NEW YORK and BOSTON, April 16, 2012 /PRNewswire-USNewswire/ -- Duane Morris partners Vincent Capuano, Ph.D., Anthony Fitzpatrick and Laura Vogel will present at American Conference Institute's (ACI) Paragraph IV Disputes Conference, which runs from April 23–25, 2012, in New York City. These three partners are part of a team of Duane Morris lawyers across the country focused on the complexities of bringing generic pharmaceuticals to market.
ACI's 6th Annual Paragraph IV Disputes conference will bring together the leading legal minds in the area of Paragraph IV litigation. Capuano, Fitzpatrick and Vogel, as well as other highly regarded Hatch-Waxman litigators—for both brand 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 April 23, Laura Vogel will participate on a panel discussing "Hatch-Waxman and BPCIA 101—A Primer on IP Basics and Regulatory Fundamentals." This workshop will provide an in-depth review of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA), along with 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 framework underlying each Paragraph IV dispute. They will explore the Hatch-Waxman litigation challenges presented during the main conference, as well as anticipated conundrums under the new BPCIA.
The following day, Anthony Fitzpatrick will moderate a panel on "Prior Art Obviousness and Obvious-Type Double Patenting: Legal Analysis and Practical Applications for Brand Names and Generics." This session will offer both legal analysis and practical applications for understanding obviousness after the Supreme Court's decision in KSR. Panelists will examine the evolving state of the law on obviousness-type double patenting and its impact on Paragraph IV litigation. Discussion topics include possible strategies for invoking and responding to an obviousness challenge, summary judgment assessments, discovery approaches and how to use experts wisely.
Vincent Capuano, Ph.D., presents on the last day of the conference, discussing "New Standards in Inequitable Conduct Post-Therasense: Ethical Considerations for Paragraph IV Cases." This panel will address 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.
Vincent L. Capuano, Ph.D., is the chair of Duane Morris' Hatch-Waxman IP practice group. He focuses on patent law in the chemical and pharmaceutical industries with an emphasis on representing generic pharmaceutical companies filing Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration. Capuano has extensive experience representing pharmaceutical companies in pre-litigation strategic planning and patent litigation. He also counsels clients in all areas of patent procurement, exploitation and enforcement, including domestic and foreign patent preparation and procurement; patent validity and infringement analysis; patent licensing; and due diligences.
Anthony J. Fitzpatrick concentrates on patent and trade secret matters. He is co-chair of the firm's Intellectual Property Litigation Practice. He has litigated matters involving diverse technologies, and has gained particular experience in pharmaceuticals, biologics, medical devices and other life sciences. Fitzpatrick has extensive experience as lead trial counsel in federal and state courts and before arbitral tribunals.
Laura A. Vogel practices IP law with an emphasis on litigating complex patent matters. She is a registered patent attorney representing high-tech and generic pharmaceutical companies in both opinion and litigation matters. Vogel's practice also includes counseling clients on intellectual property strategy; preparing validity, infringement, freedom-to-operate and patentability opinions; carrying out due diligence investigations and evaluating patent portfolios. She has significant experience representing clients in interferences before the United States Board of Patent Appeals and Interferences, as well as in the preparation and prosecution of U.S. and foreign patent applications in the areas of biotechnology; food sciences and molecular and cellular biology; recombinant DNA technology; therapeutic proteins; diagnostic assays; gene therapy; vaccines; and tissue sealant technology.
About Duane Morris' Generic Pharmaceutical Practice
Duane Morris lawyers have significant experience with the complexities involved in bringing generic pharmaceuticals to market. Our lawyers' and registered patent agents' experience involves biotechnology processes and products, chemical processes, synthesis and products, medical devices, formulations and polymorphic products, to name a few. Attorneys at Duane Morris focus on the representation of worldwide generic pharmaceutical companies in their quest to enter the U.S. market with new products. They have significant experience representing clients in litigation related to ANDAs filed under the Hatch-Waxman Act, as well as generation of non-infringement, invalidity and freedom-to-operate opinions with respect to patents listed in the Orange Book.
About Duane Morris
Duane Morris LLP, a full-service law firm with more than 700 attorneys in offices across the United States and around the world, offers innovative solutions to the legal and business challenges presented by today's evolving global markets.
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