Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s disclosure provisions are preempted by federal law under both field preemption and conflict preemption. The brief is available here. As noted in a previous post, the United States filed an amicus brief this week generally agreeing with the position taken by Sandoz and the Biosimilars Council.
The Biosimilar Council’s brief makes three primary points. First, the Council argues that federal law occupies the fields of biosimilar approval and related patent litigation, which are exclusively federal in nature “because they are governed entirely by federal law and are not part of a field that States have traditionally occupied.” The Council points out that in enacting the BPCIA’s expedited approval and streamlined litigation pathways, Congress was legislating under the background presumption that state law would play no role because patent rights and patent litigation have not historically been matters of state regulation. Because the federal interest in patent litigation is so dominant, and the BPCIA’s patent-litigation provisions are so detailed, the Council argues that Congress left no room for States to play a role by adding remedies to the BPCIA that Congress intentionally decided not to provide. Thus, the Council contends that any state-law claims based on a biosimilar applicant’s failure to participate in the patent dance’s disclosure provisions are field preempted.
Second, the Council argues that subjecting biosimilar applicants to litigation under 50 States’ laws and remedies would upset the balance Congress struck between biosimilar and biologic manufacturers. The Council contends that the BPCIA’s statutory scheme is “highly reticulated” and “carefully calibrated,” which reflects Congress’s conscious effort both to protect biologic innovation and to encourage market access to less-costly biosimilars. It states that the statute’s patent-litigation provisions and Congress’s detailed prescriptions for a party’s failure to follow those provisions “were a key part of the overall compromise.” The Council’s brief further states that patent laws in particular reflect a careful legislative decision about the appropriate balance of rewards and incentives, and where state-law claims and remedies would second-guess the balanced approach Congress decided upon, they are preempted.
Third, the amicus brief points to the practical consequences of Amgen’s position, which the Council says would turn a “streamlined” process for resolving patent disputes into a chaotic endeavor. The brief contends that allowing lawsuits under 50 States’ laws to contest compliance with the BPCIA will lead to forum shopping and thus collateral disputes over such issues as personal jurisdiction, venue, and the appropriate choice of law—all of which could be litigated separately from patent infringement and result in piecemeal litigation and appeals. The Council states that this type of fragmented approach is inconsistent with Congress’s goal of creating a single, uniform procedure for resolving patent disputes over biosimilar products. Furthermore, the Council states that this collateral litigation could result in an unworkable “patchwork of injunctions and damages” under 50 States’ rules that could be used to keep a biosimilar off the market even after FDA licensure and patent litigation were complete. The brief states that these types of collateral disputes and complications will increase litigation costs and uncertainty and thus reduce incentives for biosimilar development, thus further frustrating Congress’s purpose in enacting the BPCIA: “to decrease drug prices by introducing biosimilar competition.”