The American Bar Association (ABA) Section of Science and Technology, Section of Intellectual Property Law, and Center for Professional Development will be offering a live webinar entitled "Biosimilars and the BPCI Act: Where Are We Now and Where Are We Going?" on September 19, 2013 from 2:00 to 3:30 pm (Eastern). Ken Burchfiel of Sughrue Mion, PLLC; John M. Engel of Engel & Novitt, LLP; William J. Simmons, Ph.D of Sughrue Mion, PLLC; and Krista Hessler Carver of Covington & Burling LLP address patent and regulatory issues which arose from implementation of the BPCI Act since its implementation and the FDA’s three draft guidance's. IN particular, the panel will address the following issues:
• When to use biosimilar
pathway in section 351(k) of the Public Health Service Act versus the biologics
license application pathway in section 351(a);
• Regulatory pathway for biosimilars and FDA draft guidance on it, including study requirements and user fees;
• Interchangeability and state substitution laws;
• Evolving policy on naming of biosimilars;
• Issues in exclusivity for innovative biologics and implications for business strategies;
• The mechanics of the patent litigation process under the BPCIA; and
• Practical steps to prepare for the information exchange process.
The registration fee for the webcast is $95 for members of any of the sections sponsoring the webinar, $99 for government attorneys, $150 for ABA members, and $195 for the general public. Those interested in registering for the webinar, can do so here or by calling 800-285-2221.