Beruflich Dokumente
Kultur Dokumente
HATCH-WAXMAN
e s
The definitive Hatch-Waxman and BPCIA event for brand names and generics
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--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
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
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
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
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:
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 Institutes (AcIs) maximizing pharmaceutical patent life cycles conference is the pharmaceutical industrys 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 anyones 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 thats at stake, you cannot afford to miss this conference. Dont 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
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 companys 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 PTOs 14 4 4 clock 14 months: first action response time 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 drugs 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 PTOs initial PTA calculation
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
established markets
Assessing changes in European patent practice in light of the findings of the ECs DG Competitions 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
russia
Exploring uncertainties in an emerging patent system
India
Overview the Indian patent system and its recognition of primary patents only
china
Analysis of Chinas patent system and its treatment of U.S. pharmaceutical patents in particular * BRIC Brazil, Russia, India, China
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
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)
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 FDAs 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 FDAs 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 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 - PTOs 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
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--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--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
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 FTCs position in these matters, including: The FTCs 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 FTCs 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
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 anothers exclusivity may occur? Deciphering the FDAs stance on pre and postMMA 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
Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences When can a brand park a generics 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
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 FDAs 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 agencys 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 FDAs authority in Orange Book listings, forfeiture decisions and other Hatch-Waxman and biosimilar-related matters.
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--vis the safe harbor? exploring the applicability of the safe harbor in ITC actions?
5:00
conference ends
11
12th Annual
HATCH-WAXMAN
s
The definitive Hatch-Waxman and BPCIA event for brand names and generics
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.
ATTeNTION MAILROOM: If undeliverable to addressee, please forward to: Corporate Counsel Patents; Patent attorney ConfEREnCE CodE: 827L12-nYC o YEs! Please register the following delegate for Maximizing Pharmaceutical Patent Life Cycles
Hotel information
American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate. Please contact the hotel directly and mention the ACI Patent Life Cycles conference to receive this rate: Venue: New York Marriott Downtown Address: 85 West Street at Albany Street, New York, NY 10006 Reservations: (212) 385-4900 or (800) 242-8685
ContaCt dEtaiLs
NAME APProVING MANAGEr orGANIZAtIoN ADDrESS CItY tElEPhoNE EMAIl
o
PoSItIoN PoSItIoN
5
StAtE FAX tYPE oF buSINESS ZIP CoDE
I would like to receive ClE accreditation for the following states: ___________________. See ClE details inside.
Register & Pay by Aug. 5, 2011 $3195 $2595 $1995 Register & Pay by Sep. 9, 2011 $3295 $2695 $2095 Register after Sep. 9, 2011 $3495 $2895 $2295
Fee PeR DeLeGATe o eLITePASS*: Conference & Both Workshops o Conference & Workshop oA or oB o Conference Only
FAX
' PHONE
o I cannot attend but would like information on accessing the ACI publication library and archive *ELITEPASS is recommended for maximum learning and networking value.
PaYmEnt
Please charge my o VISA o MasterCard o AMEX o Please invoice me NuMbEr CArDholDEr
o
To reserve your copy or to receive a catalog of ACI titles go to www.aciresources.com or call 1-888-224-2480.
EXP. DAtE
I have enclosed my check for $_______ made payable to american Conference institute (t.I.N.98-0116207)
We offer special pricing for groups and government employees. Please email or call for details. Promotional discounts may not be combined. ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.