Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Nature of the Case and Issue(s) Presented: Cyclophosphamide is an antineoplastic agent used to treat various cancers, including lymphomas, myeloma, leukemia, and breast carcinoma. The ’952 patent, issued to Plaintiffs in May...more
IMMUNOGEN, INC. v. STEWART - Before Lourie, Dyk, and Prost. Appeal from the United States District Court for the Eastern District of Virginia. A solution to a problem can be obvious even when the problem itself was unknown in...more
2024 was an active year in Canadian patent law, with the Federal Court issuing several decisions on the merits regarding invalidity and/or infringement. The courts also considered issues of the regulation of patent agents,...more
On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more
On April 1, 2024 the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain claims were not indefinite and...more
避而不谈可能支持否定性权利要求限定 - 在 Novartis Pharmaceuticals 诉 Accord Healthcare Inc. 一案（上诉案件编号：21- 1070）中，联邦巡回上诉法院认为，一项对药物“速效剂量”避而不谈的专利申请，为要求不存在此类剂量的否定 性权利要求限制提供了书面说明支持。 ...more
記述がないことがクレームの否定的限定のサポートと解釈できる場合がある Federal Circuit は、Novartis Pharmaceuticals v. Accord Healthcare Inc. (Appeal No. 21-1070) に おいて、薬剤の「初回負荷用量」についての記述がない特許出願は、そのような用量がないことを要 求するクレームの否定的限定に記述によるサポートを提供していることになると判示した。 ...more
January 2022 Federal Circuit Newsletter (Japanese) January 2022 Federal Circuit Newsletter (Chinese) Silence May Support Negative Claim Limitation In Novartis Pharmaceuticals v. Accord Healthcare Inc. Appeal No. 21-1070, the...more
In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more
Challenges to Immunology Patents Lead Increase in Biotechnology Cases at the PTAB in 2017 - Throughout the history of inter partes review (IPR) proceedings, petitions have been dominated by challenges to patents directed...more
Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more
As we have previously discussed on this blog, when considering an issue of patentability such as definiteness under section 112, the PTAB and a district court may properly reach opposite conclusions. In Tinnus Enterprises LLC...more
A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This...more