The Center for Business Intelligence (CBI) will be holding its 4th Life Sciences Congress on Paragraph IV Disputes on October 25-26, 2012 in Washington, DC. The conference will offer presentations on the following topics:
• Through the
looking glass -- Fine-tune fundamentals of Hatch-Waxman and anticipate future
developments in patent litigation;
• The next big wave -- Understand the inner workings of the FDA's biosimilars pathway;
• Interpretation of Supreme Court's ruling for patent use codes;
• Examine the new era of label carve-outs;
• Navigate new provisions and procedures of the America Invents Act -- to be presented by Teresa Stanek Rea, Deputy Deputy Director of the U.S. Patent and Trademark Office
• Understand the impact of the changing bio/pharma business model on Paragraph IV litigation (panel);
• Generic -- Essential considerations and necessary requirements for the letter;
• Branded -- Strategic first steps before and after a PIV letter is received;
• Today's courtroom -- A Judge's perspective -- to be presented by the Honorable Tonianne Bongiovanni of the U.S. District Court for the District of New Jersey;
• Defining inequitable conduct in today's PIV suits;
• Qualification of combination products under Hatch-Waxman and the biosimilars pathway; and
• Recent developments on FTC settlements and pay-for-delay agreements -- to be presented by Mark Woodward of the Health Care Division, Federal Trade Commission.
An agenda for the Congress on Paragraph IV Disputes can be found here.
The registration fee is $2,495 (vendor) or $2,295 (pharma/biotech) for those registering by October 25, 2012. Those interested in registering for the conference can do so here.