference product sponsors the right to select the forum for litigation, as Genentech contends, or whether, as Amgen argues, the filing of a notice of commercial marketing allows venue to be determined by traditional factors such as the timing of lawsuits and the convenience of the parties.  The motion may also address whether Amgen has the right to file a declaratory judgment action, as discussed above.

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