American Conference Institute (ACI) will be holding its 12th Annual Maximizing Pharmaceutical Patent Lifecycles conference on October 4-5, 2011 in New York, NY. The conference will allow attendees to:
• Understand how the patent cliff will impact innovation and R&D;
• Prepare for the release of anticipated FDA regulations on biosimilars and comprehend how the further implementation of BCPIA will affect pharmaceutical patent life cycle management strategies;
• Assess how the combined evolution of prior art obvious and obvious-type double patenting is influencing the future of secondary patents;
• Evaluate patent life cycle strategies relative to personalized medicine vis-à-vis section 101 patentability and section 112 written description requirements;
• Analyze the significance of Microsoft, Myriad, and Therasense on patent life cycle strategies for small and large molecules;
• Examine the impact of REMS studies on generic entry;
• Decipher the relationship between use code controversies and inducement/divided infringement actions relative to Orange Book listings;
• 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:
• Understanding how the patent cliff will re-define the endgame;
• USPTO Keynote: The impending reality of patent reform and its potential Impact on pharmaceutical patents -- to be presented by USPTO Deputy Director Teresa Stanek Rea;
• Potential life cycle management controversies posed by the implementation of the Biosimilars Act;
• Patent term adjustment and patent term extensions update: Strategies and considerations for small and large molecules -- to be presented in part by Mary Till, Legal Advisor, USPTO Office of Patent Legal Administration;
• Exploring post-Issuance PTO procedures in the era of the patent cliff: Focus on reexam and reissue proceedings -- to be presented in part by Dr. Jean Vollano, Quality Assurance Specialist, USPTO;
• The combined impact of prior art obviousness and obvious-type double patenting on pharmaceutical patent life cycle strategies;
• Personalized medicine and patent life cycle considerations vis-à-vis Sections 101, 112, and allowable research exceptions;
• CAFC and Supreme Court watch: Three cases that may have radical Impact on pharmaceutical patent life cycle strategies;
• FTC Keynote: Analysis of competitive behaviors in pharmaceutical patent life-cycle management strategies -- to be presented by Suzanne Munck, Counsel for Intellectual Property, Federal Trade Commission;
• REMS studies and generic entry: Exploring the latest regulatory conundrum affecting pharmaceutical patent life cycle strategies;
• Carve-outs, skinny labeling and use codes: Understanding their role in Orange Book listing strategies and life cycle management;
• Inducement actions and divided Infringement: How method of use claims controversies are Influencing Orange Book listings;
• Exclusivities and forfeitures: New developments, controversies and concerns;
• FDA Keynote: Update on FDA activities impacting pharmaceutical patent life cycles for small and large molecules -- to be presented by Elizabeth Dickinson, Associate Chief Counsel, Office of the Chief Counsel, U.S. Food and Drug Administration; and
• Safe harbor or stormy port?: Calming the legal tempest left by Proveris.
Two interactive pre-conference training and strategy sessions will be offered on October 3, 2010. The first, 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 9:00 am to 12:30 pm. The second, entitled "Working group on global pharmaceutical patent life cycle management strategies for established and emerging markets: A practical, hands-on guide to patent extensions and exclusivities available to pharmaceutical products around the world" will be held from 2:00 pm to 5:30 pm.
The agenda for the Maximizing Pharmaceutical Patent Lifecycles conference 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 9, 2011 will receive a $200 discount off the registration fee, and those registering on or before August 5, 2011 (today) will receive a $300 discount. In addition, 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 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.
Comments