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Transcript of PIV Disputes 2012
Register Now • 888-224-2480 • AmericanConference.com/PIVDisputesNYC
April 24-25, 2012 | New York Marriott Downtown | New York City
Preeminent patent litigators representing brand name and generic drug makers will provide insights on every facet of Paragraph IV litigation from pre-litigation concerns to commencement of suit through to final adjudication. They will discuss the latest legal challenges affecting parties on both sides and help you:
• ASSESS how Patent Reform will influence Orange Book Patent challenges and pre-suit considerations
• REFINE Markman hearing strategies in view of the Federal Circuit split on claim construction
• UNDERSTAND how the Supreme Court’s pending ruling in Caraco will redefine the relationship between a drug’s patent, label and use code
• COMPREHEND how Global Tech, Akamai and McKesson will influence inducement of infringement and divided infringement allegations relative to method of treatment claims for pharmaceutical patents
• EXPLORE new threats to 180-day exclusivity and the repercussions of a possible extension of NCE exclusivity
• EVALUATE the use of parallel proceedings before the ITC and/or PTO
Guy Donatiello Vice President, Intellectual PropertyEndo Pharmaceuticals
Timothy X. Witkowski, M.S., J.D.Executive Director & Executive Counsel, Intellectual PropertyBoehringer Ingelheim
Conference Co-Chairs:
Honorable Garrett E. Brown, U.S.D.J. Chief Judge United States Federal District Court District of New Jersey (Trenton, NJ)
Honorable Joel A. Pisano, U.S.D.J.United States Federal District Court District of New Jersey (Trenton, NJ)
Honorable Tonianne Bongiovanni, U.S.M.J. United States Federal District Court District of New Jersey (Trenton, NJ)
Judicial Insights from:
FTC Keynote on Pay-For-Delay Settlements:
Markus H. MeierAssistant Director of the Health Care DivisionBureau of CompetitionFederal Trade Commission
Customized Working Groups, Workshops and Master Classes
April 23, 2012 - Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals
April 23, 2012 - Working Group Session: Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation
April 26, 2012 - The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics – A Hands-On, Practical Approach
Earn CLE
ETHICS Credits
Industry Insights from:
ActavisAlembic LtdBoehringer IngelheimEndo PharmaceuticalsImpax Laboratories, Inc.MedicisMerck & Co.Novartis CorporationPfizer IncSandoz, Inc.Sanofi PasteurSunovion Inc.
HATCH-WAXMANACI’s
s e r i e s
Paragraph IV Disputes
American Conference Institute’s
6th Annual
Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics
Cocktail Reception Host: Luncheon Sponsor: Associate Sponsor: VIP Breakfast Sponsor: Executive Sponsor:
Sponsored by:
Supporting Sponsors:
VIP Dinner Sponsor:
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC
Stephen R. Auten Vice President Sandoz, Inc. (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)
Lisa A. Jakob Legal Director, IP Litigation Merck & Company (Rahway, NJ)
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)
Meg Snowden VP, Intellectual Property Impax Laboratories (Hayward, CA)
Shashank Upadhye Former 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)
Co-ChairsGuy Donatiello Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA)
Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel Intellectual Property Boehringer Ingelheim (Ridgefield, CT)
Immediate Past Co-ChairsBrian P. Murphy PartnerEdwards Wildman Palmer LLP (New York, NY)
Barry S. White PartnerFrommer Lawrence & Haug LLP (New York, NY)
SpeakersYogesh BahlPartner Deloitte Financial Advisory Services LLP (New York, NY)
Aaron F. Barkoff, Ph.D Partner McAndrews, Held & Malloy, Ltd. (Chicago, IL)
Richard J. Berman Partner Arent Fox LLP (Washington, DC)
Asim M. Bhansali PartnerKeker and VanNest (San Francisco, CA)
Honorable Tonianne Bongiovanni, U.S.M.J. United States Federal District Court District of New Jersey (Trenton, NJ)
Sandra A. BresnickPartnerQuinn Emanuel Urquhart & Sullivan, LLP (New York, NY)
Honorable Garrett E. Brown, U.S.D.J. Chief Judge, United States Federal District Court District of New Jersey (Trenton, NJ)
Kenneth J. Burchfiel PartnerSughrue Mion, PLLC (Washington, DC)
Vincent L. Capuano, Ph.D. Partner Duane Morris LLP (Boston, MA)
Kathleen B. Carr Partner Edwards Angell Palmer & Dodge LLP (Boston, MA)
William F. Cavanaugh, Jr. Partner Patterson Belknap Webb & Tyler LLP (New York, NY)
Anjan ChatterjiBusiness Valuations - Life Sciences AdvisoryDeloitte Financial Advisory Services LLP (New York, NY)
Dominick A. CondePartnerFitzpatrick, Cella, Harper & Scinto (New York, NY)
Michael A. Davitz Partner Axinn, Veltrop & Harkrider LLP (New York, NY)
Michael P. Dougherty Special Counsel Cadwalader, Wickersham & Taft LLP (New York, NY)
David A. Dow Director, Senior Counsel Boehringer Ingelheim USA Corporation (Ridgefield, CT)
Kelly J. EberspecherShareholderBrinks Hofer Gilson & Lione (Chicago, IL)
Lisa M. Ferri Partner Mayer Brown LLP (New York, NY)
Thomas J. Filarski Partner Steptoe & Johnson LLP (Chicago, IL)
Jennifer L. Fox Counsel Brinks Hofer Gilson & Lione (Research Triangle Park, NC)
David P. Frazier Ph.D. Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)
Adda C. Gogoris PartnerMerchant & Gould P.C. (New York, NY)
Kelly Falconer GoldbergSenior Corporate Counsel, Regulatory LawPfizer Inc (New York, NY)
Keith J. GradyShareholder & Chair of the Intellectual Property Litigation Group, Polsinelli Shughart PC (St. Louis, MO)
Nicholas Groombridge PartnerPaul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)
Jonathan A. HarrisPartnerAxinn, Veltrop & Harkrider LLP (Hartford, CT)
Pablo D. HendlerPartnerRopes and Gray LLP (New York, NY)
Gary E. HoodShareholderPolsinelli Shughart PC (Chicago, IL)
Timothy R. Howe, Ph.D., JD, CLPVice President, Legal Affairs, General Counsel and Head, Acquisitions and Licensing TransactionsSanofi Pasteur (Swiftwater, PA)
James F. Hurst Partner Winston Strawn LLP (Chicago, IL)
Christopher J. Kelly Partner Mayer Brown LLP (Palo Alto, CA)
Thomas J. Kowalski ShareholderVedder Price (New York, NY)
Steven J. Lee Partner Kenyon & Kenyon (New York, NY)
Denise L. Loring Partner Ropes & Gray LLP (New York, NY)
Deborah L. Lu, Ph.D.ShareholderVedder Price (New York, NY)
Steven A. MaddoxPartnerKnobbe Martens Olson & Bear LLP (Washington, DC)
Jim MahannaDirector, Intellectual Property Law Actavis (Elizabeth, NJ)
Terry G. Mahn Principal Fish & Richardson P.C. (Washington, DC)
David A. Manspeizer Partner Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY)
Ryan L. MarshallShareholderBrinks Hofer Gilson & Lione (Salt Lake City, UT)
Kerry B. McTiguePartnerDuane Morris LLP (Washington, DC)
Markus H. MeierAssistant Director of the Health Care DivisionBureau of CompetitionFederal Trade Commission (Washington, DC)
Jeffrey N. MeyersVP and Assistant General Counsel, Intellectual Property EnforcementPfizer Inc (New York, NY)
Don J. Mizerk Partner Husch Blackwell LLP (Chicago, IL)
Steven J. Moore Partner Kelley Drye & Warren LLP (Stamford, CT)
Catherine NyaradyPartnerPaul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)
D. Christopher Ohly Partner Schiff Hardin LLP (Washington, DC)
Joseph M. O’Malley, Jr. Partner and Global Co-Chair, Intellectual Property Practice Paul, Hastings LLP (New York, NY)
Dr. Alpesh Pathak Head-API Patent Cell Alembic Pharmaceuticals (Vadodara Area, India)
Martin B. PavaneMemberCozen O’Connor (New York, NY)
Mark A. PerryPartnerGibson, Dunn & Crutcher LLP (Washington, DC)
Chad J. PetermanPartnerPatterson Belknap Webb & Tyler, LLP (New York, NY)
Honorable Joel A. Pisano, U.S.D.J. United States Federal District Court District of New Jersey (Trenton, NJ)
Joseph M. Reisman, Ph.D. Partner Knobbe Martens Olson & Bear LLP (San Diego, CA)
Richard T. Ruzich Partner Duane Morris LLP (Chicago, IL)
Michael A. Sitzman Partner Gibson, Dunn & Crutcher LLP (San Francisco, CA)
Len SmithPrincipal Intellectual Property CounselMedicis (Scottsdale, AZ)
Matthew A. SmithSenior CounselFoley & Lardner LLP (Washington, DC)
Sanya SukduangPartnerFinnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)
Tedd Van BuskirkPartnerK & L Gates LLP (New York, NY)
Anthony J. Viola Partner Edwards Angell Palmer & Dodge LLP (New York, NY)
Mark E. Waddell Partner Loeb & Loeb LLP (New York, NY)
Peter WaibelHead US Patent LitigationNovartis Pharmaceuticals Corporation (East Hanover, NJ)
Bruce M. Wexler Partner Paul, Hastings LLP (New York, NY)
Patrick C. WoolleyShareholderPolsinelli Shughart PC (Kansas City, MO)
ADVISory BoArD AnD FACULTy LIST
02
Distinguished Faculty:
ACI’s Hatch-Waxman Series Advisory Board:
Stephen R. Auten Vice President Sandoz, Inc. (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)
Lisa A. Jakob Legal Director, IP Litigation Merck & Company (Rahway, NJ)
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)
Meg Snowden VP, Intellectual Property Impax Laboratories (Hayward, CA)
Shashank Upadhye Former 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)
Co-ChairsGuy Donatiello Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA)
Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel Intellectual Property Boehringer Ingelheim (Ridgefield, CT)
Immediate Past Co-ChairsBrian P. Murphy PartnerEdwards Wildman Palmer LLP (New York, NY)
Barry S. White PartnerFrommer Lawrence & Haug LLP (New York, NY)
SpeakersYogesh BahlPartner Deloitte Financial Advisory Services LLP (New York, NY)
Aaron F. Barkoff, Ph.D Partner McAndrews, Held & Malloy, Ltd. (Chicago, IL)
Richard J. Berman Partner Arent Fox LLP (Washington, DC)
Asim M. Bhansali PartnerKeker and VanNest (San Francisco, CA)
Honorable Tonianne Bongiovanni, U.S.M.J. United States Federal District Court District of New Jersey (Trenton, NJ)
Sandra A. BresnickPartnerQuinn Emanuel Urquhart & Sullivan, LLP (New York, NY)
Honorable Garrett E. Brown, U.S.D.J. Chief Judge, United States Federal District Court District of New Jersey (Trenton, NJ)
Kenneth J. Burchfiel PartnerSughrue Mion, PLLC (Washington, DC)
Vincent L. Capuano, Ph.D. Partner Duane Morris LLP (Boston, MA)
Kathleen B. Carr Partner Edwards Angell Palmer & Dodge LLP (Boston, MA)
William F. Cavanaugh, Jr. Partner Patterson Belknap Webb & Tyler LLP (New York, NY)
Anjan ChatterjiBusiness Valuations - Life Sciences AdvisoryDeloitte Financial Advisory Services LLP (New York, NY)
Dominick A. CondePartnerFitzpatrick, Cella, Harper & Scinto (New York, NY)
Michael A. Davitz Partner Axinn, Veltrop & Harkrider LLP (New York, NY)
Michael P. Dougherty Special Counsel Cadwalader, Wickersham & Taft LLP (New York, NY)
David A. Dow Director, Senior Counsel Boehringer Ingelheim USA Corporation (Ridgefield, CT)
Kelly J. EberspecherShareholderBrinks Hofer Gilson & Lione (Chicago, IL)
Lisa M. Ferri Partner Mayer Brown LLP (New York, NY)
Thomas J. Filarski Partner Steptoe & Johnson LLP (Chicago, IL)
Jennifer L. Fox Counsel Brinks Hofer Gilson & Lione (Research Triangle Park, NC)
David P. Frazier Ph.D. Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)
Adda C. Gogoris PartnerMerchant & Gould P.C. (New York, NY)
Kelly Falconer GoldbergSenior Corporate Counsel, Regulatory LawPfizer Inc (New York, NY)
Keith J. GradyShareholder & Chair of the Intellectual Property Litigation Group, Polsinelli Shughart PC (St. Louis, MO)
Nicholas Groombridge PartnerPaul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)
Jonathan A. HarrisPartnerAxinn, Veltrop & Harkrider LLP (Hartford, CT)
Pablo D. HendlerPartnerRopes and Gray LLP (New York, NY)
Gary E. HoodShareholderPolsinelli Shughart PC (Chicago, IL)
Timothy R. Howe, Ph.D., JD, CLPVice President, Legal Affairs, General Counsel and Head, Acquisitions and Licensing TransactionsSanofi Pasteur (Swiftwater, PA)
James F. Hurst Partner Winston Strawn LLP (Chicago, IL)
Christopher J. Kelly Partner Mayer Brown LLP (Palo Alto, CA)
Thomas J. Kowalski ShareholderVedder Price (New York, NY)
Steven J. Lee Partner Kenyon & Kenyon (New York, NY)
Denise L. Loring Partner Ropes & Gray LLP (New York, NY)
Deborah L. Lu, Ph.D.ShareholderVedder Price (New York, NY)
Steven A. MaddoxPartnerKnobbe Martens Olson & Bear LLP (Washington, DC)
Jim MahannaDirector, Intellectual Property Law Actavis (Elizabeth, NJ)
Terry G. Mahn Principal Fish & Richardson P.C. (Washington, DC)
David A. Manspeizer Partner Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY)
Ryan L. MarshallShareholderBrinks Hofer Gilson & Lione (Salt Lake City, UT)
Kerry B. McTiguePartnerDuane Morris LLP (Washington, DC)
Markus H. MeierAssistant Director of the Health Care DivisionBureau of CompetitionFederal Trade Commission (Washington, DC)
Jeffrey N. MeyersVP and Assistant General Counsel, Intellectual Property EnforcementPfizer Inc (New York, NY)
Don J. Mizerk Partner Husch Blackwell LLP (Chicago, IL)
Steven J. Moore Partner Kelley Drye & Warren LLP (Stamford, CT)
Catherine NyaradyPartnerPaul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)
D. Christopher Ohly Partner Schiff Hardin LLP (Washington, DC)
Joseph M. O’Malley, Jr. Partner and Global Co-Chair, Intellectual Property Practice Paul, Hastings LLP (New York, NY)
Dr. Alpesh Pathak Head-API Patent Cell Alembic Pharmaceuticals (Vadodara Area, India)
Martin B. PavaneMemberCozen O’Connor (New York, NY)
Mark A. PerryPartnerGibson, Dunn & Crutcher LLP (Washington, DC)
Chad J. PetermanPartnerPatterson Belknap Webb & Tyler, LLP (New York, NY)
Honorable Joel A. Pisano, U.S.D.J. United States Federal District Court District of New Jersey (Trenton, NJ)
Joseph M. Reisman, Ph.D. Partner Knobbe Martens Olson & Bear LLP (San Diego, CA)
Richard T. Ruzich Partner Duane Morris LLP (Chicago, IL)
Michael A. Sitzman Partner Gibson, Dunn & Crutcher LLP (San Francisco, CA)
Len SmithPrincipal Intellectual Property CounselMedicis (Scottsdale, AZ)
Matthew A. SmithSenior CounselFoley & Lardner LLP (Washington, DC)
Sanya SukduangPartnerFinnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)
Tedd Van BuskirkPartnerK & L Gates LLP (New York, NY)
Anthony J. Viola Partner Edwards Angell Palmer & Dodge LLP (New York, NY)
Mark E. Waddell Partner Loeb & Loeb LLP (New York, NY)
Peter WaibelHead US Patent LitigationNovartis Pharmaceuticals Corporation (East Hanover, NJ)
Bruce M. Wexler Partner Paul, Hastings LLP (New York, NY)
Patrick C. WoolleyShareholderPolsinelli Shughart PC (Kansas City, MO)
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 03
Brand name and generic pharmaceutical companies are beginning to feel the initial impact of the patent cliff: the pecuniary perils of patent loss and the economic consequences associated with the decline of Hatch-Waxman market exclusivity. As a result, the industry has entered an era of “extreme” Paragraph IV litigation where the monetary ante has never been higher.
To help you respond to the challenges of this new era, ACI’s 6th Annual Paragraph IV Disputes conference will guarantee your access to the leading legal minds in this area. A “who’s who” of Hatch-Waxman litigators — for both brand names and generics — will help you conquer the patent crisis of 2012 by addressing such industry shaping topics as:
• TheimpactoftheAIAonHatch–Waxmanlitigation
• Carve-outs,usecodesandlabeling
• Claimconstruction
• Priorartobviousnessandobvious-typedoublepatenting
• Inducementofinfringementanddividedinfringement
• Inequitableconduct
• Damages
Hear also from renowned federal jurists and a key official from the Federal Trade Commission. Learn firsthand how the bench analyzes the theories of your case and what the FTC deems as “fair and foul” in the settlement of pharmaceutical patent disputes.
Complete your professional training by attending one or more of these customized Working Groups, Workshops and Master Classes:
• Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals which will provide the patent and regulatory backdrop for the more in-depth Hatch-Waxman litigation controversies discussed in the main conference;
• A Working Group Session on Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation which will address how new pre- and post issuance procedures may alter certain components of Paragraph IV litigation and parallel proceedings between the Federal Courts and PTO; and
• The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics which will give practical and hands-on strategies for drafting and negotiating settlement agreements that will pass muster with the FTC.
In this costly and ruthless endgame, not a moment can be lost. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563 or logging on to www.AmericanConference.com/PIVDisputesNYC.
1InPharm, A new survey shows pharma is not prepared to deal with the tough year ahead as many blockbuster drugs begin to go off patent,
1-12-12.
over 80% of drug manufacturers are unprepared to meet the legal challenges of more than $60 billion in pharmaceutical patent losses.1
Is your company one of them?
Avoid being caught off guard by attending the only event dedicated to providing brand name and generic legal professionals like you with the tools needed to master the strategies, standards and tactics of Paragraph IV litigation.
Media Partners:
A Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and regulatory Fundamentals
David A. DowDirector and Senior Counsel Boehringer Ingelheim USA Corporation (Ridgefield, CT)
Kelly Falconer GoldbergSenior Corporate Counsel, Regulatory LawPfizer Inc (New York, NY)
Ryan L. MarshallShareholderBrinks Hofer Gilson & Lione (Salt Lake City, Utah)
Kerry B. McTiguePartnerDuane Morris LLP (Washington, DC)
Mark A. PerryPartnerGibson, Dunn & Crutcher LLP (Washington, DC)
This hands-on workshop will provide you with an in-depth review of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as well as other IP and regulatory basics relative to small molecules and biologics.
The workshop leaders will lay the necessary foundation for you to comprehend thoroughly the dynamics of the IP and regulatory backdrop underlying each Paragraph IV dispute. They will help you fully appreciate the complexities of the Hatch-Waxman litigation challenges presented during the main conference as well as anticipated conundrums under the biosimilar schematic. Points of discussion will include:Regulatory Essentials Relative to Hatch-Waxman• UnderstandingthelinkbetweentheFDAapproval
process and the patenting of drugs and biologicsRx Drugs (new drugs) • Identifyingtheapplicationprocessforthe
approval of a new drug, i.e., small molecule, new chemical entities, etc.
• NDA(NewDrugApplication)- what information does it contain?- labeling, patent information, trade name
- filing requirements- the FDA review process
• INDA(InvestigationalNewDrugApplication)aka “IND”- how does it differ from an NDA?- filing requirements- what does it entitle you to do?
• Acceleratedapprovals- defining eligibility criteria for accelerated
approval and priority reviews - what portions of approval submissions might
FDA release and when? • UsingadvisorycommitteesintheapprovalprocessBiologics • Understandingtheapprovalprocessforabiologic
- how does the approval process for a biologic differ from that of a drug?
• BLA(BiologicalLicensingApplication)- how does a biologic differ from a drug?- what application needs to be filed and with
whom is it filed?- which products require BLAs instead of NDAs? - what does a BLA look like?
• Whyisita“license,”ratherthanan“approvedapplication”?
• Whatdoestheapprovalprocessfora‘biosimilar’under BPCIA entail and how is it different from the BLA approval process?
IP Protection for Drugs and Biologics• Analyzingthepatentingprocessfordrugsand
biologics • Seekingpatentprotectionduringthepre-
approval process • IPandregulatoryredressfortimelostduring
the pre-approval process • Distinguishingthepatentingprocessfordrugs
from that of biologics- which biologics are treated as drugs and why?
• IdentifyingtherespectiverolesoftheFDAand the PTO in the patenting of drugs and biological products
Drugs • ExploringthedifferencesbetweenaNDAand
an ANDA (Abbreviated New Drug Application)
• ANDA:whatdoesitrequire?• ParagraphIVCertificationsandNoticeLetters• Bioequivalencedefined• TheOrangeBook:whatisitandwhy
is it Orange?- listings and de-listings
Biologics • Identifyingbiologicsthatfallwithinthepurview
of Hatch-Waxman- why are other biologics outside of the
Hatch-Waxman rubric?• Overviewofthebiosimilar(FOB)law
- Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• Therationaleforsafetyandefficacyconcernssurrounding second generation biologics
The Pharmaceutical Patent Endgame: Hatch-Waxman Explained• OverviewofHatch-Waxmanandreformsunder
the Medicare Modernization Act (MMA)• TheroleofOrangeBookunderHatch-Waxman
vis-à-vis the MMA• Exploringdifferentconceptsinexclusivity
- exclusivity (180 day market exclusivity)- regulatory exclusivity
- NCE (new chemical entity)- 5 years marketing exclusivity- 5 years data exclusivity
- indication (new indication or use)- 3 years marketing exclusivity
- NDF (new dosage formulation)- ODE (orphan drug exclusivity)- PED (pediatric exclusivity)
• 30-monthstay• Patentextensions• Thesafeharbor• FD&C505b2(analternatepathwaytoanANDA)
Trademark and Trade Dress Issues• IdentifyingthePTOandFDAclearances
necessary for trade name/trademark approval on your product
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 04
Monday, april 23, 2012 • 9:00 AM – 12:30 PM (registration opens at 8:30 am) • Continental Breakfast will be served
Supplemental Proceedings• ExploringParagraphIVscenariosinwhichitmakes
sense for a patent holder to pursue supplemental reexamination
• Protocolsandproceduresforsupplementalproceedings• Definingasubstantialnewquestionofpatentability
(SNQP)- question of prior art
• Exploringrelationshipbetweensupplementalproceedings and inequitable conduct- circumstances in which supplemental reexam
can be used as a means to circumvent questions of inequitable conduct
- failure to disclose - presence of mind - intent v. mistake – does it make a difference
in the findings?- findings of fraud in aftermath of proceedings
and possibility of criminal prosecution- materiality
Post Grant Review• Weighingconsiderationsforwhenachallenge
should be brought under post grant review (PGR) in a Hatch-Waxman setting
• Exploringstartdates,timingandbasisoftheapplication – questions to ask- is the challenge brought within nine months
of patent issuance?- what is the basis of the invalidity challenge
- prior art- 112 deficiency under written description- lack of enablement- obviousness- inherent anticipation
- fate of best mode • EstoppelconsiderationsrelativetoParagraphIV
litigation- have you raised all bases for invalidity lest you
be precluded from raising them in other PTO or district court proceedings?
• Examiningthemechanics,protocolsandproceduresfor PGR- filing of petition- analogous nature of proceeding to district court
litigation
- discovery- hearings; motions; settlement
- appearing before the Patent Trial and Appeals Board (PTAB)
• Analyzingthepetitioner’sburdenofproof- proving that it is “more likely than not that one of
the claims challenged in the petition is unpatentable”• Proceduresforappeal
Inter Partes Review• Comparingcurrentinterpartesreexamination
protocols to inter partes review protocols under AIA• Examininghowcurrentinterpartesreexamination
procedures are being employed by both patent challengers and patent holders in Hatch Waxman scenarios- questions of economics, efficiencies and risk- what can we glean from these current behaviors
relative to the future utilization of inter partes review?
• Understandingthefinepointsofthenewinterpartes review procedure- considerations for choosing this forum- timing, cost, speed of resolution
• Revisionstopatentchallenger’sburdenofproofunder current inter partes reexamination and new inter partes review procedures- substantial new question of patentability vs.
reasonable likelihood that the petitioner will prevail on claim
- understanding the immediate repercussions of this shift on inter partes reexam and strategies for inter partes review for pharmaceutical patent litigation
• Exploringthescopeofreviewforcurrentandnewprocedures under 102 and 103- patents (prior art) and publications- comprehending the relationship between scope
of review and estoppel• Transitionandphaseout
- examining the interplay between the timing for post grant review and inter partes review
- transition in presiding forums- Central Reexam Unit (CRU) vs. Patent Trial
and Appeal Board (PTAB)- appeal to CAFC
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 05
`
B Working Group Session: Assessing The Impact of new PTo Procedures Under the AIA on Paragraph IV Litigation
Kenneth J. Burchfiel PartnerSughrue Mion, PLLC (Washington, DC)
Adda C. GogorisPartnerMerchant & Gould P.C. (New York, NY)
Deborah L. Lu, Ph.D. ShareholderVedder Price (New York, NY)
Matthew A. SmithSenior CounselFoley & Lardner LLP (Washington, DC)
Patrick C. WoolleyShareholderPolsinelli Shughart (Kansas City, MO)
Through its creation of new and amending of existing PTO Procedures, the America Invents Act (AIA) has opened the door to parallel and/or alternate administrative avenues to Paragraph IV proceedings in the District Courts. These PTO Procedures go directly to the heart of an invalidity challenge and also provide administrative mechanisms which in some instances could cure errors in the file history. There are also mechanisms that could stop the issuance of a patent during the pendency of its application. However, the use of these mechanisms may carry unintended consequences and bring about the opposite of their intended purpose. The workshop leaders will address these procedures as well as specific concerns for brands and generics. Points of discussion will include:
Third Party Pre-Issuance Submissions• Understandingwhenthepre-issuancesubmission
of prior art to the PTO by a third party challenger as outlined by this procedure would be used in a Hatch-Waxman scenario
• Examiningscenariosinwhichtheapplicationofa pending pharmaceutical patent might actually be strengthened as opposed to diminished by the invocation of this procedure
Monday, april 23, 2012 • 2:00 PM – 5:30 PM (Registration opens at 1:15 pm)
- claiming the label- filing a citizen’s petition- OTC switches
• UnderstandinghowchangesintheUSPatentSystem under the AIA may influence Orange Book listing strategies- first to file- third party pre-issuance submissions- file early, file often- provisional applications- prior user rights
9:30 Invalidity and Non-Infringement Post-Microsoft: Reaffirmation of The ANDA Applicant’s Pre-Litigation Obligations and Assertions
Stephen R. AutenVice President, Head of IP, North AmericaSandoz, Inc. (Princeton, NJ)
Richard J. BermanPartnerArent Fox LLP (Washington, DC)
Dr. Alpesh Pathak Head-API Patent CellAlembic Pharmaceuticals (Vadodara Area, India)
Joseph M. Reisman, Ph.D.Partner Knobbe Martens Olson & Bear LLP(San Diego, CA)
• ReexaminingtheinitialobligationsoftheANDA applicant under Paragraph IV in light of the Supreme Court’s ruling in Microsoft v. i4i- when is there “clear and convincing” evidence
that patent is invalid and therefore not infringed- assessing the consequences of not meeting this
burden of proof• Weighingyouroptionsinlightoftheburden:
should you file a Paragraph IV certification or choose another ANDA route?
• ChoosingwhichOrangeBookpatentstochallenge- compounds- formulations- process
• Evaluatingthestrengthofthepatentsinyourcurrent portfolio in light of the new industry dynamics created by the patent cliff- Orange Book and non-Orange Book eligible
patents • ExaminingtheOrangeBook‘tolistornotlist’
dilemma- which types of patents should you list?- alternatives to compound patents
- methods- employment of use codes
- polymorphs- special listing considerations for small proteins
filed through an NDA as opposed to a BLA in light BPCIA biosimilar provisions- what is the protein’s method of manufacture
- is it chemically derived or made through a biotechnological process?
• GaugingwhentoreasonablyexpectaParagraphIV filing by a generic competitor in the era of the‘patentcliff ’
• Learningtolookbeyondthe‘blockbusterpatents’- understanding why patents on smaller
products may be more vulnerable to challenge in some instances
• Exploringbrandnameexclusivitiesandtheircorrelation to the start of a Paragraph IV challenge- NCE
- possible extension of NCE exclusivity from 5 to 12 years?
- new use or indication- new formulation- orphan drug- pediatric
• Preparingforlitigation- developing discovery check-lists
- implementation of document retention policy
- when is a litigation hold put on all documents which may be discoverable
- e-discovery - possible e-discovery restraints in various
jurisdictions- “call back” rule for inadvertent disclosure
• PreventingaParagraphIVchallenge- entering an authorized generics agreement
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 06
`
Main Conference – Day 1 Tuesday, April 24, 2012
7:15 Registration and Continental Breakfast
8:00 Co-Chairs’ Opening Remarks
Guy Donatiello Vice President, Intellectual PropertyEndo Pharmaceuticals (Chadds Ford, PA )
Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel, Intellectual PropertyBoehringer Ingelheim (Ridgefield, CT)
Immediate Past Co-Chairs
Brian P. Murphy PartnerEdwards Wildman Palmer LLP (New York, NY)
Barry S. WhitePartnerFrommer Lawrence & Haug LLP (New York, NY)
8:30 Anticipating and Reassessing Paragraph IV Challenges in the Era of the Patent Cliff
Anjan ChatterjiBusiness Valuations - Life Sciences AdvisoryDeloitte Financial Advisory Services LLP(New York, NY)
Jennifer L. FoxCounselBrinks Hofer Gilson & Lione(Research Triangle Park, NC)
Pablo D. HendlerPartnerRopes and Gray LLP (New York, NY)
Len SmithPrincipal Intellectual Property CounselMedicis (Scottsdale, AZ)
• Understandinghowthearrivalofthe‘patentcliff ’ has changed a patent holder’s Paragraph IV due diligence strategies
Bra
nd N
ame
Side
Gen
eric
Sid
e
- methods of use- polymorphs- factoring “forfeiture” into your Orange Book
strategy- skinny labeling and carve-out considerations
via Caraco- obviousness assessments
• HowPatentReformmayimpactOrangeBookpatent challenges- elimination of Best Mode defense- prior user rights- exploring new Post Grant Review and Inter
Partes Review as another mechanism for invalidating an Orange Book patent
• Understandingtheroleofnon-OrangeBookpatents in your PIV ANDA strategies- innovator / non-innovator- API
• Procuringlegalopinionsoninvalidityand non-infringement- assessing when opinions are needed- opinion of in-house v. outside counsel- questions of privilege
- Rule 26 (b) (4) revisions regarding expert opinions
• FilingtheANDA- fulfilling requirements for FDA approval:
- pharmaceutically equivalent- bioequivalent
- identifying triggers which may necessitate new bioequivalence studies
• ContentsoftheParagraphIVcertification
10:30 Morning Coffee Break
10:45 The Throwing of the Gauntlet: The Paragraph IV Notice Letter
For the Brand Name Side:
Denise L. LoringPartnerRopes & Gray LLP (New York, NY)
Peter WaibelHead US Patent Litigation Novartis Pharmaceuticals Corporation (East Hanover, NJ)
For the Generic Side:
Shashank Upadhye Former Vice President - Global Intellectual PropertyApotex, Inc. (Toronto, ON)
Tedd Van BuskirkPartnerK & L Gates LLP (New York, NY)
Moderator:
Dominick A. CondePartnerFitzpatrick, Cella, Harper & Scinto(New York, NY)
Generic Side
Procedural requirements• PerfectingtheParagraphIVCertification• ContentsoftheNoticeletter• Delivery/serviceofNoticeLetter• MakingnecessaryamendmentstotheANDA
Substantive requirements• Identifyingtheproposedproductcovered
by the ANDA• Identifyingthepatentofthecorresponding
branded product which is the subject of the Paragraph IV letter
• Legalandfactualbasis• Examiningthedetailedstatementandquestions
of confidentiality- Nycomed v. Tolmar Civ. No. 10-2635, 2011
(D.N.J. Apr. 28, 2011)• Exploringtheuseofopinionlettersinrelation
to notice letters- are they still needed in view of Patent Reform- how detailed do they need to be to avoid
sanctions vis- â- vis Takeda
Branded Side
The response• Makingproductiveuseofthe45dayperiod• Informationgatheringtechniquesstrategies
- confidentiality agreements and document requests- obtaining the ANDA- terms
- scope of information that can reasonably expected
- negotiations• Extendingthe45dayperiod
- 21 CFR 314.95 (f )• Whenshouldapatentownerfilesuit?
- other options to explore- license
- authorized generic• StrategiestoconsiderwithmultipleANDAfilers
Questions for both sides to consider:• Optionstoexploreifsuitisnotcommenced
in 45 days- pros, cons and consequences of:
- forfeiture of 30 month stay- suing for damages- declaratory judgment actions - no contest letter
12:00 Networking Luncheon
1:15 New Claim Construction Considerations in Paragraph IV Litigation
Lisa M. FerriPartnerMayer Brown LLP (New York, NY)
Jonathan A. HarrisPartnerAxinn, Veltrop & Harkrider LLP (Hartford, CT)
Martin B. PavaneMemberCozen O’Connor (New York, NY)
Moderator:
Catherine NyaradyPartnerPaul, Weiss, Rifkind, Wharton & Garrison LLP(New York, NY)
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 07
Sponsored by:
• HowthesplitinFederalCircuitonclaimconstruction may impact Paragraph IV challenges- more narrow reading of claims vs. broader
reading- Cybor and Phillips
• ThesignificanceofdissentinRetractable Technologies, Inc. v. Becton, Dickinson and Company (Fed. Cir. 2011) - viewing claim construction as the most
important event in the course of a patent litigationincontrasttothe‘illdefinedandinconsistent rules’ in the Federal Circuit
• Revisiting112writtendescriptionandenablement distinction requirements vis-à-vis Ariad v. Lilly and Centacor relative to clarity of claims- reviewing specification requirements
- understandability- inventorship
• Strategiesforworkingaroundtheseinconsistencies at Paragraph IV Markman hearings
2:00 Prior Art Obviousness and Obvious-Type Double Patenting: Legal Analysis and Practical Applications for Brand Names and Generics
Michael A. DavitzPartnerAxinn, Veltrop & Harkrider LLP (New York, NY)
Steven J. LeePartnerKenyon & Kenyon (New York, NY)
Joseph M. O’Malley, Jr. Partner and Global Co-Chair, Intellectual Property Practice Paul Hastings LLP (New York, NY)
Sanya SukduangPartnerFinnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)
Moderator
Richard T. RuzichPartnerDuane Morris LLP (Chicago, IL)
Legal Analysis
Prior Art Obviousness
• ExploringthereaffirmationofKSR through In Re Kao (Fed. Cir. 2011)- examining secondary considerations before
the PTO under current procedures- under new AIA Post Grant Review
procedure• UnderstandingtheimpactofKSR and its
progeny on primary compound and composition claims vis-à-vis a Paragraph IV challenge- impact on secondary patents
- enantiomers- isomers- polymorphs- new formulations- new indications- crystallizations- salts
• Examiningquestionsof‘secretpriorart’and‘inherentanticipation’- Teva Pharmaceutical Industries Ltd. v.
AstraZeneca Pharmaceuticals LP (Crestor)• AssessingtheimpactoftheAIA’spriorart
provisions in Paragraph IV related obvious challenges- pre/post 2013
Obviousness-Type Double Patenting
• Analyzingtheevolvingstateofthelawonobviousness-type double patenting and its impact on Paragraph IV litigation- Sun Pharm. Indus. v. Eli Lilly & Co., No.
2010-1105 (Fed. Cir. 2010)- Boehringer Ingleheim Int’l, et al. v. Barr Labs,
Inc., et al., 592 F.3d 1340 (Fed. Cir. 2010) • Brand-nameandgenericstrategiesfornavigating
the new double patenting landscape
Practical Applications• Strategiesforinvokingandrespondingtoan
obviousness challenge in concurrence with current law- brand name and generic tactics for addressing
prior art and double patenting controversies- PTO and District Court redress
• Summaryjudgmentassessments• Discoveryapproaches
- considerations regarding the deposing of primary reference authors
• Experts- should the same expert be used for both
infringement and invalidity opinions?- new expert report provisions under
Rule 26 (b) (4)
3:00 Afternoon Refreshment Break
3:15 And They’re Off: The Start of the Paragraph IV Law Suit - Pleadings and Other Initial Considerations and Analyses
For the Brand Name Side:
Chad J. PetermanPartnerPatterson Belknap Webb & Tyler, LLP(New York, NY)
For the Generic Side:
Gary E. HoodShareholderPolsinelli Shughart PC (Chicago, IL)
Jim MahannaDirector, Intellectual Property Law Actavis (Elizabeth, NJ)
Moderator:
Kathleen B. Carr PartnerEdwards Wildman Palmer LLP (Boston, MA)
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 08
Sponsored by:
Initial considerations• Whereshouldsuitbefiled?
- attempts by the generic to influence where and when the suit will occur
- exploring transfer motions and writs of mandamus relative to venue/jurisdiction- In Re Link
- examining joinder provisions and Hatch-Waxman exceptions under AIA relative to venue
• Assessingsubjectmatterjurisdiction- Sunovion v. Sandoz (2011)- Cephalon v. Sebelius (2011)
• Questionsofstanding- considerations for multinationals and
subsidiaries- weighing probability for motions to dismiss
• Handicappingofjudgesandjurisdictions• Surveyinglocalpatentrules
- knowing which district rules favor patent holders and patent challengers- New Jersey- E.D. Texas- Delaware
• Questionofjurytrial:exploringcircumstancesthat may put you in front of a jury
• Exploringpossibleparallelproceedingsbeforethe PTO in view of Patent Reform
Crafting the initial pleadings• Thecomplaint
- challenging the Paragraph IV certification: alleging the patent is valid and infringed- what claims are made in the ANDA?
- avoiding Rule 11 sanctions- assessing whether attorney’s fees can be
properly sought?• Theanswerandcounterclaims
- de-listing improperly listed patents- antitrust and unfair competition claims- counterclaims relative to the label under
MMA- Caraco
- assertions of inequitable conduct- the generic point of view:
- attorneys fees- Rule 11
Considerations with Multiple ANDA Filers
Branded Side• Choosingwhotosue
- ANDA filers; others? - when does it make sense to only sue the first
filer or a few as opposed to all ANDA filers?- what are the consequences of not suing
all ANDA filers?• Specialforumselectionconsiderationsfor
multiples• AmendingpleadingsforlaterANDAfilers
Generic Side• Thegeneric’spositioninthequeue
- general considerations for first to file- thoughts for second and later filers
• Consolidationvs.separatecases
The Changing Dynamics of Branded and Generic Pharma • Howthe‘blurringofthelines’betweenbranded
and generic companies are influencing initial considerations in the course of Paragraph IV litigation
• GenericGenericLawSuits- exploring circumstances in which the generic
on the pleadings behaves as an innovator - pleading protection of market exclusivity
Declaratory Judgments• UnderstandingtheMMAdeclaratoryjudgment
provisions and the CAFC’s interpretation of these provisions- two prong test
• WhenisitappropriatetomoveforaDJ• CircumstanceswhenaDJwillbegranted?• ShouldDJbesoughtonallpatents–listedand
not listed?Factoring - in the 30 month stay• Commencementofthestatutory30monthstay
- understanding the scope and limits of the 30 month stay under the MMA
• The30-monthstayinthecourseoflitigation- options and strategies for the patent holder if
the stay expires during the course of litigation- early termination of the stay
4:45 A View From the Bench
Honorable Garrett E. Brown, U.S.D.J.Chief Judge, United States Federal District CourtDistrict of New Jersey(Trenton, NJ)
Honorable Joel A. Pisano, U.S.D.J.United States Federal District Court District of New Jersey(Trenton, NJ)
Honorable Tonianne Bongiovanni, U.S.M.J. United States Federal District Court District of New Jersey(Trenton, NJ)
Moderators:
Brian P. Murphy PartnerEdwards Wildman Palmer LLP(New York, NY)
Barry S. WhitePartnerFrommer Lawrence & Haug LLP(New York, NY)
Renowned jurists with some of the most active Paragraph IV litigation dockets in the country will share their thought and insights on some of the most pressing issues facing both patent holders and patent challengers. Come prepared with your most pressing questions.
6:00 Conference adjourns to Day 2
6:00 Cocktail Reception
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 09
Hosted by:
Judi
cial
R
ound
tabl
e
- the interpretation of the counterclaim provision challenging method of use patents per the MMA amendments
- delisting strategies based on use codes and labeling controversies- when can use codes be altered?
- seeking permission from the FDA to carve-out patent protected language to allow for generic entry
- possible consequences of narrowing vs. expanding the use code narrative
• UnderstandingthesignificanceofSolicitorGeneral’s /U.S. government’s position and arguments in this matter
9:15 Reassessing Paragraph IV Strategies for Method Treatment Patents in View of Recent and Pending Decisions Regarding Inducement and Divided Infringement
David P. Frazier Ph.D.PartnerFinnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)
Keith J. GradyShareholderPolsinelli Shughart LLP (St. Louis, MO)
Lisa A. JakobLegal Director, IP LitigationMerck & Company (Rahway, NJ)
Meg SnowdenVP, Intellectual PropertyImpax Laboratories, Inc. (Haywood, CA)
Moderator:
Sandra A. BresnickPartner Quinn Emanuel Urquhart & Sullivan, LLP(New York, NY)
• Defininginducementofinfringementanddivided infringement under current law- how the Supreme Court’s ruling in Global
Tech v. SEB has altered the standard for inducement findings
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 10
- mens rea requirements- 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) and McKesson Technologies Inc. v. Epic Systems Corp. (Fed. Cir. 2011)
• Exploringtherelationshipbetweeninducementactions and divided infringement allegations and how they apply to methods of treatment claims in pharmaceutical patents
• Examininginducementanddividedinfringement challenges to methods of treatment claims listed in the Orange Book- AstraZeneca LP v. Apotex, Inc.: exploring
the role of Section viii carve-outs and the inducement controversy
• HowmaytheFederalCircuit’senbancrulingsin Akamai and McKesson influence Paragraph IV challenge of these types of Orange Book listed patents going forward?
10:15 Morning Coffee Break
10:30 Exclusivities and Forfeitures: New Developments, Controversies and Concerns Relative to Paragraph IV Litigation
Michael P. DoughertySpecial CounselCadwalader, Wickersham & Taft LLP(New York, NY)
Kelly J. EberspecherShareholderBrinks Hofer Gilson & Lione (Chicago, IL)
D. Christopher Ohly Partner Schiff Hardin LLP (Washington, DC)
Moderator:
Thomas J. FilarskiPartnerSteptoe & Johnson LLP (Chicago, IL)
Main Conference – Day 2 Wednesday, April 25, 2012
7:15 Registration and Continental Breakfast
8:00 Co-Chairs’ Opening Remarks and Recap of Day One
8:15 Of Labels, Patents and Use Codes: The Significance and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges
Aaron F. Barkoff, Ph.D.PartnerMcAndrews, Held & Malloy Ltd. (Chicago, IL)
James F. HurstPartnerWinston Strawn LLP (Chicago, IL)
Michael A. SitzmanPartnerGibson, Dunn & Crutcher LLP (San Francisco, CA)
Anthony J. ViolaPartnerEdwards Wildman Palmer LLP (New York, NY)
Moderator:
Terry G. MahnPrincipalFish & Richardson P.C. (Washington, DC)
• Exploringtherelationshipbetweenadrug’slabel,patents, use codes and Orange Book listings relative to Hatch-Waxman litigation
• Decipheringtherapeuticequivalenceevaluationcodes- what are the roles of AB ratings and OB use
codes in the Orange Book • DefiningSectionviiicarve–outsand
understanding their significance to Orange Book listings and Paragraph IV challenges- skinny labeling- off-label uses
• ExamininghowtheSupremeCourt’spending ruling in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. may alter the landscape in this area with respect to:
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 11
• AssessingthepossibleimpactoftheproposedFAIR Generics Act on 180 day exclusivity- evisceration of 180 day market exclusivity?- sharing of exclusivities among competitors
- proposed extension of NCE exclusivity and related impact on 180-day market exclusivity
• DecipheringtheFDA’sstanceonpreandpost–MMA 180-day exclusivity
• Whencanthe180-dayexclusivityperiodbetransferred to another ANDA applicant?
• Evaluatingwhenthe180-dayexclusivityperiod can be relinquished, and exploring the consequences
• Whencanabrand“park”ageneric’sexclusivity?• Defining“sharedexclusivity”• Howhaveauthorizedgenericschangedthe
playing field relative to 180-day exclusivity?• Exploringregulatorybarstoexclusivity
- GMP violations- SEC
• Forfeitureprovisions:circumstancesunderwhich exclusivity is forfeited- identifying circumstances under which
forfeiture of another’s exclusivity may occur?• Interpretingthe“earlierof”,laterof”language
in making a forfeiture determination• Evaluatingthestrengthof“thefailuretomarket”
provision post-Lipitor• Exploringsimultaneousqualificationforand
forfeiture of exclusivity for failure to obtain tentative approval
• Evaluatingtheimpactof“delisting”onforfeiture• Forfeiturerelativetopatentexpiration• Understandingtherelationshipbetweenforfeiture
and the increase in generic/generic litigation• Revisitingtherelationshipbetweenexclusivity,
forfeiture and the 30 month stay- circumstances under which a second stay may
be granted impact on grant of exclusivity
11:15 Pay-for- Delay Update
Markus H. MeierAssistant Director of the Health Care DivisionBureau of CompetitionFederal Trade Commission (Washington, DC)
The FTC continues to vigorously use its enforcement and policy tools to prevent anticompetitive business practices in the pharmaceutical industry. Over the last several years, the Commission has used much of this arsenal on the matter of “reverse settlement” or “pay-for-delay” agreements which it views as a very anticompetitive practice. The FTC is not alone in this view, as the DOJ and some members of Congress have also come to the conclusion that these agreements are in restraint of trade and cause great harm to the consumer.
Markus Meier, Assistant Director of the FTC’s Bureau of Competition’s Health Care Division will discuss the current status of the FTC’s efforts to end “pay-for-delay” settlements and address such matters as:
• ThestatusofpendingFTClitigationconcerningpatent settlements
• Thestatusofpendinglegislationregarding “pay-for-delay” settlements
• TheenforcementoftheMMAreportingrequirements
• ThefindingsoftheFTC’sauthorizedgeneric’sstudy
12:00 Networking Luncheon
1:15 New Standards in Inequitable Conduct Post-Therasense: Ethical Considerations for Paragraph IV Cases
Matthew P. Blischak Vice President, Intellectual Property & Associate General CounselSunovion Pharmaceuticals Inc. (Marlborough, MA)
Vincent L. Capuano, Ph.D.PartnerDuane Morris LLP (Boston, MA)
Stephen J. MoorePartnerKelley Drye & Warren LLP (Stanford, CT)
Bruce M. WexlerPartnerPaul Hastings LLP (New York, NY)
Moderator:
Mark E. WaddellPartnerLoeb & Loeb LLP (New York, NY)
• ExaminingtheFederalCircuit’stightening of the of the inequitable conduct standard in Therasense- intent to deceive
- single most reasonable inference- materiality
- ‘but’fortest- possible Supreme Court review?
• ExploringtheapplicationofTherasense in a Paragraph IV scenario- Pfizer v. Teva - awarding sanctions for asserting
unsubstantiated claims of inequitable conduct- repercussions of this ruling and its impact
for future inequitable conduct filings• Re-examiningtherelationshipbetween
inequitable conduct and corporate fraud - future question of corporate intent in a
Hatch-Waxman setting• InequitableconductandPatentReform
- supplemental proceedings under the AIA: an opportunity to cure inequitable conduct?
2:15 Afternoon Refreshment Break
2:30 New Controversies Surrounding Damages and Injunctions Relative to At Risk Launches
William F. Cavanaugh, Jr.PartnerPatterson Belknap Webb & Tyler LLP(New York, NY)
Nicholas Groombridge PartnerPaul, Weiss, Rifkind, Wharton & Garrison LLP(New York, NY)
FTC
Key
note
Eth
ics
Sponsored by:
Sponsored by:
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 12
David A. ManspeizerPartnerWilmer Cutler Pickering Hale and Dorr LLP(New York, NY)
Don J. MizerkPartnerHusch Blackwell LLP (Chicago, IL)
• Launchingatriskduringlitigationortheappealperiod- benefits and risks analysis
Injunctions• Examiningtheinconsistenciesbetweenthe
Federal Circuit and the Supreme Court relative to the granting of a preliminary injunction- intra-Circuit split - Kimberly-Clark Worldwide, Inc. v. First Quality
Baby Products, LLC, Case No. 10-1382 (Fed. Cir., Sept. 29, 2011)- eBay Inc. v. MercExchange, LLC, 547 U.S.
388 (2006)- considerations by the District Courts in light
of this inconsistency• Practicalstrategiesforbrandnamesandgenerics
in dealing with this discord before the District Courts and Federal Circuit
• Seekingapreliminaryinjunctionintheeventthat the stay ends in the course of the litigation - posting of bond by the branded side
• Exploringthepossibilityofastipulatedinjunction- why a stipulated injunction may be of benefit
to both sides
Damages Analysis
Yogesh BahlPartner Deloitte Financial Advisory Services LLP (New York, NY)
Jeffrey N. MeyersVP and Assistant General Counsel, Intellectual Property EnforcementPfizer Inc (New York, NY)
The question of damages in at risk launch has caused considerable concern of late. Not too long ago, all eyes were on Sanofi v. Apotex (Plavix) and its
provisions on stipulated damages. Now, the industry is carefully watching the Protonix litigation to see how damages may be assessed in an at risk launch in the absence of such stipulation. This panel will explore these matters as well as:
• Thequantificationofdamages- brand–name vs. generic point of view- small v. large generic company concerns
• Lostprofits:- assessment of profit as a true measure of damages
- is the drug profitable?- a question of sales
- when is it the only thing that you can seek?• Reasonableroyalties:
- basis for royalty- looking at market share- the point where infringement began
• Mitigatingfactorsimpactingdamageaward
4:00 Parallel Proceedings in Paragraph IV Disputes: Strategies for Balancing and Streamlining Proceedings Before the Federal Courts, PTO and ITC
Asim M. BhansaliPartnerKeker and VanNest (San Francisco, CA)
Timothy R. Howe, Ph.D., JD, CLPVice President, Legal AffairsGeneral Counsel and Head, Acquisitions and Licensing TransactionsSanofi Pasteur (Swiftwater, PA)
Thomas J. KowalskiShareholderVedder Price (New York, NY)
The passage of the America Invents Act and the recent acceptance of a Paragraph IV case by the ITC have brought the matter of parallel proceedings in Hatch-Waxman litigation into greater focus. This panel will examine the different forums and proceedings before which Paragraph IV litigants may seek simultaneous redress. Points of discussion will include:• ForumsinwhichparallelParagraphIV
challenges may be brought- PTO
- Federal District Court- ITC
• Evaluatingthetypesofproceedingswhichmayrun parallel to a Paragraph IV Dispute- traditional District Court litigation- new PTO proceedings
- post grant review- inter partes review
- existing ex partes reexam mechanism- ITC investigatory actions under section 337
of the Tariff Act of 1930• Analyzingwhetherparallelproceedingsmake
sense in view of the particular circumstances of your Paragraph IV challenge
• Costandtimecomparisons- which proceedings make the most economic
sense in terms of time and money?• SpecificconcernsforjoinderrelativetoDistrict
Court and PTO Procedures under the AIA• Exploringcircumstancesinwhicha337
Complaint can be brought before the ITC in a Paragraph IV matter- In the Matter of Certain Gemcitabine and
Products Containing the Same (Eli Lilly Section 337 Complaint)
• StaysofDistrictCourtandITCproceedings in view of pending decisions from the PTO
• FederalCircuitappealsduringthependency of parallel proceedings
• Factoringinnewrulesrelatingto:- how each type of proceeding will be conducted
- e.g., what types of validity attacks can be raised in each proceeding
- scope of proceeding - scope of discovery in each type of proceeding- legal standards of review
• Estoppeleffects
5:00 Conference Ends
WHo yoU WILL MEET
Patent attorneys and litigators (in-house & law firm) who represent:
• Brandnamepharmaceuticalcompanies
• Genericpharmaceuticalcompanies
• Biopharmaceuticalcompanies
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PIVDisputesNYC 13
C Christopher J. KellyPartnerMayer Brown LLP(Palo Alto, CA)
Steven A. Maddox Partner Knobbe Martens Olson & Bear LLP(Washington, DC)
The MMA mandated that pharmaceutical companies provide the FTC with advance notice of proposed settlements of pharmaceutical patent disputes. The FTC and state attorneys general and private plaintiffs have challenged a number of settlements on antitrust grounds. The DOJ has also lent its support to the FTC in also challenging the legality of these settlements.
Both brand names and generic drug companies have expressed their frustration with the FTC in attempting to come to an agreeable resolution in this matter. There is also fear in the pharmaceutical industry over proposed legislation – introduced term after term- which may, in certain circumstances deem these types of settlements to be per se illegal and eviscerate 180-day exclusivity.
This hands-on, interactive workshop will examine how in the current environment, parties to a Paragraph IV dispute can resolve their differences and receive the government’s blessing. The workshop leaders will explore best practices to reach and finalize successful and sound settlements. Through the use of a hypothetical, they will help you:
• DraftandstructureanagreementthatwillreceiveFTCapproval• IdentifyandavoidredflagsthatmayleadtoFTCscrutiny• Anticipatepossiblerequirementsregardingpatentsettlementsunderproposed
legislation - Preserve Access to Affordable Generics Act- The Fair Generics Act
• UnderstandtheroleofauthorizedgenericsintheseagreementsandtheFTC’sviewon this topic
• Incorporateelementsintheagreementthatemphasizethepreservationofcompetition
• DevisestrategiestoemploypendingcompletionoftheFTC’sreview
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]
Global Sponsorship opportunitiesContinuing Legal Education 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 of which 1.0 will apply to ethics. An additional 4.0 credit hours will workshop A-C 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 of which 1.0 will apply to ethics. An additional 3.5 credit hours will apply to workshop A-C participation.
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ThUrSday, april 26, 2012 • 9:00 aM - 12:30 pM (registration opens at 8:30 am) ConTInEnTAL BrEAKFAST WILL BE SErVED
C The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generic – A Hands-On, Practical Approach
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SPonSorS AnD EXHIBITorS
Brinks Hofer Gilson & Lione has over 140 attorneys, scientific advisors and patent agents who specialize in intellectual property, making it one of the largest intellectual property law firms in the U.S. Clients around the world use Brinks to help them identify, protect, manage and enforce their intellectual property. Brinks lawyers provide expertise in all aspects of patent, trademark, unfair competition, trade secret and copyright law. The Brinks team includes lawyers with bachelors and advanced degrees in all fields of technology and science. Brinks has offices in Chicago, Washington, D.C., Research Triangle Park, Salt Lake City, Ann Arbor and Indianapolis. More information is available at www.usebrinks.com
Deloitte Financial Advisory Services LLP (“Deloitte FAS”) advises clients on managing business controversy and conflict, executing deals, and maintaining regulatory compliance. We provide services to companies throughout their lifecycle - from purchasing a company to investigating potential fraud. Specifically, we help clients address serious business concerns involving fraud, forensic investigations, litigation and reorganization.
Through Deloitte Corporate Finance LLC, our wholly owned securities brokerage subsidiary, we assist clients with originating and executing transactions and strategic investments for mergers and acquisitions, divestitures, and capital planning. We also advise businesses on valuation issues and other matters to help them remain compliant in today's rigorous regulatory environment.
Our dedicated Deloitte FAS professionals bring vast experience, specialized skill sets and deep industry knowledge to our Health Sciences clients.
Duane Morris' ANDA lawyers represent worldwide generic pharmaceutical companies in their quest to enter the U.S. market with new products, with significant experience in litigation related to ANDAs filed under the Hatch-Waxman law. www.duanemorris.com
Edwards Wildman attorneys have represented several of the world’s largest brand pharmaceutical companies in Hatch-Waxman Paragraph IV patent litigation against many major generic drug companies. These cases have protected billions of dollars worth of small molecule pharmaceutical sales for our clients. Our pharmaceutical patent litigation experience is characterized by effective lead trial counsel well-versed in Hatch-Waxman issues. Teams are based in New York and Boston and have enforced patents covering NCEs, polymorphs, solid and liquid dosage forms, salts, treatment methods,
stabilizers, and sustained release formulations. We are also seasoned and successful appellate advocates at the Court of Appeals for the Federal Circuit. More information can be found at ip.edwardswildman.com.
With more than 375 intellectual property lawyers, Finnegan is one of the largest IP law firms in the world. From offices in the United States, Europe, and Asia, we handle all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation. www.finnegan.com
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Knobbe Martens is an agent of innovation, providing clients worldwide with forward-focused Intellectual Property law service and representation. We are one of the largest and fastest-growing IP law firms, with more than 275 attorneys and scientists representing the complete spectrum of technologies and IP practice areas.
We combine unmatched technical and litigation expertise to deliver superior results in both transactional and contested matters, for both cutting edge start-ups and established Fortune 500 companies. Our work spans fields ranging from physics to pharmaceuticals and entertainment to engineering.
But perhaps more impressive than our scope is our skill. We are established experts in our fields—scientists, engineers and thinkers who blend deep educational and technical knowledge with a strategic focus gleaned from our real-world business experience. We know your issues. Your pressures. And should the need arise, we know how to aggressively protect the assets that give your business its competitive edge—with extensive experience and intimate knowledge of domestic and international judicial systems.Whatever our role, our goal is simple: to advance and protect those whose innovations propel the world forward.
Patterson Belknap Webb & Tyler LLP, is based in New York City with approximately 200 lawyers delivering a full range of services across more than 20 practice groups in both litigation and commercial law. More than half of the attorneys at
Patterson Belknap are devoted to litigation. Our litigating partners have tried hundreds of cases, including many of the most complex in their fields. Our attorneys secured a settlement of $1.725 billion, the largest settlement ever of a patent infringement case in the United States on behalf of a Fortune 50 client.
The Paul Weiss patent litigation group has extensive experience in the life sciences field, including ANDA litigation as well as patent disputes on biologics, medical devices and diagnostics. The group is currently handling significant matters for BiogenIdec, Edwards Life Sciences, Genentech, Life Technologies, Medicis and Yeda, among others.
Polsinelli Shughart has a national presence in the pharmaceutical and life sciences industries. Our work includes Hatch-Waxman Act litigation, intellectual property litigation and enforcement, patent prosecution, opinion work, and advice regarding transactional matters. We work with manufacturers of generic pharmaceuticals and biologics, along with start-up and entrepreneurial clients.
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