Understanding the Impact of IPR Estoppel and PTAB Discretionary Denials — Patents: Post-Grant Podcast
Navigating PTAB’s New Approach to IPR and PGR Discretionary Denial - Patents: Post-Grant Podcast
5 Key Takeaways | Building a Winning Evidentiary Record at the PTAB (and Surviving Appeal)
Director Review Under the USPTO's Final Rule – Patents: Post-Grant Podcast
Patent Considerations in View of the Nearshoring Trends to the Americas
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
Wolf Greenfield Attorneys Preview What’s Ahead in 2024
USPTO Director Review — Patents: Post-Grant Podcast
5 Key Takeaways | PTAB Update: The Waning Impact of Fintiv on Discretionary Denials
3 Key Takeaways | Third party Prior Art Submissions at USPTO
Discretionary Denials at the PTAB: What to Expect? - Patents: Post-Grant Podcast
Secondary Considerations of Non-Obviousness - Patents: Post-Grant Podcast
JONES DAY TALKS®: Supreme Court Rules on Constitutionality of Administrative Patent Judges
Five Impactful USPTO Procedural Developments for Patent Practitioners
Jones Day Talks®: Patent Litigation, PTAB, Iancu's Legacy, and Institution Discretion
The Briefing: COVID 19 Bill Stimulates the Economy and Changes in the Intellectual Property Law
[IP Hot Topics Podcast] Innovation Conversations: Andrei Iancu
Fallout from the Fintiv Precedential Decision
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Federal district court cases that are filed pursuant to the Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more
On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab)...more
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more
Teva Branded Pharmaceutical Products R&D, Inc., et al. v. Amneal Pharmaceuticals of New York, LLC, et al., No. 2024-1936 (Fed. Cir. (D.N.J.) Dec. 20, 2024). Opinion by Prost, joined by Taranto and Hughes....more
This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...more
Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more
Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more
Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...more
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more
REGENTS OF THE UNIVERSITY OF MINNESOTA V. GILEAD SCIENCES, INC. Before Lourie, Dyk, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: For drug patents, adequate written description of a broad genus...more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more
President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more
On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more
This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
Ranges for Interdependent and Interactive Components Can Be Tricky to Derive - In Modernatx, Inc. v. Arbutus Biopharma Corporation, Appeal No. 20-2329, the Federal Circuit held that a presumption of obviousness based on...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more