5 Key Takeaways | AI and Your Patent Management, Strategy & Portfolio
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
The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
(Podcast) The Briefing: A Very Patented Christmas – The Quirkiest Inventions for the Holiday Season
The Briefing: A Very Patented Christmas – The Quirkiest Inventions for the Holiday Season
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
Innovating with AI: Ensuring You Own Your Inventions
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
The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...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
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
Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more
The Federal Circuit's recently issued decision in the Amarin/Hikma case continues the drama around skinny labeling for generic and biosimilar products, but the panel certainly went out of its way to couch its analysis as an...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
Turning 40 is a big milestone for most of us. When I turned 40 – I won't tell you how long ago that was – I was knee-deep in Paragraph IV patent litigation and in legal challenges to FDA's exclusivity and approval decisions...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
Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more
In June 2021, the US Patent and Trademark Office (USPTO) published an update to its study of America Invents Act (AIA) trials involving challenges to Orange Book-listed and biologic patents from September 16, 2012, through...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
For nearly a decade, the Supreme Court’s FTC v. Actavis decision has guided pharmaceutical litigators and advisors exploring the antitrust risks inherent in settling pharmaceutical patent lawsuits, especially when such...more
Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more
After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more
On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more
Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2). While recognizing that this...more
The Federal Circuit Thursday issued a decision that narrows the venue options available to patent owners bringing suit against generic drug manufacturers under the Hatch-Waxman Act. In a unanimous decision, the court held...more
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...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
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
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
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