AbbVie Sues Amgen Over Biosimilar to HUMIRA®

By Lynn C. Tyler

On August 4, AbbVie Inc. and AbbVie Biotechnology Ltd. filed a Complaint for patent infringement against Amgen Inc. and Amgen Manufacturing Ltd. based on Amgen’s submission to the FDA of an application for approval of a biosimilar to AbbVie’s HUMIRA® biologic (adalimumab).

According to the Complaint, AbbVie owns over 100 patents related to HUMIRA®. Amgen filed its application for approval of ABP 501, its proposed biosimilar of HUMIRA®. The parties then engaged in the “patent dance” prescribed by the Biologics Price Competition and Innovation Act (“BPCIA”), although AbbVie accuses Amgen of not following all the steps as prescribed. AbbVie alleges that eventually it identified 61 patents infringed by ABP 501 or its method of manufacture. AbbVie further alleged that the outcome of the patent dance identified ten patents for litigation. AbbVie stated that it was reserving its right to assert the remaining 51 patents after Amgen served a notice of commercial marketing or in other appropriate circumstances. The ten patents asserted by AbbVie are U.S Patent Nos. 8,663,945, 8,911,964, 8,916,157, 8,961,973, 8,986,693, 9,096,666, 9,220,781, 9,272,041, 9,359,434, and 9,365,645.

According to published reports, HUMIRA® generated $14 billion in revenue for AbbVie, leading one to believe this litigation will be hotly-contested and take years to resolve. Eventually, it may resolve some of the many ambiguities in the patent dance provisions of the BPCIA. The steps involved in the patent dance include the generation of two sets of lists, a “Paragraph 3” list (named for its place in the statute) identifying all patents that either party thought “could reasonably be asserted,” and a “Paragraph 5” list identifying the patents that the parties thought should be involved in litigation.

In this case, the Paragraph 3 list (61 patents) is longer than the Paragraph 5 list (10 patents). Can AbbVie bring suit on patents that were included on the Paragraph 3 lists, but not the Paragraph 5 lists? The statute does not say that the sponsor cannot include such patents, only that the sponsor must include the patents on the agreed list or the patents on both parties’ lists if the parties did not agree. AbbVie appears to believe it cannot assert the other 51 patents at this time.

Further, section 271(e)(2) of the Patent Act was amended by the BPCIA to provide that an applicant infringes each patent on a Paragraph 3 list by filing an application for approval of the product (and recall that the lists are not generated until after the application has been filed). If the Paragraph 5 lists are exclusive, Congress would have eliminated key property rights of sponsors in some cases. These considerations make it appear that the statute does not limit patent infringement suits to patents on a Paragraph 5 list.

On the other hand, the provisions governing the creation of the Paragraph 5 lists would arguably be meaningless if they did not limit the potential patents-in-suit. What is the point of allowing the applicant to limit the number of patents on the Paragraph 5 lists if the sponsor can sue on any and all patents it chooses? One principle of statutory construction is that statutes are to be construed as a whole, giving meaning to all the provisions. This consideration suggests that the statute does limit litigation to patents on one of the Paragraph 5 lists, at least initially.

Another section of the statute addresses preliminary injunctions and creates further issues. This section provides that the applicant must give the sponsor 180 days advance notice of its intention to begin commercial marketing of the biosimilar. Between its receipt of the notice and the expiration of the 180 days, the sponsor can seek a preliminary injunction against sales of the applicant’s biosimilar based on any patent that (1) was included on a Paragraph 3 list but (2) was not included on a Paragraph 5 list (or, under another section of the statute, based on a patent that issued or was licensed after the sponsor created its Paragraph 3 list).

The preliminary injunction section raises the exclusivity issue again. On what patents can the patentee seek a preliminary injunction? If there is pending litigation involving the Paragraph 5 list patents (as here), can a patentee seek a preliminary injunction based on one or more of those? The statute does not expressly say that the sponsor cannot. If the answer is that the patentee can seek a preliminary injunction based on such patents, however, what is the point of the provision limiting the requests for preliminary injunctions to patents on Paragraph 3 lists but not the later lists? AbbVie asserts it can seek a preliminary injunction on the Paragraph 3 patents once Amgen serves a notice of commercial marketing.

Other than providing that the notice of commercial marketing must be given 180 days before the first sale of the biosimilar, the BPCIA does not specify any procedures for a preliminary injunction. The court and parties will face a variety of challenges if AbbVie seeks a preliminary injunction on 51 patents, or even a fraction of that number, in a 180-day period.
Nothing herein should be construed as legal advice or legal representation.