What Were the Cooler Wars? (Part 2) — No Infringement Intended Podcast
A Guide to SEP: Standard Essential Patents for Tech Startups
Hilary Preston, Vice Chair at Vinson & Elkins, Discusses Energy Innovation: Protecting Your Intellectual Property Portfolio
What Were the Cooler Wars? (Part 1) — No Infringement Intended Podcast
5 Key Takeaways | Building a Winning Evidentiary Record at the PTAB (and Surviving Appeal)
(Podcast) The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
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Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
(Podcast) The Briefing: A Very Patented Christmas – The Quirkiest Inventions for the Holiday Season
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A Conversation with Phil Hamzik
5 Key Takeaways | Alice at 10: A Section 101 Update
PODCAST: Williams Mullen's Trending Now: An IP Podcast - IP and M&A Transactions
4 Tips for Protecting Your AI Products
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Director Review Under the USPTO's Final Rule – Patents: Post-Grant Podcast
AGG Talks: Cross-Border Business Podcast - Episode 20: Mastering ITC Section 337 Investigations
Navigating Intellectual Property Challenges in the Renewable Energy Sector - Energy Law Insights
Using Innovative Technology to Advance Trial Strategies | Episode 70
Patent Considerations in View of the Nearshoring Trends to the Americas
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...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
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
Case Name: Association for Accessible Medicines v. Bonta, Civ. No. 2:20-cv-01708-TLN-DB, 2021 WL 5853431 (E.D. Ca. Dec. 9, 2021) (Nunley, J.) - Drug Product and Patent(s)-in-Suit: N/A - Nature of Case and Issue(s) Presented:...more
Approval Processes - The regulatory approval pathway for a new “biological product” submitted as a Biologics License Application (BLA) under the Biologics Price Competition and Innovation Act (BPCIA), is now separate from...more
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent...more
For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. The approval process…pre-approval concerns…product...more
Recently, the U.S. Food and Drug Administration, or the FDA, announced enhancement of the FDA's Paragraph IV Patent Certification List (the List) as part of the agency's stated goal of bringing more generic drugs to market...more
Some commentators have suggested that since Hatch-Waxman actions share certain similarities with declaratory judgment (“DJ”) actions to prevent future infringement, venue in such actions should be governed by the general...more
On March 8th, a canonical "bipartisan of Senators" (a phrase used to signal bills that must be in the public interest because these Senators put aside business as usual to reach across the aisle) introduced S.659, entitled...more
This month we highlight two Federal Circuit obviousness-type double patenting decisions. CASES - Federal Circuit - Section 156 Patent Term Extension and Obviousness-Type Double Patenting - Novartis AG v. Ezra...more
Sen. Orrin Hatch has introduced a bill that would augment the Hatch-Waxman Act, limiting challengers ability to proceed with patent challenges both in court and at the PTAB. Following is the introduction of the “Hatch-Waxman...more
On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes...more
Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more
This month we highlight two reversals by the Federal Circuit and a summary judgment of indefiniteness from New Jersey. CASES - Federal Circuit - Grant of Preliminary Injunction Reversed - Indivior Inc. v. Dr....more
This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more
This month we highlight the possibility that the Supreme Court will consider the standard for adequacy of written description and a Federal Circuit exposition on the relationship between “blocking patents” and objective...more
This month we highlight a district court opinion from Judge Dyk, sitting by designation, denying a preliminary injunction in a brand-vs-brand litigation, and a lengthy district court opinion from Judge Bryson, sitting by...more
This month, we highlight significant developments from July 2018, including the FDA’s Biosimilar Action Plan for “reducing gaming of FDA requirements or other attempts to unfairly delay competition” and the much anticipated...more
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more
Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed (but has not yet introduced) an amendment titled the “Hatch-Waxman Integrity Act of 2018” during the Senate Judiciary Committee held on...more
Last week, Senator Orrin Hatch of Utah introduced the “Hatch-Waxman Integrity Act of 2018,” which seeks “to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.” ...more