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 will provide multi-disciplinary insights on navigating these challenges in both the U.S. and Europe.

The panelists will discuss:

·    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

Don’t miss this opportunity to gain valuable insights into managing clinical trial disclosures and maximizing patent protection for your innovative pharmaceutical products.

Register

Time: 10:30 AM – 12:30 PM ET | 5:30 – 7:30 PM WEST | 3:30 PM – 5:30 PM BST

CLE credit for this course is available in New York and California. This program is offering 2.0 Skills CLE credits in NY, and 2.0 General CLE credits in CA. The program is appropriate for both newly admitted attorneys and experienced attorneys. Please note that CLE credit is only valid for live attendance. At this time, we are not able to provide credit for recorded views. Please contact us for details regarding CLE.