The judge in the Humira case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.
Plaintiffs in a novel class-action lawsuit against AbbVie have until the end of June to try again to pursue their claims that the maker of the blockbuster originator adalimumab (Humira) had created a patent thicket of invalid and unenforceable patents as well as conspired in so-called “pay-for-delay” schemes with competitors to delay market entry.
The judge in the case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.
In its motion for the dismissal, filed last fall, AbbVie said that the suit seeks to “upend the well-settled balance between the patent and antitrust laws,” that the complaint would end international early-entry patent settlements that do not have the same global market entry date, and that it would “chill medical and therapeutic innovation.”
In his ruling, US Northern District Court Judge Manish Shah dismissed the consolidated class action suit filed by unions and local governments without prejudice and gave the plaintiffs until June 29 to file a statement as to whether they wish to file an amended complaint or ask that the dismissal convert to a dismissal with prejudice so they can seek appellate review.
AbbVie has more than 100 patents on Humira, which the plaintiffs tried to assert was anticompetitive. In addition, the plaintiffs alleged that the agreements AbbVie reached with Samsung Bioepis, Mylan, Sandoz, Fresnius Kabi, Momenta, Pfizer, Amgen, and Coherus to prevent competition in the United States, while allowing entry in Europe, constituted illegal market allocation based on geography.
The judge wrote that AbbVie may have acted aggressively to protect the Humira patents, but wrote that the suit does not meet the standard for competitive harm that falls under antitrust law.
In his dismissal, the judge said the company is immunized from antitrust liability by the Noerr-Pennington doctrine, which holds that there is immunity for defendants’ efforts to petition the government for relief that allegedly has anticompetitive effects.
Shah would have had to find that the firm’s petitions (patent applications, patent dance exchanges, and resulting lawsuits) are “objectively baseless.” With a success rate of 53.4% of AbbVie’s patent applications resulting in patents, “it compels the conclusion” that they are not objectively baseless, the court wrote. As well, the company had a high rate of success during inter partes review proceedings.
The judge did find that not all of AbbVie’s conduct was protected by Noerr-Pennington during the patent dance, but said that the “plaintiffs’ theory depends on all the components of AbbVie’s conduct as the means to suppress competition.”
He also did not find a basis for the assertion that the “European entry dates are the quid pro quo for the U.S. market entry dates, and for the period that falls between the two, AbbVie effectively allocated to itself the U.S. market while allocating to the other defendants the European market.”
These arrangements were not illegal and did not meet the Supreme Court’s standard to be considered an anticompetitive “reverse payment.” Furthermore, the court found that plaintiffs failed to plead antitrust injury, as the existence of even “one valid and infringed patent” would have precluded biosimilar manufacturers from entering the US market prior to 2023.
In addition, the judge said the plaintiffs were not successful in pleading antitrust injury because they did not allege that all of AbbVie’s asserted patents were invalid or unenforceable.
Some observers think the case is not yet over, calling it an area of unsettled law, but for now, it appears to give an advantage to originator firms looking to defend themselves against aggressive patent portfolios and to settle cases with rivals under the Biologics Price Competition and Innovation Act.
A request for comment from the plaintiffs' attorneys was not immediately returned.