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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Written by: Paige L. Cappelli On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated...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...

CASE OF THE WEEK Volvo Penta of the Americas, LLC v. Brunswick Corp., Appeal No. 2022-1765 (Fed. Cir. Aug. 24, 2023) In its... Read More »
Written by: Nefi R. Oliva & Nathan D. Reeves IN RE CELLECT, LLC Before Lourie, Dyk, and Reyna.  Appeal from the... 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: Alistair J. McIntyre & Brandon G. Smith Volvo Penta of the Americas, LLC, v. Brunswick Corp. Before Moore... Read More »
Written by: Kenneth McNeill & Daniel P. Hughes INCEPT LLC v. PALETTE LIFE SCIENCES, INC. Before Newman, Schall, and... Read More »
In the intricate world of pharmaceuticals, where innovation meets regulation, ANDA litigation stands as a pivotal battleground... Read More »
CASE OF THE WEEK Incept LLC v. Palette Life Sciences, Inc., Appeal Nos. 2021-2063, -2065 (Fed. Cir. Aug. 16, 2023) In the... 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 January, we published the Patent Litigation 2023 Report analyzing all patent infringement cases filed in district courts during the period from... 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 »
CASE OF THE WEEK Axonics, Inc. v. Medtronic, Inc., Appeal Nos. 2022-1532, -1533 (Fed. Cir. Aug. 7, 2023) In this week’s ... Read More »
In the dynamic realm of patent law, the Patent Trial and Appeal Board (PTAB) serves as a critical battleground for challenging the... 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 & Justin J. Gillett AXONICS, INC. v. MEDTRONIC, INC. Before Dyk, Lourie, and Taranto. Appeal... Read More »
Abbreviated New Drug Application (ANDA) litigation stands at the crossroads of pharmaceutical innovation and legal prowess. As generic... 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 »
When it comes to generic medications, the Abbreviated New Drug Application (ANDA) process plays a crucial role in bringing affordable... Read More »
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