Navigating the Inflation Reduction Act: Insights on Brownfield Energy Community Credits - Energy Law Insights
Consumer Finance Monitor Podcast Episode: A Close Look at the Consumer Financial Protection Bureau’s Final Credit Card Late Fee Rule: Have Cardholders Been Dealt a Winning or Losing Hand?
Time to Amend the Defend Trade Secrets Act
Consumer Finance Monitor Podcast Episode: A Close Look at the Consumer Financial Protection Bureau’s Credit Card Late Fees Proposal with Special Guest Todd J. Zywicki
Podcast: The Briefing by the IP Law Blog - SCOTUS Issues First IP Ruling of 2022 in Unicolors, Inc. v. H&M Hennes & Maurits, LP
The Briefing by the IP Law Blog: SCOTUS Issues First IP Ruling of 2022 in Unicolors, Inc. v. H&M Hennes & Maurits, LP
PODCAST: Williams Mullen's Trending Now: An IP Podcast - DMCA Takedowns – Benefits to Content Owner
Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program - Diagnosing Health Care
Challenges for Infrastructure Projects in the Current Environment
No Harbor is Limitless: Restrictions of the Federal Anti-Kickback Statute's Safe Harbor Provisions
The SECURE Act: Significant Changes for Retirement Plans and IRAs
PODCAST: Williams Mullen's Benefits Companion - New Hardship Distribution Regulations for 401(k) Plans
Overview For Employers: More State Pay Equity Laws Coming Online
PODCAST: Recruiting and Retention: Can Your 401K Make a Difference?
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
Jones Day Talks: Navigating Foreign Direct Investment in Germany
Podcast: Tax Reform and Its Impact on Exempt Organizations, One Year In
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Bill on Bankruptcy: Easterbrook Turns the Tide on Student Loans
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 2024-2274, 2024-2277, 2024-2278, 2025 WL 1298920 (Fed. Cir. May 6, 2025) (Circuit Judges Lourie, Reyna, and Taranto presiding; Opinion by Lourie, J.) (Appeal from...more
The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more
Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more
In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe...more
In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more
The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more
The safe harbor exception in 35 U.S.C. § 271(e)(1) applies “solely for uses reasonably related to the development and submission of information” to the Food and Drug Administration (FDA). The Federal Circuit interpreted the...more
The US Court of Appeals for the Federal Circuit affirmed that the 35 U.S.C. § 271(e)(1) safe harbor protecting certain infringing acts undertaken for regulatory approval applied to an alleged infringer’s importation of...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
Sarepta and Catalent File Answers in REGENXBIO v. Sarepta Litigation - As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics,...more
ACI’s 21st Advanced Summit on Life Sciences Patents returns to New York City, this May, to provide practical insights on how to maximize your patent term and develop strategies to enhance global protections for your patent...more
Are patented products that are not themselves subject to FDA approval, but used to develop products that are subject to FDA approval, protected under the Hatch-Waxman safe harbor? While courts have reached different...more
Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more
The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute. As we have previously reported, that ruling upheld a jury verdict...more
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more
On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more
A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more
In In re: Janssen Biotech, Inc., the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“Board”) holding that, for the purposes of the safe harbor provision of 35 U.S.C. § 121, a patent owner of a...more
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more
The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more
Case Name: Shire LLC v. Amneal Pharms. LLC, 2014-1736, -1737, -1738, -1739, -1740, -1741, 2015 U.S. App. LEXIS 16908 (Fed. Cir. Sept. 24, 2015) (Circuit Judges Moore, Mayer, and Linn presiding; Opinion by Linn, J.) (Appeal...more
Addressing the “safe harbor” provision under 35 U.S.C. § 121, the U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that a reissue patent was invalid for obviousness-type double patenting. G.D....more
In 2008, the Federal Circuit determined that claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 were invalid for obviousness-type double patenting (OTDP) over a related parent patent, in part because the ‘068 patent was filed...more