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
Bill on Bankruptcy: Fee Agreement Puts Law Firm In Trustee's Sights
We have been monitoring the dispute between Edwards Lifesciences Corp. (“Edwards”) and Meril Life Sciences Pvt., Ltd. (“Meril”) before and after the initial Federal Circuit decision. The dispute focused on whether Meril’s...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
Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more
The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more
A split Federal Circuit panel recently held that the safe harbor provision of 35 U.S.C. §271(e)(1) providing a defense to infringement applies if the allegedly infringing activity is “reasonably related to submitting...more
The Federal Circuit considered the relevance of an alleged infringer’s intent in a safe harbor analysis in Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. The District Court had previously granted summary judgment that...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
A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...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
On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more
The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...more
On January 5, 2024, in litigation between REGENXBIO and Sarepta Therapeutics, Judge Richard Andrews of the U.S. District Court for the District of Delaware District Court granted summary judgment for Sarepta and ruled that...more
Proponents of marijuana reform have had cause for celebration in 2023. Despite challenges facing the industry, the political and social momentum surrounding cannabis is ticking upward. Most recently, the marijuana industry...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
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more
The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more
In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more
Congress’s protection from patent infringement for drug developers created under the Hatch-Waxman Act of 1984 (Act) has been extensively litigated over the past three+ decades, but the scope of the so-called “safe harbor...more
We increasingly encounter research and development collaboration partners relying on various research tools, cell lines, and other technologies to develop products and therapies within the cell, tissue, and gene therapy...more
On April 20, 2022, OIG issued an advisory opinion regarding an arrangement involving a family of physicians having an ownership interest in a medical device company that manufactures products that the physicians also order. ...more
*This alert was originally published on January 28, 2022 and updated on February 4, 2022. On January 27, 2022, the Federal Communication Commission (FCC or Commission) moved to implement a provision of the bipartisan...more
On January 27, 2022, the Federal Communication Commission (FCC or Commission) moved to implement a provision of the bipartisan Infrastructure Investment and Jobs Act by adopting a Notice of Proposed Rulemaking (NPRM) that...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
On January 4, 2022, Judge Andrews from the United States District Court for the District of Delaware denied Sarepta Therapeutics, Inc.’s (“Sarepta”) Rule 12(b)(6) motion to dismiss a complaint for infringement of U.S. Patent...more