A court battle between two of the nation’s largest biotechs — Regeneron Pharmaceuticals and Amgen — is testing the legal limits of how far drugmakers can go in using patents to thwart competition. And the case is being closely watched by companies that sell biosimilar medicines amid concerns that the U.S. patent system is being gamed in ways that critics say can maintain high prices for medicines.
The saga began early last year when Regeneron filed a lawsuit accusing Amgen of infringing a key patent on its best-selling Eylea injectable drug, which is used to combat such eye diseases as wet age-related macular degeneration, among other ailments. The treatment, with a list price of nearly $1,900 a shot, is at the heart of a multibillion-dollar product line.
At the time, Amgen was one of several companies that hoped to sell a biosimilar version, which is a variant of a brand-name biologic medicine that yields the same health outcomes, generally at a lower price. But Amgen’s approach set it apart from the others — and paved its way to the marketplace earlier than Regeneron had hoped.
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