Lawsuits Are Flying Over Generic-Drug Disputes

New Jersey’s federal courts are in the midst of a surge in patent litigation, driven by pharmaceutical companies’ claims of infringement against generic-drug producers.

Plaintiffs filed seven patent suits in the District of New Jersey from May 20-26, representing a major escalation when compared with the average rate of one new patent suit per week. And the surge continued in the period from May 26-30, when another three patent suits were filed.

All but one of the 10 cases were brought by holders of drug patents seeking to stop the production of generic versions of their products.

And five of the suits were filed by Esperion Therapeutics, which seeks to stop competitors from selling generic versions of the company’s cholesterol drug Nexletol.

Big Law, Big Pharma

Esperion brought suits against Aurobindo Pharma Ltd., Hetero USA, MSN Pharmaceuticals, Dr. Reddy’s Laboratories and Sandoz.

The suits arise out of the defendants’ abbreviated new drug applications to produce generic versions of Esperion’s Nexletol. Some of the defendants are also seeking to produce another Esperion drug, Nexlizet.

An abbreviated new drug application is an application to the Food and Drug Administration for review of a generic drug product. It allows the application to refer to the safety and effectiveness of an existing drug, which can provide for a streamlined application process.

Pacira Pharmaceuticals filed a suit naming eVenus Pharmaceutical Laboratories, Jiangsu Hengrui Medicine Co. and Fresenius Kabi USA.

The suit concerns the defendants’ efforts to make a generic version of Exparel, an anesthetic, before the expiration of Pacira’s patents.

Amgen filed a suit against Celltrion over its submission to the FDA of a biologic license application to manufacture and sell biosimilar versions of Amgen’s Prolia and XGEVA products for treatment of osteoporosis and bone cancer.

GE Healthcare Ltd. brought a suit against Jubilant DraxImage over its abbreviated new drug application to the FDA to produce and sell a generic version of the plaintiff’s Myoview, a diagnostic agent for cardiac testing.

And Axsome Therapeutics and Antecip Ventures sued Teva Pharmaceuticals over its abbreviated new drug application to sell dextromethorphan hydrobromide and bupropion hydrochloride, which are sold under the trade name Auvelity for treatment of major depressive disorders.


Source Link