Generic Drugs and Brand Lifecycle Strategies

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 “Branded 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 

19.1 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 

20.1 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