Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses current BPCIA litigation concerning biosimilar products.
What are current litigations that could impact biosimlars?
I think I’ve got to give a little bit of background there. To date there have been about 10 [Biologics Price Competition and Innnovation Act, BPCIA] cases filed give or take, and several of these actually addressed similar procedural issues to those in Sandoz v Amgen, so a lot of those have already been covered. Initially, as an example, several biosimilars applicants took the position that if they complied with the patent dance, they were not required to provide the 180-day notice of commercial marketing. In Amgen v Apotex, which came up shortly after Sandoz v Amgen, the Federal Circuit ruled that the notice of commercial marketing, that provision, is always mandatory and enforceable by injunction. So that’s basically all resolved.
Now the nature of the disputes is starting to look at more specific requirements of the BPCIA. For example, several biosimilar applicants have provided their aBLA (their abbreviated Biologic License Application), but not manufacturing information, as required by the statute. In Genentech v Amgen, the district court held that the only remedy under the BPCIA for the reference product sponsor under those circumstances is an infringement action, and not declaratory judgment. In Janssen v Celltrion, the district court found that because the defendant had not complied with the patent dance, the plaintiff’s damages would not be limited to a reasonable royalty despite the fact that the patent in question was not asserted until more than 30 days after the patent dance was completed. So as parties are getting more experience with the BPCIA, we are seeing some more procedural issues being clarified.
In terms of non-BPCIA cases, though, the most important case right now is probably Amgen v Sanofi, which concerns the availability of permanent injunction in drug patent disputes. Amgen and Sanofi market competing anti-PSKC9 inhibitor antibodies for controlling cholesterol. Their products are the only drugs in that class. The district court granted a permanent injunction, which the Federal Circuit temporarily stayed pending the outcome of Sanofi’s appeal. Depending on the outcome of Amgen v. Sanofi, we may see the stakes get significantly higher for biosimilar applicants considering at-risk launches.