Celltrion and Teva Sue Genentech Over Trastuzumab, Rituximab Patents

On January 11, Celltrion and its partner Teva filed 2 new lawsuits against Genentech in a California district court.

The first complaint seeks a declaratory judgment that 38 patents covering reference trastuzumab (Herceptin) are either invalid, unenforceable, or not infringed by the biosimilars developers’ proposed trastuzumab, currently under consideration by the FDA, which Celltrion and Teva plan to market as Herzuma.

Celltrion and Teva’s complaint states that Genentech has relied on “a complex series of patents from [2] dozen patent families” to forestall biosimilar competition, and that Genentech’s “panoply of vague allegations are simply intended to interfere with Celltrion and Teva’s entry into the market.”

The patents in question include those addressing methods of production, protein purification, the cell culture process, dosage, fixed dosing, methods of treatment, and extending time to disease progression, among others.

Similarly, the second suit seeks a declaratory judgement of non-infringement or invalidity of 37 patents covering reference rituximab (Rituxan), including patents that address combination therapies for B-cell lymphomas, methods for growing mammalian cells in vitro, and treatment of hematologic malignancies using anti-CD20 antibodies, among others.

Celltrion’s rituximab product is also under FDA consideration, and the company plans to eventually market the drug under the brand name Truxima. The product is already approved and marketed in the European Union, and its trastuzumab biosimilar is awaiting final authorization from the European Commission before it, too, begins to make its way to European patients.

This new patent litigation clearing the way for eventual US marketing of the 2 biosimilar products comes as Celltrion prepares to ramp up production capabilities with a new 360,000-liter-capacity plant. By comparison, the company currently owns 2 plants that, when running at their full capability, have capacities of 50,000 liters and 90,000 liters each. The new facility will help to “ensure stable supplies as well as leverage on economy of scale to further lower the prices of its biosimilar drugs,” said Celltrion’s CEO, Jung Jin Seo.