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
A divided panel of the Federal Circuit affirmed a district court’s grant of summary judgment of noninfringement, holding that importation of two product samples into the U.S. was reasonably related to obtaining FDA approval...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
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more
In early October 2023, Deputy Attorney General (DAG) Lisa Monaco announced a “new” (but not new) Department of Justice (DoJ) policy intended to incentivize acquiring companies to voluntarily self-disclose criminal misconduct...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
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
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
Life sciences companies often engage physicians as consultants and advisors to serve on scientific or clinical advisory boards, or to otherwise obtain their expertise relating to product-specific research and development,...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...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 Small Business Administration (“SBA”) issued another Interim Final Rule (SBA-2020-0038) on June 22, 2020 (“IFR”) clarifying certain issues surrounding the forgiveness of Paycheck Protection Program (“PPP”) loans. For the...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
The US Court of Appeals for the Federal Circuit recently upheld the district court’s denial of a judgment as a matter of law (JMOL) or, alternatively, motion for a new trial, reinforcing the fine line that exists between...more
On December 10, 2019, Judge Jennifer A. Dorsey of the United States District Court for the District of Nevada denied a motion to dismiss a putative securities class action asserting claims under Section 10(b) of the...more
Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services (HHS) published on October 9 two long-awaited proposed rules...more
Legislation - Consumer Product Safety: House Committee Approves Six Bills - Responding to what they claim has been a failure of the Consumer Product Safety Commission (CPSC) to act in recent years, the House Energy and...more
• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny. • Conducting effective legal and regulatory due diligence can mean uncovering risks...more
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...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