The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and Reliability...more
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving...more
The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.” The portion of the requested budget directed to advancing access to...more
On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help...more
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more
TEVA PHARMACEUTICALS USA, INC., v. CORCEPT THERAPEUTICS, INC.
Before Moore, Newman, and Reyna. Appeal from the Patent Trial and Appeal Board.
Summary: Limitations, such as specific drug doses, in claim language can...more
12/10/2021
/ Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Teva Pharmaceuticals
On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions...more
JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC. Before Moore, Prost, and O’Malley. Appeal from the United States District Court for the Central District of California. Summary: Knowledge of a common general structure and the...more
The medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic. Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices. ...more
UNILOC 2017 LLC v. APPLE INC.
Before Prost, Bryson, and Reyna. Appeal from the Patent Trial and Appeal Board.
Summary: Evidence of the plain and ordinary meaning of the term “intercepting” as set forth in dictionary...more