Navigating Clinical Trial Regulations: Strategies for EPO and USPTO Patent Filings
August 07, 2024
WEBINAR
August 07, 2024 10:30 AM — 12:30 PM
The clinical trial landscape is rapidly evolving, with new regulations like the EU Clinical Trials Regulation (EU-CTR) increasing public disclosure requirements. These disclosures can have significant implications for patent and regulatory strategies globally. In this comprehensive webinar, our panel of lawyers from Foley Hoag and Europe's HGF provided multi-disciplinary insights on navigating these challenges in both the U.S. and Europe.
The panelists discussed:
Understanding the impact of clinical trial disclosures on patentability in the U.S. and Europe, including public use and printed publications
Strategies for controlling disclosures, such as utilizing confidentiality agreements and carefully drafting trial protocols and press releases as well as strategies for deferral requests and redactions under the EU-CTR
Timing considerations for patent filings relative to clinical trial disclosures
Leveraging prior art teachings to support non-obviousness arguments
Monitoring competitor activities through public trial databases
Best practices for cross-functional coordination on patent and regulatory strategies
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