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Patent Infringement After FDA Approval: Remapping the Safe Harbor


Product Code - LGN98
Speaker(s): David P. Halstead, Ropes & Gray LLP; Melissa S. Rones, Ropes & Gray LLP
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Drug makers have come to rely on exemptions for patent infringement that occur during the Food and Drug Administration (FDA) approval process, such as while performing clinical trials. In a recent Federal Circuit decision, this exemption was applied to post-approval activities as well, potentially eviscerating a potentially powerful way of blocking generic and biosimilar companies who need to be able to demonstrate identity or similarity of their product to a reference product in order to short-cut lengthy approval processes. However, in a conflicting Federal Circuit decision, the court found that the exemption does not apply after approval.

How can these differences be resolved? The answer will affect the value of some drug-related patents, determine when some generic and biosimilar products can enter the market, and change the way companies perform further research on their approved products. Resolution could, for example, impact (i) patents on methods of monitoring patients, such as during Phase IV trials; (ii) patents on QA/QC protocols for characterizing a drug or biologic product; and (iii) patents on collecting adverse event reports, such as under the Adverse Event Reporting System.

Educational Objectives:

• Understand what kinds of patents are most likely to be affected by this uncertain area of law.
• Learn how drug makers and investors think about these patents when assessing a product’s exclusivity period.
• Gain a better understanding of whether companies should change their behavior now to prepare for the resolution of the scope of the safe harbor.

Who would benefit from attending?

Intellectual property attorneys; life science business professionals; investors in FDA-regulated life science companies.

Program Level: Intermediate

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

David P. Halstead, Ropes & Gray LLP; Melissa S. Rones, Ropes & Gray LLP

David P. Halstead, Ropes & Gray LLP
David Halstead is a partner at Ropes & Gray who helps clients obtain, analyze and evaluate patent protection in an environment marked by rapid changes in legislation, case law, and regulation. He works with clients in the biotechnology, chemical, and pharmaceutical industries on a wide range of intellectual property issues. He helps clients obtain robust and enforceable patents and navigate the existing patent landscape. Using his experience working with patents and applications in many foreign countries, Mr. Halstead helps clients devise effective global patent strategies designed to satisfy the idiosyncratic requirements of foreign patent offices.

Mr. Halstead teams with members of the Life Sciences Group to help clients create and manage relationships with business partners. He evaluates the intellectual property portfolios of target companies to identify strengths, weaknesses, and opportunities to create value by revising patent strategies and addressing latent issues. Using his understanding of the regulatory environment for pharmaceutical and biotech products, he also advises clients regarding product life-cycle management, including Hatch-Waxman and Orange Book issues.

Before beginning his legal career, Mr. Halstead completed a Ph.D. in Organic Chemistry from Harvard University, where he studied the synthesis of complex organic molecules and completed the total synthesis of discodermolide in the laboratory of Professor David A. Evans.

Mr. Halstead earned a J.D. from Harvard Law School and a B.S. in Chemistry, summa cum laude, from Pennsylvania State University. He is admitted in Massachusetts and registered to practice before the United States Patent and Trademark Office.

Melissa S. Rones, Ropes & Gray LLP
Ms. Rones is an associate at Ropes & Gray with over ten years of experience counseling clients in all areas related to the development and evaluation of robust intellectual property portfolios, as well as the analysis of third party assets. She counsels clients in the biotechnology, biopharmaceutical, medical device and instrumentation industries on a wide range of intellectual property issues, including patent portfolio development and life cycle management, patent prosecution, and freedom-to-operate. She works with clients to develop and execute effective patent strategies focused on obtaining robust and enforceable patent protection in the United States and around the world and also helps clients evaluate and navigate the existing patent landscape.

Ms. Rones partners with the Life Sciences group and the Intellectual Property Transactions group to advise clients on intellectual property issues in connection with transactions, including mergers and acquisitions, strategic partnerships, in- and out-licensing relationships, and venture financings. She evaluates the intellectual property portfolios of target companies, as well as potentially blocking third-party intellectual property, to identify strengths, weaknesses, and opportunities to create value by mitigating or remedying identified issues.

Prior to joining the firm, Ms. Rones completed a Ph.D. in cell and developmental biology from Harvard University. Her graduate work focused on examining signaling events involved during the patterning of tissues to generate complex organs and helped define specific roles for Notch signaling in both cardiogenesis and nephrogenesis.

Ms. Rones earned a J.D., magna cum laude, from the Boston University School of Law after completing a Ph.D. in cell and developmental biology through the Division of Medical Sciences at Harvard University and Harvard Medical School. She also earned a B.S. from the Massachusetts Institute of Technology. She is admitted in Massachusetts and registered to practice before the United States Patent and Trademark Office.

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.