As is common with a blockbuster drug, AbbVie's Humira faced an antitrust challenge from third-party payers. The third-party payers filed an antitrust action claiming AbbVie's patent strategy stifled competition by forcing prospective competitors to settle on terms allowing Humira to enjoy a monopoly long after patent protection should have ended. The complaint alleges that AbbVie cornered the market for Humira and its biosimilars by obtaining a thicket of patents which allowed it to gain the market power it needed to prevent competitors from entering the U.S. market (violation of Sherman Act section 2). It used this market power to enter into settlement agreements with potential competitors to keep their products out of the U.S. market in return for early launch dates in Europe, also an important market which they termed a pay-for delay and market division (violation of Sherman Act section 1). Judge Shah, of the Northern District of Illinois, dismissed the complaint without prejudice on June 8, 2020. The opinion begins with a discussion of three reasons Humira might hold its commanding position foreshadowing his decision. First, the more than one hundred Humira-related patents made it difficult if not impossible to seek a non-infringing competing product.  Second, the FDA lengthy approval process imposes further costs on would-be competitive products. And, third, the “expansive, complicated, and expensive patent infringement litigation that often follows on the heels of FDA approval.” Page 1 of slip opinion.

Humira began the creation of its patent thicket with the purchase of U.S.P. 6,090,382 from BASF in 2000 to prepare for its 2002 Humira launch. The patent expired December 31, 2016.  A patent program began in 2002 when AbbVie filed the first of 20 patent families to protect its market. Fifteen of the families relate to formulation and process patents.  Twelve patent families were filed after 2006 comprising almost 60 patents. Humira filed 247 patent applications in the USPTO and had obtained 132 patents with over 90% granted after 2014, twelve years after Humira was approved. The complaint alleges for its Sherman antitrust claim the novel theory that by obtaining the patents and asserting “swaths of invalid, unenforceable, or noninfringed patents without regard for the patents' merits” AbbVie had monopolized the Humira market.  There was no claim the patents were obtained by knowing and willful fraud, nor did they allege it was unlawful to obtain a large patent portfolio.  Nor did they allege that AbbVie's activities in petitioning for patents was objectively baseless.  Petitioning the government through filing patent applications is protected by the Noerr – Pennington doctrine, See E. R. R. Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S.  127 (1961); United Mine Workers of Am. v. Pennington, 381 U.S. 657 (1965).  However, this doctrine does not protect such activities if the petitioning is a sham meant to inhibit competition. It was necessary to demonstrate that AbbVie's petitions—its patent applications, patent dance exchanges, and the lawsuits that followed—were objectively baseless. U.S. Futures Exch., L.L.C. v. Bd. of Trade of the City of Chicago, Inc., 953 F.3d 955, 958 (7th Cir. 2020), reh'g and reh'g en banc denied (Apr. 23, 2020).

The court looked to AbbVie's success with its petitions to determine if they were objectively baseless. As to filing patent applications, AbbVie succeeded in more than half (53.4%) of its patent applications in obtaining a patent. This was more than enough to show that filing patent applications was not objectively baseless. The court noted that other courts had found a 41% success rate was indicative that the petitions were not objectively baseless.  In the PTAB, the court noted that while AbbVie lost three and terminated two IPRs, it succeeded in 13 in having the PTAB find no reasonable likelihood of success. The court considered that AbbVie's high success rate rendered implausible that AbbVie's submissions in the proceedings were objectively baseless.

The court did not consider AbbVie's assertions of infringement in the patent dance to be protected under Noerr-Pennington. The court did note that the patent dance was initiated by the biosimilar applicants and not by AbbVie. As to the resulting litigation, the court noted that under the statutory scheme AbbVie had only 30 days to sue. AbbVie settled litigation with both Amgen and Sandoz by granting both companies and others that followed the right to enter the U.S. market in 2023, 3 years before the asserted patents expired. The settlements also provided for a biosimilar launch in Europe in October 2018, 8 years before the patents expired.

The section 1 claim was based on AbbVie's granting Amgen, Samsung, Bioepis, and Sandoz the right to an early launch in Europe. The plaintiffs asserted this was a form of pay-for-delay and a market allocation. As for market allocation, AbbVie did not agree to withdraw from the European market. The court also distinguished over cases finding market allocation because the patents came with the right to selectively license the patents. The court noted that none of the biosimilar companies received any payment for the delayed start to marketing.  The agreement allowed for an entry into the U.S. market 3 years ahead of the 2026 patent expiration of the patents relevant to Amgen et al. In the court's view, the settlement had a pro-competitive effect.

The takeaway for pharma is that simply having a large patent portfolio is not enough to trigger anti-trust liability. Further, that an aggressive patent program after a drug's launch also does not trigger anti-trust liability absent some other impermissible action like filing a baseless litigation. Since often after a drug's approval both valid and important inventions may be made such as developing an administration protocol which allow for the dosing of antipsychotic while avoiding QT prolongation. Other inventions which improve a drug's safety or activity may be discovered only after extensive experience with the drug in the marketplace. Patenting these inventions will not by themselves trigger anti-trust liability but may afford a long period of patent exclusivity.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.