• Navigate the
evolving case law surrounding obvious-type double patenting and formulate
litigation strategies based on prior art obviousness analysis;
• Examine method of treatment claims in view of recent and pending decisions regarding inducement of infringement and divided infringement;
• Comprehend the impact of Therasense on the standard for inequitable conduct and its implications for Hatch-Waxman cases;
• Evaluate new trends in validity challenges including extended and delayed release formulations; and
• Weigh the risks and benefits of at-risk launches and assess potential damages.
• Anticipating and
reassessing Paragraph IV challenges in the era of the patent cliff;
• Analyzing invalidity & non-infringement assertions in light of the ANDA applicant's pre-litigation obligations and assertions;
• Prior art obviousness and obviousness-type double patenting: Legal analysis and practical applications for brand names and generics;
• Labels, patents and use codes: Understanding the significance of Novo Nordisk v. Caraco to Hatch-Waxman challenges;
• Reassessing Paragraph IV strategies for method treatment patents in view of recent and pending decisions regarding inducement and divided infringement;
• A view from the bench;
• FTC keynote: Pay-for-delay update -- to be presented by Markus H. Meier, Assistant Director, Health Care Division Bureau of Competition, Federal Trade Commission;
• Settling Paragraph IV disputes: Drafting and negotiation strategies for brand-names and generics;
• Exclusivities and forfeitures: New developments, controversies and concerns relative to Paragraph IV litigation;
• Controversies surrounding damages and injunctions relative to at risk launches; and
• Updating the standards in inequitable conduct post-Therasense: Ethical considerations for Paragraph IV cases.
In addition, two pre-conference workshops will be offered on December 3, 2012. The first, entitled "Hatch-Waxman and BPCIA 101 -- A Primer on IP Basics and regulatory Fundamentals" will take place from 9:00 am to 12:30 pm, and the second, entitled "AIA/PTO Working Group Session: Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation" will take place from 2:00 pm to 5:30 pm. A post-conference working group session entitled "Biosimilars: Product Development Strategies, Regulatory Review, and Anticipated Litigation Through A Hatch-Waxman Lens" will be offered from 3:00 to 6:00 pm on December 5, 2012.
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 $2,295 (conference alone), $2,895 (conference and one workshop), $3,495 (conference and two workshops), or $4,095 (conference and all workshops). Those registering by October 5, 2012 will receive a $300 discount and those registering by November 2, 2012 will receive a $200 discount. Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. Those interested in registering for the conference can do so here, by e-mailing [email protected], 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.