Antitrust Class Action Lawsuits Emerging Against Big Pharma Over Alleged Patent Abuse

The number of lawsuits against large pharmaceutical companies alleging the use of incorrect patent listings to discourage competitors from developing generic alternatives to prescription drugs continues to grow.

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 caused by 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 lawsuits is RDC Liquidating Trust, an agent of Rochester Drug Co-Operative Inc., which was established during the company’s bankruptcy proceedings.

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

Many of the allegations in these cases are similar to those made by the Federal Trade Commission, which on April 30 sent warning letters to 10 companies, including Teva, questioning more than 300 U.S. Food and Drug Administration patent entries in the Orange Book.

The FTC said it promoted competition because the patents at issue delayed the entry of cheaper generic drugs into the market.

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

The lawsuit alleged that Teva’s patent on QVAR, “its blockbuster line of branded asthma inhalers,” was set to expire in July 2015. However, before the patent expired, Teva allegedly filed incorrect patent listings, which allowed it to initiate patent proceedings against generic competitors, automatically blocking them to enter the market for 30 months.

Additionally, Teva allegedly made “unnecessary changes” to the mechanics of the inhaler, an anticompetitive strategy called “product jumping,” the complaint said.

“Thus, Teva has stifled QVAR’s potential generic competitors because drug regulations do not allow for a given drug-device combination to be substituted by a generic unless the generic drug is approved for that particular drug-device combination,” the complaint said. “As a result, generic equivalents of QVAR could not replace QVAR Redihaler. They also cannot replace QVAR because Teva has withdrawn it from the market.”

Teva allegedly “entered into a reverse payment agreement – i.e., an agreement in which a generic competitor refrains from bringing its product to market – to create a bottleneck for all competition,” the complaint said. This led to a further delay in competition because, under FDA law, the first applicant for a generic drug has six months solely to bring it to market, the complaint said.

“By reaching an agreement with the first complainant not to bring the company to market, Teva may delay all competition,” the complaint said.

Teva’s media contact, Kelley Dougherty, declined to comment. The defendants’ lawyer has not appeared yet.

An attorney for the plaintiffs did not respond to a request for comment.

The named plaintiffs and other proposed class members seek to recover alleged excessive charges for asthma inhalers.

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