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since its implementation and the FDA’s three draft guidance's. IN particular, the panel will address the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biosimilars and FDA draft guidance on it, including study requirements and user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.
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