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
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 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
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
The District Court for the District of Delaware recently held on summary judgment that a patent with 2,295 days of combined patent term adjustment (PTA) and patent term extension (PTE) was not invalid for obviousness-type...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 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
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
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
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
Are research tools protected from patent infringement under the Hatch-Waxman safe harbor, section 271(e)(1)? While different courts have reached different conclusions on this question, one recent district court decision...more
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-CV-06593 (N.D. Cal. Oct. 16, 2020). On October 16, 2020, the US District Court for the Northern District of California granted a motion for summary...more
This somewhat arcane question took on significant, real-world consequences when Judge Andrews of the Delaware District Court denied Hospira’s JMOL to overturn a jury’s $70 million award to Amgen for Hospira’s manufacture and...more
Bolar Exemptions in the U.S. Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more
Worldwide Bolar Exemptions - Many countries have exemptions for patent infringement for a product and/or process that is not being used for direct commercialization and profit. For biopharmaceuticals, this exemption,...more
The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval...more
The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by...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
The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more
The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more
Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute. Both of the cases relied heavily on the Federal Circuit case Momenta Pharm....more
In This Issue: Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?;...more
In This Issue: ..News From the Bench: - Clarification of the “Vitiation Test” when applying the Doctrine of Equivalents. - The “Success More Likely Than Not” and “Ordinary Observer” Standards for a...more