Big Pharma Fights Over Patented Mouse

WHITE PLAINS, N.Y. (CN) - Four of the world's largest drug companies violated patent by bankrolling an effort to produce genetically modified mice for medical research, Regeneron Pharmaceuticals claims in Federal Court.

Regeneron, founded in New York in 1988 by two university professors, has grown to a global biopharmaceutical research firm with 2,500 employees.

The company develops, manufactures and commercializes medicines for treatment of serious medical conditions, including Neovascular (Wet) Age-Related Macular Degeneration, one of the leading causes of blindness in the world; Cryoprin-Associated Periodic Syndrome (CAPS), a rare and debilitating hereditary condition; and Colorectal Cancer.

The cornerstone of this work is the antibody, a molecule produced by the immune system which attacks foreign organisms that attack the body, such as viruses and bacteria. As critical as they are, both to medical research and human health, they are also stubbornly difficult to create in the lab.

"To address these problems, Regeneron scientists launched a scientific research program to design a rodent that could create an extraordinary diversity of human antibodies in a rapid and efficient manner," Regeneron says in the 37-page lawsuit. "This type of rodent is known as a 'genetically modified' animal.

"Earlier generations of genetically modified animals used to produce antibodies suffered from serious health and functionality issues. Regeneron's work led to the creation of the VelocImmune mouse. The VelocImmune mouse makes part-human and part-mouse antibodies, which allows the VelocImmune mouse to mount a healthy, functional and diverse immune response to produce antibodies that can be used in making human therapeutics. This work led to the grant of an important family of patents throughout the world.

"Following on the demonstrated success of the VelocImmune technology, the biopharmaceutical community recognized the power of Regeneron's inventions to create new genetically modified mice useful in making antibody therapeutics."

Regeneron claims that in response to this realization, "A group of venture capitalists, in concert with four of the largest pharmaceutical companies in the world (Pfizer and three other companies who have concealed their involvement), funded Ablexis - an entity whose sole apparent purpose is to create and use a genetically modified mouse that copies Regeneron's intellectual property."

Ablexis LLC is the only defendant.

Regeneron claims that Ablexis made no secret of its piggybacking on Regeneron's research. In fact, its CEO Larry L. Green published articles acknowledging the importance of Regeneron's work.

"Unfortunately, Ablexis's appreciation of the novelty and importance of Regeneron's work did not extend to respecting Regeneron's intellectual property," the complaint states. "When Regeneron put Ablexis on notice of the patent family that includes the '018 patent, Ablexis claimed that it did not use Regeneron's technology to make Ablexis's mice. Regeneron is informed and believes, and on this basis alleges, that Ablexis's representation was false. Ablexis's business is built on a willful infringement on Regeneron's intellectual property."

Regeneron seeks an injunction and treble damages for patent infringement.

It is represented by Marshall Camp, with Irell & Manella, of Los Angeles.

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