New Biosimilar Litigation Reflects Benefits of Complying with BPCIA
On August 2, AbbVie sued Boehringer in the District of Delaware, alleging infringement of multiple patents related to AbbVie’s blockbuster biologic Humira (adalimumab). Though AbbVie has “more than 100 issued United States patents” that protect Humira and says that Boehringer infringes 74 of them, AbbVie explains that it was only able to assert 8 of the patents against Boehringer in its complaint. As AbbVie explains, Boehringer was able to limit the scope of litigation to 8 patents by complying with the procedures of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).
The BPCIA provides for a series of back-and-forth information exchanges, known as the “patent dance,” between an innovator and a biosimilar maker. Though the Supreme Court recently concluded that initiation of the patent dance, and therefore all of its requisite information exchanges, is not enforceable under federal law, biosimilar makers obtain significant benefits by complying with its procedures. One of the key benefits is the ability to limit the number of patents at issue in the first wave of BPCIA litigation, the so-called immediate litigation phase. The second wave of BPCIA litigation is triggered by a notice of commercial marketing, which Boehringer will have to provide before it can market its proposed biosimilar product.
Under the BPCIA, parties negotiate which patents should be litigated after they complete the patent dance. If the parties are unable to agree on which patents to litigate, the biosimilar maker has to identify the number of patents it wants to litigate in the immediate litigation phase. The parties then simultaneously exchange lists of patents. But each party cannot list more patents than identified by the biosimilar maker. The only exception is if the biosimilar maker identifies zero as the number of patents. In that case, the innovator may list one patent. The innovator then files an infringement lawsuit limited to the patents on the lists. As a result of the BPCIA’s procedures, a biosimilar applicant who has followed all of the steps of the BPCIA controls the maximum number of patents that appear on each party’s patent list, effectively limiting the scope of first-wave litigation.
Here, AbbVie’s complaint describes how the parties proceeded through the steps of the BPCIA. After the FDA accepted its aBLA for review, Boehringer provided its aBLA to AbbVie. (AbbVie notes, however, that Boehringer did not provide the “other information that describes the process or processes used to manufacture” the biosimilar that the BPCIA requires.) AbbVie next listed the 72 patents it believed could be infringed and then supplemented that list with 2 newly issued patents for a total of 74 patents. The parties exchanged their contentions and entered negotiations over which patents to litigate immediately but did not come to agreement. Boehringer chose to cap the number of patents each party could list for immediate litigation at 5. The parties exchanged lists of 5 patents each. This led to selection of 8 patents for immediate litigation, as two patents appeared on both parties’ lists.
AbbVie will, of course, be able to litigate the rest of its patents at a later date. Before Boehringer can begin selling its proposed biosimilar, the BPCIA requires it to provide a notice of commercial marketing. After it provides this notice, AbbVie is no longer limited to asserting the 8 patents selected through the BPCIA’s procedures. As AbbVie put it, “[w]hile Boehringer can delay justice, it cannot prevent it.” Boehringer, however, controls when this second wave of patent litigation begins by determining when to provide its notice.
The AbbVie-Boehringer litigation provides a good example of the benefits of complying with the BPCIA’s procedures as discussed in the Supreme Court’s recent Amgen v. Sandoz decision. A biosimilar maker that provides the innovator with information about its product and follows the other steps required by the BPCIA has substantial control over the timing and scope of litigation. A biosimilar maker that disregards the procedures of the BPCIA loses that control.