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Current Issues in ANDA and other Pharmaceutical Patent Litigation

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DESCRIPTION

Personal jurisdiction in abbreviated new drug application (ANDA) litigation may be restricted after the U.S. Supreme Court’s decision in Daimler v. Bauman. ANDA plaintiffs rely upon general jurisdiction. In the past, this has been just about anywhere the company is regularly conducting business – even unrelated to the subject matter of the lawsuit. Daimler appears to limit general jurisdiction to the state of incorporation or the company’s principal place of business.

The faculty presenting this program will also address how defendants Teva (Copaxone), Lupin (Antara), Anesta (Amrix), and Astra Zeneca (Nexium) – who have won at the trial level – have been enjoined pending appeal in case there is a reversal; how Novozymes A/S v. DuPont Nutrition Biosciences APS has rekindled debate over the propriety of functional claiming in biotechnology inventions and the implications of the written description requirement under 35 U.S.C. § 112; and the vitality of the 2004 Noelle v. Lederman “antibody exception,” offering a forecast for biotechnology claim drafting practices, particularly with respect to biologics and biosimilars.

Also discussed will be Hoffmann-LaRoche v. Apotex, in which the Federal Circuit noted that evidence supporting invalidity under an obvious-to-try standard was properly considered as of patent’s filing date and overcame evidence generated after the filing date that in fact demonstrated unexpected results.

Educational Objectives:
• Hear an analysis of important rapidly changing jurisdictional, validity and relief topics.
• Understand personal jurisdiction in ANDA litigation.
• Learn about specific cases that have recently been decided or are pending in the courts.

Who would benefit most from attending this program?
Intellectual property practitioners, especially those involved in pharmaceutical patent litigation.

SPEAKERS

A. NEAL SETH, PARTNER, WILEY REIN LLP

Neal Seth, a partner with Wiley Rein, focuses his practice on patent litigation and appeals. He provides a thoughtful, detailed analysis of the matters facing his clients and keeps his eye on the clients’ final goals. Beyond his litigation practice, Mr. Seth advises on patent prosecution and portfolio matters, providing comprehensive opinions of counsel and effectively settling disputes to support his clients’ interests.

Mr. Seth earned a J.D. from The George Washington University Law School and a B.S. from Cornell University. He is admitted to practice in the District of Columbia and Virginia as well as before the U.S. Supreme Court, the U.S. Courts of Appeals for the Fourth and Federal Circuits, the U.S. District Court for the Eastern District of Virginia, and the U.S. Patent and Trademark Office.


LAWRENCE M. SUNG, PARTNER, WILEY REIN LLP

Lawrence Sung, a partner with Wiley Rein, is a registered patent attorney with a Ph.D. in microbiology. He has more than 20 years of experience in biotechnology, medical device, and pharmaceutical (small molecule and biologics) patent counseling, litigation, and technology transfer. Having served on several professional school faculties, he is also a recognized intellectual property law scholar.

Dr. Sung earned a J.D., cum laude, from American University Washington College of Law, a Ph.D. from the Uniformed Services University of the Health Sciences, and a B.A. from the University of Philadelphia. He served as Federal Circuit Editor for The American University Law Review and clerked for the Honorable Raymond C. Clevenger III, U.S. Court of Appeals for the Federal Circuit. Dr. Sung is admitted to practice in the District of Columbia and Pennsylvania as well as before the Supreme Court for the District of Columbia and Federal Circuits, the U.S. District Court for the District of Columbia, and the U.S. Patent and Trademark Office.


JAMES H. WALLACE, JR., PARTNER, WILEY REIN LLP

James Wallace, a partner with Wiley Rein, has more than 30 years of experience litigating patents in the fields of communications satellites, data transmission, network interface devices, Internet business methods, pharmaceuticals, biotechnology, and semiconductors. A founding partner of the firm, he was named by Legal Times as a “Leading Intellectual Property Attorney” and recognized as one of the “Best Lawyers in America” in intellectual property law. Mr. Wallace also is rated by Chambers USA as one of Washington, D.C.’s “Leading Lawyers” in his field.

Mr. Wallace earned a J.D. from Georgetown University Law Center and a B.S.E.E. from the University of South Carolina, where he was a member of Tau Beta Pi, Eta Kappa Nu, and Pi Mu Epsilon. He served as Associate Editor for the Georgetown Law Journal. Mr. Wallace is admitted to practice in the District of Columbia as well as before the U.S. Supreme Court; the U.S. Courts of Appeals for the Fourth, Fifth, Sixth, Eighth, Ninth, Eleventh, Federal and District of Columbia Circuits; the U.S. District Courts for the District of Columbia, Eastern District of Arkansas, Eastern District of Texas, Eastern District of Wisconsin, Northern District of California, Western District of Arkansas and Western District of Michigan; the U.S. Court of Federal Claims; the U.S. Court of International Trade; the U.S. Patent and Trademark Office; and the District of Columbia Court of Appeals.


ERIC H. WEISBLATT, PARTNER, WILEY REIN LLP

Eric Weisblatt, a partner with Wiley Rein, has more than 30 years of experience litigating patents in all fields of scientific endeavor before the federal district courts and the Court of Appeals for the Federal Circuit.

Mr. Weisblatt earned a J.D., cum laude, from Boston College Law School and a B.A. from Johns Hopkins University. He is admitted to practice in the District of Columbia and Virginia as well as before the U.S. Supreme Court, the U.S. Courts of Appeals for the Fourth and Federal Circuits, the U.S. District Courts for the Eastern District of Virginia and Eastern District of Wisconsin, and the U.S. Patent and Trademark Office.


ANDREW ZOLTAN, SENIOR COUNSEL, SHIONOGI INC.

Andrew Zoltan is Senior Counsel – Intellectual Property and Litigation to Shionogi Inc., where he manages all litigation including I.P., contract, and employment matters. He is also responsible for the company’s global I.P. portfolio and evaluating I.P. aspects of potential licensing and acquisition opportunities. Prior to joining Shionogi, Mr. Zoltan was a Senior Associate in WilmerHale’s Intellectual Property Litigation group. Before law school, he spent seven years at Wyeth Research developing formulations and analytical methods for vaccines and protein-based therapeutics.

Mr. Zoltan earned a J.D., magna cum laude, from George Mason University School of Law, an M.P.H. from Tufts University School of Medicine, and a B.S. from the College of William and Mary. He is admitted to practice in New York and Massachusetts as well as before the U.S. Patent and Trademark Office and the U.S. District Court for the District of Massachusetts.