News and Analysis
Innovation, Technology, and IP News
Prosecution History May Support a Motivation to Combine
Written by: Rhett D. Ramsey & Jacob R. Rosenbaum Elekta Limited v. Zap Surgical Systems, Inc. Before: Reyna, Stoll, and Stark. Appeal from the Patent Trial and Appeal Board. ...
Landmark CAFC Cases in Patent Law: Shaping the Future of Innovation
In the ever-evolving landscape of patent law, the Court of Appeals for the Federal Circuit (CAFC) has played a pivotal role in shaping the rules and precedents governing intellectual...
FDA Releases Draft Guidances on 510(k) Submissions
Written by: Paige L. Cappelli On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated...
IPR Decision Based on a Barely Mentioned Typo Violated the APA Notice Requirement
Written by:Brianne M. Kingery & Daniel Kiang APPLE INC. v. COREPHOTONICS, LTD. Before Stoll, Linn, and Stark. Appeal from the Patent Trial and Appeal Board. Summary: An IPR...
Feed tagged as "fda":
Written by: Alistair J. McIntyre & Jason J. Jardine
On September 26, 2023, Nexus Pharmaceuticals, LLC[1] announced[2] that it had... Read More »
Written by: Paige L. Cappelli
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft... Read More »
Written by: Ari Feinstein & Jane Dai, Ph.D.
On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC... Read More »
Written by: Nima Zargari, Ph.D.
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on... Read More »
We are proud to announce that tomorrow marks the release of the fourth edition of our ANDA Litigation Intelligence Report. This year's report... Read More »
Written by: Kenneth O. Aruda, Ph.D.
Software is increasingly used as a medical device, transforming the healthcare industry with the... Read More »
In the realm of pharmaceuticals, the approval process for generic and brand-name drugs holds significant importance. The Hatch-Waxman Act, ... Read More »
Written by: Philip M. Nelson
Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve... Read More »
Written by: Joshua C. Loader
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical ... Read More »
British drugmaker GlaxoSmithKline (GSK) has taken American pharmaceutical giant Pfizer to court, alleging a violation of its patent rights ... Read More »
In the world of pharmaceuticals, access to affordable generic drugs is crucial for ensuring cost-effective healthcare solutions. The Drug... Read More »
Written by: Arash Pia
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory... Read More »
Written by: Zachary B. Messick
The FDA implemented the breakthrough device program in 2015. The program was designed to... Read More »
Written by: Michael R. Christensen
On August 22-23, 2023, the FDA will conduct an Advisory Committee... Read More »
Written by: Mark Rubinshtein, Ph.D.
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the... Read More »
Written by: Julie Kim
On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE... Read More »
Written by:Matthew Ruth & Philip M. Nelson
Going forward, medical device approval will require the device maker to provide... Read More »
In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market... Read More »
Written by: Raina Patel
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled ... Read More »
Written by: Alistair J. McIntyre
The FDA recently announced release of final transition guidance documents for... Read More »
