ACI 22nd Annual Paragraph IV Conference

Axinn partner Aziz Burgy and counsel Ricardo Camposanto will speak at American Conference Institute's Paragraph IV Disputes Conference, being held April 21-22 in New York. 

On April 22, Aziz will speak on the “Ethical Rules and Obligations for the Paragraph IV Practitioner: A Scenario Based Discussion on Professional Responsibility and the Dilemmas that Can Arise" panel. Panelists will discuss: 

• Flagging examples of inequitable conduct
• Navigating client communication
• Finding a balance between client interests and expectation and ethical obligations
• Reviewing what constitutes a Rule 11 violation

On April 22, Ricardo will speak on the "Promise and Peril for Patents: Navigating Mandated Disclosures and Clinical Trials as Prior Art" panel. Panelists will discuss: 

• Clarifying whether the clinical trial itself is public-use-prior-art

• Determining whether patient confidentiality and other confidentiality agreements amongst clinical investigators eliminate 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

• Navigating the tension between FDA disclosure rules for clinical trials and IP protection

• Understanding how patent examiners view clinical trials published on ClinicalTrials.gov

• Analyzing the Federal circuit’s assessment of the phrase "clinically proven effective” as support for patent claims in Bayer v. Mylan

• Devising filing strategies to maximize patent term while managing risk of invalidation

• Strategizing around dosing regimens that are disclosed prior to efficacy data

• Assessing how the district courts and CAFC have dealt with ongoing clinical trials and whether there is a reasonable expectation of success in the unpredictable arts