4,415 results found

On March 14, 2018, FDA issued draft guidance on Pediatric HIV Infection: Drug Development for Treatment. The draft guidance provides general guidance on the development of drug products ...

On September 10, 2018, the FDA issued draft guidance on Postapproval Changes to Drug Substances, with recommendations regarding changes to drug substance ...

On September 24, 2018, FDA issued final guidance on ANDA Submissions – Content and Format. The guidance outlines recommendations for the information that should be provided in each section...

In January 2019, in conjunction with Version 1.0 of its Working Model for the Software Precertification Program,

On December 11, 2018, FDA issued its fifth final guidance document related to the development of biosimilars and interchangeability products entitled Questions and Answers on Biosimilar

The Life Sciences industry can be particularly challenging for companies to navigate, often requiring careful navigation through rigorous testing and regulatory compliance.

Finnegan attorneys Greg Gramenopoulos, Elliot Cook, and Forrest Jones authored the Patent Litigation - United States chapter of The Legal 500's 2020 Comparative Legal Guide.

AI is reshaping legal practice through copyright disputes over training data and emerging regulations governing data use and model deployment. Two Finnegan attorneys explore the evolving legal framework surrounding AI training data, examining critical questions about fair use, authorship, consent, and accountability that law students and practitioners must navigate.

In Bearbox LLC v. Lancium LLC, No. 2023-1922 (Fed. Cir. January 13, 2025), the Federal Circuit affirmed, among other things, the district court's determination that BearBox had not met its burden to establish.

Antibodies are proteins produced in nature by the immune system and used frequently in biologic therapies for their ability to bind and alter signaling pathways involved in various diseases such as cancer, infection, and inflammation.

In In re Arunachalam, No. 2016-1607, the Federal Circuit affirmed the PTAB decision holding that Dr. Lakshmi Arunachalam is collaterally estopped from asserting claims in U.S. Patent No. 6,212,556 ...

The Supreme Court handed down its decision in the design patent case of Samsung v. Apple in December, 2016.

In Perfect Surgical Techniques, Inc. v. Olympus America, Inc., No. 15-2043 (Fed. Cir. Nov. 15, 2016), the Federal Circuit found the diligence standard the PTAB applied in an IPR "too exacting" . . .

In a recent case, the Board denied ScentAir's request to file a motion to disqualify Prolitec's lead counsel from representing Prolitec in an inter partes review because they were subject to a protective order in a related district court case.

Swiss watchmaker giant Swatch Group Ltd. filed an opposition against an application to register the mark iWATCH in 2008, alleging that the applicant, M.Z. Berger & Co., Inc., did not have an intent to use the mark...

In In re: MaxPower Semiconductor, Inc., No. 2021-146 (Fed. Cir. Sept. 8, 2021), the Federal Circuit denied MaxPower's petition for mandamus seeking review of four PTAB decisions to institute...

The Federal Circuit recently reviewed a patent infringement case involving communication systems that use non-uniform satellite constellations to transmit digital information. While the lower court had granted summary judgment on patent eligibility and found infringement, the appellate court reached a split decision on the validity of the patents. The case highlights the ongoing challenges in determining patent eligibility under the Alice framework, particularly for claims involving mathematical concepts ve

The Federal Circuit considered choice-of-law, bankruptcy, and contract law in vacating the district court's grant of a motion to dismiss in Fraunhofer-Gesellschaft zur Förderung der Angewandten ...