Patent-Thickets in the News

Recently the practice of establishing so called patent-thickets for biologic products has been questioned as a potentially abusive way of preventing biosimilar competition.  In June 2020, the Honorable Judge Manish S. Shah in the United States District Court for the Northern District of Illinois Eastern Division issued a Memorandum Opinion and Order dismissing a class action lawsuit against AbbVie.  The Memorandum Opinion and Order dismissed claims against AbbVie for allegedly violating federal and state antitrust laws and consumer protection laws regarding AbbVie’s “patent thicket” covering the world’s best-selling pharmaceutical product, Humira^® (adalimumab).

Humira^® (adalimumab), an anti-inflammatory biologic product, is the world’s top selling prescription product.  Humira^® has generated over $130 billion in total sales since its launch in 2003.  In 2019 alone, the global and U.S. sales of Humira^® were approximately $19.1 billion and $14.9 billion, respectively.  AbbVie has obtained well over 100 patents covering Humira^® which has been commonly referred to as a “patent thicket.”  As of May 2019, AbbVie had entered into settlements with eight pharmaceutical companies over Humira^® biosimilars.  Humira^® biosimilar competitors in the U.S. are expected to launch in 2023.

In a 2019 class action lawsuit, AbbVie was accused of violating federal antitrust laws, state antitrust laws, and consumer protection laws regarding Humira^®.  The Plaintiffs, who were indirect purchasers of Humira^®, alleged that AbbVie cornered the market for Humira^® through allegedly anticompetitive conduct.

According to Judge Shah’s Order, the Plaintiffs alleged that AbbVie obtained and asserted patents to gain power in order to elbow its competitors out of and maintain its position in the U.S. Humira^® market.  Plaintiffs further alleged that AbbVie repeatedly and aggressively asserted “swaths of invalid, unenforceable, or non-infringed patents without regard to the patents’ merits.”

Judge Shah’s Order states the alleged anticompetitive conduct described by Plaintiffs was not an antitrust violation. “AbbVie has exploited advantages conferred on it through lawful practices and to the extent this has kept prices high for Humira^® [adalimumab], existing antitrust doctrine does not prohibit it.”

AbbVie claimed there was nothing illegal about amassing a broad portfolio of legitimate patents, even if a few were issued erroneously.  Furthermore, the Order stated that the legal and regulatory backdrop for patented biologic drugs, together with a well-resourced litigation strategy, gave AbbVie the ability to maintain control over Humira^®.

“The allegations-even when considered broadly and together for their potential to restrain trade –fall short of alleging the kind of competitive harm remedied by antitrust law.”

AbbVie anticipates biosimilar competition for Humira^® in the U.S. starting in 2023.  AbbVie continues to pursue strategies to differentiate Humira^® from competing products and add to Humira^®’s sustainability.

Sources:

1. AbbVie Inc. Form 10-K for the fiscal year ended December 31, 2019
2. Memorandum Opinion and Order, In Re: Humira (Adalimumab) Antitrust Litigation, No. 19 CV 1873, Judge Manish S. Shah, dated June 8, 2020
3. Class Action Complaint, UFCW Local 1500 Welfare Fund, on behalf of itself and all others similarly situated v. AbbVie Inc., AbbVie Biotechnology Ltd., Amgen Inc., Samsung Bioepis Co., Ltd., Mylan Inc., Mylan Pharmaceuticals, Inc., Sandoz, Inc., Fresenius Kabi USA, LLC, Pfizer Inc., and Momenta Pharmaceuticals, Inc. Civil Action No. 1:19-cv-01873, dated March 18, 2019