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AbbVie Dodges Antitrust Challenge to Its Humira ‘Patent Thicket’

June 8, 2020, 5:22 PM

AbbVie Inc., Amgen Inc., a Samsung subsidiary, and Novartis unit Sandoz Inc. don’t have to face antitrust claims over patent infringement settlements that delayed generic competition for the blockbuster arthritis drug Humira, a Chicago federal judge ruled Monday.

“AbbVie has exploited advantages conferred on it through lawful practices,” Judge Manish S. Shah wrote. “To the extent this has kept prices high for Humira, existing antitrust doctrine does not prohibit it.”

The proposed class action accused AbbVie of shielding its monopoly on Humira—the country’s top-selling prescription drug, with $20 billion a year in global sales—with more than 100 patents, including many that won’t expire until 2034. Humira injections cost about $4,500 a month.

AbbVie’s “patent thicket” deterred generics by ensuring that invalidation of any one—or any 99—wouldn’t open the market, according to the lawsuit, which was consolidated in the U.S. District Court for the Northern District of Illinois on behalf of “indirect purchasers” led by unions.

The other drugmakers targeted in the suit sought to launch Humira “biosimilars,” or generics, before being hit with patent infringement claims. AbbVie allegedly resolved those cases by licensing them to sell their drugs in Europe while keeping the U.S. market clear for its flagship brand.

Those settlements were illegal market allocation agreements and “reverse payment” deals, the suit said.

Such settlements—so called because they involve payments from a plaintiff to a defendant, rather than in the normal direction—were once generally considered legal, but they’ve been subject to antitrust scrutiny since the U.S. Supreme Court’s 2013 ruling in FTC v. Actavis.

Dismissing the case, Shah noted that patent applications are normally covered by the Noerr-Pennington doctrine, which shields companies from antitrust liability for petitioning the government.

Because AbbVie succeeded in obtaining the patents, its applications didn’t qualify for the “sham” exception, even if the suit described “a kernel of objectively baseless petitioning,” the judge found.

He acknowledged the hypothetical risk that “focusing only on each individual action” might obscure “a broader pattern of anti-competitive conduct.”

But “the vast majority of the alleged scheme is immunized from antitrust scrutiny, and what’s left are a few sharp elbows thrown at sophisticated competitors,” Shah wrote.

Nor did the company use its patents in prohibited ways when it leveraged them into settlements, the judge said.

AbbVie continued selling brand-name Humira in Europe, and the launch of generic alternatives actually made the market more competitive, he found.

AbbVie is represented by Kirkland & Ellis LLP. Amgen is represented by Sidley Austin LLP. Samsung is represented by O’Melveny & Myers LLP. Sandoz is represented by Baker Botts LLP and Benesch Friedlander Coplan & Aronoff LLP.

Labaton Sucharow LLP, Girard Sharp LLP, and Hagens Berman Sobol Shapiro LLP are interim co-lead counsel for the plaintiffs.

The case is In re Humira (Adalimumab) Antitrust Litig., N.D. Ill., No. 19-cv-1873, 6/8/20.

To contact the reporter on this story: Mike Leonard in Washington at mleonard@bloomberglaw.com

To contact the editor responsible for this story: Rob Tricchinelli at rtricchinelli@bloomberglaw.com

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