On January 9, 2026, the USPTO designated a Director decision in IPR2025-00258 as precedential, offering guidance on when the Patent Trial and Appeal Board (PTAB) will exercise its discretion to deny institution of inter...more
5/14/2026
/ Denial of Institution ,
Inter Partes Review (IPR) Proceeding ,
Joinder ,
Litigation Strategies ,
New Guidance ,
Parallel Proceedings ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Stays ,
USPTO
On 10 March 2026, the European Parliament ("EP") adopted a Resolution titled "Copyright and Generative Artificial Intelligence – Opportunities and Challenges" (the "EU Resolution"); on 18 March, 2026, the UK Government...more
5/5/2026
/ AI Act ,
Artificial Intelligence ,
Copyright ,
Copyright Infringement ,
EU ,
France ,
Intellectual Property Protection ,
Machine Learning ,
New Legislation ,
Popular ,
Proposed Legislation ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Transparency ,
UK
2025 was an incredibly busy year for digital health, and 2026 is likely to be no different. This edition of Vital Signs covers numerous developments, along with a look to 2026 in Industry Insights. Thank you to our Jones Day...more
2/10/2026
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicare ,
New Legislation ,
Request For Information ,
State and Local Government ,
Telehealth
On December 23, 2025, the U.S. Department of Health and Human Services ("HHS") issued a request for information ("RFI") seeking input on ways it could accelerate the adoption and use of AI as a part of clinical care,...more
2/10/2026
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Emerging Technologies ,
Health Care Providers ,
Healthcare ,
Innovation ,
Payment Systems ,
Regulatory Reform ,
Regulatory Requirements ,
Request For Information ,
Research and Development
EMA and FDA have jointly issued guiding principles for the safe and responsible use of AI across the medicines life cycle, aiming to harmonize the path for drug developers using AI-driven programs to advance innovation that...more
On January 9, 2026, USPTO Director John A. Squires designated four recent discretionary-denial rulings as precedential and nine more as informative, formalizing a developing framework for how and when the Office will exercise...more
1/22/2026
/ America Invents Act ,
Claim Construction ,
Denial of Institution ,
Inter Partes Review (IPR) Proceeding ,
Joinder ,
Parallel Proceedings ,
Patent Trial and Appeal Board ,
Patent Validity ,
Precedential Opinion ,
Time-Barred Claims ,
USPTO
New guidance rescinds Biden-era guidance from February 2024 and signals a pro-patent, pro-AI landscape.
On November 28, 2025, the United States Patent and Trademark Office ("USPTO") published revised guidance on...more
12/8/2025
/ Artificial Intelligence ,
Biden Administration ,
Executive Orders ,
Intellectual Property Protection ,
Inventors ,
New Guidance ,
Patent Applications ,
Patent Examinations ,
Patents ,
Regulatory Reform ,
Trump Administration ,
USPTO
The Patent Trial and Appeal Board (PTAB) has designated as precedential a decision that squarely reaffirms the statutory requirement to identify all real parties in interest (RPI) in AIA petitions. By elevating Corning...more
12/1/2025
/ America Invents Act ,
Disclosure Requirements ,
Filing Requirements ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
National Security ,
Patent Litigation ,
Patent Trial and Appeal Board ,
PTAB Precedential Opinion Panel (POP) ,
Regulatory Requirements ,
Statutory Interpretation ,
USPTO
California's new Transparency in Frontier Artificial Intelligence Act creates the nation's first standardized safety disclosure framework for frontier AI models. On September 29, 2025, Governor Newsom signed the Transparency...more
10/27/2025
/ Artificial Intelligence ,
California ,
Disclosure Requirements ,
Innovative Technology ,
Machine Learning ,
New Legislation ,
Regulatory Requirements ,
Reporting Requirements ,
Risk Management ,
Transparency ,
Whistleblowers
Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Supply Chain ,
Tariffs ,
Trump Administration
On July 9, 2025, the European Parliament's Committee on Legal Affairs ("JURI") published a study examining how generative artificial intelligence ("AI") interacts with European Union copyright law....more
8/14/2025
/ AI Act ,
Artificial Intelligence ,
Copyright ,
Court of Justice of the European Union (CJEU) ,
Data Mining ,
EU ,
Innovative Technology ,
Intellectual Property Protection ,
IP License ,
Machine Learning ,
Regulatory Reform ,
Training
The European Union's Artificial Intelligence Act ("AI Act") establishes a comprehensive, risk-based regulatory framework including provisions relating to general-purpose AI ("GPAI") models that apply as from 2 August 2025. In...more
8/6/2025
/ Artificial Intelligence ,
Copyright ,
EU ,
European Commission ,
Innovative Technology ,
Machine Learning ,
New Legislation ,
Popular ,
Regulatory Requirements ,
Risk Management ,
Transparency
On May 1, 2025, the Patent Trial and Appeal Board (PTAB) denied institution of inter partes review (IPR) of U.S. Patent No. 11,140,841 in the case of Aardevo North America, LLC v. Agventure B.V. The patent in question, owned...more
7/10/2025
/ Agribusiness ,
Agricultural Sector ,
Denial of Institution ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art
Federal courts continue to address whether training artificial intelligence ("AI") models on copyrighted materials without a license constitutes copyright infringement....more
7/1/2025
/ Algorithms ,
Artificial Intelligence ,
Books ,
Copyright ,
Copyright Infringement ,
Copyright Litigation ,
Fair Use ,
Innovative Technology ,
Intellectual Property Protection ,
Machine Learning ,
Training ,
Transformative Use
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
6/4/2025
/ Artificial Intelligence ,
Clinical Trials ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Drug Pricing ,
Executive Orders ,
FDA Approval ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Telehealth
To address the legal issues presented by artificial intelligence ("AI"), the U.S. Copyright Office ("Office") launched a multi-part Copyright and Artificial Intelligence Report ("Report") (see our Commentaries on Part One and...more
5/27/2025
/ Algorithms ,
Artificial Intelligence ,
Copyright ,
Copyright Infringement ,
Copyright Litigation ,
Copyright Office ,
Fair Use ,
Government Agencies ,
Innovative Technology ,
Intellectual Property Protection ,
Machine Learning ,
New Guidance
In two recent decisions, the Patent Trial and Appeal Board (PTAB) denied institution of inter partes review (IPR) proceedings sought by Apple Inc. against Haptic, Inc. regarding U.S. Patent No. 9,996,738 B2. These...more
5/9/2025
/ Apple ,
Claim Construction ,
Inter Partes Review (IPR) Proceeding ,
Litigation Strategies ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Stays
The Office of Management and Budget releases highly anticipated guidance to federal agencies on the use and deployment of artificial intelligence and how to manage its risks....more
5/7/2025
/ Artificial Intelligence ,
Executive Orders ,
Federal Contractors ,
Government Agencies ,
Machine Learning ,
National Security ,
New Guidance ,
OMB ,
Regulatory Requirements ,
Risk Management ,
Technology Sector ,
Trump Administration
Back in May of 2020, European patent-licensing company Sisvel filed a flurry of lawsuits against a dozen tech companies who had allegedly infringed Sisvel’s portfolio of wireless communication and networking patents. A...more
3/12/2025
/ Appeals ,
Claim Construction ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
USPTO ,
Wireless Industry ,
Wireless Technology
The European Union's Artificial Intelligence Act ("AI Act"), the world's first comprehensive legal framework on AI, entered into force on August 1, 2024. The AI Act sets out staggered compliance deadlines for the various...more
There are numerous actions currently pending in federal courts that involve artificial intelligence ("AI") and copyright law. Among other things, courts must determine if infringement occurs when an AI is trained on...more
2/26/2025
/ Artificial Intelligence ,
Copyright ,
Copyright Infringement ,
Copyright Litigation ,
Fair Use ,
Intellectual Property Protection ,
Legal Research ,
Legal Training ,
Machine Learning ,
Thomson Reuters ,
Westlaw
Artificial intelligence ("AI") raises unique challenges in the context of copyright law. To address and clarify various issues arising at the intersection of AI and copyright, the U.S. Copyright Office ("Office") is in the...more
The European Commission has released a new template for summarizing training data used in general-purpose artificial intelligence ("AI") models, as part of its broader AI regulatory framework....more
The U.S. Patent and Trademark Office (USPTO) recently released its Fiscal Year 2024 roundup for the Patent Trial and Appeal Board (PTAB) America Invents Act (AIA) proceedings. This comprehensive report provides valuable...more
1/17/2025
/ America Invents Act ,
Corporate Counsel ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Inventions ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Settlement ,
USPTO
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more