Tuesday, May 03 to Wednesday, May 04, 2011
Marriott Downtown, New York City, NY
American Conference Institute’s Paragraph IV Disputes conference is the undisputed source for Hatch-Waxman litigation strategies for brand-names and generics. This event — which is widely recognized for setting the standards for Paragraph IV litigation and which also serves as the annual meeting place for the “who’s who” of pharmaceutical patent litigation — is now the single forum on which brand name and generic companies can rely for answers during this turbulent time in which the balance of power designed by the Hatch-Waxman Act may completely unravel.
Patents covering critical pharmaceutical products worth more than $30 billion annually are on the verge of expiration. However, generic manufacturers are facing their own hurdles as fewer opportunities for 180-day exclusivity will remain. Paragraph IV litigation is a no-holds barred fight and have raised the monetary ante to an unprecedented level.
Moreover, the passage of biosimilars legislation, the possible resurrection of patent reform and the never ending controversy surrounding reverse payment settlements have only added to the complexities surrounding this litigation.
An experienced faculty comprised of respected and renowned counsel for brand name and generic pharmaceutical companies will provide insights on all facets of Paragraph IV litigation: pre-litigation concerns – the commencement of suit – final adjudication – and every step in between. Sessions will address the key elements of Paragraph IV litigation in addition to some of the most pressing and recent controversies surrounding Paragraph IV cases, including:
- Possible re-evaluation of the Invalidity standard
- Double patenting obviousness
- Inducement of infringement
- Section 8 carve-outs
- Inequitable conduct
We will once again offer our informative and hands-on workshops:
- Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals will provide you with the patent and regulatory backdrop for the more in-depth Hatch-Waxman litigation controversies discussed in the main conference; and
- The Master Class on Settling Paragraph IV Disputes – Drafting and Negotiating Strategies for Brand-Name and Generics will give you practical and hands-on strategies for drafting and negotiating settlement agreements that will pass muster with the FTC.
Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563 or logging on to www.AmericanConference.com/ParagraphIVDisputesNYC