By Andrew Williams --
To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price Competition and Innovation Act ("BPCIA"). For example, Amgen's lawsuit against Sandoz was one of the first in which a district court and the Federal Circuit had the opportunity to interpret sections of that statute (see "Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)"). And just last month, the Federal Circuit confirmed that the Notice of Commercial Marketing is mandatory, regardless of whether or not the biosimilar applicant participated in the Patent Dance (see "Amgen Inc. v. Apotex Inc. (Fed. Cir. 2016)"). It was therefore noteworthy that Amgen is once again involved in a BPCIA litigation -- but this time as the aBLA filer. Last week, on August 4, 2016, AbbVie sued Amgen pursuant to the BPCIA and 35 U.S.C. § 271(e)(2)(C) because Amgen submitted an application to the FDA to market a biosimilar version of adalimumab, AbbVie's anti-TNFα therapeutic antibody that is otherwise known as HUMIRA®.
While this is case is significant, it has been expected for some time. As we reported last October, Amgen had completed significant Phase III clinical trials for this biosimilar drug last year. Moreover, Amgen filed two IPR petitions last year directed to two AbbVie anti-TNFα antibody formulation patents, although the PTAB decline to institute both of these proceedings earlier this year. This activity culminated in Amgen filing its biosimilar application near the end of last year, which the FDA accepted on or around January 22, 2016. It had been previously unknown, however, if the parties had been engaging in the BPCIA's patent dance since that time, because the process consists of various disclosures and exchanges, none of which are meant to be publically available. Therefore, AbbVie's complaint is the first glimpse into what has been occurring since January. It is important to keep in mind, however, that the complaint only provides the point of view of one of the parties (AbbVie), and that we will need to wait until Amgen files its answer before we see its side of the story.
The question most people were wondering was whether Amgen would disclose its aBLA to AbbVie after it was accepted by the FDA. Famously, Amgen argued to the Federal Circuit that this BPCIA requirement was mandatory, although the Court ultimately disagreed. Amgen would have been justified in relying on this current state of the law if it has chosen not disclose its aBLA. However, according to the complaint, Amgen did so disclose its biosimilar application. On the other hand, Amgen allegedly did not disclose the "other information that describes the process or processes used to manufacture" the biosimilar, as is also required by 42 U.S.C. § 262(l)(2)(A). Amgen also allegedly refused to make the application available to others beyond the limited number provided for in the BPCIA -- Amgen did not allow more than one AbbVie in-house attorney or AbbVie outside expert witness to have access to the aBLA.
With regard to the patent estate that covers adalimumab, AbbVie alleged that there are more than 100 patents that it could have potentially asserted. Instead, when AbbVie took its first dance step, it identified 61 patents and 5 allowed patent applications that could reasonably be asserted against Amgen and its biosimilar drug product. AbbVie followed this list with at least three supplemental lists: the first indicating that one of the allowed patent applications had subsequently issued, the second indicating that two more of the allowed applications had issued, and finally a third when the final two applications issued. After Amgen provided its statement contesting infringement and the validity of these patents, AbbVie responded by allegedly providing Amgen with a nearly 1,500 page statement showing how ABP 501 (the biosimilar drug product) would infringe more than 1,100 claims of 60 AbbVie patents. At the same time, AbbVie withdrew its infringement claims related to the remaining six identified patents. Finally, on June 22, AbbVie supplemented its list a final time, pursuant to 42 U.S.C. § 262(l)(7), and added one more issued patent. This brought the number of patents that AbbVie has signaled will ultimately be asserted against Amgen's biosimilar drug product to 61.
In the BPCIA process, after all of the patents have been identified, the parties can negotiate as to which patents will be litigated in an initial phase of litigation. Amgen apparently chose not to negotiate, and instead dictated that both parties could chose up to six patents for litigating in this initial stage. For its own part, AbbVie alleged that it had suggested that they litigate all patents to avoid the two waves of litigation. Nevertheless, it is the biosimilar applicant that has the option and ability to limit the scope of the initial phase of litigation. Both parties identified six patents, but because two of the patents were in common on both lists, the litigation was limited to ten patents. Specifically, AbbVie identified:
The entire list of 60 patents can be found on pages 13-15 of the complaint. Of course, neither party was required to indicate why it had selected the patents it had, and even if they were, AbbVie would have had no reason to include that in the complaint. We can only speculate that AbbVie may have chosen its patents as a representative sample of its estate with the goal of finding at least one claim that will delay the launch of Amgen's biosimilar drug product. We can also only speculate that Amgen may have chosen its particular set of patents because they may represent the most significant concern for a "launch at risk" scenario. It is also possible that Amgen chose these patents because they have the longest patent remaining patent term (although we have not assessed the relative remaining term of all 61 identified patents). It is interesting that Amgen chose to litigate the patent that issued most recently -- on June 14, 2016. There is no guarantee that this patent has the longest remaining term, however. It is also interesting that AbbVie, but not Amgen, chose to litigate one of the patents, U.S. Patent No. 8,916,157, which was the subject of one of Amgen's failed IPR attempts.
One final insight that can be gleaned from the complaint is that Amgen apparently failed to assure AbbVie that it will provide the Notice of Commercial Marketing once it receives FDA approval. According to the complaint, at paragraph 218-19, AbbVie had asked Amgen to confirm by June 28, 2016 that it would provide the requisite 180-day notice, but Amgen apparently failed to respond. As a result, AbbVie is also seeking an order compelling Amgen to comply with the notice provision and preliminary and/or permanent equitable relief enjoining Amgen from engaging in any infringing activity until after the 180-day period would run. It might not be insignificant that AbbVie's imposed deadline came just days before the Federal Circuit decided the Amgen v. Apotex case. That case made clear that the notice provision is mandatory in all cases, and that it is enforceable by an injunction. Considering that the FDA committee reviewing Amgen's application has recommended approval of the biosimilar, it would not be surprising to see AbbVie more forward on this remedy sooner than later.
As indicated above, the information found in the complaint is all from AbbVie's perspective, and we will need to wait until Amgen files its Answer before we get its side of the story. Until then, we will continue to monitor this case and provide updates as warranted.