On November 14, 2019, the parties in the Amgen v. Accord (previously Apotex) follow-on BPCIA litigation filed a Stipulation of Dismissal, agreeing “to the dismissal, without prejudice, of all remaining claims and...more
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more
Amgen has sued Apotex in connection with Apotex’s efforts to market biosimilar versions of Amgen’s cancer drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim). In a complaint filed on August 7 in the Southern District of...more
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS - On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and...more
On November 13th, in an opinion drafted by Judge Taranto, the Federal Circuit affirmed the Southern District Court of Florida’s judgment that Apotex’s biosimilar versions of Neulasta® and Neupogen® do not infringe Amgen’s...more
Patent owner Amgen has appealed to the Federal Circuit seeking to overturn a non-infringement ruling with respect to Apotex’s manufacturing processes for its biosimilar versions of Amgen’s NEULASTA® (pegfilgrastim) and...more
Below is our Fall 2016 update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly update...more
On November 21, 2016, Apotex submitted a reply brief in support of its petition for certiorari. A procedural note: the case was also distributed on November 21 for consideration at the Supreme Court’s private conference...more
On November 8, 2016, Amgen asked the Supreme Court to deny Apotex’s September 9, 2016 petition for review in Apotex v. Amgen, No. 16-332. Apotex had asked the High Court to clarify 42 U.S.C. § 262(l)(8)(A) of the Biologics...more
Mylan filed an amicus brief in support of Apotex’s petition for certiorari in Amgen v. Apotex. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after...more
On October 14, 2016, Mylan Pharmaceuticals and the Biosimilars Council, a subsidiary of the Generic Pharmaceuticals Association (GPhA), filed amicus briefs in support of granting review in Apotex v. Amgen, No. 16-332. As...more
Last week, Amgen filed a notice of appeal to the Federal Circuit from the district court’s judgment of non-infringement. The Federal Circuit has docketed the appeal as Case No. 17-1010. Amgen’s opening brief will be due in...more
On October 3, 2016, Amgen filed a Notice of Appeal in the U.S. District Court for the Southern District of Florida and thereby laid the groundwork for its next move in the ongoing Amgen v. Apotex dispute. (D.I. 272.) - ...more
Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen...more
On September 9, 2016, Apotex Inc. filed a petition for writ of certiorari in the U.S. Supreme Court seeking review of the Federal Circuit’s decision in Amgen Inc. v. Apotex Inc., Case No. 2016-1308. This case involves...more
We have been closely following the Amgen v. Apotex case. On September 9, 2016, Apotex petitioned the Supreme Court for certiorari to review the Federal Circuit’s decision. In its petition, Apotex presents two questions for...more
On September 9, 2016, Apotex Inc. petitioned the United States Supreme Court for a writ of certiorari seeking review of the Federal Circuit’s July 2016 ruling in Amgen v. Apotex (Apotex) holding that the 180-day commercial...more
In what may be the first decision on the merits in a patent infringement suit brought under the Biologics Price Competition and Innovation Act (BPCIA), the U.S. District Court for Southern District of Florida has found that...more
Amgen’s claims against Apotex’s Neulasta® (pegfilgrastim) and Neupogen® (filgrastim) biosimilars have failed at the district court level. On September 6, 2016, the District Court for the Southern District of Florida found no...more
In an opinion that details many intricacies of both the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and related portions of the Patent Act, the US Court of Appeals for the Federal Circuit affirmed a...more
In July, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed, Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009...more
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product....more
Many biosimilar applicants have resorted to inter partes review (IPR) proceedings to challenge innovator patents as an alternative forum to district court litigation under the BPCIA. For those biosimilar applicants that...more
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...more
Hospira’s motion to dismiss Count I of Amgen’s complaint has been denied, and Amgen will be able to seek declaratory judgment relief in the form of an injunction requiring Hospira to comply with the notice of commercial...more