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?
Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...more
The Federal Circuit’s March 21, 2025 decision in Maquet Cardiovascular LLC v. Abiomed Inc. et al. (No. 2023-2045) and the recent Patent Trial and Appeal Board (PTAB) Delegated Rehearing Panel decision in SynAffix B.V. v....more
The United States Court of Appeals for the Federal Circuit recently affirmed a district court ruling that a pharmaceutical dosing claim limitation was unpatentable due to obviousness-type double patenting. The court found...more
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
GLP-1 receptor agonists (GLP-1RAs) were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health...more
Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more
Since President Biden's July 2021 executive order directing the FDA Commissioner to collaborate with the PTO on potential misuse of the patent system, I've been skeptical as to whether such efforts will have any impact on the...more
In a final written decision of an inter partes review proceeding, the Patent Trial and Appeal Board found all 12 claims of a challenged patent unpatentable as either anticipated or obvious. Each ground of unpatentability...more
Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. The Supreme Court emphasized “the need...more
Almost four years ago, in a relatively rare occurrence based on there being an insufficient factual record to permit proper appellate review, the Federal Circuit vacated a District Court decision rendering invalid the claims...more
On February 10, in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed a district court’s holding that Adapt’s methods of treatment of opioid overdose is invalid as obvious. The...more
BELCHER PHARMACEUTICALS v. HOSPIRA, INC. Before Reyna, Taranto, and Stoll. Appeal from the District of Delaware. Summary: A patentee committed inequitable conduct by advancing an argument during patent prosecution...more
You’ve thought long and hard about how your company’s clinical stage invention is novel over anything that’s ever been done before. Your analysis is finished, right? Not even close. The novelty barrier to patentability can be...more
Congratulations! Your team has made a critical discovery based on its analysis of your company’s clinical data. You want to file a patent application so that your company can secure patent rights for that discovery. Simple,...more
In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this...more
Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more
On January 22, the Supreme Court clarified an important issue of patent law that had been left open since the enactment of the America Invents Act several years ago. ...more
The Decision: The French Cour de cassation, in a case concerning a dosage regime patent, recently clarified the "plausibility" requirement, an element of sufficiency of disclosure or inventive step. The Result: The wording...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
Addressing enablement and written description issues in the context of a priority challenge, the Patent Trial and Appeal Board (PTAB or Board) found that the challenged claims were not entitled to the benefit of the parent...more
When does a prior art disclosure of a concentration range of a medicament render obvious the use of a species that falls within that range, when that same use was also known in the prior art? After all, common sense should...more