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Kaye Scholer Hosts Aug 9th Webinar on Biosimilars Featuring the FDA’s Denise Esposito

July 17, 2012

New York: Kaye Scholer announced that, in partnership with Thomson Reuters’ WestLegalEd Center, it will be hosting a webinar, “Understand Biosimilars and Develop Strategies to Maximize and Defend Your Intellectual Property: Addressing the FDA’s Current Position on Defining Biosimilars” on August 9, 2012.

Noted panelists, including the FDA’s Deputy Director of the Office of Regulatory Policy, Denise Esposito and Kaye Scholer Intellectual Property Litigation Partners Daniel DiNapoli and Benjamin Hsing, will address the FDA's current position on defining biosimilars and demonstrating interchangeability under the abbreviated pathway; devising a patent strategy to protect intellectual property of biologics and to maximize the biologics life cycle, preparing for the patent dispute resolution process concerning biosimilars; and ascertaining the level of clinical trial data needed to demonstrate safety and efficacy.

As Deputy Director of the Office of Regulatory Policy in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, Esposito’s group is responsible for implementing laws governing the development, manufacture and sale of pharmaceutical and biotechnology products, and for establishing FDA policy relating to those products. She also serves on FDA's Biosimilars Implementation Committee (BIC) and as an FDA panel member for public meetings on the implementation of the BPCI Act; members of her staff serve on the agency's Biosimilars Review Committee (BRC).

To register for the seminar, please click here.

Kaye Scholer’s Intellectual Property practice heavily focuses on patent litigation, combining years of trial experience with sophisticated scientific, technical and business knowledge. Twenty of our IP partners have strong track records when it comes to trying exceptionally complicated patent infringement cases, particularly in the life sciences and technology sectors, as well as prosecuting and defending high-stakes trademark, false advertising, and copyright lawsuits. The remaining partners focus on IP and outsourcing issues working in conjunction with Kaye Scholer’s transactional teams. Several of our patent litigators also have advanced degrees in chemistry, engineering or biomedicine.

The 2012 US News & World Report’s Best Law Firms guide named our Patent Litigation, Trademark Litigation and Biotech teams among the 10 best in the nation. Our IP practice is also recognized by 2012 Chambers Global, 2012 Benchmark Litigation, Euromoney’s 2012 LMG Life Sciences Guide and recently received a National “Gold” ranking from 2012 IAM Patent 1000.

About Kaye Scholer LLP

Founded in New York in 1917, Kaye Scholer combines the continuity and business acumen of a century-old law firm with a forward-looking, tech savvy, results-driven approach focused around lasting client relationships. With industry strengths in life sciences, financial services, technology, real estate and energy & infrastructure, Kaye Scholer offers strategic guidance and legal services to public and private entities facing litigation, transactional or governance challenges. Kaye Scholer’s lawyers regularly advise on matters across multiple legal jurisdictions, including in the US, Canada, UK, EU, China and Japan.

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Andrea Orzehoski
PR & Communications Manager Kaye Scholer

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