On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA® infringes a number of AbbVie patents. The complaint specifically asserts infringement of ten HUMIRA® patents, but indicates that 51 others may be infringed. Did Congress strike the right balance when it gave biosimilar applicants the right to decide how many patents can be litigated in the first round of litigation under the BPCIA?

The Patent Dance

The BPCIA requires a complicated process for determining which patents can be litigated, referred to as the “patent dance.” (Please see this article for an outline of each step of the patent dance.)

According to the Complaint, after AbbVie received a copy of Amgen’s biosimilar application, it provided Amgen with a list of “61 patents and 5 allowed patent applications … from among the more than 100 patents in the HUMIRA ® estate,” and shortly thereafter “updated” that list to include several additional patents. After Amgen provided its statement of non-infringement and/or invalidity of the patents, AbbVie provided its statement of infringement and validity of 61 patents from its original lists.

Because the parties did not agree on which patents to litigate, the procedures of 42 USC § 262 (l)(5) applied. In accordance with § 262 (l)(5)(A), Amgen notified AbbVie that it would be listing six patents on its list of patents to be litigated, which gave AbbVie the right to list up to six patents on its list. Thereafter the parties exchanged their lists of patents, which collectively identified ten patents—the ten patents that AbbVie could and did assert in the first round of patent litigation under the BPCIA:

U.S Patent No. 8,663,945; U.S Patent No. 8,911,964; U.S Patent No. 8,916,157; U.S Patent No. 8,961,973; U.S Patent No. 8,986,693; U.S Patent No. 9,096,666; U.S Patent No. 9,220,781; U.S Patent No. 9,272,041; U.S. Patent No. 9,359,434; and U.S. Patent No. 9,365,645

The Other HUMIRA® Patents

In addition to laying the foundation for its patent infringement claims, AbbVie complains about its inability to assert all of its patents in this case. For example, paragraph 48 of its complaint states:

At this time, and as a result of Amgen’s gamesmanship and delay throughout the exchange and negotiation process, AbbVie is limited to seeking redress on 10 of its 61 infringed patents. But AbbVie will have a second opportunity, if and when Amgen provides a 180-day Notice of Commercial Marketing (or as circumstances otherwise warrant), to assert its remaining patents. So while Amgen’s tactics may create delay, it still must deal with AbbVie’s patents before going to market.

Letting The Biosimilar Applicant Lead The Patent Dance

In the context of Abbreviated New Drug Application (ANDA) litigation, it is the NDA holder (originator) who largely controls the patents that can be litigated, since it is the NDA holder who decides which patents to list in the Orange Book. For each Orange Book-listed patent, the ANDA applicant (generic) must certify that the patent is invalid or not infringed (a “paragraph IV certification”) or certify that its application is not be approved until the patent expires (a “paragraph III certification”). The NDA holder can bring suit on all patents the ANDA applicant included in a paragraph IV certification.

Why did Congress give biosimilar applicants more control over the first round of biosimilar application? (The reference product sponsor can assert other patents after the biosimilar applicant gives its post-approval 180-day pre-marketing notice.)

  • One reason may be that there can be more differences between a biosimilar product and the reference product than between a generic and originator drug product, and biosimilar applicants may have a better understanding of whether their products infringe.
  • Another reason may be that process/manufacturing patents can be litigated under the BPCIA, but cannot be listed in the Orange Book. Again, biosimilar applicants may have a better understanding of whether their processes infringe.
  • A more compelling reason may be the potentially longer and more uncertain approval process for biosimilars. The patent dance starts shortly after the biosimilar application is filed, and it may take years for the application to be approved. During that time, product features and/or process parameters may change and patents may expire. Perhaps Congress wanted biosimilar applicants to be able to decide to focus their resources on obtaining approval and postpone patent issues until the second round of litigation.
  • A less palatable reason may be that Congress wanted to favor biosimilar applicants and make it harder for reference product sponsors to assert all of their patents. Even though additional patents can be asserted after the biosimilar applicant gives its post-approval 180-day pre-marketing notice, it is likely that two rounds of patent litigation will be more expensive than one.

Does The Patent Dance Strike The Right Balance?

Biosimilar patent litigation is too new to assess whether Congress struck the right balance when it gave biosimilar applicants the right to control the number of patents litigated in the first round of biosimilar litigation. Indeed, this case may present the first case where the parties did not agree on the patents to be litigated.