The District Court for the Southern District of Florida today ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). The court, having found in favor of Apotex on the infringement issue, did not reach Apotex’s counterclaim that the…
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.
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…
As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written description, indefiniteness and obviousness. The Court did not address lack of enablement, however, nor did…
As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it receives FDA licensure, gives Amgen a post-licensure notice of commercial marketing, and then waits for 180 days to…
Tuesday’s Federal Circuit opinion in Amgen v. Apotex is already being picked up and analyzed in other BPCIA litigation: in Amgen v. Hospira, Hospira has submitted the Federal Circuit’s opinion to the District Court for the District of Delaware (J. Andrews) in connection with its pending motion to dismiss Amgen’s…
As we posted yesterday, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it has received FDA licensure, given Amgen a post-licensure notice of commercial marketing, and then…
The Federal Circuit issued its decision in Amgen v. Apotex (re: Apotex’s Neulasta biosimilar) this morning. The Court affirmed the district court, holding that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A) is mandatory and enforceable by injunction, even where the biosimilar applicant has triggered the patent dance by providing its…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). Last week, we also reported that in Janssen v. Celltrion, Janssen filed a letter to the court stating that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…
Attorneys for Amgen and Apotex appeared before the Federal Circuit yesterday to argue about whether the notice of commercial marketing provision, 42 U.S.C. § 262(l)(8)(A), is optional when a biosimilar applicant has provided its application and information to the reference product sponsor (RPS) under paragraph (l)(2)(A). The notice of commercial marketing triggers a…