Antitrust Class Action Lawsuits Emerge Against Big Pharma Companies Over Alleged Patent Misuse

Lawsuits against major pharmaceutical companies alleging the use of inaccurate patent listings to deter competitors from creating generic alternatives to prescription drugs continue to mount.

The lawsuits were filed by Silver Golub & Teitell, Faruqi & Faruqi, Garwin Gerstein & Fisher, Berger Montague, Odom & Des Roches, Smith Segura Raphael & Leger and Heim Payne & Chorush.

Both class actions brought claims under Section 4 of the Clayton Act, 15 USC §§15(a), for injuries due to alleged violations of Section 2 of the Sherman Act, 15 USC § 2, against Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals. USA Inc., Teva Branded Pharmaceutical Products R&D Inc., Norton (Waterford) Ltd. and Amneal Pharmaceuticals Inc.

The named plaintiff in one of the actions is RDC Liquidating Trust, the representative of Rochester Drug Co-Operative Inc., which was created during the company's bankruptcy proceedings.

The second class action lawsuit was filed by Value Drug Co., a wholesaler that works with independent pharmacies.

Many of the allegations in these cases resemble those flagged by the Federal Trade Commission when it sent warning letters to 10 companies, including Teva, on April 30, challenging more than 300 of the company's Orange Book patent listings. United States Food and Drug Administration.

The FTC said it encouraged competition because the challenged patents delayed the market entry of cheaper generic drugs.

One of the letters was also sent to Boehringer Ingelheim Pharmaceuticals Inc., which also faces an antitrust class-action lawsuit for allegedly using expired patents for its two inhalers, Combivent Respimat and Spiriva Respima, to control market prices.

The lawsuits claimed that Teva's patent for QVAR, “its successful line of branded asthma inhalers,” was set to expire in July 2015. However, before the patent expired, Teva allegedly submitted inappropriate patent listings. , which would have allowed it to file patent litigation against generic drugs. competitors, automatically blocking their entry into the market for 30 months.

Additionally, Teva allegedly made an “unrequired modification” to the inhaler mechanism, an anti-competitive strategy called “product hopping,” the complaint states.

“In doing so, Teva stifled QVAR's potential generic competitors because drug laws do not permit generic substitution of a given drug-device combination unless the generic is approved for that drug-device combination. specific device,” the complaint states. “As a result, generic equivalents of QVAR could not replace QVAR Redihaler. They also could not replace QVAR because Teva had removed it from the market.”

Teva also allegedly “entered into a reverse payment agreement – ​​that is, an agreement whereby the generic competitor refrains from launching its product – to hinder all competition,” the complaint states. This resulted in further competitive delay because, under FDA law, the first generic applicant benefits exclusively from six months of marketing, the complaint states.

“By reaching an agreement with First Plaintiff not to launch, Teva could delay any competition,” the complaint states.

Teva media contact Kelley Dougherty declined to comment. The defendants' lawyers have not yet appeared.

The plaintiffs' attorney did not respond to a request for comment.

The named plaintiffs and other proposed class members seek to recover alleged overcharging on asthma inhalers.

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