Mere days before the Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program’s (“Pilot”) scheduled January 1, 2026 effective date, a federal district court granted a preliminary injunction that temporarily halts the scheduled implementation of the Pilot approved
In a move that will fundamentally change how the 340B Drug Pricing Program (“340B Program”) operates for a subset of medications, HRSA’s Office of Pharmacy Affairs (“OPA”) opted late last week to approve eight manufacturer plans for participation in the
As we wrote about recently here, Examiners continue to rely on the USPTO’s current guidance on the definiteness standard set forth by the Court of Appeals for the Federal Circuit (“Federal Circuit”) in In re Maatita, 900 F.3d 1369, 1377
On August 8, 2025, Baylor University filed a federal lawsuit against Boston University alleging trademark infringement and unfair competition over Boston University’s use of an interlocking BU design.
Robery Hinyub, III co-authored this article and it was originally published in the American Health Law Association Health Law Connections magazine. Copyright 2025, American Health Law Association, Washington, DC. Reprint permission granted.
As some studies estimate that nearly 23% of
The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting various types of 340B legislation.[1] On top of navigating
While federal funding for addiction treatment programs and research is being cut, more than $50 billion is being distributed to state and local programs from opioid-related lawsuits. There is great debate on the use of these funds as states are implementing
The U.S. Patent and Trademark Office (USPTO) has announced the rollout of DesignVision, an advanced AI‑powered image search tool now integrated into the examination system for U.S. design patent applications. According to the Official Gazette notice published July 16, 2025,
Expedited Patent Issuance
Starting May 13, 2025, the USPTO has begun accelerating the issuance of patents after the issue fee has been paid. Specifically, the duration between the Issue Notification and the Issue Date will be reduced to approximately two
In 2024, design patent law encountered a couple of major changes: the implementation of a new design patent bar, and the upending of decades of obviousness law under 35 U.S.C. § 103 in view of the en banc United States Court of Appeals
