As we frequently report here on the blog, there has been increasing activity in BPCIA litigation concerning a variety of proposed and marketed biosimilar products. The coming year is likely to bring even more activity, with three cases scheduled for trial, several others in discovery or appeal, and new complaints likely. …
With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…
Law360 has published an article by three of our contributing editors here at Big Molecule Watch. As suggested by the title, “The Biosimilars Litigation Landscape for 2017,” the article provides an analysis of the expected BPCIA litigation activity, including potential new litigations, in 2017. Click here for a link to…
As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed a notice that they are appealing the district court’s judgment to the Federal Circuit. Meanwhile, Celltrion’s partner Pfizer announced last week that it will begin shipping…
A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July opinion in the case must now be…
Yesterday, the Supreme Court announced its decision in Halo Electronics, decision in Halo Electronics, Inc. v Pulse Electronics, Inc., in which the Court rejected the Federal Circuit’s Seagate test and established a new framework for imposing enhanced damages for patent infringement. Under the new framework, district courts will have greater…
Apotex has filed its reply brief in Amgen v. Apotex, which is currently on appeal before the Federal Circuit. The brief is available here. As we covered previously, the district court granted Amgen a preliminary injunction to prevent Apotex from marketing its biosimilar pegfilgrastim product until 180 days after Apotex provides a…