American Conference Institute (ACI) will be holding its 13th Annual Maximizing Pharmaceutical Patent Lifecycles conference on October 10-11, 2012 in New York, NY. The conference will allow attendees to:
• Understand how the patent cliff will impact innovation and alter the industry dynamic between brand names and generics;
• Explore how generic user fees and other new and revised items under PDUFA will affect R&D and market entry;
• Demystify the provisions of the America Invents Act and learn how post-grant review, inter partes review, and institution of a global prior art regime will impact life cycle management;
• Analyze the recently issued FDA regulations on biosimilars and comprehend how the further implementation of BPCIA will affect pharmaceutical patent life cycle management strategies;
• Assess how the combined evolution of prior art obvious and obvious-type double patenting are influencing the future of secondary patents;
• Evaluate patent life cycle strategies relative to personalized medicine in light of Prometheus;
• Examine the link between inducement and divided infringement actions relative to methods of use claims for pharmaceutical patents;
• Appreciate how Caraco has affected Orange Book listings and redefined the relationship between a drug's patent, label and use code;
• Explore forfeiture rulings post-Lipitor; and
• Navigate new safe harbor dilemmas for both general screening and research tool patents.
In particular, ACI's faculty will offer presentations on the following topics:
• From product development to patent portfolio management: Patent life cycle strategies for a post-AIA world;
• An industry perspective on implementation of the AIA, new PTO proceedings, and their collective impact on life cycle management;
• Preparing for the implementation of the FDA's biosimilars pathway and its effects on life cycle planning;
• Exploring the latest regulatory conundrums affecting pharmaceutical patent life cycle strategies;
• Personalized medicine and patent life cycle considerations in light of Prometheus and other recent challenges to subject matter patentability, written description, and more;
• Employing strategies to avoid findings of obviousness: Legal analysis and practical applications for brand names and generics;
• Inequitable conduct post-Therasense and how it impacts life cycle planning;
• USPTO keynote: The brave new world of patent reform and its impact on pharmaceutical patents -- to be presented by USPTO Deputy Director Teresa Stanek Rea;
• Understanding how Caraco has redefined the relationship between pharmaceutical patents, labels, and use codes;
• Analyzing method claims and the madness over recent and pending inducement and divided infringement cases;
• Exclusivities and forfeitures: New developments, controversies and related concerns;
• An update on FDA activities impacting pharmaceutical patent life cycle planning;
• Safe harbor or stormy port? Calming the legal tempest left by Proveris; and
• Understanding the importance of Rx to OTC switches to the future of pharmaceutical patent life cycle management.
Two pre-conference workshops will be offered on October 9, 2012. The first, entitled "Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Hatch-Waxman Strategies Relative to Patent Life Cycle Management" will be held from 9:00 am to 12:30 pm. The second, entitled "PTA-PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry" will be held from 2:00 pm to 5:30 pm.
The agenda for the Maximizing Pharmaceutical Patent Lifecycles conference can be found here, and additional information regarding the wrokshops 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 fees are $2,295 (conference only), $2,895 (conference plus one workshop), or $3,495 (conference plus two workshops). Those registering by September 10, 2012 will receive a $200 discount off the registration fee, and those registering on or before August 13, 2012 will receive a $300 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 ACI's Maximizing Pharmaceutical Patent Lifecycles conference.
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