The Evolving Life Sciences IP Rulebook: Tracking Congress, the USPTO and FDA

The rules governing life sciences innovation are increasingly being shaped across multiple fronts. Congress continues to consider legislation affecting patents and biopharmaceutical competition, while the USPTO and FDA are pursuing policies and initiatives that can materially alter patent protection, regulatory strategy and market entry. For companies investing billions in products with development timelines measured in years or decades, changes in any one part of this interconnected system can have consequences far beyond their stated purpose.

This panel will track the most consequential legislative and agency developments affecting life sciences IP, including patent eligibility for diagnostics and genetic technologies; congressional scrutiny of patent families and so-called patent thickets; skinny labels; FDA-USPTO coordination and concerns over allegedly inconsistent submissions; proposals affecting generic and biosimilar market entry; and efforts to protect valuable biological intellectual property from foreign adversaries. Panelists will separate proposals from likely changes and consider what developments life sciences companies should be watching most closely.