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?
It is well established that an enantiomerically pure compound exhibiting advantageous properties not present in its isomer or its corresponding racemic mixture, can be patented even if its corresponding racemic mixtures are...more
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
For many, the journey to IP law is circuitous. And that’s undoubtedly true for Wolf Greenfield Shareholder Dan Young and Technology Specialist Colin White. Both had interesting careers outside of the legal industry before...more
Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more
In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin. Cast21’s device seeks...more
When it comes to product development, the management of third-party intellectual property (IP) to ensure freedom to operate is of paramount importance. Drug development is no different. Imagine investing years of research,...more
The Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s long-standing requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions...more
Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more
The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...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
AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC., Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Evidence of generic industry skepticism cannot, by itself, form...more
In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s...more
The recently reversed jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno...more
Patent and trademark issues effecting pharmaceutical laboratories, biotechs, food supplements and dietary products professionals, cosmetics companies and medical devices manufacturers is continually evolving across France and...more
Striking a blow to patent applicants seeking to assert inventorship by artificial intelligence (“AI”) systems, the U.S. District Court for the Eastern District of Virginia ruled on September 3, 2021 that an AI machine cannot...more
On August 23rd, the Federal Circuit upheld in part and reversed in part a decision from the Patent Trial and Appeal Board’s (PTAB or Board) concerning Ethicon’s patent on a robotic surgical tool, holding that the Board’s...more
The question whether an artificial intelligence (“AI”) system can be named as an inventor in a patent application has obvious implications for the life science community, where AI’s presence is now well established and...more
Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more
The U.S. Patent and Trademark Office (USPTO) allows a patent applicant to pay reduced fees if it qualifies as a “small entity.” Many types of filing fees are reduced by 50%. These savings can be important for companies on a...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
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more