Innovators are flagging concerns over clinical trials being used against them as prior art in the district courts and IPR. In Salix Pharms., Ltd. v. Norwich Pharms. Inc., the federal circuit upheld a district court decision to invalidate method of treatment claims for obviousness, making it an important time to discuss best practices for managing disclosures and protecting IP.

• Distinguishing between publication of clinical trials and how that creates publication-based prior art; and whether the clinical trial itself is public-use prior art
• Determining whether patient confidentiality and other confidentiality agreements amongst clinical investigators eliminates the public use prong of prior art
• Examining how generics are using clinical trial summaries as evidence of obviousness to challenge patents through IPR and the district courts
• Understanding how patent examiners view clinical trials published on ClinicalTrials.gov
• Reconciling IP protection with FDA disclosure rules for clinical trials
• Devising filing strategies to maximize patent term while managing risk of invalidation
• Considerations for dosing regimen patents
• Reviewing the Federal Circuit’s analysis of:
• Janssen v. Teva, Salix v. Norwich Pharms. Inc., Vanda Pharms. Inc. v. Teva Pharms. USA Inc.
• Determining if an ongoing clinical trial can be connected to a reasonable expectation of success in the unpredictable arts