On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv)....more
Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv). The Complaint alleges infringement of 46 of...more
The English High Court has held that a patent relating to a once-daily dosing of an active ingredient was invalid for lack of inventive step over prior art posters presented to the public at conferences. The decision has been...more
Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
In Sandoz Inc. v. Acerta Pharma B.V. (IPR2023-00478), a Patent Trial and Appeal Board (“PTAB”) panel denied IPR institution where the asserted prior art was cumulative of that considered during prosecution. This denial...more
Case Name: Amgen Inc. v. Sandoz Inc., Nos. 2022-1147, 2022-1149, 2022-1150, 2022-1151, 2023 WL 2994166 (Fed. Cir. Apr. 19, 2023) (Circuit Judges Lourie, Cunningham, and Stark presiding; Opinion by Lourie, J.) (Appeal from...more
As we previously reported, Biogen sued Sandoz and Polpharma (“Defendants”) in a BPCIA litigation related to Defendants’ natalizumab biosimilar. On October 19, 2022, Biogen filed a Motion for Preliminary Injunction and Motion...more
In October 2022, we reported that Biogen was seeking a preliminary injunction in its BPCIA case brought in the District of Delaware against Sandoz relating to Sandoz’s proposed multiple sclerosis biosimilar of TYSABRI...more
On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz’s denosumab biosimilar of Amgen’s PROLIA® and XGEVA®. This is Amgen’s first BPCIA case filed with respect to a...more
On March 21, 2023, Sandoz, announced FDA approval of its citrate-free high-concentration formulation (HCF) of its biosimilar HYRIMOZ® (adalimumab-adaz) injection....more
The US FDA has accepted a Biologics License Application (BLA) from Sandoz for a proposed denosumab biosimilar. ...more
Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint...more
In a decision rendered on August 17, 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its Statement of Defence to add new allegations, contingent on an adjournment of the trial and an extension of a...more
On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics. Biogen’s complaint is filed under seal. Based on the list of 28 asserted patents, the case appears to...more
September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more
Over the last seven years there has been commotion in Obviousness-type Double Patenting (“ODP”) practice. One of the latest cases to spur a considerable amount of interest is Mitsubishi Tanabe Corp. v. Sandoz, Inc., which is...more
As previously reported, Amgen sought leave to appeal a decision of the Federal Court of Appeal (2020 FCA 188) affirming Justice Southcott’s decision that the relevant claims of its filgrastim (NEUPOGEN) patent were invalid...more
The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently filed a petition for certiorari requesting review of the judgement of the...more
Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more
Last week, the Federal Circuit denied Sandoz’s petition for an en banc rehearing of its precedential July 1st panel decision upholding two of Immunex’s patents covering Enbrel®... ...more
Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more
The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market. The BPCIA, signed into law...more
Introduction - In many ways, 2019 was a notable year for biosimilars in the U.S. FDA approved the 26th biosimilar product and the 13th biosimilar product was launched in the U.S. market. These developments were...more