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
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
12/27/2024
/ Artificial Intelligence ,
FDA Approval ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Post-Market Approval ,
Regulatory Agenda
On December 11, 2024, the French High Council for Literary and Artistic Property ("CSPLA") published a report on the implementation of the European regulation on artificial intelligence ("AI"), focusing on the transparency of...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
12/16/2024
/ Artificial Intelligence ,
Breach Notification Rule ,
Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Data Breach ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Telehealth ,
Telemedicine
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
On September 19, 2024, California adopted the California AI Transparency Act ("SB 942") to create transparency mechanisms that allow consumers to determine whether an "image, video, or audio content, or content that is any...more
The Patent Trial and Appeal Board (PTAB) in an inter partes review: Keysight Technologies, Inc. and Palo Alto Networks, Inc. v. Centripetal Networks, LLC found a rule set file used by a network security program to be a...more
The USPTO has extended the public comment deadline in order to afford all stakeholders an opportunity to weigh in on the subject matter eligibility of AI inventions....more
9/23/2024
/ Artificial Intelligence ,
Comment Period ,
Deadlines ,
Innovative Technology ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Machine Learning ,
Patent Applications ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Public Comment ,
USPTO
The Situation: In early 2023, the U.S. Copyright Office ("Office") launched a new initiative to examine the intersection of copyright law and artificial intelligence ("AI"). Later that year, the Office issued Registration...more
The Situation: Concerns that uncertain and unpredictable patent subject matter eligibility jurisprudence thwarts U.S. economic and technological advancements are especially acute in the fast advancing AI space. Stakeholders...more
The PTAB recently updated its Standard Operating Procedure 1 (SOP), which describes the process and guidelines for assigning judges to panels in all jurisdictions of the Board. This blog post highlights some of the key...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
7/22/2024
/ Algorithms ,
Artificial Intelligence ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Digital Health ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Personal Data ,
Pharmacies ,
Popular ,
Telemedicine
Following similar decisions in other countries, a Japanese court held for the first time on May 16, 2024, that an inventor in the Patent Act is limited to a natural person and does not include an artificial intelligence...more
On May 17, 2024, Colorado enacted S.B. 24-205 (the "Act"), which imposes a duty of reasonable care on developers and deployers of high-risk artificial intelligence ("AI") systems to protect consumers from risks of algorithmic...more
On April 19, 2024, the USPTO issued a Notice of Proposed Rulemaking (the “Notice”) regarding discretionary denial in post-grant proceedings and other issues. The Notice addresses stakeholder feedback responsive to the...more
5/3/2024
/ Comment Period ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Notice of Proposed Rulemaking (NOPR) ,
Patent Ownership ,
Patents ,
Petition for Review ,
Post-Grant Review ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
USPTO
The USPTO is seeking public input on whether prior art must be authored by humans and how, if at all, AI-generated disclosures should be treated differently from non-AI generated disclosures....more
The USPTO's April 11, 2024, guidance clarifies how existing USPTO rules apply to the use of AI by practitioners when interacting with the USPTO....more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
3/20/2024
/ Consent ,
Data Privacy ,
Data Security ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
OCR ,
Personal Information ,
Popular ,
Risk Management ,
Telehealth
The Patent Trial and Appeal Board (PTAB) in Videndum Production Solutions, Inc. v. Rotolight Limited (IPR2023-01219), recently denied a petition for inter partes review (IPR) of a patent on a lighting system and control for...more
Recently, the Court of Appeals for the Federal Circuit reversed one and vacated another Patent Trial and Appeal Board (“PTAB”) final written decision in which the PTAB determined that Weber Inc. (“Weber”) failed to...more
The Background: In response to the Biden administration's "Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence" on October 30, 2023, the U.S. Patent and Trademark Office...more
2/19/2024
/ Artificial Intelligence ,
Biden Administration ,
Executive Orders ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Joint Inventors ,
New Guidance ,
Patent Act ,
Patent-Eligible Subject Matter ,
Patents ,
Popular ,
Public Comment ,
USPTO
USPTO Director Katherine K. Vidal issued guidance on February 6, 2024 regarding the use of AI in drafting materials submitted to the USPTO’s administrative boards, including the PTAB. Of biggest concern in the guidance is...more
On November 16, 2023, USPTO Director Kathi Vidal ordered a Delegated Rehearing Panel (“DRP”) to review whether the PTAB misapprehended or overlooked certain issues when denying challenger SynAffix B.V.’s petition for inter...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more
11/27/2023
/ Artificial Intelligence ,
California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Data Privacy ,
Data Security ,
DEA ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Popular ,
Public Health ,
Telehealth