AbbVie, bracing for biosim impact, scores another win against Humira antitrust allegations

For years, AbbVie has faced criticism—and antitrust allegations—over its enforcement of a so-called “patent thicket” on the world's best-selling drug Humira. But the company's defense has once again held up in court.

Even though Humira's original patent expired in 2016, AbbVie secured and enforced more than 100 additional patents, adding many years of market exclusivity for the immunology blockbuster, court filings show. Now, as biosims near the U.S. market thanks to patent settlements between AbbVie and other companies, an appeals court has concluded that the pharma giant's conduct was legal.

After officials in Baltimore and elsewhere filed an antitrust lawsuit against AbbVie back in 2019, a U.S. federal judge in Illinois ruled in favor of the company the following year. Now, the United States Court of Appeals For the Seventh Circuit affirmed (PDF) that decision. 

In their case, the Baltimore officials took aim at AbbVie's sheer number of patents and said rivals would need to navigate a "thicket" to reach the market, hindering competition. The plaintiffs said that AbbVie's aggressive defense of its blockbuster drug led to higher prices.

The argument that the patents are weak didn't hold up, the appeals court said, concluding that “weak patents are valid." Further, the court ruled that in both the U.S. and Europe, AbbVie “surrendered its monopoly” before all of its patents expired, and that the rivals weren’t paid for delay.

This marks another win for AbbVie in its Humira defense. Earlier in the case, U.S. District Judge Manish Shah ruled that the company’s strategy was legal.

Still, by next year, Humira will be challenged with nine biosimilars by makers including Amgen, Samsung, Boehringer Ingelheim, Novartis and Pfizer. Amgen’s Amjevita will be up first with a January launch, while Boehringer Ingelheim touts an established “interchangeable” competitor that will launch in July.

Humira generated $20.7 billion worldwide last year despite tough biosim competition already on the market in Europe.

AbbVie’s CEO Rick Gonzalez said in February that he expects the company's earnings per share to decline in 2023, despite sales for new drugs Skyrizi and Rinvoq being on the upswing.