AI-llowed or Infringing? Are AI Research Tools Protected Under the Safe Harbor?

As artificial intelligence (AI) continues to transform pharmaceutical and medical device innovation, legal questions may emerge around its role in preclinical and regulatory research. The statutory safe harbor under 35 U.S.C. § 271(e)(1) has long shielded pharmaceutical and medical device developers from patent infringement liability when using patented inventions for activities reasonably related to the development and submission of information to the U.S. Food and Drug Administration (FDA). Research tools are typically excluded from such protection, but it is unclear whether AI-enabled research tools that require FDA approval may be treated any differently.

Join us to learn about:

• The evolving FDA framework governing the regulation of AI-enabled tools, including as used in drug development and for treatment and diagnostic uses
• How courts have historically treated research tool inventions and the current legal tension surrounding their inclusion within the safe harbor
• Whether AI-enabled tools, particularly those regulated by the FDA, might be afforded similar protection
• Insights into the boundaries of the safe harbor and the implications for clients developing or relying on AI in regulated life sciences research