4 Key Takeaways | Trade Secret Update 2024 Legal Developments and Trends
New Developments in Obviousness-Type Double Patenting and Original Patent Requirements — Patents: Post-Grant Podcast
3 Key Takeaways | Corporate Perspectives on Intellectual Property
3 Key Takeaways | What Corporate Counsel Need to Know About Patent Damages
5 Key Takeaways | Rolling with the Legal Punches: Resetting Patent Strategy to Address Changes in the Law
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
Legal Alert: USPTO Proposes Major Change to Terminal Disclaimer Practice
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Artificial Intelligence Patents & Emerging Regulatory Laws
John Harmon on the Evolving Impact of Artificial Intelligence on Intellectual Property
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Patent Litigation: How Low Can You Go?
Rob Sahr on the Administration’s Aggressive Approach to Bayh-Dole Compliance
The Briefing: The Patent Puzzle: USPTO's Guidelines for AI Inventions
The Briefing: The Patent Puzzle: USPTO's Guidelines for AI Inventions (Podcast)
4 Key Takeaways | Updates in Standard Essential Patent Licensing and Litigation
Behaving Badly: OpenSky v. VLSI and Sanctions at the PTAB — Patents: Post-Grant Podcast
Scott McKeown Discusses PTAB Trends and Growth of Wolf Greenfield’s Washington, DC Office
PODCAST: Williams Mullen's Trending Now: An IP Podcast - U.S. State Data Privacy Update
From Academia to the Marketplace: The Ins and Outs of University Spinout Licenses with Dan O’Korn
Wolf Greenfield Attorneys Preview What’s Ahead in 2024
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
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
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
The US Court of Appeals for the Federal Circuit endorsed for the first time the “all substantial rights” test to determine whether inventions are commonly owned for purposes of obviousness-type double patenting validity...more
We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product...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
As of the end of 2019, reference product sponsors (“RPSs”) have filed dozens of patent infringement cases against biosimilar manufacturers under the Biologics Price Competition and Innovation Act (“BPCIA”). The doctrine of...more
As 2019 draws to a close, a handful of actions regarding biologics are pending in the federal courts. The current cases are listed below, in order from most-recently-filed to oldest....more
On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the...more
On petition for panel rehearing, the US Court of Appeals for the Federal Circuit stripped the phrase “applies only in exceptional cases and” from its previous opinion, but otherwise denied the petition. Amgen, Inc. v. Sandoz...more