As part of our continuing coverage, we are following the parties’ briefing in the appeal of the preliminary injuction, which prohibits Apotex’s launch of its pegfilgrastim biosimilars, in Amgen v. Sandoz. As we have previously reported, Apotex filed a motion to expedite the appeal of the preliminary injunction. Last week,…
As we’ve covered previously, Apotex has moved to expedite the briefing schedule for its appeal of the district court order in Amgen v. Apotex, in which the district court granted Amgen a preliminary injunction prohibiting Apotex from launching its biosimilar pegfilgrastim product until at least 180 days after FDA licensure of the product. Today,…
As we covered last week (here), Apotex is appealing the district court’s grant of a preliminary injunction to Amgen in Amgen v. Apotex. Apotex has now moved to expedite the briefing schedule on its appeal in the Federal Circuit. In its motion, Apotex explains: “Under the district court’s order, Apotex suffers immediate harm because the launch…
The Federal Circuit recently denied en banc rehearing of Ariosa Diagnostics, Inc. v. Sequenon, Inc.. The original panel decision is at 788 F.3d 1371, (Fed. Cir. Jun. 12, 2015). In the original panel decision, Judges Linn, Wallach, and Reyna decided that the claims at issue were drawn to not- patentable…
On December 7 Samsung Bioepis and Merck announced that Samsung Bioepis had received approval for its RENFLEXIS product by the Ministry of Food and Drug Safety in Korea. RENFLEXIS, a biosimilar version of Janssen Biotech’s Remicade (infliximab), was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative…
After winning a preliminary injunction in Amgen v. Apotex, Amgen now hopes to capitalize on that win in another pending BPCIA case, Amgen v. Hospira, which is being litigated in the District of Delaware. Amgen filed a notice of supplemental authority in the Hospira case citing the Florida District Court’s order in Apotex in an attempt to provide further support for…
As we covered yesterday, the district court issued an order in Amgen v. Apotex granting Amgen a preliminary injunction that would prohibit Apotex from launching its biosimilar pegfilgrastim product until 180 days after it receives FDA approval and gives notice of commercial marketing. Today, Apotex filed a notice of appeal…
We’ve been covering Amgen’s motion for a preliminary injunction in Amgen v. Apotex, where Amgen sought to prevent Apotex from marketing its biosimilar pegfilgrastim product until 180 days after Apotex notifies Amgen that its biosimilar application has received FDA approval and that Apotex intends to begin commercial marketing (see our post on the…
The order can be found here. Analysis to follow shortly.
Last Thursday, December 3, the U.S. district court for the Southern District of Florida heard oral arguments on Amgen’s motion for a preliminary injunction in Amgen v. Apotex. As we’ve discussed in previous posts (here, here, and here), Amgen is seeking a preliminary injunction to prevent Apotex from launching its…