On June 6, 2023, the Senate Judiciary Committee’s Subcommittee on Intellectual Property introduced a Bill entitled “Patent Eligibility Restoration Act of 2023” (PERA) aiming to amend the law relating to patent subject matter eligibility. The bill seeks to eliminate the so-called “judicial exceptions” to patent eligibility that have led to a significant number of “inventions” being deemed ineligible for patent protection. Additionally, this legislation seeks to clarify the confusion and inconsistency brought about by the Alice/Mayo framework, which has been criticized for its failure to provide a clear and consistent standard for patent eligibility, negatively impacting the protection of innovations in various fields.
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing data in premarket submissions.” According to the Letter, this suspect testing data can come from “entities that contract with device firms to conduct testing on medical devices (‘third-party test labs’).”
RAI STRATEGIC HOLDINGS, INC. v. PHILIP MORRIS PRODUCTS S.A
Before Chen, Stoll, and Cunningham. Appeal from the Patent Trial and Appeal Board.
Summary: Claimed ranges can be narrower than alternative, broader ranges disclosed in the specification if one of ordinary skill in the art can adequately determine that the broader range does not result in a different invention than the narrower range.
WEBER, INC. v. PROVISUR TECHNOLOGIES, INC.
Before Reyna, Hughes, and Stark. Appeal from the Patent Trial and Appeal Board.
Summary: Copyright notices in product manuals, which prohibited their reproduction and transfer, did not remove the manuals from the prior art.
The U.S. Food and Drug Administration (“FDA”) recently approved the Edwards EVOQUE® Tricuspid Valve Replacement System (the “EVOQUE® system”) for use in treating Tricuspid Regurgitation (“TR”). The EVOQUE® system is designed to replace the native tricuspid valve in patients suffering from severe TR without the need for conventional open-heart surgery, according to the system’s Instructions For Use. As shown in the following illustrations from page 5 of the EVOQUE® system’s Patient Guide, the EVOQUE® valve is made of a nitinol self-expanding frame, an intra-annular sealing skirt and anchors, and tissue leaflets made from bovine pericardial tissue.
The World Health Organization (WHO) recently released guidelines for the ethics and governance of large multi-modal models (LMMs). In the past year, LMMs like Chat GPT have come to the forefront of the news, and people have begun using them in different fields with varying success. Within the healthcare space, LMMs have the potential to respond to patients’ inquiries, identify research topics, and maintain electronic health records. However, the use of LMMs in healthcare raises many legal and ethical questions, such as how they can be used effectively without jeopardizing patient safety and privacy.
The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023 following the White House’s announcement of initiatives to lower health care and prescription drug costs via competition.
On December 27, 2023, Judge Thomas S. Kleeh of the United States District Court for the Northern District of West Virginia issued an order finding that Mylan (Viatris) infringed claims 4, 7, 9, 11, and 14-17 of Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) after a nine-day bench trial held in June 2023.
A recent paper published by market.us projects that the Deep Brain Stimulation (DBS) devices market is expected to reach around $3.5 Billion by 2033, compared to the projected $1.5 Billion for 2024.
A recent paper published by market.us projects that the Deep Brain Stimulation (DBS) devices market is expected to reach around $3.5 Billion by 2033, compared to the projected $1.5 Billion for 2024.