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ACI Maximizing Pharmaceutical Patent Life Cycles 2011 NYC

ACI Maximizing Pharmaceutical Patent Life Cycles 2011 NYC

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Register Now • 888-224-2480 • AmericanConference.com/LifeCycles
Earn
CLE
 
Credits
MaximizingPharmaceuticalPatent Life Cycles
Te
defnitive
Hach-Waxman and BPCIA even for brand names and generics
Ocober 4 – 5, 2011 | New York Marriot Downown | New York 
12
th
  Annual
HATCH-WAXMAN
series
 ACI’s
Industry InsIghts rom:
and ACI’s Hatch-Waxman Series Advisory Board –See P.2
Key AgencIes spotlIght
Hear rom the:
•
ui sa pa a taak o :pa r
 
Teresa Stanek Rea (Invited)Deputy Under Secretary o Commerce or Intellectual Property and Deputy Director, USPTO 
ptA a pte Aai 
 Mary C Till (Invited), Legal Advisor Ofce o Patent Legal Administration, USPTO 
rxa a ri
 Jean F. Vollano, Ph.D(Invited)Quality Assurance Specialist, USPTO 
•FederalTradeCommissionon:|
 ciiv Bavi Iaipaaia pa li c maa
 
Suzanne Munck  , Counsel or Intellectual Property Ofce o Policy and Planning, FTC 
•U.S.FoodandDrugAdministrationon:
 dA Aivii Ai paaia pali c  sa a la m 
Elizabeth Dickinson(Invited), Associate Chie Counsel, Ofce o the Chie Counsel, FDA
Homann-LaRoche Apotex, Inc.BIOEli Lilly & Company Endo PharmaceuticalsLundbeck ResearchUSA, Inc.Medicis PharmaceuticalCorporationMerck & Company Pzer, Inc.PhRMA Roche Diagnostics IndiaPvt Ltd.Sandoz, Inc.
Preeminent patent counsel and advisors to leading brand name and genericpharmaceutical companies, as well as representatives rom key government agenciesand industry associations will provide insights on the latest challenges aectingpharmaceutical patent lie cycles or small and large molecules and help you:
•
understAnd
how the
a i 
will impact
ivai
and
r&d
•
prepAre
or the release o anticipated
dA ai
on
biiia
 and
comprehend
how 
  iai  BpcIA 
will aect
aaia a i  aa ai
•
 Assess
how the combined evolution o 
i a bvi
and
bvi-b ai
is infuencing the uture o 
a a
•
eVAluAte
patent lie cycle strategies relative to
aiz ii vi-à-vii 101
patentability and
i 112
written description requirements
•
 AnAlyZe
the signicance o 
 Microsot 
,
 Myriad 
and
Therasense 
on patent liecycle strategies or
a
and
a 
•
eXAmIne
the impact o 
rems
studies on
i  
•
decIpher 
the relationship between
  vi
and
i/
 
ivi ii
actions relative to
oa Bk ii
•
eXplore
 
i
rulings
-
Lipitor 
•
nAVIgAte
new 
a ab
dilemmas or both
a i
and
a
patents
ob 3, 2011: Iaiv p-c taii a sa si
 A.
ptA- pte B ca: Bai taii i  eia  pa t Aj a pa t rai  pa law svi Biaaia I 
B.
 Wki g  gba paaia pa li cmaa sai  eabi a ei mak: A paia, ha-o gi t pa exi a exivii Avaiab  paaia p A  W
si s:s b: Aias:ckai rih b:
 
Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles
sak:
StephenR.Auten
Vice President, IPSandoz, Inc. (Princeton, NJ)
 AaronF.Barkoff,Ph.D.
PartnerMcAndrews, Held & Malloy, Ltd.(Chicago, IL)
NicolasG.Barzoukas
Partner Weil, Gotshal & Manges LLP(Huston, TX)
 AllenR.Baum
Shareholder and Chair, ChemicalPractice GroupBrinks Hoer Gilson & Lione(Research Triangle Park, NC)
ScottBeeser,Ph.D.LLB
Patent Attorney – Biopharmaceuticals Apotex Inc. (Toronto, ON)
Margaret“Peg”M.Buck 
Head o Section,US Legal Aairs & PatentsLundbeck Research USA, Inc.(Paramus, NJ)
paiia ca
PartnerKaye Scholer LLP (New York, NY)
BrianD.Coggio
Senior PrincipalFish & Richardson, P.C. (New York)
MichaelA.Davitz
Partner Axinn, Veltrop & Harkrider LLP(New York, NY)
eizab diki
(Invited) Associate Chie Counsel, Oceo the Chie CounselU.S. Food and Drug Administration(Rockville, MD)
g dai
Vice President, Intellectual Property Endo Pharmaceuticals(Chadds Ford, PA )
MichaelP.Dougherty 
Special CounselCadwalader, Wickersham & Tat LLP(New York, NY)
TedJ.Ebersole,Ph.D.
 Assistant General Patent CounselEli Lilly and Company (Indianapolis, IN)
BartonW.Giddings,Ph.D
 PartnerStoel Rives LLP (Salt Lake City, UT)
GregoryJ.Glover,MD,JD
PrincipalPharmaceutical Law Group PC(Washington, DC)
 JamesM.Gould
Legal Director –Intellectual Property LitigationMerck & Co., Inc. (Rahway, NY)
RobertM.Gould,Ph.D.
PartnerDuane Morris LLP (Chicago, IL)
 JohnM.Griem,Jr.
PartnerLoeb & Loeb LLP (New York, NY)
nia gbi
Partner and Co-Chair Patent Litigation Weil, Gotshal & Manges LLP(New York, NY)
ThomasD.Hoffman
Consultant – Patent CounselSandoz,Inc. (East Hanover, NJ )
KurtR.Karst
DirectorHyman, Phelps & McNamara, P.C.(Washington, DC)
gabi Kia
 Assistant General CounselPzer Inc. (New York, NY)
davi K
Senior Assistant General CounselPhRMA (Washington, DC)
ThomasJ.Kowalski
ShareholderVedder Price P.C. (New York, NY)
StevenJ.Lee
PartnerKenyon & Kenyon (New York)
EdwardT.Lentz
Patent Attorney (New Lisbon, NY)
DeniseL.Loring
PartnerRopes & Gray LLP (New York, NY)
BrianJ.Malkin
PartnerFrommer Lawrence & Haug LLP(New York, NY)
KevinW.McCabe
DirectorSterne, Kessler, Goldstein& Fox P.L.L.C. (Washington, DC)
RashadL.Morgan
Patent Attorney Brinks Hoer Gilson & Lione(Research Triangle Park, NC)
sza mk 
Counsel or Intellectual Property Oce o Policy and PlanningFederal Trade Commission(Washington DC)
BrianP.Murphy 
PartnerEdwards Angell Palmerand Dodge LLP (New York, NY)
 JustinJ.Oliver
PartnerFitzpatrick, Cella, Harper & Scinto(Washington, DC)
B oi
PartnerHogan Lovells (Amsterdam, NE)
RichardS.Parr
 Assistant CounselMerck & Co., Inc. (Rahway, NJ)
BruceA.Pokras
Senior Corporate Counsel, IntellectualProperty Pzer Inc. (Madison, NJ)
RichardT.Ruzich
PartnerDuane Morris LLP (Chicago, IL)
ta sak ra (Ivi)
Deputy Under Secretary o Commerceor Intellectual Property and Deputy DirectorUnited States Patent andTrademark Oce (Alexandria, VA)
HansSauer,Ph.D.,J.D.
Deputy General Counsel orIntellectual Property Biotechnology Industry Organization(Washington, DC)
BrianV.Slater
PartnerFitzpatrick, Cella, Harper & Scinto(New York, NY)
LenS.Smith
Principal Intellectual Property CounselMedicis Pharmaceutical Corporation(Scottsdale, AZ)
sja sbaaia
Head o LegalRoche Diagnostics India Pvt Ltd.(Mumbai, India)
ma c ti
(Invited)Legal Advisor, Oce o Patent Legal AdministrationUnited States Patent and Trademark Oce (Alexandria, VA)
c ta 
Partner
Fitzpatrick, Cella, Harper & Scinto
(New York, NY)
saak ua
Vice President –Global Intellectual Property  Apotex, Inc. (Toronto, ON)
ChristopherA.Vellturo,Ph.D.
,President, Quantitative EconomicSolutions, LLC (Cambridge, MA)
 JeanF.Vollano,Ph.D
(Invited)Quality Assurance SpecialistUnited States Patent and Trademark Oce (Alexandria, VA)
2
 Advisory Board & Faculty List
StephenR.Auten
Vice President, IPSandoz, Inc.(Princeton, NJ)
MatthewP.Blischak
Vice President, Intellectual Property & Associate General CounselSunovion Pharmaceuticals Inc.(Marlborough, MA)
g dai
Vice President, Intellectual Property Endo Pharmaceuticals(Chadds Ford, PA )
LisaA.Jakob
Legal Director, IP LitigationMerck & Company (Rahway, NJ)
GeorgeW.Johnston
Vice President & Chie PatentCounselHomann-La Roche(Nutley, NJ)
 JamesP.Leeds
  Assistant General Patent CounselEli Lilly & Company (Indianapolis, IN)
m sw
VP, Intellectual Property Impax Laboratories(Hayward, CA)
saak ua
Vice President –Global Intellectual Property  Apotex, Inc.(Toronto, ON)
TimothyX.Witkowski,M.S.,J.D.
Executive Director & ExecutiveCounsel, Intellectual Property Boehringer Ingelheim(Ridgeeld, CT)
 JohnC.Vassil
(Formerly O Counsel to Morgan& Finnegan LLP)(New York)
cai:
GeorgeW.Johnston
 Vice President & Chie Patent CounselHomann-La Roche(Nutley, NJ)
MarkE.Waddell
PartnerLoeb & Loeb LLP(New York, NY)
 AcIha-WaxasiAviBacaiaei:
Media Partners:
 
u a   a  aaia  avi
 valuesinexcessof$130billionannuallywilloccurby2016.*
 A awa  biiia a b a, b aai ai av 
tobepromulgated.
nw i  i  ba a a i aaia ai  ik 
therulesofthepatentendgame.
g  iai a    avia  ha-Waxa a i 
andthepatentchallengesprecipitatedbyBPCIA.Attendtheoneeventwhich
 a ai “ i a”  ai ii a ai  b
brandnamesandgenerics.
Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/LifeCycles
3
 Aia c Ii’ (AcI’) maxiizi paaiapa li c
conerence is the pharmaceutical industry’s leadingsource or inormation and analysis on patent lie cycle managementor both small and now, large molecule pharmaceutical products. It isthe orum where lawyers, executives and policy makers or brand nameand generic manuacturers gather each year to prepare or the lie cyclechallenges they currently ace as well as those which they anticipate.
nw Ip a i ai  wi vvi aw a ai av a w a i  a
forbrandnamesandgenerics.
The pharmaceutical industry now stands on the edge o the patentcli. By 2016, patents on myriad block buster pharmaceuticalproducts or treating ailments and conditions ranging rom asthmato high cholesterol to psychosis and beyond will go o patent. Thispatent decline does not only pose problems or brand name drugmanuacturers, but also proves troubling or generics; the ultimateHatch-Waxman prize o 180-day exclusivity may be short-lived inthe uture as there will be ew patented drug products worth coveting.Moreover, as the industry awaits FDA guidance on biosimilars, itremains anyone’s guess as to what eect, i any these new medicinalentities and therapies will have on the patent endgame.
pa    aaia i 
challengeshead-on.
This
12

AcI   maxiizi paaia pali c
will bring you the thoughtul and targeted commentary and in-depth analysis that you have come to expect rom thisindustry-leading event. This year’s conerence eatures:
•PresentationsfromkeyrepresentativesfromtheUSPTO
(invited), FTC, and FDA (invited). They will provide you with direct insights and the logic o these agencies on someo most pressing lie cycle management challenges that theindustry is acing today, including the latest on:- Patent reorm; PTE and PTA determinations; and reissueand reexam proceedings- Pay-or-delay and the ndings o the FTC Report on theIP Market Place- Foreiture determinations
•Anupdateonbiosimilarsandthefurtherdevelopmentof
these second generation biological products will infuencepharmaceutical patent lie cycle and portolio strategies in view o the urther implementation o BPCIA and the inevitability o the patent cli 
•In-depthdiscussionsonkeyregulatorydevelopments
impacting lie cycle management including- REMS studies- Use codes, skinny labeling, and carve outs, and theirrelationship to divided inringement and inducement theories- Regulatory bars to exclusivity 
•Analysesofrecentcriticalcasesaffectingpatentlifecycle
planning including:
Sun Pharma
(double patenting);
 Microsoft 
 (standard o invalidity);
 Ariad 
(patentability);
Therasense 
 (inequitable conduct) and strategies or using these casesto your advantage
B  i- a aia aii a a i a wi a  ia a i  aaia a i 
management
.
In response to your requests, we have added the ollowingpre-conerence training and strategy sessions:
•
ptA- pte B ca: Bai taii i  eia  pa t Aj a pa t rai pa law svi  Biaaia I 
willoer critical instruction on the undamentals and mechanicso PTA and PTE practice which help to ensure patent andprot longevity; and
•
 Wki g  gba paaia pa li cmaa sai  eabi a ei mak: A paia, ha-o gi t pa exi aexivii Avaiab  paaia p A  W
will oer in-depth and pragmatic advice or navigatingpatent systems in Europe and emerging BRIC markets
na 3,000 aaia a ia –  b baa a i – av a i  i   iai   a i i i  aa
fornearlythelasttwelveyears.
This updated event will bring youthe latest legal strategies and tactics or successul maneuvering inthe 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
, axing yourregistration orm to
877-927-1563
or registering on-line at
 www.americanconference/LifeCycles
.
* Wall Street Journal, February 15, 2011

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