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AbbVie Says Humira's Many Patents is No Antitrust Violation

AbbVie and several other drugmakers have asked an Illinois federal court to dismiss a sweeping proposed class action accusing the company of illegally shielding its immunosuppressant Humira from competition with a "patent thicket," saying there is no limit to how many patents a company can hold.

The complaint accuses AbbVie Inc. of violating antitrust laws by amassing more than 100 patents to keep biosimilar versions of Humira off the U.S. market until 2023. It also names seven other biosimilar makers as defendants and accuses them of agreeing to carve up markets with AbbVie to allow biosimilar sales in Europe but delay those sales in the U.S.

AbbVie argued Friday, however, that the antitrust accusations should be tossed because there is no law limiting the number of patents a company can hold. U.S. Supreme Court precedent has held that no number of patents is illegal, and if a court ever did decide on a limit, it would be engaging "in arbitrary and unworkable line-drawing," AbbVie said.

Humira, which has become the world's top-selling drug, was first approved in 2002 and is now cleared for numerous conditions, including rheumatoid arthritis, plaque psoriasis and ulcerative colitis. Its main patent expired in 2016, but AbbVie's many additional patents have kept biosimilar versions of Humira out of American pharmacies.

In March, the largest grocery union in New York hit AbbVie with a proposed class action, accusing it of using its "patent thicket" to block less-expensive biosimilars and raising prices for indirect purchasers. That suit also accuses Amgen Inc., Mylan Inc., Sandoz Inc., Samsung Bioepis Co. Ltd., Fresenius Kabi USA LLC and Momenta Pharmaceuticals Inc. of conspiring with AbbVie to delay biosimilar sales in the U.S while allowing them in Europe.

Several other suits were subsequently filed by indirect purchasers against AbbVie, and in June U.S. District Judge Manish Shah consolidated the proposed class actions.

The indirect purchasers filed an amended complaint in August which also accuses AbbVie of unlawfully granting "de facto exclusivity" to Amgen by authorizing it to launch the first Humira copycat.

In the August suit, the purchasers said they seek to represent class of consumers who indirectly purchased Humira from Dec. 31, 2016, through the present.

AbbVie also argued Friday that it is not illegal for the company to grant biosimilar makers early access to European markets as a way to settle a patent infringement dispute.

The company said as a means to accuse AbbVie of attempting to block competition, the purchasers conflate the settlements — in which the biosimilar makers pay AbbVie a royalty — with a reverse payment, or a pay-for-delay agreement. 

"The Supreme Court has been clear that early-entry-only settlements, as here, stand 'in contrast' to settlements that provide for a 'reverse payment' (a payment flowing from the patent holder to the licensee), and only the latter are subject to antitrust scrutiny," AbbVie said.

Additionally, the pharmaceutical company shot down accusations that it cut a deal allowing Amgen to launch the first Humira copycat in the U.S., saying the allegation is simply "false."

Fresenius Kabi was voluntarily dismissed as a defendant last week.

Samsung Bioepis and Sandoz also filed separate motions to dismiss Friday.

Representatives for the parties did not immediately respond to requests for comment.

The purchasers are represented by Labaton Sucharow LLP, Girard Sharp LLP, Hagens Berman Sobol Shapiro LLP, the Dugan Law Firm LLC, Grant & Eisenhoffer PA, Fine Kaplan and Black RPC, Robbins Geller Rudman & Dowd LLP, Seeger Weiss LLP, Cohen Milstein Sellers & Toll PLLC, Shepherd Finkelman, Miller & Shah LLP, Wexler Wallace LLP, Lite Depalma Greenber LLC, Lockridge Grindal Nauen PLLP, Heins Mills & Olson PLC, Hach Rose Schirripa & Cheverie LLP, Bransetter Stranch & Jennings PLLC, Myers & Flowers, Freed Kanner London & Millen LLC, Scharf Banks Marmor LLC, Freedman Boyd Hollander Goldberg Urias & Ward PA and Kessler Topaz Meltzer & Check LLP.

AbbVie is represented by James Hurst PC and Diana Watral and Damon Andrews of Kirkland & Ellis LLP.

Amgen is represented by Bruce Braun, David Giardina and Steven Horowitz of Sidley Austin LLP.

Samsung Bioepis is represented by Thomas Quinn, Ronald Safer and Sondra Hemeryck of Riley Safer Holmes & Cancila LLP and Ian Simmons, Benjamin Bradshaw and Stephen McIntyre of O'Melveny & Myers LLP.

Sandoz is represented by Stephen Weissman, Michael Perry, William Lavery, Christopher Wilson and Elisa Beneze of Baker Botts LLP.

The case is In re: Humira (Adalimumab) Antitrust Litigation, case number 1:19-cv-01873, in the U.S. District Court for the Northern District of Illinois.