The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
1/15/2025
/ Artificial Intelligence ,
Comment Period ,
Compliance ,
Data Management ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management
AI is vaulting drug discovery forward leaps and bounds—and now regulators are beginning to catch up, with the United States Patent and Trademark Office recently issuing new guidelines on the patentability of AI-assisted...more
Inventors are generally counseled to file a patent application as soon as they have a patentable invention to avoid potential forfeiture of important rights in today’s first inventor-to-file system. However,...more
Written Description of Therapeutic Efficacy -
In two 2019 rulings, the Federal Circuit invoked the “written description requirement” of 35 U.S.C. § 112 to require evidentiary support for therapeutic efficacy. Now that the...more
2/24/2021
/ Appeals ,
Copyright ,
Defend Trade Secrets Act (DTSA) ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Misappropriation ,
Patent-Eligible Subject Matter ,
Pharmaceutical Patents ,
Section 101 ,
Social Media ,
Trade Secrets ,
USPTO ,
Written Descriptions