• Assess how new
PTO proceedings will influence the course of Hatch-Waxman litigation;
• Understand how new 271(e)(1) controversies under Claussen and Momenta will affect ANDA filings;
• Decipher the impact of new obvious considerations in the courts and PTO on primary compound and composition claims;
• Assess the implications of new regulatory considerations under FDASIA, the GAIN Act, and Generic User Fees Act on Paragraph IV proceedings;
• Explore inducement and divided infringement in the context of Orange Book-listed method patents;
• Identify new challenges to market as well as regulatory exclusivities; and
• Examine possible damages quantifications for launching at risk.
• Anticipating a Paragraph IV challenge: New
considerations in light of AIA and the patent cliff;
• Asserting invalidity or non-infringement under Paragraph IV: Exploring the ANDA applicant's pre- litigation obligations and options;
• Safe harbor or stormy port?: Analyzing how new 271(e)(1) controversies will impact Paragraph IV disputes;
• Throwing down the gauntlet: The Paragraph IV notice letter;
• Obviousness in retrospect: Making sense of prior art, obvious-type double patenting, inherency, and new AIA controversies;
• Let the games begin: The start of the Paragraph IV lawsuit -- Pleadings and other initial considerations and analyses;
• A view from the Bench;
• Pay-for-delay update -- to be presented by Markus H. Meier, Assistant Director, Health Care Division Bureau of Competition, Federal Trade Commission;
• Settlement of Paragraph IV lawsuits: The industry perspective;
• Parallel and alternate proceedings in Paragraph IV disputes: Seeking simultaneous or sole redress before the PTO, ITC and other alternative forums;
• FDA proceedings and regulatory developments impacting Paragraph IV litigation;
• New exclusivity challenges: Brand names take notice -- It's not just a concern for generics anymore;
• Examining new rulings in inducement of infringement and divided infringement and their application to method claims in Hatch-Waxman litigation;
• New developments in damages theories and injunctions relative to at risk launches: Legal and economic assessments; and
• Inequitable conduct developments in the courts and at the PTO: Ethical considerations for Paragraph IV cases.
In addition, two pre-conference workshops will be offered on May 6, 2013. The first, entitled "Hatch-Waxman and BPCIA 101 -- A Primer on IP Basics and Regulatory Fundamentals" will take place from 8:15 to 11:30 am, and the second, entitled "Assessing the Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation" will take place from 12:45 to 4:00 pm. A post-conference session entitled "The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Name and Generic -- A Hands-On, Practical Approach" will be offered from 9:00 am to 12:30 pm on May 9, 2013.
The agenda for the Paragraph IV Disputes conference can be found here. More information regarding the workshops and master class can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference is $2,395 (conference alone), $2,995 (conference and one workshop), $3,595 (conference and two workshops), or $4,195 (conference and all workshops). Those registering by March 16, 2013 will receive a $400 discount and those registering by April 12, 2013 will receive a $200 discount. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of the Paragraph IV Disputes conference.