Federal Court Rejects Antitrust Challenge To AbbVie's Humira "Patent Thicket"

• Published date: 01 July 2020
• Law Firm: Arnold & Porter
• Author: Mr C. Scott Lent, Matthew Tabas and Javier Ortega

On June 8, 2020, an Illinois Federal District Court Judge dismissed without prejudice a Complaint by indirect purchasers of the autoimmune disorder biologic product, Humira. Plaintiffs alleged that AbbVie Inc. and its subsidiary, AbbVie Biotechnology, Ltd. (collectively, AbbVie), violated Sections 1 and 2 of the Sherman Act and state laws by engaging in allegedly anticompetitive conduct to protect AbbVie's share of the "market for Humira" in the United States. In particular, the Complaint asserted that AbbVie unlawfully obtained and asserted patents against potential biosimilar competitors, and then entered into settlements with those potential competitors (also named as Defendants in the lawsuit) as part of a market allocation scheme.

The court's decision is notable in that it roundly rejects allegations that AbbVie's lawful enforcement of patent rights violated the antitrust laws, and confirms there is no "one size fits all" requirement for settling patent litigations in different jurisdictions.

The Complaint

In March 2019, the initial Indirect Purchaser Plaintiffs' (IPPs) class action complaint against AbbVie related to Humira was filed by a New York grocery union. That action was joined later by other indirect purchasers of Humira in a consolidated action, In re Humira (Adalimumab) Antitrust Litigation, in the Northern District of Illinois.¹

Filed in August 2019, the consolidated IPP amended Complaint alleged that in the years leading up to the expiration of Humira's main patent in 2016, AbbVie sought intellectual property protection to create "a thicket of intellectual property protection so dense that it prevented would-be challengers from entering the market with cheaper biosimilar alternatives."² IPPs alleged that AbbVie filed a total of 247 patent applications covering the uses of Humira, as well as manufacturing processes, ingredients, and alternative formulations. AbbVie ultimately obtained 132 patents'more than 90% of which were issued two years before expiration of Humira's main patent.

According to the Complaint, AbbVie then allegedly leveraged that "patent thicket" during negotiations with other Defendants'potential Humira competitors'to force them to agree to delay biosimilar entry in the United States in return for licensing agreements to permit those competitors to launch in Europe sooner.

While AbbVie secured patent protection for Humira, the other Defendants filed applications with the Food & Drug Administration (FDA) for approval of their biosimilar products. Amgen filed the first application for a biosimilar in November 2015. AbbVie then filed a patent infringement suit against Amgen, which settled in the fall of 2017. AbbVie sued and settled actions against other manufacturers seeking to market Humira biosimilars, including Defendants Samsung Bioepsis, Sandoz, and Fresenius Kabi USA. According to IPPs, the settlement agreements required those manufacturers to delay product launch of their Humira biosimilars in the United States until at least 2023, and in Europe until the second half of 2018.

IPPs asserted that the assertion of AbbVie's so-called "patent thicket" constituted monopolization in violation of Section 2 of the Sherman Act as well as state laws. In addition, IPPs alleged that AbbVie's agreements with Amgen, Samsung Bioepis, Sandoz, and Fresenius Kabi USA were market allocation and so-called "pay-for-delay" schemes in violation of Section 1 of the Sherman Act as well as state laws.

The Decision

On June 8, 2020, Judge Manish S. Shah of the US District Court for...