SKIPPING THE PATENT DANCE: SCOTUS MAKES IT MORE DIFFICULT FOR PATENT OWNERS TO DELAY MARKETING OF BIOSIMILARS

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent disputes that might affect the marketing of generic versions of biological drugs (so-called “biosimilars” that are made by living organisms rather than by conventional chemical synthesis) and in doing so interpreted the statute in a way that appears to assist the producers of such generic products.

Two issues were before the court:
1) whether failure to follow the scheme referred to as “the patent dance” which was intended to secure early resolution of passible patent issues relating to a biosimilar could be the subject of an injunction; and
2) the point in time when the proposed marketer of a biosimilar had to advise the originator of the product of its intention to market the biosimilar.

See our full article in the Education Center.