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LimeGreenIP News

A changing competitive landscape: the role of the ITC in the biosimilars space

As biosimilar competition from companies outside the United States continues, innovator companies are increasingly likely to turn to the International Trade Commission as a first line of defense for protecting critical IP.

Competition for innovator biologics companies has traditionally been relatively low, but since the FDA’s first biosimilar approval in 2015, the U.S. marketplace is seeing a surge of new biosimilar offerings from foreign competitors and a recent surge of biosimilar patent litigation in the U.S. District Courts. IP Partenrs Tony Pezzano and Michael Dougherty say;

when it comes to competing against these new products, innovator companies should know they have an important line of defense in initiating a Section 337 investigation within the International Trade Commission (ITC).”

Read more here and watch the related video-log here