The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in a position of increasing uncertainty. This article synthesizes these key developments of 340B Program developments and trends from the past
The Manual of Patent Examining Procedure (“MPEP”) is the examination manual used internally at the United States Patent & Trademark Office (“USPTO”) to guide examiners in the process of examining patent applications. In practice, patent applicants frequently rely on the contents of the MPEP during patent prosecution to guide their arguments and hold examiners accountable
While obtaining a design patent is often quicker than obtaining a utility patent, current design patent application pendency is often still a lengthy period of time. Based on data released by the USPTO in July 2024 and shown below, over the previous year the average length of time from a design application filing date to
As commerce moves more and more online, companies are facing unique challenges with respect to protecting their products, and the low cost of entry for online sellers has contributed to proliferations of knock-off and potentially counterfeit products being sold. This is particularly true when the product being sold is a simple disposable or replaceable product,
In the world of furniture design, aesthetics often play as crucial a role as functionality since the unique appearance of a furniture piece can set it apart in a competitive marketplace and help establish a brand’s identity. Fortunately, design patents are uniquely suited to protect the visual innovation embedded in furniture designs, and can help
As outlined in our previous post, partial design claiming in China continues to be a moving target, as variations in the interpretation of partial design claims persist among Chinese examiners. As of this writing, the Chinese National Intellectual Property Administration (CNIPA) has still not yet released formal guidelines or recommendations detailing partial claiming that
Upending decades of continuity in the world of design patents, the United States Court of Appeals for the Federal Circuit (“CAFC”), sitting en banc in LKQ Corporation v. GM Global Technology Operations LLC, overturned the Rosen/Durling standard for obviousness of design patents, originally set forth in In re Rosen, 673 F.2d 388, 391
Quarles & Brady Partner and editor-in-chief of the firm’s Protecting the Product design rights blog, James Aquilina, Partner Michael Piery, Associate Rachel Ackerman, and patent professionals Harrison Powell and Audrey Jacobson attended the 17th Annual USPTO Design Day on May 9, 2024 at the USPTO’s Headquarters in Alexandria, Virginia.
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for resolving certain types of disputes between 340B covered entities and drug manufacturers. 340B Program observers are cautiously optimistic that the ADR process will serve as
Over the past two decades, the World Intellectual Property Organization (WIPO) has been working on a Design Law Treaty focused on aligning examination and procedural guidelines associated with what have historically been referred to as “industrial designs.” One main goal of the Design Law Treaty is to help designers in domestic and foreign jurisdictions obtain
