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American Conference Institute 4th Annual Paragraph IV Disputes Conference

Loeb & Loeb LLP is proud to sponsor the American Conference Institute’s 4th Annual Paragraph IV Disputes Conference: Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics, where partner Mark Waddell is a speaker.

From the conference website:

Now in its fourth year, ACI’s Paragraph IV Disputes conference has become the most trusted source for the ‘ins and outs’ of Paragraph IV litigation. This first and original conference of its kind serves as the litigation playbook for brand name and generic drug companies in the high-stakes arena of Hatch-Waxman litigation.

The inherent intensity of Paragraph IV litigation has been magnified of late by the seemingly unending repercussions of the Hatch-Waxman reforms of the MMA, pending Patent Reform legislation, the imminent approval of an abbreviated pathway for follow-on biological products and the threat of proposed legislation, which may make settlements of these matters near impossible — let alone illegal. These factors have all added to the complexity of this litigation, and have also raised the monetary ante to unprecedented heights.

In this environment, it is imperative that brand name and generic pharmaceutical companies and their counsel, have the offensive moves and defensive plays that they need to meet the challenges of pharmaceutical patent endgame litigation.

ACI’s Paragraph IV Disputes conference has been designed to give counsel for both brand name and generic drug companies the critical up-to-the minute information that they need to plan their Hatch-Waxman litigation strategies.

An experienced faculty comprised of respected and renowned counsel for both brand name and generic pharmaceutical companies will provide insights on every facet of Paragraph IV litigation from pre-litigation concerns to the commencement of suit through to final adjudication — and every step in between. This conference will also provide you with access to renowned federal jurists and a key official from the FTC’s Bureau of Competition’s Health Care Division. You will not only hear firsthand how the bench analyzes the theories of your case, but will also learn what the FTC deems ‘fair and foul’ in the settlement of Paragraph IV disputes.

By popular demand — and in light of current legislative developments — we will once again offer our exclusive Master Class on Settling Paragraph IV Disputes: Brand-Name and Generic Perspectives. This in-depth workshop will offer valuable up-to-the minute insights and strategies from both sides as to what may now well be the most critical consideration in a Paragraph IV challenge.

Also, this year, in response to your requests, we have added the following specialized class: Hatch-Waxman Boot Camp – A Primer on IP Basics and Regulatory Fundamentals.

Agenda

Day One: Tuesday, April 27, 2010
7:15 Registration and Continental Breakfast

8:00 Co-Chairs’ Opening Remarks
Brian P. Murphy, Partner & Deputy Practice Group Leader, Patent Litigation Group - Morgan Lewis & Bockius LLP (New York, NY)
Barry S. White, Partner - Frommer Lawrence & Haug LLP (New York, NY)

8:30 Pre-Suit Due Diligence Strategies in Anticipation of the Paragraph IV Challenge
Bart Newland, Vice President, Chief Intellectual Property Counsel - Biogen-Idec Inc. (Cambridge, MA)
Filko Prugo, Partner - Fitzpatrick, Cella, Harper & Scinto (New York, NY)

  • Predicting and preparing for Paragraph IV litigation
  • Examining the Orange Book: the “to list or not list” quandary
         --which types of patents should you list?
         --special listing considerations for small proteins filed through an NDA (as opposed to a BLA) in light of pending FOB legislation
         --which are the most likely targets of an eventual Paragraph IV challenge?
  • Evaluating the strength of the patents — for both small molecules and biologics — in your current portfolio
  • Gauging when to reasonably expect a Paragraph IV filing by a generic competitor
  • Looking at the different types of brand name exclusivities and their tie the start of a Paragraph IV challenge
         --NCE
         --new use or indication
         --new formulation
         --orphan drug
         --pediatric
  • Preparing for litigation
         --preparing for discovery 
         --implementation of document retention policy
         --when is a litigation hold put on all documents which may be discoverable
         --e-discovery considerations
  • Considerations for heading off a Paragraph IV challenge at the pass
         --entering an authorized generics agreement
         --claiming the label
         --filing a citizen’s petition
  • Biological patents: anticipating new challenges and how they may compare to a Paragraph IV dispute
  • Coordinating with outside counsel on these matters

 

9:30 Assessing the ANDA Applicant’s Initial Obligations
Richard J. Berman, Partner - Arent Fox LLP (Washington, DC)
Lawrence Brown, Senior Director, Intellectual Property - Par Pharmaceutical Companies, Inc. (Woodcliff Lake, NJ)

  • Deciphering the ANDA applicant’s Orange Book strategy
         --how to choose which patents to challenge
         --compounds
         --formulations
         --process
         --methods of use
         --factoring “forfeiture” into your Orange Book strategy
  • Rethinking non-Orange Book patents
         --innovator / non-innovator
         --API
         --new considerations/strategies for biological products in light of proposed FOB legislation
  • Identifying the initial obligations of the ANDA applicant under Paragraph IV
  • Getting a legal opinion on invalidity and non-infringement
         --assessing when opinions are needed
         --opinion of in-house vs. outside counsel
  • Tactics for identifying the best art
  • Attempting to influence where and when the suit will occur
  • Filing the ANDA
         --fulfilling requirements for FDA approval:
         --pharmaceutically equivalent
         --bioequivalent
         --identifying triggers which may necessitate new bioequivalence studies
  • Contents of the Paragraph IV certification

 

10:30 Morning Coffee Break

10:45 New Takes on Obviousness: Pre-Suit Considerations for Brand-Names and Generics
Michael A. Davitz, Partner - Axinn, Veltrop & Harkrider LLP (New York, NY)
Teresa Stanek Rea, Partner - Crowell & Moring LLP (Washington, DC) and Immediate Past President, American Intellectual Property Lawyers Association

  • Analyzing the major post-KSR obviousness decisions in the District Courts and Federal Circuit
         --Sanofi v. Apotex (Plavix) (Fed. Cir. Dec. 2008)
         --Aventis v. Lupin (Ramipril) (Fed. Cir. 2007)
         --Forest Labs v. Ivax (Celexa )(Fed. Cir. 2007)
         --Ortho McNeil v. Mylan Labs (Topomax) (Fed. Cir. 2008)
         --Takeda v. Alpharma (Actos) (Fed. Cir. 2008)
  • Incorporating the post-KSR obviousness precedent into brand name and generic Paragraph IV litigation strategies
         --how have these decisions rendered primary compound and pharmaceutical composition claims more vulnerable to generic challenge?
         --understanding how these decisions have impacted the patentability of secondary patents:
         --enantiomers; isomers
         --new formulations; new indications
         --crystallization; salts
         --determining when and how secondary patents should be pursued/challenged in light of this jurisprudence
  • What judicial trends can be discerned from these decisions?
  • In re Kubin: what can the pharmaceutical industry learn from this case vis-a-vis a Paragraph IV challenge?

 

11:30 Throwing Down the Gauntlet: The Paragraph IV Notice Letter – Delivery and Receipt
GENERIC SIDE:
Thomas J. Filarski, Shareholder & Chair, Chemical Group - Brinks Hofer Gilson & Lione (Chicago, IL)
Meg Snowden, VP, Intellectual Property - Impax Laboratories, Inc. (Hayward, CA)

BRANDED SIDE:
Patricia C. Lukens, Assistant General Counsel - Johnson & Johnson (Raritan, NJ)
Christopher N. Sipes, Partner - Covington & Burling LLP (Washington, DC)

The ANDA filer must notify the patent owner and the NDA owner of its actions within twenty days of the ANDA filing. This section will explore the procedural and substantive requirements for the Paragraph IV Notice Letter and related filings.

PROCEDURAL REQUIREMENTS:

  • Perfecting the Paragraph IV Certification
  • Contents of the Notice letter
  • Delivery/service of the Notice Letter
  • Making necessary amendments to the ANDA
         --sending the notice letter
         --receipt of notice letter

SUBSTANTIVE REQUIREMENTS:

  • Identifying the proposed product covered by the ANDA
  • Identifying the patent of the corresponding branded product which is the subject of the Paragraph IV letter
  • Legal and factual basis
  • Exploring the use of opinion letters in relation to Notice letter

Upon receipt of the Notice Letter, the patent holder has 45 days to commence suit. If a law suit is filed, a 30-month stay on the FDA’s approval of the ANDA is granted. If suit is not commenced within the 45 day period, the 30-month stay is forfeited and the ANDA filer may be entitled to 180 days of market exclusivity on its ANDA product. This session will delve into the strategies and deliberations of the 45 day period.

  • Using the 45 day period productively
  • Information gathering techniques for the 45 day period
         --confidentiality agreements and document requests
         --obtaining the ANDA
         --terms
         --scope of information that can reasonably expected
         --negotiations
  • Extending the 45 day period
         --21 CFR 314.95 (f)
  • When should a patent owner file suit?
         --other options to explore
         --license
         --authorized generic
  • Strategies to consider with multiple ANDA filers

QUESTIONS FOR BOTH SIDES TO CONSIDER:

  • Options to explore if suit is not commenced in 45 days
         --pros, cons and consequences of:
         --forfeiture of 30 month stay
         --sue for damages
         --declaratory judgment actions
         --no contest letter
  • Factoring in the potential impact of possible Patent Reform legislation

 

12:45 Networking Luncheon

2:00 Let the Games Begin: The Start of the Paragraph IV Law Suit – Pleadings and Considerations
GENERIC SIDE:
Kevin W. McCabe, Director - Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)
Shashank Upadhye, Vice President - Global Intellectual Property - Apotex, Inc. (Toronto, ON)

BRANDED SIDE:
James P. Leeds, Assistant General Patent Counsel - Eli Lilly & Company (Indianapolis, IN)
Denise L. Loring, Partner - Ropes & Gray LLP (New York, NY)

MODERATOR:
Brian M. Poissant, Partner & Chair, IP Practice - Jones Day (New York, NY) 

INITIAL CONSIDERATIONS:

  • Where should suit be filed?
         --attempts by the generic to influence where and when the suit will occur
  • Handicapping of judges and jurisdictions
  • Surveying local patent rules
         --knowing which district rules favor patent holders and patent challengers, e.g.,
         --New Jersey
         --E.D. Texas
         --Michigan
  • Question of a jury trial: exploring circumstances that may put you in front of a jury
  • Cost considerations
  • Factoring-in corporate/organizational changes, e.g., mergers

CRAFTING THE INITIAL PARAGRAPH IV PLEADINGS:

  • The complaint
         --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 attorneys fees can be properly sought
  • The answer and counterclaims
         --de-listing improperly listed patents
         --antitrust and unfair competition claims
         --the generic point of view:
         --attorneys’ fees
         --Rule 11

DECLARATORY JUDGEMENTS:

  • Understanding the MMA declaratory judgment provisions and the CAFC’s interpretation of these provisions
         --two prong test
  • When is it appropriate to move for a DJ
  • Circumstances when a DJ will be granted?
  • Should DJ be sought on all patents – listed and not listed?

FACTORING IN THE 30-MONTH STAY:

  • Commencement of the statutory 30 month stay
         --understanding the scope and limits of the 30 month stay under the MMA
  • The 30-month stay in the course of litigation
         --options and strategies for the patent holder if the stay expires during the course of litigation
         --early termination of the stay

 

3:30 Afternoon Refreshment Break

3:45 Exploring Exclusivity and Forfeiture Dilemmas Relative to Paragraph IV Litigation
David Fox, Partner - Hogan & Hartson LLP (Washington, DC)
Steven J. Lee, Partner - Kenyon & Kenyon LLP (New York, NY)

  • Identifying the qualifying criteria for 180-day exclusivity
  • How can an ANDA applicant determine who is “first-to-file”?
  • Spotting triggers for the running of the 180-day exclusivity period
  • When can the 180-day exclusivity period be transferred to another ANDA applicant?
  • Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences
         --understanding the relevance to the outcome of a Paragraph IV case
  • When can a brand “park” a generic’s exclusivity?
  • Defining “shared exclusivity”
  • Assessing the impact of “authorized generics” in Paragraph IV litigation
  • Forfeiture provisions: circumstances under which exclusivity is forfeited
         --when can forfeiture of another’s exclusivity occur?
         --how do subsequent P IV filers influence forfeiture?
  • Interpreting the “earlier of”, “later of” language in making a forfeiture determination
  • Triggering “the failure to market” provision
  • Evaluating the impact of “delisting” on forfeiture
  • Survey and analysis of recent FDA forfeiture rulings
         --Kytril
         --Altace
         --Precose
         --Cosopt
         --Camptosar
  • Exploring the FTC/DOJ stance on forfeiture

 

4:30 A View from the Bench on Paragraph IV Litigation
Honorable Garrett E. Brown, Jr., 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)

Renowned jurists with some of the most active Paragraph IV litigation dockets in the country will share their thoughts and insights on some of the most pressing issues facing both patent holders and patent challengers. Come prepared with your most pressing questions.

5:45 Cocktail Reception
Hosted by: Loeb & Loeb LLP

Day Two: Wednesday, April 28, 2010
7:30 Continental Breakfast

8:30 Co-Chairs’ Opening Remarks and Recap of Day One

8:45 A Closer Look at Generic v. Generic Law Suits
Stephen R. Auten, Vice President, Intellectual Property - Sandoz, Inc. (Princeton, NJ)
Richard Ruzich, Partner - Duane Morris LLP (Chicago, IL)
Don J. Mizerk, Partner - Husch Blackwell Sanders LLP (Chicago, IL)

  • Understanding the impetus for generic/generic litigation
         --180 day exclusivity
         --protecting market share or something more?
  • Identifying factors making this type of litigation more prevalent
         --how have authorized generics changed the playing field?
         --generic innovation? / R & D?
  • Strategies employed in and leading to these law suits
         --citizens petitions to block other generic competitors
  • How to better position your company in these challenges
  • Predicting future trends in this type of litigation

 

9:45 Litigating with Multiple ANDA Filers: Brand Name and Generic Perspectives
Lisa M. Ferri, Partner - Mayer Brown LLP (New York, NY)
Tedd W. van Buskirk, Partner - K & L Gates LLP (New York, NY)

  • Choosing who to sue
         --ANDA filers; others?
         --when does it make sense to only sue one or a few as opposed to all ANDA filers?
         --suing the first filer
         --what are the consequences of not suing all ANDA filers?
         --non-party ANDA filers and dealing with the repercussions of “at risk” launches
  • Choosing where to sue: special considerations for multiples
         --risks and opportunities regarding forum selection
         --evaluating MDL options
  • Dealing with later ANDA filers
         --consolidate, stay or keep separate: analyzing the alternatives and selecting strategy
  • The generic’s position in the queue
         --general considerations for first to file
         --thoughts for second and later filers
  • Consolidation vs. separate cases
         --dealing with your co-defendants
  • Taking advantage of the multiple defendant situation
         --strategies during fact discovery
         --scenarios arising from experts
  • Achieving a successful outcome with multiple players
  • Maintaining or improving your scenario by the end of discovery

 

10:45 Morning Coffee Break

11:00 FTC Keynote: Pay For Delay Settlements
Markus H. Meier, Assistant Director of the Health Care Division - Bureau of Competition, Federal Trade Commission (Washington, DC)

The Federal Trade Commission continues to vigorously use its enforcement and policy tools to prevent anticompetitive business practices in the pharmaceutical industry. “Reverse settlement” or “pay-for-delay” agreements have been viewed by the FTC as a very anticompetitive practice. It now appears that the DOJ, and even Congress have taken a similar view and see these agreements as being in restraint of trade and causing great harm to the consumer.

In this session, Markus Meier, Assistant Director of the FTC’s Bureau of Competition’s Health Care Division will discuss the FTC’s position on these agreements and address such matters as:

  • The enforcement of the MMA reporting requirements
  • FTC and DOJ alignment on ‘pay-for-delay’ agreements
  • Pending legislation regarding these settlements
  • The competitive implications of other pharmaceutical life cycle management strategies
  • The findings of the FTC’s authorized generic’s study

 

12:00 Networking Luncheon

1:15 Recent Decisions Impacting Paragraph IV Challenges and Motion Practice
Aaron F. Barkoff, Ph.D, Partner - McDonnell, Boehnen Hulbert & Berghoff LLP (Chicago, IL)
Matthew P. Blischak, Vice President and Associate General Counsel Intellectual Property - Sepracor Inc. (Marlborough, MA)
Bruce M. Wexler, Partner - Paul, Hastings, Janofsky & Walker LLP (New York, NY)

  • Identifying and analyzing the latest judicial trends from the CAFC and District Courts concerning PIV challenges and understanding how they will affect your litigation strategies
  • Declaratory Judgment actions
         --Merck & Co. v. Apotex, No. 2008-1133 (Fed. Cir. 2008)
         --Prasco v. Medicis Pharm. Corp., No. 2007-1524 (Fed. Cir. 2008)
         --GlaxoSmithKline v. Mutual Pharm., No. 08-549 (E.D. Pa. 2008)
         --Impax Labs. v. Medicis Pharm., No. C-08-0253 MMC (N.D. Cal. 2008)
         --Janssen v. Apotex (Fed. Cir. 2008)
         --Ivax v. AstraZeneca (D.N. J. 2008)
         --Dr. Reddy’s v. Astra Zeneca (D.N. J. 2008)
  • Covenants not to sue
         --Caraco Pharm. Labs. v. Forest Labs., No. 2007-1404 (Fed. Cir. 2008)
  • Preliminary/permanent injunctions
         --Eisai Co. v. Teva Pharms. USA, No. 05-5727 (D.N.J. 2008)
         --Altana Pharma and Wyeth v. Teva, No. 2008-1039 (Fed. Cir. 2009)
         --Eisai Co. v. Teva Pharms. USA, No. 05-5727 (D.N.J. 2008)
  • Inequitable conduct
         --AstraZeneca Pharmaceuticals LP v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)
         --Aventis Pharma v. Amphastar and Teva, No. 2007-1280 (Fed. Cir. 2008)
  • Double patenting
         --Pfizer v. Teva (Fed. Cir. 2008)
  • Rule 11 sanctions
         --Celgene and Novartis v. KV Pharm., No. 07-4819 (D.N.J. 2008)

 

2:30 Afternoon Refreshment Break

2:45 Discovery Strategies and Pre-trial Maneuvering Tactics for Brand Names and Generics
F. Dominick Cerrito, Partner - Jones Day (New York, NY)
Brian D. Coggio, Senior Principal - Fish & Richardson P.C. (New York, NY)
D. Christopher Ohly, Partner - Schiff Hardin LLP (Washington, DC)

DOCUMENTS:

  • Exploring brand and generic perspectives on document review
         --what is legitimately discoverable by generics?
         --at what point is a discovery request overburdensome?
         --finding a way to balance the perceived inequities between document requests made by brand-names and generics
  • Assessing the impact of e-discovery and revisions to the FCPR on paper discovery in Paragraph IV matters

EXPERTS:

  • Optimizing the use of experts in Paragraph IV proceedings
  • Identifying key points on which the opinion of an expert is sought by both sides 
         --inherent anticipation
         --obviousness
         --infringement and invalidity
         --what is the nature of the claims?
         --compound
         --formulation
         --method of treatment

QUESTIONS OF PRIVILEGE:

  • Addressing questions of attorney-client privilege with respect documents and witnesses in Paragraph IV cases
  • Determining whether the attorney-author of an opinion or Paragraph IV Certification letter can be deposed?

MARKMAN HEARINGS:

  • Understanding and perfecting the timing of Markman hearings in a Paragraph IV case
  • Should Markman hearings be before or after expert reports and discovery?
  • Analyzing the nature of the claims presented
  • Deciding which claims should be presented in a Markman hearing and which should be saved for trial

 

4:00 Assessing Danger and Mitigating Liabilities Associated with Injunctions and “At Risk Launches”
Patricia Carson, Partner - Kaye Scholer LLP (New York, NY)
Martin B. Pavane, Partner - Cohen Pontani Lieberman & Pavane LLP (New York, NY)

  • Seeking a preliminary injunction in the event that the stay ends in the course of the litigation
         --posting of bond by the branded side
  • Exploring the possibility of a stipulated injunction
         --why a stipulated injunction may be of benefit to both sides
  • Appealing to the CAFC
  • Re-assessing the meaning of irreparable harm as per Winter v. Natural Resources Defense Council
  • Launching at risk during litigation or the appeal period
         --weighing of benefits and risks
  • How do authorized generics impact the decision to launch at risk?
  • Calculating damages for launching at risk

 

5:00 Conference Adjourns