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The Third Henry Stewart One-Day Briefing on
Latest Thinking
on
Attacking/Defending Patent Rights in the
U.S. Pharmaceutical Market

Chair:
David B. Clissold
Partner
Hyman, Phelps & McNamara, PC

Speakers:
Meredyth Smith Andrus
Assistant Attorney General
Antitrust Division
Office of the Attorney General

Donald O. Beers
Partner
Arnold & Porter LLP

Richard J. Berman
Partner
Arent Fox PLLC

Paul M. Booth
Shareholder
Heller Ehrman White & McAuliffe, LLP

Robert W. Esmond
Director
Sterne Kessler Goldstein & Fox, PLLC

Barton W. Giddings
Senior Patent Counsel
NPS Pharmaceuticals

Michael Kades
Staff Attorney
U.S. Federal Trade Commission

Steven Lieberman
Partner
Rothwell Figg Ernst & Manbeck, PC

Robert C. Millonig
Director
Sterne Kessler Goldstein & Fox, PLLC

 

Hatch-Waxman: Strategies for NDA Holders, Generics and Other Challengers

  • Recent legislative and regulatory changes to the Hatch-Waxman scheme, e.g., Orange Book listing restrictions and limitations on the 30-month stay
  • The impact of these legislative and regulatory changes on NDA holder strategy
  • The generic challenger’s response

Robert C. Millonig
Director
Sterne Kessler Goldstein & Fox, PLLC

 

Generics: Declaratory Judgments and Exclusivity Battles

  • The Hatch-Waxman Declaratory Judgment Provision: Success Or Failure?
    The recent legislative changes to the Hatch-Waxman Act provided generic firms with the opportunity to file declaratory judgment actions against a pioneer, provided no suit is filed by the pioneer within the 45-day notice window. This presentation explores the history of the Declaratory Judgment provision and analyzes whether this provision will be a useful tool for generic firms in the future. Cases to be discussed include:
    - Glaxo v. Apotex
    - Torpharm v. Pfizer
    - Glaxo v. Dr. Reddy’s
    - Teva v. Abbott
  • Generic Exclusivity Battles: Fighting For 180 Days
    Although the recent Hatch-Waxman Amendments were designed to curtail exclusivity battles, there are a number of ongoing exclusivity contests. The speaker will discuss current exclusivity battles and the legislative changes designed to curb them. Cases to be discussed include:
    - Apotex (paroxetine)
    - Purepac (gabapentin)
    - Ranbaxy (metformin)
    - Dr. Reddy’s (omeprazole)

Richard J. Berman
Partner
Arent Fox PLLC

 

Defending Patents: Strategies for Patent Holders

  • Preparing for validity challenges
  • Use of U.S. continuation practice to obtain additional protection
  • Obtaining additional protection from:
    - new forms of active ingredient (crystal forms)
    - new formulations
    - new methods of manufacture
    - new method of treatment claims
  • Challenging equivalence of the generic product

Paul M. Booth
Shareholder
Heller Ehrman White & McAuliffe, LLP

 

How the Attorneys General are Responding to Unwarranted Patent Extensions and Curtailing Improper Patent Manipulation
The speaker will discuss the recent efforts undertaken by Attorneys General throughout the country to curtail unwarranted extensions of patent protection in the pharmaceutical industry, while, at the same time, supporting and protecting valuable intellectual property rights, including:

  • Recent cases involving antitrust allegations against brand name drug companies
  • The latest FTC/States prosecution and settlement in the Rx industry, State of Maryland, et al v. Perrigo Co. and Alpharma, Inc. Lessons learned from investigation into the generic OTC market
  • Latest efforts of the Pharmaceutical Pricing Task Force multidisciplinary approach to artificially high drug prices
  • What to do if your client becomes a target of State law enforcement

Meredyth Smith Andrus
Assistant Attorney General, Antitrust Division
Office of the Attorney General

 

How FTC Policy and Practice Affects Decision Making
In this presentation, Michael Kades, Attorney from the Bureau of Competition at the Federal Trade Commission (FTC) will explain how the FTC’s enforcement action in the pharmaceutical industry can affect decision-making regarding patent and market exclusivity. The speaker will discuss:

  • How generic competition is unique and its implications for antitrust analysis
  • Antitrust issues that arise in the settlement of pharmaceutical litigation
  • Settlement in which the NDA holder pays the ANDA holder not to enter (exclusion payments)
  • The FTC’s action challenging Schering Plough’s settlement of patent litigation involving Schering’s K-Dur 20 product
  • Settlements in which the holder supplies the ANDA holder with product (authorized generics)
  • Antitrust issues that arise in agreements between ANDA holders
  • Discussion of the FTC’s recent action challenging an agreement between Perrigo and Alpharma involving over-the-counter liquid ibuprofen in which the parties paid $6 million in disgorgement

Michael Kades
Staff Attorney
U.S. Federal Trade Commission

 

How to Win Paragraph IV Litigations on Behalf of the ANDA Applicant
A number of patent cases brought under the Hatch-Waxman Amendments have been decided in favor of generic challengers. Led by an experienced patent litigator, this session will explore the strategies available to ANDA applicants engaged in patent litigation including:

  • The use of “Paragraph IV” certifications and “viii” statements
  • Methods for challenging improper Orange Book listings
  • Successful strategies on the merits of “Paragraph IV” patent litigations
  • Recent events regarding the use of an “authorized generics” strategy
  • Inducing infringement issues with respect to patents on off-label uses
  • Antitrust counterclaims and other aggressive defensive strategies

Steven Lieberman
Partner
Rothwell Figg Ernst & Manbeck, PC

 

New Developments in the Law on Patent Term Extensions

  • The laws governing patent term extensions for products subject to pre-market government approval
  • How to file an application for patent term extension
  • Recent case law related to patent term extensions

Barton W. Giddings
Senior Patent Counsel
NPS Pharmaceuticals

 

Statistics Concerning ANDA Patent Challenges: The Winners and Losers

  • Discussion of ANDA patent challenges
    - changes in the numbers of filings over the years
    - wins by innovator companies
    - wins by generic pharmaceutical companies
  • Types of patent challenges
    - case studies
  • Bases for wins by generic pharmaceutical companies including invalidity and non-infringement
  • What hasn’t worked
  • Future trends

Robert W. Esmond
Director
Sterne Kessler Goldstein & Fox, PLLC

 

Coordinating Patent Defense with FDA Regulatory Strategy

  • Relationship of FDA marketing exclusivities to patent listing and defense
    - 5 year (4 year with a patent challenge) exclusivity
    - 3-year exclusivity
    - pediatric exclusivity
    - Orphan Drug Act exclusivity
    - 180-day exclusivity and authorized generics
  • Arguing lack of sameness to FDA and equivalence to the courts

Donald O. Beers
Partner
Arnold & Porter LLP