Bioethics Blogs

Update on the Patent Dance Case – Zarxio® Enjoined Pending Appeal

In an earlier post, I discussed a recent district court decision holding that the “patent dance” provisions of the Biologics Price Competition and Innovation Act are not mandatory. Yesterday, there was a new development in this case. The Court of Appeals for the Federal Circuit entered an injunction pending appeal preventing Sandoz “from marketing, selling, offering for sale, or importing into the United States its FDA approved ZARXIO® biosimilar product.” The oral argument in Amgen v. Sandoz on appeal is scheduled to be held on June 3.

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.