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The Patent Act’s “Safe Harbor”: Open Issues and Their Impact



Tuesday, November 13, 2012
Product Code - LGN71
Speaker(s): Elizabeth Stotland Weiswasser, Weil, Gotshal & Manges LLP; Nicolas G. Barzoukas, Weil, Gotshal & Manges LLP
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The “safe harbor” provision of the Patent Act (35 U.S.C. § 271(e)(1)) provides that certain activities, otherwise covered by a patent, are not infringing to the extent they reasonably relate to obtain regulatory approval to market pharmaceutical and biologic products as well as medical devices. The Supreme Court has decided two cases directed to the scope of the safe harbor provision -- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), and Merck KGaA v. Integra Lifesciences, Ltd., 545 U.S. 193 (2005)). In Merck, the Court reversed a Federal Circuit decision limiting section 271(e)(1)’s safe harbor protection to preclinical research ultimately included in a submission to the FDA. 545 U.S. 193, 195 (2005). Previously, in Eli Lilly & Co. v. Medtronic, Inc., the Court held that medical devices fall under safe harbor protection.

The Court is now expressing interest in another safe harbor case, this one directed to the status of post-FDA approval activities under the safe harbor. See Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011). In addition, a recent panel decision by the Federal Circuit -- Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 2012-1062, 2012-1103, 2012-1104, 2012 U.S. App. LEXIS 16160 (Fed. Cir. Aug. 3, 2012) -- is arguably in conflict with Momenta and has the potential to elevate the importance of the Classen decision.

The ultimate decision regarding the scope of the safe harbor provision may have important consequences beyond the traditional small molecule drug context. For example, the Biologics Price Competition and Innovation Act of 2009 created an approval pathway for biosimilars, i.e., generic versions of biological products. Whether and to what extent the safe harbor provision protects post-approval activities could have important implications for biosimilars.

The faculty for this program will provide an overview of the safe harbor provision in the context of the Hatch-Waxman Act and discuss several issues related to the safe harbor provision, including its current status, open issues, the apparent split in Federal Circuit precedent regarding post-approval activities and the status of both Classen and Momenta. Open issues to be discussed include: whether and to what extent post-approval activities are covered by the safe harbor, the potential implications of Momenta’s interpretation of “submission” in the safe harbor provision, and the potential impact of these decisions on biosimilars.

Educational Objectives:

• Gain an understanding of the framework and history of the Safe Harbor Provision and how it has been construed by the Supreme Court and the Federal Circuit.
• Understand how specific regulatory-related activities are evaluated under the safe harbor and whether they are protected.
• Understand the open questions regarding regulatory-related activities and the extent to which their protection is uncertain/unresolved.
• Understand considerations as to whether and to what extent the safe harbor provision is implicated in biosimilars-related regulatory activities.

Who would benefit from attending the program?

In-house patent and regulatory attorneys in areas involving pharmaceuticals, biologics or the like; private practitioners who litigate or counsel companies involved in pharmaceutical or biologic products. 

Program Level: Intermediate

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

Elizabeth Stotland Weiswasser, Weil, Gotshal & Manges LLP; Nicolas G. Barzoukas, Weil, Gotshal & Manges LLP

Elizabeth Stotland Weiswasser, Weil, Gotshal & Manges LLP
Elizabeth Stotland Weiswasser is a partner in the Patent Litigation practice at Weil, residing in the New York office. Ms. Weiswasser has litigated patent cases in venues across the country, and across a broad range of technology areas, with a particular emphasis on biological, pharmaceutical, and chemical technologies. For her work in patent litigation, She was recently named “Up & Coming Intellectual Property Lawyer of the Year” by Chambers USA Women in Law. She is recognized for her work in the area of patent litigation by Chambers USA - America's Leading Lawyers for Business in 2012, which states: “In the words of clients, Elizabeth Weiswasser ‘inspires confidence.’ Ms. Weiswasser is praised for her ‘strong background in molecular biology and the life sciences, which allows her to communicate effectively with scientists and medical professionals and explain scientific concepts to non-scientists.’”

Ms. Weiswasser has a diverse pro bono practice and has handled matters involving prisoner rights, human rights and racial discrimination. She earned a J.D. from the University of Chicago Law School and a B.A. from Northwestern University.

Nicolas G. Barzoukas, Weil, Gotshal & Manges LLP
Nicolas Barzoukas’ practice is devoted to intellectual property litigation, including patent, trade secret, and trade dress litigation. He concentrates on patent litigation in the pharmaceutical field. He has also litigated in industries related to chemistry, electronics, biotechnology, medical devices, lasers and mechanical systems. In 2001, the Texas Lawyer recognized him as one of 40 “up-and-comers” in the Texas legal community. Mr. Barzoukas was recognized in Chambers USA - America’s Leading Lawyers for Business 2005 - 2010 in the field of Patent Litigation in Texas.

Mr. Barzoukas’ representations in Hatch-Waxman Act patent infringement suits have resulted in the protection of the franchises for blockbuster pharmaceutical products, such as FOSAMAX®, FOSAMAX® OW, VASOTEC®, PEPCID®, ACTONEL®, and VIOXX®. In addition, Mr. Barzoukas successfully challenged the U.S. Patent and Trademark Office’s rule denying the application of Hatch-Waxman Act patent term restoration to patents receiving a new, 20-year, patent term established by the Uruguay Round Agreements Act.

Mr. Barzoukas earned a J.D. from the University of Texas Law School, an M.B.A. from Baylor University, and a B.S. from Baylor University.

This program is CLE-credit eligible.

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 Legal and Business 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 Lindsey Pace, CLE Accreditations Coordinator, or email us at accreditations@bna.com.

Questions
For more information about Mandatory or Minimum Continuing Legal Education (MCLE) requirements, visit the American Bar Association website at http://www.abanet.org/cle/mandatory.html.