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Hatch-Waxman Patent Settlements in the Aftermath of FTC v. Actavis

Hatch-Waxman Patent Settlements in the Aftermath of FTC v. Actavis
Product Code - LGA166
Speaker(s): James N. Czaban, Wiley Rein LLP; Steven G. Bradbury, Dechert LLP
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The U.S. Supreme Court’s recent decision in Federal Trade Commission v. Actavis addressed the question of whether so-called “reverse payment” or “pay for delay” settlements of Hatch-Waxman patent cases are subject to judicial review under the antitrust laws. To the dismay of both innovator and generic pharmaceutical companies, the Court’s ruling has now unshackled the FTC, as well as private plaintiffs, to pursue antitrust cases against brand and generic drug companies under the amorphous ‘‘rule of reason.’’ To complicate matters, however, the Court’s decision raises multiple new questions while providing little in the way of concrete rules for the lower courts to use in what will likely be a blizzard of new antitrust cases.

Join the Chair of Wiley Rein’s Food & Drug Law Practice, James N. Czaban, and Dechert’s Steven G. Bradbury, in a lively, practical, and informative discussion of the case and its immediate and long-term impacts.

This program will explore the specifics of the Court’s decisions, with practical advice and guidance on how drug companies can and should approach patent litigation under the rule established by the Court.

Educational Objectives:

• Understand the law of Hatch-Waxman patent settlements.
• Learn strategies that innovator and generic drug companies can pursue when involved in Hatch-Waxman litigation.
• Discover whether the Court’s decision alters the careful balance of the Hatch-Waxman system so dramatically that new legislation may be necessary.
• Find out if the decision will have any impact on future biosimilars patent litigation.

Who would benefit most from attending the program?

• Pharmaceutical company in-house counsel and regulatory affairs leaders.
• Patent litigation attorneys.
• Investment banks, venture capitalists, and hedge fund administrators active in the biopharmaceutical space.

Program Level: Intermediate.

Credit Available: CLE. For more information, please click on the “CLE Credit” tab.

James N. Czaban, Wiley Rein LLP; Steven G. Bradbury, Dechert LLP

James N. Czaban, Wiley Rein LLP
Jim Czaban is a partner with Wiley Rein and Chair of the firm’s FDA Practice Group. He has extensive experience in government regulation of pharmaceutical, biotechnology, food, medical device and health care related companies. Mr. Czaban’s practice focuses on counseling clients on complex regulatory strategies and compliance matters and representing clients in administrative and judicial enforcement actions and other proceedings involving the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Drug Enforcement Administration (DEA), the Department of Justice (DOJ), and other federal and state agencies.

A particular emphasis of Mr. Czaban’s practice is navigating the myriad interrelated legal, regulatory and policy issues implicated by competitive pressures within the pharmaceutical industry. He is recognized as a leading authority on the Hatch-Waxman Amendments and the legal and regulatory strategies available to both innovator and generic drug companies.

Mr. Czaban’s clients include a wide range of pharmaceutical, biotechnology, food and medical device companies, as well as banks, venture capitalists and other entities involved with life sciences companies. He guides these clients at all stages of a product’s lifecycle, from product development, marketing applications, advertising and promotional compliance, good manufacturing practices and post-approval safety requirements. He also counsels clients and performs regulatory due diligence in connection with financings, public offerings, mergers and acquisitions, licensing and joint venture agreements involving life sciences companies.

Mr. Czaban earned a J.D. from the University of Virginia School of Law and a B.A. from University of California—Berkeley. He is a member of the Bars of the District of Columbia, Virginia, and New York and is admitted to practice before the Supreme Court of the United States.

Steven G. Bradbury, Dechert LLP
Steve Bradbury is a partner in Dechert’s Washington office, where he focuses his practice on antitrust, administrative law, commercial litigation, and appellate matters. Mr. Bradbury filed an amicus brief in the Supreme Court on behalf of the American Intellectual Property Law Association in support of respondents in FTC v. Actavis, Inc.

Mr. Bradbury was formerly the head of the Office of Legal Counsel in the Department of Justice, where he served from 2004 until 2009. He served as a law clerk to Justice Clarence Thomas on the Supreme Court and to Judge James Buckley on the D.C. Circuit.

Mr. Bradbury earned a J.D., magna cum laude, from the University of Michigan Law School, where he was a member of the Order of the Coif and Article Editor of the Michigan Law Review, and a B.A. from Stanford University. He is a member of the District of Columbia Bar and is admitted to practice before the Supreme Court of the United States.

This program’s CLE-credit eligibility varies by state. Bloomberg BNA is an accredited provider in the states of New York*, California, Pennsylvania, Texas and Virginia, and most other jurisdictions grant CLE credit on a per-program basis. At this time, Bloomberg BNA does not apply directly to the states of Florida, Rhode Island, Montana and Hawaii although credit is usually available for attorneys who wish to apply individually. Additionally, the following states currently do not grant credit for Bloomberg BNA OnDemand programming: Arkansas, Ohio, Nebraska, and Delaware. All requests are subject to approval once the live webinar has taken place or the customer has viewed the OnDemand version. Please contact the Bloomberg BNA accreditations desk if you have specific questions that have not been addressed.

If you have further questions regarding a specific state or how to file for CLE credit, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditation Coordinator.

Hardship Policy
Bloomberg BNA offers a hardship policy for attorneys earning less than $50,000 per year. If an attorney wishes to take advantage of this option, he or she must contact Bloomberg BNA directly. For attorneys who are unemployed or earning less than $35,000 per year, a full discount off the price of the program will be awarded upon written proof of hardship. Attorneys earning between $35,000 and $50,000 per year will receive a 50% discount off the price of the program. Any attorney working in the public service sector also qualifies for a special price. If you have further questions regarding the hardship policy or seek additional information, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditations Coordinator, or email us at

For more information about Mandatory or Minimum Continuing Legal Education (MCLE) requirements, visit the American Bar Association website at

*Bloomberg BNA is an accredited provider in New York for experienced attorneys only