On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more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On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.”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
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