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Events

Duane Morris Partners Vincent Capuano, Robert Gould and Richard Ruzich to Present at American Conference Institute's 5th Annual Paragraph IV Disputes Conference

May 2, 2011 | New York City | Marriott Downtown

Duane Morris partners Vincent L. Capuano, Ph.D., Robert M. Gould, Ph.D., and Richard T. Ruzich will be presenters at the American Conference Institute's fifth annual Paragraph IV Disputes Conference, to be held on May 3-4, 2011, in New York City. Pre-conference workshops will be held on May 2.

Dr. Gould will be conducting a pre-conference workshop on Monday, May 2, at 1:45 p.m. on the topic of "Patent and Non-Patent Exclusivity." This workshop will explore the following:

• Patent exclusivity v. non-patent, i.e., regulatory exclusivity
• The concept of market exclusivity under the Hatch-Waxman Act
• Understanding which drug products are eligible for regulatory exclusivity
• Market exclusivity for biosimilars as defined by BPCIA
• The different modes and methods of regulatory exclusivity (non-patent) for small molecule drugs
• What role does the FDA play in regulating these modes of exclusivity?

Mr. Ruzich will speak on the topic of "Invalid or Will Not Be Infringed": Reassessing the ANDA Applicant's Pre-Litigation Considerations and Obligations Under Paragraph IV vis-á-vis Microsoft v. i4i" on Tuesday, May 3, at 9:30 a.m. Topics to be discussed in this session include comprehending the initial obligations of the ANDA applicant under Paragraph IV, reexamining the standard of invalidity in view of Microsoft v. i4i, demystifying the ANDA applicant's Orange Book strategy, understanding the role of non-Orange Book patents in your Paragraph IV ANDA strategies, procuring legal opinions on invalidity and noninfringement, attempting to influence where and when the suit will occur, and contents of the Paragraph IV certification.

Dr. Capuano will participate in a panel discussion on the topic, "New Standards and Controversies in Double Patenting Type Obviousness: Repercussions for Paragraph IV Challenges," on Tuesday, May 3, at 10:45 a.m. The panelists will analyze the evolving state of the law on double patenting type obviousness and its impact on Paragraph IV litigation strategies, examining cases such as Sun Pharm. Indus. v. Eli Lilly & Co. and Boehringer Ingleheim Int'l, et al. v. Barr Labs, Inc., et al..

About the Paragraph IV Disputes Conference

American Conference Institute's Paragraph IV Disputes conference is the undisputed source for Hatch-Waxman litigation strategies for brand-names and generics. This event—which is widely recognized for setting the standards for Paragraph IV litigation and which also serves as the annual meeting place for the "who's who" of pharmaceutical patent litigation—is now the single forum on which brand name and generic companies can rely for answers during this turbulent time in which the balance of power designed by the Hatch-Waxman Act may completely unravel. Come to this conference and get the up-to-the minute information that you need to prepare for the new litigation confrontations to come.

For more information or to register to attend, please visit the American Conference Institute website.