Generics Defense Strategies: Effective brand protection through patent, formulation, OTC and DTC strategies

Table of Contents

Generics Defense Strategies

Executive summary 10

Pressure on the pharmaceutical industry 10

The generics threat 11

General generics defense strategies 12

Legal and patent strategies 14

Formulation strategies 15

DTC and OTC strategies 16

Conclusions 17

Chapter 1 Pressure on the pharmaceutical

industry 22

Summary 22

Introduction 23

Falling R&D productivity 24

Delays getting product to market 26

Parallel imports � the generics dimension 29

Price controls and moves to promote generics 31

How Big Pharma views generics 34

Major future patent expiries � brands at risk 36

Chapter 2 The generics threat 38

Summary 38

The generics threat � the leading players 39

Generic penetration rates - US and Europe 43

Recent generics market trends 44

US 44

Europe 46

Legislative changes and their impact 47

The generics growth model 48

The generics pre-development process 51

Chapter 3 General generics defense

strategies 54

Summary 54

Integrated product defense planning 55

Increase R&D innovation through co-operation 57

Alliances with generics companies 59

R&D alliances 60

Generics alliances 61

Moving into generics 63

Develop biotech products 66

Profile: Pfizer - Norvasc 69

Chapter 4 Legal and patent strategies 72

Summary 72

Relevance of patents 73

Differences between the US and Europe 74

Patent clusters 75

Aggressive patent defense 79

US strategies 80

Patent defense 80

Success rates of patent defense 82

Pfizer � aggressive patent defense 83

Recent patent challenges 84

New indications 85

Pediatric indications 86

European strategies 88

The impact of new EU �Bolar� clause 88

Obtain an SPC 90

New indications 94

New dosage form 95

Extend data exclusivity 96

Product withdrawal 98

Chapter 5 Formulation strategies 100

Summary 100

Introduction 101

The benefits of reformulation 103

Types of reformulation 104

Modified release 104

New dosage forms / delivery systems 105

Combination products 109

Launch timing and patient switching 112

Key features of successful reformulations 114

Timing 114

Competitive differentiation and promotional support 116

Chapter 6 DTC and OTC strategies 120

Summary 120

DTC strategies 121

DTC promotion as part of the strategic objectives of brand defense 123

DTC promotion as a driver of brand loyalty and compliance 124

OTC switching 126

Europe 130

US 132

Chapter 7 Conclusions 136

Summary 136

The need for comprehensive defense strategies 137

Levels of preparedness 140

Key defensive strategies 141

What strategies do branded pharmaceutical companies tend to use? 141

What are the most effective defensive tactics? 142

Changing legal and regulatory environment 144

Index 146

List of Figures

Figure 1.1: Map of integrated planning in generics defense 13

Figure 1.2: Outcomes of US litigation against the first generic applicant 14

Figure 1.3: Levels of preparedness for generics defense 18

Figure 1.4: Number of NCEs launched by year 24

Figure 1.5: Pricing and reimbursement delays 26

Figure 1.6: Comparison of pricing vs delays, by country 27

Figure 1.7: Parallel imports in Europe, 2002 30

Figure 1.8: Forecasts of generics market growth, 2004 34

Figure 2.9: Growth in R&D expenditures of leading generics players, 2003-03 42

Figure 2.10: Generic penetration, 2003 43

Figure 2.11: Importance of growth strategies to generics companies in the next five years 49

Figure 2.12: The generics pre-development process 51

Figure 3.13: Map of integrated planning in generics defense 56

Figure 3.14: No economies of scale in pharmaceutical R&D 57

Figure 3.15: Breakdown of projects by clinical phase and source of drug 58

Figure 4.16: Patent defense in the US: outcomes of litigation against the first generic applicant 82

Figure 4.17: Proposed pediatric studies and written requests by type 87

Figure 4.18: Differences between US and Europe (as at start of 2004) 89

Figure 4.19: SPC applications by company 93

Figure 4.20: SPC applications by country 94

Figure 7.21: Generics growth by country, 2002-2003 137

Figure 7.22: Survey respondents, by company type 138

Figure 7.23: Brands at risk in the next five years 139

Figure 7.24: Levels of preparedness for generics defense 140

Figure 7.25: Defense strategies used by companies 141

Figure 7.26: The most effect deterrent strategies 142

List of Tables

Table 1.1: Leading generics players, 2003/4 11

Table 1.2: Price regulation schemes across Europe 31

Table 1.3: Best selling pharmaceuticals (2003) and their patent expiry dates 36

Table 2.4: Leading generics players, 2003/4 39

Table 2.5: Legislative changes and their impact 47

Table 3.6: Generics/branded pharmaceutical company co-operation 59

Table 3.7: Some branded pharmaceutical divestments of generics subsidiaries 64

Table 3.8: Benefits of acquisition vs organic growth of generics companies 65

Table 3.9: Generics company ownership in the Netherlands 65

Table 4.10: Extent of patent clusters for selected blockbuster drugs 77

Table 4.11: New indications bringing extended market exclusivity 85

Table 4.12: EU data exclusivity times following accession of new EU members 97

Table 5.13: Change in total US sales across six franchises following generic incursion 104

Table 5.14: Launches of reformulations and generic variants of originals 113

Table 6.15: Leading US brands using DTC promotion, 2003 122

Table 6.16: The prescription status of codeine, by country 127

Table 6.17: OTC markets in UK, US and France, 2001-2003 127