Background
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discussion and over 100 weblinks to key internet sources of information.
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Report Format
- 230+ pages of fully edited transcripts
- 50+ tables and figures
- 100+ weblinks
- Available as printed hardcopy with searchable CD-ROM
Executive Summary
This report captures the perspectives, insights and discussions presented by
industry leaders at two conferences relating to pharmaceutical products:
Pharmaceutical Product Lifecycle Strategies, held November 15-16, 2001, and
Generic Drugs, held November 29-30, 2001. Both conferences were organized by The
Center for Business Intelligence and held in Washington, DC.
The report focuses on four areas:
1) an overview of current trends and issues in the generic drug industry
2) laws and policies that have come into dispute from both brand and generic
companies
3) international issues in sourcing from or selling to foreign countries
4) the use of intellectual property to extend market exclusivity for brand drugs
and delay competition from generic products.
Each chapter in this book is based on an edited transcript from one of the
presentations and contains additional background information and/or editorial
commentaries
1. Executive Summary
1.1 Industry Overview
1.2 Laws and Policies
1.3 International Issues
1.4 Intellectual Property
2. Introduction
2.1 Generic Drug Market Drivers
2.2 Pharmaceutical Product Lifecycle Strategies
2.3 Patent Infringement Settlement Agreements
2.4 Major Issues Facing the Generic Drug Industry Today
2.5 Biogeneric Drugs
2.6 Regulatory Challenges for Approving Biogenerics
2.7 Concern Over Biogeneric Drug Safety
2.8 Other Challenges for Biogenerics
2.9 Possible Precedents for Biogeneric Drug Approvals
2.10 Compulsory Licensing in a National Emergency
2.11 Proposed Compulsory Licensing of AIDS Drugs
2.12 Further Reading
Industry Overview
3. Market Trends in the U.S. Generic Drug Industry
3.1 Current Issues in Generic Drug Development
3.2 Retail Sources for Drug Sales
3.3 Generic Drug Markets
3.4 Generic Drug Approval Process
3.5 Impact of Drug Patent Expirations
4. Overview of the Generic Drug Industry
4.1 Landmarks of the Generic Drug Industry
4.2 Industry Scandals
4.3 Big Pharma's Role in the Generic Drug Industry
4.4 Biotechnology: The Next Generic Frontier
4.5 Evergreen Patents to Extend Market Life
4.6 釘randed Generic"Drugs
4.7 Future Trends in the Global Generic Drug Industry
5. Distinguishing Generic Products Through Drug Delivery Technology and
Super-Generics
5.1 Lifecycle Strategies to Maximize Return on Investment for NCEs
5.2 Challenges in Sustaining Market Dominance
5.3 Advancing Development of Generic Products
5.4 Super-Generics
5.5 Using Novel Drug Delivery Technologies for Product Differentiation
5.6 Selecting the Right Drug Delivery Technology
5.7 Leveraging Super-Generic Products in the Marketplace
5.8 Summary
6. The Age of Biogenerics: Therapeutically Equivalent Biotechnology Drugs
6.1 Regulatory Standards for Manufacturing
6.2 Regulatory Authority
6.3 Approval of Novel Biological Drugs and Biogenerics
6.4 The Concept of Therapeutic Equivalence
6.5 Establishing Bioequivalence
6.6 Establishing Pharmaceutical Equivalence
6.7 Analytical Methods
6.8 Considerations for Biogeneric Drug Regulation
6.9 Production of Biogeneric Drugs
6.10 Prospects for Biogeneric Drugs
7. General Issues in the Generic Drug Industry
7.1 Are there Truly Global Generic Drug Companies?
7.2 Are Indian Generic Drug Companies Attempting to Penetrate the U.S. Market on
their Own?
7.3 Does India have a National Strategy for Entering the Global Generic Drug
Market?
7.4 Will Patent Protection Remain a Barrier to Low-Cost Drug Access?
7.5 How Feasible will it be to Produce Biogeneric Drugs?
7.6 How will Generic Companies be Able to Sell Super-Generics?
7.7 What are the Barriers for Acceptance of Generic Substitutions?
Laws and Policies
8. The Hatch-Waxman Act and the Generic Drug Industry
8.1 Introduction
8.2 Modernization of the Hatch-Waxman Act
8.3 Revisiting the Provision of the 30-Month Stay
8.4 Best Pharmaceuticals for Children Act
8.5 Attempts to Delay Generic Drug Competition
8.6 Alternatives to Exclusivity for Pediatric Research
8.7 Other Needs for Reform
8.8 Conclusions
9. 180-Day Exclusivity: Help or Hindrance?
9.1 Reform of the Hatch-Waxman Act
9.2 Controversy Over the 180-Day Exclusivity Provision
9.3 Pediatric Exclusivity
9.4 Proposed Amendments to FDA Rules
9.5 McCain-Schumer Initiative
9.6 Other Legislative Initiatives
9.7 Revisions to Orange Book Patent Listing Procedures
9.8 FTC Decisions
9.9 FTC Study of the Pharmaceutical Industry
9.10 Predictions for the Future
10. Market Exclusivity Strategies for Brand-Name and Generic Drugs
10.1 Market Exclusivity Under the Hatch-Waxman Act
10.2 Basic Principles of Pioneer vs. Generic Drug Competition
10.3 Key Features of the Generic Drug Approval Process
10.4 Rewarding Product Development with Exclusivity
10.5 Patent Term Restoration for Pioneer Drugs
10.6 Exemption from Patent Infringement
10.7 Data Exclusivity for Pioneer Drugs
10.8 30-Month Market Exclusivity for Pioneer Drugs
10.9 180-Day Market Exclusivity for Generic Drugs
10.10 Controversy Over Orange Book Listings
10.11 Pediatric Exclusivity
10.12 The Orphan Drug Act
10.13 Further Reading
11. Antitrust and Pharmaceutical Patent Settlements
11.1 The FTC and the Pharmaceutical Industry
11.2 FTC Study of Generic Drug Competition in the U.S.
11.3 Patent Infringement Settlements
11.4 Issues Surrounding the 180-Day Exclusivity Provision
11.5 Settlement Enforcement Actions
11.6 Financial Incentives to Agree to Anti-Competitive Terms
11.7 Anti-Competitive Terms of Settlement Agreements
11.8 Practical Advice for Structuring Settlement Payments
11.9 FTC Investigation of Patent-Evergreening Strategies
11.10 Further Reading
12. The View from Capitol Hill: Will 2002 be the Year for Legislation to
Improve Access to Generic Drugs?
12.1 Congressional Action on Generic Drugs
12.2 Factors that Favor Legislative Action
12.3 The Impact of High Drug Costs on Access to Drugs
12.4 Economic Incentives to Block or Delay Generic Drugs
12.5 Erosion of Public Support for the U.S. Pharma Industry
12.6 Renewal of the Prescription Drug User Fee Act
12.7 "September 11"Fallout on Generic Drug Reform
12.8 Compulsory Licensing in the Face of an Emergency
12.9 Pending Legislations
12.10 A Winning Strategy to Provide Affordable Access to Drugs
International Issues
13. Trends in the European Generic Drug Market
13.1 Generic Medicines in Europe
13.2 Generic Drug Markets
13.3 European Regulatory Organizations
13.4 Abridged Registration Procedure
13.5 Mutual Recognition Procedure
13.6 Problems with the MRP
13.7 Centralized Procedure
13.8 Intellectual Property Issues
13.9 Generic Drug Legislation and Regulations
13.10 Future Prospects
14. Canadian Generic Drug Market Approval Process and Pricing
14.1 The Canada Health Act of 1984
14.2 Government Influences on Healthcare in Canada
14.3 Patent Medicine Price Review Board
14.4 Provincial Drug Plans and Usage
14.5 Prescription Drug Spending
14.6 Provincial Distribution and Cost Containment
14.7 Cost Containment and Price Control
14.8 Cipro
14.9 Suggestions for Future Control of Drug Expenditures
15. Export Assistance from the U.S. Department of Commerce
15.1 Foreign Trade Promotion by the U.S. Government
15.2 International Trade Administration
15.3 Trade Discussions with China
15.4 Follow-Up in China
15.5 Developing Marketing Programs for Foreign Countries
15.6 Export Assistance from the Department of Commerce
15.7 Premium Services
15.8 Leads, Ads and Financing
15.9 Agency Contacts
16. Manufacturing Active Pharmaceutical
Ingredients in Taiwan
16.1 Contract API Manufacturing in Asia
16.2 Intellectual Property Protection
16.3 The Asian Advantage
16.4 Financial Incentives
16.5 Talented Labor Pool
16.6 Case Study: ScinoPharm Taiwan
16.7 Summary of Key Advantages for API Production in Taiwan
16.8 Further Reading 160
17. Changes in Pharmaceutical Patent Protection in India
17.1 History of Intellectual Property Protection in India
17.2 Indian Patent Act of 1970
17.3 India Prepares to Enter Western Markets
17.4 Patent Harmonization
17.5 Impact of Patent Law Revisions
17.6 Long-term Effects of Patent Harmonization on Indian Drug Companies
Intellectual Property
18. Developing and Managing an Effective Intellectual Property Strategy
18.1 The Importance of IP
18.2 Basic Principles of the U.S. Patent Law
18.3 Patent and Licensing Strategies
18.4 Breadth of Patent Claims
18.5 Doctrine of Equivalents: Two Case Studies
18.6 Narrowed Doctrine of Equivalents
18.7 Creating an IP Strategy
18.8 Step One: IP Review
18.9 Step Two: Documentation of IP
18.10 Step Three: IP Portfolio Strategy
18.11 Step Four: Invention Disclosure
18.12 Step Five: IP Enforcement
18.13 Step Six: Valuation and Licensing of IP
Income Valuation Approach
TRRU Valuation Approach
Grow-Fix-Sell Valuation Approach
18.14 Step Seven: Defense Against IP Infringement
18.15 The EPO Patent Wars
18.16 Further Reading
19. The Application Process for Patent Term Extensions
19.1 Market Exclusivity for Pharmaceutical Products
19.2 Patent Term Restoration
19.3 Conditions for Patent Term Extensions
19.4 Timeline & Costs of the Patent Term Extension Application Process
19.5 Recent Cases Relating to Patent Term Extension
Merck v. Kessler
Astra v. Lehman
19.6 The American Inventor's Protection Act
19.7 Limitations on Adjustments of Exclusivity Terms
19.8 Determination and Tracking of Patent Term Adjustments
20. Global Approaches to Exclusivity Rights: An E.U. Perspective
20.1 The Creation of the E.U.
20.2 "Safe Harbor"Provision
20.3 Safe Harbor Exclusion for Research Tools
20.4 Research Tools Used to Develop Regulated Products
20.5 Genes Used to Develop Regulated Products
20.6 Safe Harbor Provision Outside the U.S.
20.7 Data Exclusivity Laws in the E.U.
20.8 Disputes Over Generic Drug Regulations
20.9 Proposals to Review Drug Laws
20.10 Remaining Issues
21. Establishing Productive Partnerships with Indian Pharmaceutical Companies
21.1 Prior Experience with Pharmaceutical Alliances Between India and the West
21.2 New Strategies to Attract U.S. Partners
21.3 Additional Requirements to Establish Mutually Beneficial Partnerships
21.4 Indian Companies as API Suppliers for the U.S. Market
21.5 The Expanding Presence of Indian Companies in the U.S.
21.6 Advantages of Partnerships between Indian and U.S. Companies
21.7 Prospects for Future Partnerships
22. Patenting Adverse Drug Reactions: A New Business Strategy
22.1 Patenting Adverse Drug Reactions
22.2 ADRs to Vaccines
22.3 Overview of ADRs
22.4 A Duty to Warn
22.5 Business Patents
22.6 Patenting ADRs
22.7 Provisional Patent Rights
22.8 Business Strategy for Using ADR Patents
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