On April 20, 2024, New York State approved several updates to its consumer protection laws, including enactment of Public Health Law § 18-C. Section 18-C provides new requirements for patient consent for treatment and payment of medical services. The updates (discussed further below) went into effect on October 20, 2024. However, due to the
OIG Releases New Industry-Specific Compliance Program Guidance for Nursing Facilities
On November 20, 2024, the Office of Inspector General (OIG) released its updated Industry-Specific Compliance Program Guidance (ICPG) for nursing facilities, marking an important step in its broader compliance initiative. This guidance builds upon and updates the 2000 Compliance Program Guidance (CPG) and the 2008 Supplemental Compliance Program Guidance (Supplemental CPG) for Nursing Facilities, carrying…
Unlocking Innovation: Understanding the Impact of the Bayh-Dole Act
The Bayh-Dole Act, 35 U.S.C. §§ 200-212[1], creates a program that, ostensibly, encourages the practical use of inventions that are supported by federally funded research. As stated in Bayh-Dole, Congress seeks “to use the patent system to promote the utilization of inventions arising from federally supported research or development.”[2] The Bayh-Dole Act…
Website and Press Releases Created Plausible Claim of Inducement of Infringement by a Skinny Labelled Generic Product
In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., [2023-1169] (June 25, 2024), the Federal Circuit reversed the dismissal of Amarin’s complaint for failure to state a claim for induced infringement.
Less than a month after Hikma launched its generic icosapent ethyl product, Amarin sued under 35 U.S.C. § 271(b), alleging that Hikma had…
Plaintiff Failed to Show It was Entitled to a Preliminary Injunction to Protect its Trade Secrets
In Insulet Corp. v. Eoflow, Co, Ltd., [2024-1137] (June 17, 2024), the Federal Circuit reversed a preliminary injunction against manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on alleged trade secrets of Insulet.
Insulet and EOFlow are medical device manufacturers that make insulin…
Court Strikes Down HHS “Guidance” Regarding Online Tracking Technologies and HIPAA: Implications for Healthcare Providers
In a recent landmark decision, the United States District Court for the Northern District of Texas issued an opinion and order with significant implications for healthcare providers and their use of online technologies. The case, filed by the American Hospital Association, Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, challenged a…
Newly Released FTC Health Breach Notification Rule: A Guide for Non-HIPAA Health Apps and Technologies
As healthcare regulatory attorneys, we’ve seen firsthand the confusion and challenges that arise when health-related entities fall outside the purview of the Health Insurance Portability and Accountability Act (HIPAA). One crucial, newly released, regulation that often gets overlooked is the Federal Trade Commission’s (FTC) Health Breach Notification Rule (HBN Rule). This rule is particularly relevant…
Supreme Court Affirms 100+ Year Period for Copyright Damages
In Warner Chappel Music, Inc., v. Sherman Nealy, [22–1078] (May 9, 2024), the Supreme Court finally clarified copyright’s 3-year statute of limitations (17 U. S. C. §507(b)), holding that a copyright plaintiff who timely brings a copyright infringement claim, can recover damages for the entire period of infringement, and not limited to the three…
What Foreign [And U.S.] Patent Practitioners Need To Know About Means-Plus-Function Claim Interpretation In the U.S. – Understanding 35 U.S.C. § 112(f)
Introduction
We’ve all seen it. Patent attorneys love making up words. For example, instead of claiming a pipe, a hose, or a tube, we draft patent claims reciting “a fluid delivery system” or “a fluid conduit.”
Why do we do it? Because it is our job to secure the broadest patent protection available for our…
Routine Optimization Does Not Necessarily Require a Disclosure of Ranges Under the Results-effective Variable Doctrine – Pfizer v. Sanofi, No. 19-1871 (Fed Cir 2024)
The results-effective variable doctrine is a caselaw principle where prior art disclosing the “general conditions of a claim” invokes a presumption of obviousness if the particular workable ranges are identifiable through routine experimentation. The presumption can be rebutted with evidence that the given parameter was not recognized as being result-effective. Sanofi Pasteur, Inc. and SK…