After US court ruling, Merus reaffirms freedom to operate for its MeMo® transgenic mouse for therapeutic human antibodies

January 06, 2015

- Regeneron’s ‘018 patent’ is considered invalid and Merus not infringing -

Utrecht, The Netherlands, January 5, 2015 - Merus B.V., a leader in developing best-in-class antibody therapeutics to treat cancer patients, today announced a series of pivotal events in its litigation with Regeneron Pharmaceuticals Inc. Previously, Regeneron sued Merus accusing it of infringing U.S. Patent No. 8,502,018 (‘018 patent’) directed to a particular method of making a genetically modified mouse, which Regeneron asserted was useful to produce therapeutic antibodies.

Merus argued that Regeneron had interpreted its patent in an overbroad manner, and that the patent claims were indefinite and invalid. On November 21, 2014, in a fifty-nine page decision, the United States District Court for the Southern District of New York agreed with Merus on virtually every issue, stating: “[t]his Court generally agrees with the constructions Merus proposes, limiting the Patent to a far narrower scope than asserted by Regeneron.” The court also ruled that Merus has demonstrated “clear and convincing evidence that [a key claim term] lacks reasonable certainty and is therefore indefinite.” On December 19, 2014, Regeneron filed papers with the court conceding that under these rulings, Merus does not infringe any asserted claim of the ‘018 patent, and that these claims are invalid. With this ruling and Regeneron’ s concessions, there are no outstanding claims against Merus. The only remaining issues include Merus’ claim against Regeneron that it unlawfully procured its patent from the U.S. Patent Office and Merus’ request that Regeneron pay the legal fees incurred by Merus.

“We are very pleased with the court’s multiple rulings in our favor,” said Ton Logtenberg, CEO of Merus. “This recent decision strongly supports Merus’ position throughout this litigation that the Regeneron patent is invalid and not infringed by Merus. Our company remains uniquely positioned to produce best-in-class bispecific antibody therapeutics for application in oncology and other disease areas with unmet medical needs.”

About Merus B.V.
Merus is a fully-integrated biotechnology company developing cancer therapeutics that combine the benefits of monoclonal antibodies with the ability of simultaneously addressing multiple targets. Merus has two lead programs in development, MCLA-128 for the treatment of solid tumors and MCLA-117 for the treatment of hematological malignancies. The company is also developing a broad pipeline of preclinical programs that are available for partnering. Merus’ technologies encompass the proprietary MeMo® transgenic mouse for common light-chain human antibodies and the CH3 heterodimerization technology for the production of full-length IgG Biclonics™. These Biclonics™ are robustly produced from a single clonal manufacturing cell line, using industry-standard systems. Merus’ Biclonics™ bind to multiple disease-associated targets, thereby eliminating tumor cells more efficiently and preventing treatment escape. In Merus´ Biclonics™-ENGAGE approach applied in the MCLA-117 program, bispecific antibodies are used to induce the cytotoxic activity of T cells to kill cancer cells. All of Merus’ technologies are available for licensing.

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