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?
The August 2025 edition of our Texas Round-Up focuses on developments in cases involving pharmaceutical and medical device products....more
In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products...more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more
(December 27, 2023) Natera Inc. succeeded in obtaining a preliminary injunction against NeoGenomics Laboratories, Inc.’s medical assay test. Natera’s ongoing federal lawsuit alleges that NeoGenomics’ product “RaDaR,” a tumor...more
Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more
IP rights can be vital to the success of medical device companies. Significant legislative changes governing some of these rights may be on the horizon. Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and...more
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more
Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more
Objective Evidence in Determining Obviousness - In Medtronic, Inc. v. Teleflex Innovations, Appeal No. 21-2357, the Federal Circuit held that a close prima facie case of obviousness can be overcome by strong evidence of...more
In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the Federal Circuit reversed an obviousness determination by the PTAB. At issue was Sanofi’s reissued U.S. Patent No. RE47,614 (the ’614 patent),...more
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS - Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board. Summary: A close prima facie case of obviousness can be overcome by strong evidence of objective...more
Be careful of showing your claimed inventions at tradeshows. On February 15, 2023, the Federal Circuit (“CAFC”) affirmed a summary judgment ruling that, by merely showcasing an embodying device at an industry event (the...more
This is an appeal from a District of Delaware summary judgment order that held that the asserted claims of U.S. Patent No. 9,186,208 (the ’208 Patent) are anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b). ...more
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more
A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more
On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit alleged that St. Jude Medical S.C....more
NIAZI LICENSING CORPORATION v. ST. JUDE MEDICAL S.C., INC. Before Taranto, Bryson, and Stoll. Appeal from the U.S. District Court for the District of Minnesota. Summary: Providing examples in the claim language and...more
PureWick Corp., a Becton Dickinson company, succeeded in its infringement lawsuit PureWick Corp. v. Sage Products LLC. PureWick’s lawsuit alleged that Sage Products infringed U.S. Patent Nos. 10,226,376; 10,390,989;...more
Rasmussen Instruments, LLC (“Rasmussen”) won a $20M jury verdict against DePuy Synthes (“Depuy”), a part of Johnson & Johnson Medical Devices Companies. Rasmussen asserted Patent Nos. US 9,492,180 (‘180 patent) and US...more
On February 10, 2022, in Junker v. Medical Components, Inc., the U.S. Court of Appeals for the Federal Circuit reversed the Eastern District of Pennsylvania’s grant of summary judgment of no invalidity under the “on-sale bar”...more
UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...more
On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled...more
On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.” ...more