Aci Maximizing Pharmaceutical Patent Life Cycles 2011 Nyc

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12th Annual Maximizing Pharmaceutical Patent Life Cycles ACI’s r i s e HATCH-WAXMAN e s The definitive Hatch-Waxman and BPCIA event for brand names and generics October 4 – 5, 2011 | New York Marriott Downtown | New York Industry InsIghts from: Hoffmann-LaRoche Apotex, Inc. BIO Eli Lilly & Company Endo Pharmaceuticals Lundbeck Research USA, Inc. Medicis Pharmaceutical Corporation Merck & Company Pfizer, Inc. PhRMA Roche Diagnostics India Pvt Ltd. Sandoz, Inc. Preeminent patent counsel and advisors to leading brand name and generic pharmaceutical companies, as well as representatives from key government agencies and industry associations will provide insights on the latest challenges affecting pharmaceutical patent life cycles for small and large molecules and help you: • 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 BpcIA 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 • nAVIgAte new safe harbor dilemmas for both general screening and research tool patents and ACI’s Hatch-Waxman Series Advisory Board – See P.2 Key AgencIes spotlIght Hear from the: • united states patent and trademark office on: patent reform Teresa Stanek Rea (Invited) Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director, USPTO ptA and pte Analysis reexam and reissue Mary C Till (Invited), Legal Advisor Office of Patent Legal Administration, USPTO Jean F. Vollano, Ph.D (Invited) Quality Assurance Specialist, USPTO • Federal Trade Commission on: | competitive Behaviors Impacting pharmaceutical patent life cycle management Suzanne Munck, Counsel for Intellectual Property Office of Policy and Planning, FTC october 3, 2011: Interactive pre-conference training and strategy sessions A. ptA- pte Boot camp: Basic training in the essentials of patent term Adjustment and patent term restoration for patent lawyers serving the Biopharmaceutical Industry B. 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 cocktail reception hosted by: Associate sponsor: sponsored by: • U.S. Food and Drug Administration on: fdA Activities Affecting pharmaceutical patent life cycles for small and large molecules Elizabeth Dickinson (Invited), Associate Chief Counsel, Office of the Chief Counsel, FDA supporting sponsors: CLE Credits Earn Register Now • 888-224-2480 • AmericanConference.com/LifeCycles Ad v i s ory Bo a r d & Fa cult y L i s t AcI’s hatch-Waxman series Advisory Board Lisa A. Jakob Stephen R. Auten Legal Director, IP Litigation Vice President, IP Merck & Company Sandoz, Inc. (Rahway, NJ) (Princeton, NJ) Matthew P. Blischak Vice President, Intellectual Property & Associate General Counsel Sunovion Pharmaceuticals Inc. (Marlborough, MA) guy donatiello Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA ) George W. Johnston Vice President & Chief Patent Counsel Hoffmann-La Roche (Nutley, NJ) James P. Leeds Assistant General Patent Counsel Eli Lilly & Company (Indianapolis, IN) chairman emeritus: John C. Vassil (Formerly Of Counsel to Morgan & Finnegan LLP) (New York) chairmen: George W. Johnston Vice President & Chief Patent Counsel Hoffmann-La Roche (Nutley, NJ) Mark E. Waddell Partner Loeb & Loeb LLP (New York, NY) meg snowden VP, Intellectual Property Impax Laboratories (Hayward, CA) shashank upadhye Vice President – Global Intellectual Property Apotex, Inc. (Toronto, ON) Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel, Intellectual Property Boehringer Ingelheim (Ridgefield, CT) Steven J. Lee Partner Kenyon & Kenyon (New York) Edward T. Lentz Patent Attorney (New Lisbon, NY) Denise L. Loring Partner Ropes & Gray LLP (New York, NY) Brian J. Malkin Partner Frommer Lawrence & Haug LLP (New York, NY) Kevin W. McCabe Director Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC) Rashad L. Morgan Patent Attorney Brinks Hofer Gilson & Lione (Research Triangle Park, NC) suzanne munck Counsel for Intellectual Property Office of Policy and Planning Federal Trade Commission (Washington DC) Brian P. Murphy Partner Edwards Angell Palmer and Dodge LLP (New York, NY) Justin J. Oliver Partner Fitzpatrick, Cella, Harper & Scinto (Washington, DC) Bert oosting Partner Hogan Lovells (Amsterdam, NE) Richard S. Parr Assistant Counsel Merck & Co., Inc. (Rahway, NJ) Bruce A. Pokras Senior Corporate Counsel, Intellectual Property Pfizer Inc. (Madison, NJ) speakers: Stephen R. Auten Vice President, IP Sandoz, Inc. (Princeton, NJ) Aaron F. Barkoff, Ph.D. Partner McAndrews, Held & Malloy, Ltd. (Chicago, IL) Nicolas G. Barzoukas Partner Weil, Gotshal & Manges LLP (Huston, TX) Allen R. Baum Shareholder and Chair, Chemical Practice Group Brinks Hofer Gilson & Lione (Research Triangle Park, NC) Scott Beeser, Ph.D. LLB Patent Attorney – Biopharmaceuticals Apotex Inc. (Toronto, ON) Margaret “Peg” M. Buck Head of Section, US Legal Affairs & Patents Lundbeck Research USA, Inc. (Paramus, NJ) patricia carson Partner Kaye Scholer LLP (New York, NY) Brian D. Coggio Senior Principal Fish & Richardson, P.C. (New York) Michael A. Davitz Partner Axinn, Veltrop & Harkrider LLP (New York, NY) elizabeth dickinson (Invited) Associate Chief Counsel, Office of the Chief Counsel U.S. Food and Drug Administration (Rockville, MD) guy donatiello Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA ) Michael P. Dougherty Special Counsel Cadwalader, Wickersham & Taft LLP (New York, NY) Ted J. Ebersole, Ph.D. Assistant General Patent Counsel Eli Lilly and Company (Indianapolis, IN) Barton W. Giddings, Ph.D Partner Stoel Rives LLP (Salt Lake City, UT) Gregory J. Glover, MD, JD Principal Pharmaceutical Law Group PC (Washington, DC) James M. Gould Legal Director – Intellectual Property Litigation Merck & Co., Inc. (Rahway, NY) Robert M. Gould, Ph.D. Partner Duane Morris LLP (Chicago, IL) John M. Griem, Jr. Partner Loeb & Loeb LLP (New York, NY) nicholas groombridge Partner and Co-Chair Patent Litigation Weil, Gotshal & Manges LLP (New York, NY) Thomas D. Hoffman Consultant – Patent Counsel Sandoz,Inc. (East Hanover, NJ ) Kurt R. Karst Director Hyman, Phelps & McNamara, P.C. (Washington, DC) gabriel Kleiman Assistant General Counsel Pfizer Inc. (New York, NY) david Korn Senior Assistant General Counsel PhRMA (Washington, DC) Thomas J. Kowalski Shareholder Vedder Price P.C. (New York, NY) Richard T. Ruzich Partner Duane Morris LLP (Chicago, IL) teresa stanek rea (Invited) Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director United States Patent and Trademark Office (Alexandria, VA) Hans Sauer, Ph.D., J.D. Deputy General Counsel for Intellectual Property Biotechnology Industry Organization (Washington, DC) Brian V. Slater Partner Fitzpatrick, Cella, Harper & Scinto (New York, NY) Len S. Smith Principal Intellectual Property Counsel Medicis Pharmaceutical Corporation (Scottsdale, AZ) suja subramaniam Head of Legal Roche Diagnostics India Pvt Ltd. (Mumbai, India) mary c till (Invited) Legal Advisor, Office of Patent Legal Administration United States Patent and Trademark Office (Alexandria, VA) colleen tracy Partner Fitzpatrick, Cella, Harper & Scinto (New York, NY) shashank upadhye Vice President – Global Intellectual Property Apotex, Inc. (Toronto, ON) Christopher A. Vellturo, Ph.D., President, Quantitative Economic Solutions, LLC (Cambridge, MA) Jean F. Vollano, Ph.D (Invited) Quality Assurance Specialist United States Patent and Trademark Office (Alexandria, VA) Media Partners: 2 Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles unprecedented patent losses on small molecule pharmaceutical products having values in excess of $130 billion annually will occur by 2016.* A pathway for biosimilars has been created, but accompanying regulations have yet to be promulgated. now is the time for brand name and generic pharmaceutical companies to rethink the rules of the patent endgame. get the information that you need to navigate the hatch-Waxman patent cliff and the patent challenges precipitated by BPCIA. Attend the one event which has remained “the industry constant” for shaping policies and strategies for both brand names and generics. American conference Institute’s (AcI’s) maximizing pharmaceutical patent life cycles conference is the pharmaceutical industry’s leading source for information and analysis on patent life cycle management for both small and now, large molecule pharmaceutical products. It is the forum where lawyers, executives and policy makers for brand name and generic manufacturers gather each year to prepare for the life cycle challenges they currently face as well as those which they anticipate. • In-depth discussions on key regulatory developments impacting life cycle management including - REMS studies - Use codes, skinny labeling, and carve outs, and their relationship to divided infringement and inducement theories - Regulatory bars to exclusivity • Analyses of recent critical cases affecting patent life cycle planning including: Sun Pharma (double patenting); Microsoft (standard of invalidity); Ariad (patentability); Therasense (inequitable conduct) and strategies for using these cases to your advantage new Ip and industry dynamics coupled with evolving law and regulation have created new patent life cycle challenges for brand names and generics. The pharmaceutical industry now stands on the edge of the patent cliff. By 2016, patents on myriad block buster pharmaceutical products for treating ailments and conditions ranging from asthma to high cholesterol to psychosis and beyond will go off patent. This patent decline does not only pose problems for brand name drug manufacturers, but also proves troubling for generics; the ultimate Hatch-Waxman prize of 180-day exclusivity may be short-lived in the future as there will be few patented drug products worth coveting. Moreover, as the industry awaits FDA guidance on biosimilars, it remains anyone’s guess as to what effect, if any these new medicinal entities and therapies will have on the patent endgame. Benefit from in-depth and practical training and strategy sessions that will address the essentials and emerging focus of pharmaceutical patent life cycle management. In response to your requests, we have added the following pre-conference training and strategy sessions: • 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 offer critical instruction on the fundamentals and mechanics of PTA and PTE practice which help to ensure patent and profit longevity; and • 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 offer in-depth and pragmatic advice for navigating patent systems in Europe and emerging BRIC markets nearly 3,000 pharmaceutical patent professionals – for both brand names and generics – have made this conference their source of information for the legal issues surrounding life cycle management for nearly the last twelve years. This updated event will bring you the latest legal strategies and tactics for successful maneuvering in the evolving patent endgame. With all that’s at stake, you cannot afford to miss this conference. Don’t delay – register now by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering on-line at www.americanconference/LifeCycles. * Wall Street Journal, February 15, 2011 prepare to meet these pharmaceutical life cycle challenges head-on. This 12th AcI conference on maximizing pharmaceutical patent life cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry-leading event. This year’s conference features: • Presentations from key representatives from the USPTO (invited), FTC, and FDA (invited). They will provide you with direct insights and the logic of these agencies on some of most pressing life cycle management challenges that the industry is facing today, including the latest on: - Patent reform; PTE and PTA determinations; and reissue and reexam proceedings - Pay-for-delay and the findings of the FTC Report on the IP Market Place - Forfeiture determinations • An update on biosimilars and the further development of these second generation biological products will influence pharmaceutical patent life cycle and portfolio strategies in view of the further implementation of BPCIA and the inevitability of the patent cliff Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles 3 Interactive Training and Strategy Sessions Monday, October 3, 2011 A 9:00 AM – 12:30 PM (Registration begins at 8:15 AM) ptA- pte Boot camp: Basic training in the essentials of patent term Adjustment and patent term restoration for patent lawyers serving the Biopharmaceutical Industry Scott Beeser, Ph.D. LLB Patent Attorney – Biopharmaceuticals Apotex Inc. (Toronto, ON) Justin J. Oliver Partner Fitzpatrick, Cella, Harper & Scinto (Washington, DC) Richard S. Parr Assistant Counsel Merck & Co., Inc. (Rahway, NJ) Patent Term Adjustment (PTA) and Patent Term Extensions (PTE) are essential to patent life cycle longevity – especially in the pharmaceutical and biotechnology industries. Biopharmaceutical companies invest numerous resources into preserving the patent life and the subsequent profits of products which take years to produce. Each day of patent life equals millions of dollars in profits. A loss of even one day can have substantial impact on a company’s profit margin. Recent court decisions and the introduction of an abbreviated pathway for follow-on biological products have made knowing the “ins and outs” of PTE and PTA a critical competency for every patent practitioner servicing the pharmaceutical and biotechnology industries. This intensive half-day workshop will help you master the skills you need to face your greatest PTA and PTE challenges head on. A faculty of PTA and PTE experts will offer practical solutions and in-depth instruction for everything from eligibility requirements to calculations to the application and reconsideration processes. They will also discuss to the interplay of these mechanisms. Points of discussion will include: • Overview of Patent Term Adjustment (PTA)and Patent Term Extension (PTE) - statutory authorities  Patent Act  Hatch-Waxman Act • Understanding the unique role of PTA and PTA in the longevity of patent life cycles in the life sciences industries • PTA vs. PTE - seeking redress for PTO delays - seeking redress for FDA delays • Which point of patent life does each of these devices extend? - full scope of patent vs. full scope of patent life of patent product • • • • • •  request for Reconsideration /Application for Correction - when can PTA be corrected after the issuance of the patent PTO delays v. applicant delays A-Delays: what are they and when are they granted? - understanding the PTO’s 14 – 4 – 4 clock  14 months: first action response time º how to measure the initial 14 month delay  4 months: response/appeal  4 months: patent issuance - identifying the point in time when A delays accumulate? B-Delays: what are they and what are the criteria for their issuance? - triggers: PTO 3 year patent issuance deadline  starting point for B-Delay accumulation  how are B-Delays measured? C- Delays: how are they different for A and B-Delays - triggering events:  interferences  secrecy orders  notices of appeal - when are they granted? - how are they calculated? Identifying events which stop the 3 year B-Delay clock and their relation to C-Delays - other clock stoppers  RCE- Request for Continued Examination Analyzing and solving A and B Delay overlap dilemmas - Wyeth v.Dudas - Japan Tobacco pte • Overview of PTE - 35 USC 156 - 37 CFR 1.710 – 1.791 • Identifying important benchmarks in a drug’s development and patent timelines relative to seeking PTE - what is the patent term restored and to what does it apply?  defining “drug product” under PTE provisions of Hatch-Waxman Act  salts  esters  enantiomers - regulatory review period determinations  testing phase  review phase • Understanding why PTE provisions in the Hatch-Waxman Act extend to products outside the scope of HatchWaxman, i.e., biologics and certain medical devices - the importance of PTE in the newly ratified follow-on biologic scenario - exploring PTE applicability relative to:  antibiotics  animal drugs  food/color additives  combination products • Reviewing eligibility requirements/prerequisites for patent term extension • Calculating the patent term restored - FDA/ PTO interplay • Criteria and eligibility for interim extensions • The PTE application - strategies for preparation and submission ptA • • • • Review of 35U.SC. 154(b) and 37 C.F.R. 1.702 -1.705 Comprehending the criteria for PTA eligibility Reconciling discrepancies in certain PTA and PTO Rules Seeking PTA - starting point and the Notice of Allowance - addressing dispute with PTO’s initial PTA calculation 4 Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles B 2:00 PM – 5:30 PM (Registration begins at 1:15 PM) 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 James M. Gould Legal Director- Intellectual Property Litigation Merck & Co., Inc. (Rahway, NY) Gabriel Kleiman Assistant General Counsel Pfizer Inc. (New York, NY) Bert Oosting Partner Hogan Lovells (Amsterdam, NE) Suja Subramaniam Head of Legal Roche Diagnostics India Pvt Ltd. (Mumbai, India) Workshop objectives • Developing a global pharmaceutical patent life cycle management plan that responds to changes which impact intellectual property protection in established as well as emerging markets • Learning to extend pharmaceutical patent life in foreign jurisdictions • Identifying and seeking available international patent and non-patent exclusivities • Contemplating whether or not a new SPC can be obtained for new combinations, isomers, etc. • Identifying what (if any) alternatives exist for obtaining an SPC when seeking to extend the patent term on your product • Evaluating differing standards for obtaining an SPC on a country-by-country basis • Considering issues unique to seeking an SPC when the original Marketing Authorisation (MA) was granted in a country that is not part of the European Economic Area (EEA), i.e., Switzerland • Obtaining a springboard injunction for marketing and distribution after patent expiry in case of offering and inclusion in pricelists before patent expiry regulatory exclusivities – eu and elsewhere • Regulatory Data Protection • The Paediatric Medicines Regulation - scope and key obligations - what kind of reward/exclusivity are available (SPC extension/patent protected products, orphan drugs, off-patent products)? • The Orphan Drugs Regulation – obtaining orphan market exclusivity exploring strategies to extend pharmaceutical patent life in: • • • • • Japan South Korea Taiwan Singapore Israel Emerging Markets – BRIC* • Examining the treatment of pharmaceutical patents in BRIC* countries • Learning when and how patent term can be preserved/ extended in these countries in the absence of a formal patent extension mechanism • Assessing when filing in these jurisdictions make sense from a global patent life cycle management perspective • Navigating the parameters of regulatory data protection throughout these countries established markets • Assessing changes in European patent practice in light of the findings of the EC’s DG Competition’s Pharmaceutical Sector Inquiry • What bearing have these changes had on patent life cycle strategies in Europe - extensions of patent term - regulatory exclusivities Brazil • Examining a system that provides a separate review protocol for pharmaceutical patents • Looking at Brazilian antitrust authorities view on “pay-fordelay” and how it is influencing patent life cycle strategies patent extensions in the eu • Supplementary Protection Certificates (SPCs) – extension of patent life in the EU - scope of the protection - how do you apply for it? - interaction between the Pharmaceutical Directive and the SPC Regulation • Meeting the requirements to obtain an SPC - tips for maximizing the patent extension obtained under an SPC for human medicinal products - weighing the pros and cons of seeking a pediatric extension - obtaining a zero term or SPC or quasi patent term extension - determining what extension term is best for your product based on an assessment of the type of rights you will be granted russia • Exploring uncertainties in an emerging patent system India • Overview the Indian patent system and its recognition of primary patents only china • Analysis of China’s patent system and its treatment of U.S. pharmaceutical patents in particular * BRIC – Brazil, Russia, India, China Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles 5 M ain Conference – Day One Tuesday, October 4, 2011 7:15 8:15 registration and continental Breakfast co-chairs’ opening remarks Chairmen: George W. Johnston Vice President & Chief Patent Counsel Hoffmann-La Roche (Nutley, NJ) Mark E. Waddell Partner Loeb & Loeb LLP (New York, NY) Chairman Emeritus: John C. Vassil (Formerly Of Counsel to Morgan & Finnegan LLP) (New York) 9:30 uspto Keynote: the Impending reality of patent reform and Its potential Impact on pharmaceutical patents Teresa Stanek Rea (Invited) Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director United States Patent and Trademark Office (Alexandria, VA) On March 8, 2011, the Senate by a 95-5 vote passed S. 23, i.e., The America Invents Act or Patent Reform Act of 2011. A little more than a month later, the House Judiciary Committee voted to approve its own version of the Patent Reform Act, i.e., H.R. 1249. It is anticipated that this bill will go to a full House vote sometime in mid-June. If passed, proceedings would begin to reconcile both the Senate and House versions of this legislation. In light of these developments, Patent Reform is now an impending reality of which the biopharmaceutical industry must become well acquainted. Teresa Stanek Rea will address the provisions of the proposed Patent Reform legislation and its implications for the pharmaceutical and biotechnology industries. Points of discussion will include: • • • • • • First to file vs. first to invent Proposed changes in PTO practice False marking The future of reexamination practice Post Grant Review proceedings The Goodlatte Supplemental Proceeding Amendments 8:30 understanding how the patent cliff Will re-define the endgame George W. Johnston Vice President & Chief Patent Counsel Hoffmann-La Roche (Nutley, NJ) Christopher A. Vellturo, Ph.D., President, Quantitative Economic Solutions, LLC (Cambridge, MA) Mark E. Waddell Partner Loeb & Loeb LLP (New York, NY) • Defining the patent cliff • How will the patent cliff impact the future of the pharmaceutical industry? - brand-name and generic perspectives • Understanding how the patent cliff could unravel the balance of power established by Hatch-Waxman between brand names and generics • Exploring modes of innovation that will make up for patent cliff losses - drug delivery modalities - combination products  combined drugs  combined drug and device therapies - the future of gene patenting  other section 101 controversies • Identifying the role of biosimilars in the era of the small molecule patent cliff 10:30 10:45 morning coffee Break potential life cycle management controversies posed By the Implementation of the Biosimilars Act Stephen R. Auten Vice President, IP Sandoz, Inc. (Princeton, NJ) David Korn Senior Assistant General Counsel PhRMA (Washington, DC) Hans Sauer, Ph.D., J.D. Deputy General Counsel for Intellectual Property Biotechnology Industry Organization (Washington, DC) Moderator: Gregory J. Glover, MD, JD Principal Pharmaceutical Law Group PC (Washington, DC) 6 Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles It has been more than a year since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) which established a pathway for biologics to be approved as biosimilars under section 351k of the Public Health Service Act. Although the FDA still has not issued regulations which would allow the industry to make critical determinations in pursuing the development of these products, the statutory structure suggests several life cycle management issues that are likely to arise from FDA’s regulations and the implementation of BPCIA. In this session, our panelists will explore the regulatory, patent, and exclusivity issues raised by BPCIA as well as the status and anticipated content of FDA rulemaking in this area. Points of discussion will include: • FDA regulatory issues in the implementation of BPCIA - highly similar - interchangeability - user fees for expedited review - FDA waiver  analytical studies  animal studies  human clinical studies - what can we glean from FDA’s individual meetings with would-be biosimilar manufacturers? - regulatory lessons learned from Europe • Market protection issues raised by the patent exchange procedures - benefits and risks of the patent exchange procedures  disclosure of the biosimilars application  question of what constitutes infringement º perspective of the reference product sponsor  list exchanges conundrum - weighing economic and cost considerations of the biosimilars pathway and the full BLA • The potential impact and practical implications of the exclusivity provisions - 12-year exclusivity  nature of the exclusivity  criteria for eligibility  importance of “sameness” definitions - interchangeability exclusivity  uncertain duration  potential need for “at-risk” launch - pediatric exclusivity - orphan drug exclusivity 11:45 ptA • Re-examining A and B overlaps in a post-Wyeth world - equitable tolling  Schering v. Kappos (D.C. Cir.) • Post-Wyeth PTO procedures and calculations - PTO’s PTA computer program overhaul - proposed changes by the PTO to the PTA Rules - factoring-in BPAI appeals - holidays • Identifying circumstances when filing a District Court complaint before the DC Circuit is still your best option for PTA redress pte • Examining substantive and procedural PTE controversies impacting not only drugs but biological products as well • The Medicines Company v. PTO (E.D. Va.) - denying PTE application filed on day 62 - potential legislative solution to Medicines Company dilemma under Patent Reform • Genetics & IVF Institute v. Kappos (E.D. Va.) - interim PTE rejection • Schering Corp. v. Mylan Pharmaceuticals, Inc., (D.N.J. 2011) - duty to disclose prior art 12:30 1:45 networking luncheon exploring post-Issuance pto procedures in the era of the patent cliff: focus on reexam and reissue proceedings Robert M. Gould, Ph.D. Partner Duane Morris LLP (Chicago, IL) Kevin W. McCabe Director Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC) Len S. Smith Principal Intellectual Property Counsel Medicis Pharmaceutical Corporation (Scottsdale, AZ) Jean F. Vollano, Ph.D (Invited) Quality Assurance, Specialist United States Patent and Trademark Office (Alexandria, VA) • Examining the recent upswing in reexam and reissue proceedings and what their implications are for patent life cycle strategies • Understanding how reexam proceedings are being used by both patent challengers and patent holders - ex-parte and inter-partes proceedings - economics and efficiencies of reexam - what are the inherent risks for third party challengers - when does it make sense for a patent holder to file for reexam? patent term Adjustment and patent term extensions update: strategies and considerations for small and large molecules Barton W. Giddings, Ph.D Partner Stoel Rives LLP (Salt Lake City, UT) Mary C Till (Invited) Legal Advisor, Office of Patent Legal Administration United States Patent and Trademark Office (Alexandria, VA) • Assessing the impact of evolving PTA and PTE precedents in pharmaceutical patent life cycle management strategies Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles 7 Main Conference – Day One (cont’d) Tuesday, October 4, 2011 • Assessing the future of reexam proceedings in light of pending Patent Reform legislation • Current reexam proceeding vs. proposed post-grant review under Patent Reform • Evaluating the risks and benefits of reissue proceedings in patent life cycle management • Exploring the significance of In Re Tanaka on reissue filings in the pharmaceutical industry - addition of narrow claim - preservation of original claim 2:45 3:00 obviousness-type double patenting • Analyzing the evolving state of the law on obviousness-type double patenting • Sun Pharm. Indus. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. 2010): how denial of both en banc review and certiorari by the Supreme Court has resulted in a culmination of a new double patenting standard - deciphering the Federal Circuit’s rationale regarding an extension of a prior art analysis to a double patenting controversy - exploring why the Federal Circuit strayed from prior Federal Circuit precedent holding that double-patenting is based upon that which is already claimed - understanding the importance of the dissent in this opinion  examining the heretofore used “obvious variant” standard • Boehringer Ingleheim Int’l, et al. v. Barr Labs, Inc., et al., 592 F.3d 1340 (Fed. Cir. 2010) - exploring the respective roles of patent term extensions and terminal disclaimers in the double patenting controversy • Brand-name and generic strategies for navigating the new double patenting landscape - examining the link between double patenting and inequitable conduct • Understanding the impact of the Sun and Boehringer cases on pharmaceutical patent life cycle strategies 4:15 Afternoon refreshment Break the combined Impact of prior Art obviousness and obvious-type double patenting on pharmaceutical patent life cycle strategies Margaret “Peg” M. Buck Head of Section, US Legal Affairs & Patents Lundbeck Research USA, Inc. (Paramus, NJ) Thomas J. Kowalski Shareholder Vedder Price P.C. (New York, NY) Steven J. Lee Partner Kenyon & Kenyon (New York) Brian P. Murphy Partner Edwards Angell Palmer and Dodge LLP (New York, NY) Brian V. Slater Partner Fitzpatrick, Cella, Harper & Scinto (New York, NY) • Comparing obviousness based on prior art to obvious-type double patenting and understanding their collective impact on pharmaceutical patent and portfolio strategies personalized medicine and patent life cycle considerations Vis-à-Vis sections 101, 112, and Allowable research exceptions Patricia Carson Partner Kaye Scholer LLP (New York, NY) Michael A. Davitz Partner Axinn, Veltrop & Harkrider LLP (New York, NY) Denise L. Loring Partner Ropes & Gray LLP (New York, NY) • Patent controversies relative to research on genetic material - Section 101 Patentability  exploring the patentability of genes and related diagnostic claims patentable – should they be patentable?  patent drafting and claiming strategy to protect the genetic and diagnostic inventions. • Examining Section 112 written description and enablement vis-à-vis personalized medicine - recap of Ariad v. Lilly and its current application by the Federal Circuit to Centocor Ortho Biotech Inc. v. Abbott Laboratories - reaffirming the distinction between written description and enablement - reviewing specification requirements  understandability  inventorship prior Art obviousness • Prior art obviousness revisited: lessons learned from KSR and its progeny and In Re Kubin relative to life cycle and portfolio strategies for large and small molecules • Reaffirmation of KSR through In Re Kao (Fed. Cir. 2011) • Understanding the impact of KSR and its progeny on primary compound and composition claims vis-à-vis generic challenge - impact on secondary patents  enantiomers  isomers  new formulations  new indications  crystallizations  salts • Anticipated obviousness challenges to proteins and biosimilars • Examining the USPTO 2010 Revisions to its obviousness guidelines 8 Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles M ain Conference – Day T wo Wednesday, October 5, 2011 - examining Abbott’s impact on future written description challenges regarding antibodies and other biological products  anticipating written description challenges relative to biosimilars - what level of description is required to satisfy the Patent Office to meet the written description and enablement requirements? - how much information is sufficient for diagnostic claims to an expert in the field, i.e., one skilled in the art - revisiting the role of written description in patent life cycle strategies for the biopharmaceutical industry - assessing how written description will be used as a means of invalidity challenges in light of this jurisprudence • Scope of patent Infringement exception under § 271(e)(1) as it applies to genetic research and development 5:15 7:15 8:15 8:30 continental Breakfast co-chairs’ opening remarks and recap of day one ftc Keynote: Analysis of competitive Behaviors in pharmaceutical patent life-cycle management strategies Suzanne Munck Counsel for Intellectual Property Federal Trade Commission (Washington DC) The FTC continues to vigorously use its enforcement and policy tools to prevent anticompetitive business practices in the pharmaceutical industry. The Commission remains steadfast in its position that certain industry behaviors concerning patent settlements are anticompetitive. In this session, Suzanne Munck will discuss the FTC’s position in these matters, including: • The FTC’s current stance on “pay-for-delay” settlements - enforcement of MMA reporting requirements - FTC and DOJ alignment on “pay-for-delay” - status of pending legislation regarding settlements • Analysis of the competitive implications of other pharmaceutical life cycle management strategies • FTC Report on the IP Market Place • The FTC’s Report on Follow-On Biologic Drug Competition cAfc and supreme court Watch: three cases that may have radical Impact on pharmaceutical patent life cycle strategies John M. (Jack) Griem, Jr. Partner Milbank, Tweed, Hadley & McCloy LLP (New York, NY) Edward T. Lentz Patent Attorney (New Lisbon, NY) Rashad L. Morgan Patent Attorney Brinks Hofer Gilson & Lione (Research Triangle Park, NC) Colleen Tracy Partner Fitzpatrick, Cella, Harper & Scinto (New York, NY) There are currently three matters before the Federal Circuit and U.S. Supreme Court that may greatly impact patent life cycle strategies in the biopharmaceutical industry. These matters go to the very heart of patent validity, the subject matter of that which is patentable, and the ethical considerations affecting the manner in which patents are obtained. Our panel will address the legal and strategic implications raised by these matters as they discuss: • Microsoft Corporation v. i4i Limited Partnership (Supreme Court ___) • Association for Molecular Pathology v. Myriad (Fed. Cir. __) • Therasense, Inc. v. Becton, Dickinson and Co. (Fed. Cir. ___) 9:15 9:30 morning coffee Break rems studies and generic entry: exploring the latest regulatory conundrum Affecting pharmaceutical patent life cycle strategies Guy Donatiello Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA ) Kurt R. Karst Director Hyman, Phelps & McNamara, P.C. (Washington, DC) • Understanding how REMS (Risk Evaluation and Mitigation Strategies) studies are impacting the generic entry of certain drugs - cost of REMS study - obligation of generic to continue or mimic REMS study • The FDA prohibition against using REMS as a blocking strategy: fact vs. reality • Exploring the patentability of a REMS study - the incorporation of certain REMS elements in Orange Book listings • Exploring the potential use of a 505(b)(2) application as a design around REMS obligations by the generic • Novel questions of sample request under and ANDA as posed by Thalidomide 6:15 conference Adjourns to day two cocktail reception hosted by Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles 9 M ain Conference – Day T wo (cont’d) Wednesday, October 5, 2011 New Orange Book Strategies and Controversies 10:15 part A: carve-outs, skinny labeling and use codes: understanding their role in orange Book listing strategies and life cycle management Nicolas G. Barzoukas Partner Weil, Gotshal & Manges LLP (Huston, TX) Bruce A. Pokras Senior Corporate Counsel, Intellectual Property Pfizer Inc. (Madison, NJ) Richard T. Ruzich Partner Duane Morris LLP (Chicago, IL) • Exploring the relationship between a drug’s label, patents and Orange Book listings • Defining Section viii carve –outs and understanding their significance to Orange Book listings - skinny labeling  off-label uses • Therapeutic equivalence evaluation codes - the role of AB ratings and OB use codes in the Orange Book and how they impact pharmaceutical patent life cycle strategies • Examining delisting strategies based on use codes and labeling controversies vis-à-vis Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2010) - when can use codes be altered? - will seeking permission from the FDA to carve-out patent protected language allow for generic entry? - significance of Solicitor General’s filing of an invitation brief in this matter 11:15 • Examining inducement challenges to methods of use claims listed in the Orange Book • Defining inducement of infringement and divided infringement under current law - how the Supreme Court’s ruling in Global Tech v. SEB has altered the standard for inducement findings  mens rea requirements º willful blindness vs. deliberate indifference  indirect vs. direct infringement - the concept of divided and joint infringement vis-à-vis Akamai Technologies, Inc. v. Limelight Networks, Inc., (Fed. Cir. 2011) • Exploring the relationship between inducement actions and divided infringement and how they apply to methods of use claims in pharmaceutical patents • AstraZeneca LP v. Apotex, Inc.: the role of Section viii carveouts and the inducement controversy - Orange Book listed methods of use patents vs. that which is actually listed in the label - Indentifying the indirect infringer in these circumstances - how might a similar rationale be used in a matter of divided infringement? 12:30 1:45 networking luncheon exclusivities and forfeitures: new developments, controversies and concerns Allen R. Baum Shareholder and Chair, Chemical Practice Group Brinks Hofer Gilson & Lione (Research Triangle Park, NC) Thomas D. Hoffman Consultant – Patent Counsel Sandoz,Inc. (East Hanover, NJ ) Brian J. Malkin Partner Frommer Lawrence & Haug LLP (New York, NY) Shashank Upadhye Vice President – Global Intellectual Property Apotex, Inc. (Toronto, ON) • Forfeiture provisions: circumstances under which exclusivity is forfeited - identifying circumstances under which forfeiture of another’s exclusivity may occur? • Deciphering the FDA’s stance on pre and post–MMA 180-day exclusivity • Interpreting the “earlier of ”, later of ” language in making a forfeiture determination • Evaluating the strength of “the failure to market” provision post-Lipitor • Exploring simultaneous qualification for and forfeiture of exclusivity for failure to obtain tentative approval • Evaluating the impact of “delisting” on forfeiture • Forfeiture relative to patent expiration • When can the 180-day exclusivity period be transferred to another ANDA applicant? part B: Inducement Actions and divided Infringement: how method of use claims controversies Are Influencing orange Book listings Aaron F. Barkoff, Ph.D. Partner McAndrews, Held & Malloy, Ltd. (Chicago, IL) Michael P. Dougherty Special Counsel Cadwalader, Wickersham & Taft LLP (New York) Ted J. Ebersole, Ph.D. Assistant General Patent Counsel Eli Lilly and Company (Indianapolis, IN) Nicholas Groombridge Partner and Co-Chair, Patent Litigation Weil, Gotshal & Manges LLP (New York, NY) 10 Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles • Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences • When can a brand “park” a generic’s exclusivity? • Defining “shared exclusivity” • How have authorized generics changed the playing field relative to 180-day exclusivity? • Exploring regulatory bars to exclusivity - GMP violations - SEC • Revisiting the relationship between exclusivity, forfeiture and the 30 month stay - circumstances under which a second stay may be granted impact on grant of exclusivity 3:00 3:15 Who You Will Meet: patent Attorneys (in-house and law firm), Business executives and policy Analysts for: • Brand name pharmaceutical companies • Generic pharmaceutical companies • Biopharmaceutical companies Afternoon refreshment Break fdA Keynote: update on fdA Activities Impacting pharmaceutical patent life cycles for small and large molecules Elizabeth Dickinson (Invited) Associate Chief Counsel, Office of the Chief Counsel U.S. Food and Drug Administration (Rockville, MD) The FDA’s jurisdiction over the Orange Book and listed patents; its decision-making powers concerning the consequences of de-listing patent; and its recent determinations regarding forfeitures are indicative of the agency’s critical role in the patent endgame. The discretionary Rule Making authority allowed to the agency over follow-on biologics under BPCIA further enhances this role. This session will cover the present state of the FDA’s authority in Orange Book listings, forfeiture decisions and other Hatch-Waxman and biosimilar-related matters. Continuing Legal Education Credits CLE Credits Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation. AcI certifies that the activity has been approved for CLE credit by the New York State Continuing Legal Education Board in the amount of 15.0 hours. An additional 4.0 credit hours will apply to workshop A/B participation. AcI certifies that this activity has been approved for CLE credit by the State Bar of California in the amount of 12.75 hours. An additional 3.5 credit hours will apply to workshop A/B participation. You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4-8 weeks after a conference is held. AcI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and AcI will make every effort to process your request. Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/CLE 4:15 safe harbor or stormy port?: calming the legal tempest left by Proveris Brian D. Coggio Senior Principal Fish & Richardson, P.C. (New York) • Analyzing the pivotal role that the Hatch-Waxman safe harbor plays in patent portfolio management and life cycle management • Overview of the safe harbor exemption to patent infringement • Identifying “research tools” under Proveris? − if a patent can be extended under § 156, does Proveris still apply? − does Proveris control “compounds” used as research tools (e.g., comparators)? • Under which circumstances does the safe harbor protect general screening (high through-put screening)? − if not, where is the dividing line between unprotected screening and protected research? − what is a “reasonable basis for believing” a compound or compounds “may work” for their intended purposes under Merck v. Integra − when is post-approval testing protected under the safe harbor? − can aspects of the research be “farmed-out” and still be protected? − special considerations for antibodies vis-à-vis the safe harbor? − exploring the applicability of the safe harbor in ITC actions? Global Sponsorship Opportunities With more than 500 conferences in the United States, Europe, Asia Pacific, and Latin America, American conference Institute (AcI) provides a diverse portfolio devoted to providing business intelligence to senior decision makers who need to respond to challenges spanning various industries in the US and around the world. As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your organization to create the perfect business development solution catered exclusively to the needs of your practice group, business line or corporation. For more information about this program or our global portfolio of events, please contact: Wendy tyler Head of Sales, American Conference Institute Tel: 212-352-3220 x5242 | Fax: 212-220-4281 [email protected] © American Conference Institute, 2011 5:00 conference ends Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles 11 12th Annual Maximizing Pharmaceutical Patent Life Cycles ACI’s r i s e e HATCH-WAXMAN s october 3, 2011: Interactive pre-conference training and strategy sessions A. PTA- PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry B. 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 Registration fee The fee includes the conference‚ all program materials‚ continental breakfasts‚ lunches and refreshments. The definitive Hatch-Waxman and BPCIA event for brand names and generics October 4 – 5, 2011 | New York Marriott Downtown | New York R E g i s t R at i o n f o R m PRIORITY SERVICE CODE .827L12.INH Payment Policy Payment must be received in full by the conference date. All discounts will be applied to the Conference Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to individuals employed by the same organization. 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