The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Jamaica P. Szeliga, Member, Leydig, Voit & Mayer will speak at the Knowledge Group’s webcast entitled: “The BPCIA Patent Dance – What Biosimilar Companies Need To Know.” This event is scheduled for November 3, 2016 from 3:00pm – 5:00pm (ET).
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About Jamaica P. Szeliga
Jamaica Potts Szeliga is a partner at Leydig, Voit & Mayer in its Washington, D.C. office. Ms. Szeliga is a former clerk for the United States Court of Appeals for the Federal Circuit and is registered to practice before the United States Patent and Trademark Office. Her practice focuses primarily on intellectual property litigation, where she has participated in ANDA litigation on behalf of both brand and generic companies. She has also litigated cases involving biotechnology and biologics, medical devices, telecommunications, electronics, consumer goods, and mechanical products.
Ms. Szeliga graduated magna cum laude from Harvard Law School in 2002, and received her Bachelor of Science degree in Chemistry, with a minor in Biology, with distinction, from Stanford University in 1999. She is admitted to the District of Columbia and the New York State bars.
About Leydig, Voit & Mayer
At the forefront of intellectual property law for more than a century, Leydig, Voit & Mayer provides valued advice and trusted counsel on intellectual property issues to industry leaders around the world. Leydig’s IP litigation, licensing, and prosecution services encompass patent, trademark, copyright, trade secrets, Internet and other IP issues, including post-grant proceedings. The firm represents clients in various industries including pharmaceuticals, chemical and chemical engineering, software, electronics, manufacturing and machine design, biotechnology, medical devices, financial services, and consumer products. The wealth of litigation and technical experience of the firm’s attorneys and staff enables the firm to tailor its services to the unique needs of each client.
For about seven years now, the Biologics Price Competition and Innovation Act (“BPCIA”) of 2009 has continually facilitated entry of biosimilar products into the market. By allowing submission of an abbreviated Biologics License Application (“aBLA”) to an already approved and licensed FDA product, BPCIA aids in making the pioneer and the applicant meet halfway. However, meeting halfway is not as easy as it sounds. There are matters to deal with: agreements and disclosures to be settled down before the commercial marketing of a biosimilar product begins. Patent disputes are among the most debated, and often controversial issues that biosimilar companies are faced with.
In its second part, BPCIA addresses certain patent resolution issues. Commonly called as the “patent dance”, 42 U.S.C. § 262(l) provides the steps and schedule when a reference sponsor product and a biosimilar applicant exchange “confidential information” about the aBLA. Typically, the confidential information disclosed by the applicant is its application and manufacturing trade secrets.
Indeed, the music hasn’t stopped for biosimilar companies, and “patent dance” is still obviously becoming a dance craze for them. Questions remain as to whether or not companies facing the “dance” will minimize the potential for litigation under the BPCIA, and to what extent will this craze bring the industry.
The Knowledge Group has assembled a panel of key thought leaders to provide the audience with an in-depth analysis of the BPCIA “Patent Dance” and its recent developments. In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders will help biosimilar companies understand the important aspects of this significant topic. Speakers will also offer best practices in helping the audience better understand the steps and legal issues brought by the latest litigations.
About The Knowledge Group /The Knowledge Congress Live Webcast Series
The Knowledge Group was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register for an event, please visit: http://theknowledgegroup.org/