Events
Duane Morris Partners Vincent Capuano, Anthony Fitzpatrick and Laura Vogel to Participate at the American Conference Institute's Paragraph IV Disputes Conference
April 23, 2012 | New York City
| New York Marriott Downtown
  
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Duane Morris partners Vincent Capuano, Anthony Fitzpatrick and Laura Vogel all will be participants in the American Conference Institute's (ACI) Paragraph IV Disputes Conference, which runs from Monday, April 23, 2012 through Wednesday, April 25, 2012, in New York City. The three partners are among the Duane Morris lawyers focused on the complexities involved in bringing generic pharmaceuticals to market. Brand name and generic pharmaceutical companies are beginning to feel the initial impact of the patent cliff: the pecuniary perils of patent loss and the economic consequences associated with the decline of Hatch-Waxman market exclusivity. As a result, the industry has entered an era of "extreme" Paragraph IV litigation where the monetary ante has never been higher. ACI's 6th Annual Paragraph IV Disputes conference will help attendees respond to the challenges of this new era, and provide access to the leading legal minds in this area. Highly regarded Hatch-Waxman litigators—for both brand names and generics— will address industry-shaping topics such as: the impact of the AIA on Hatch-Waxman litigation; carve-outs, use codes and labeling; claim construction; prior art obviousness; inducement of infringement and divided infringement; inequitable conduct; and damages. On Monday, April 23, Laura Vogel will be a panelist discussing "A Hatch-Waxman and BPCIA 101—A Primer on IP Basics and Regulatory Fundamentals." This hands-on workshop will provide attendees with an in-depth review of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as well as other IP and regulatory basics relative to small molecules and biologics. The workshop leaders will lay the foundation for thoroughly understanding the dynamics of the IP and regulatory backdrop underlying each Paragraph IV dispute. They will explore the complexities of the Hatch-Waxman litigation challenges presented during the main conference as well as anticipated conundrums under the biosimilar schematic. Points of discussion will include: |
- Regulatory Essentials Relative to Hatch-Waxman
- Rx Drugs (new drugs)
- IP Protection for Drugs and Biologics
- Drugs
- Biologics
- The Pharmaceutical Patent Endgame: Hatch-Waxman Explained
- Trademark and Trade Dress Issues
The following day, Anthony Fitzpatrick will be serving as the moderator for "Prior Art Obviousness and Obvious-Type Double Patenting: Legal Analysis and Practical Applications for Brand Names and Generics." This panel will provide both legal analysis as well as practical applications for understanding KSR and its impact. Panelists will examine questions of 'secret prior art' and 'inherent anticipation' and also analyze the evolving state of the law on obviousness-type double patenting and its impact on Paragraph IV litigation. Discussion also includes possible strategies for invoking and responding to an obviousness challenge; summary judgment assessments; discovery approaches; and how to use experts wisely.
Vincent Capuano presents on the last day of the conference, discussing "New Standards in Inequitable Conduct Post-Therasense: Ethical Considerations for Paragraph IV Cases." Panelists will examine the possible consequences of the Federal Circuit's tightening of the inequitable conduct standard in Therasense and how the decision may be applied in a Paragraph IV scenario. Discussion will also cover the relationships between inequitable conduct and corporate fraud, and inequitable conduct and patent reform.
For more information, or to register, please visit the ACI website.
