Patent Strategies - Effective Strategies for Extension of Product Lifecycles and Combating Aggressive Generics Markets


#3174

71pages

GBI Research

$ 3500

In Stock


GBI Research’s new report, “Patent Strategies - Effective Strategies for Extension of Product Lifecycles and Combating Aggressive Generics Markets”, provides in-depth analysis of various patent protection strategies adopted by pharmaceutical companies for maximizing revenues returns from the branded drugs. 

The report analyzes the effective patent strategies and provides you a multi-strategy approach to defend your products from generics. It gives you a robust idea on successful patent portfolio management. Furthermore, the report analyzes the patent strategies that shape the global markets. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts. 

Scope

The scope of this report includes:

  • Understanding of the R&D process and the necessity of patent protection.
  • An overview of current patent protection mechanisms employed by pharmaceutical companies.
  • Detailed study of pre-patent protection strategies with special emphasis on strategies which help combating generic competition.
  • Post-patent expiry strategies like authorized generics and orange book delisting with case studies.
  • Inputs for customized patent strategy based on business situation.
  • Case studies of successful patent strategies.

Reasons to buy

The report will enhance your decision making capability. It will provide you with:

  • Build understanding of the key Patent strategies in place and the trends in the market
  • Optimize your R&D pipeline through identification and understanding of the key strategy for your drug.
  • Identify the key players best positioned to capitalize on their products through effective management of the lifecycle of their patented products.
  • Develop effective business strategies related to Patents through the analytical insight gained from case studies covering different strategies in the market.
  • Understand the fit between the patent strategy and your product considering various factors pertaining to the market, product and therapeutic area.
  • Ensure success in patent portfolio management through the analysis of key success and failure factors and the use of the framework for measuring performance.
Table of Contents

1 Table of Contents 3

1.1 List of Tables 5
1.2 List of Figures 6

2 Patent Strategies Introduction 7
2.1 GBI Research Report Guidance 7

3 Patent Strategies Need for Robust Patent Portfolio 8
3.1 Introduction 8
3.1.1 The Long and Uncertain R&D Process Cost of Drug Development and Pipeline Risks 9
3.1.2 The Drug Lifecycle 9
3.2 Need to Optimize Returns from Successful Drugs 10
3.2.1 Peak Years of Patent Expiries 10
3.2.2 Declined Patent Applications by Top Pharmaceutical Companies 11
3.2.3 Declining Returns on R&D Investment 13
3.2.4 Patent Expiration of Blockbuster Drugs 14
3.2.5 Massive Decline in Sales Dependence on Blockbuster Drugs 16
3.2.6 Penetration of Aggressive Generic Companies 17
3.2.7 Drought in the R&D Pipeline Products (Low R&D Productivity) 19
3.2.8 Stricter FDA Rules and Regulations for Drug Approval 21
3.2.9 Restriction on Pricing and Reimbursement of Originals 22
3.2.10 Conclusion 22

4 Patent Strategies Overview of Patent Protection Methodology 23
4.1 Introduction 23
4.2 What is a Patent? 23
4.2.1 Effective Patent Life 23
4.2.2 Data Exclusivity Period 23
4.2.3 When Does a Patent Expire? Which Patent? 24
4.2.4 Patent Families Extension of Patent Expiry 24
4.3 Patent Term Extensions 25
4.3.1 Supplementary Protection Certificates 25
4.3.2 Pediatric Exclusivity 27
4.4 Orphan Drug Legislation 28
4.4.1 Special Cases of Orphan Drug Exclusivity 29
4.5 Hatch-Waxman Amendments and Abbreviated New Drug Applications (ANDA) 30
4.5.1 First on the Market ANDAs 30
4.5.2 Paragraph IV Challenges 31
4.5.3 Generic Companies are not actually in Favor of Low Prices 180-Day Marketing Exclusivity 32
4.6 FDA Citizen Petitions 32

5 Patent Strategies Pre-Patent Expiry Strategies 33
5.1 Introduction 33
5.2 Strategic Patenting/Patent Layering 33
5.2.1 Many Secondary Patents Provide No Legal Protection 33
5.3 Formulation Patents 34
5.3.1 Introducing Formulation Variants (Tablets, IVs, Syrups) 34
5.4 Improved Formulations 39
5.4.1 Extended/Controlled Release Versions 39
5.5 New Indications 44
5.5.1 Introduction 44
5.6 Probability of Generics Entry for a Drug 50
5.6.1 Introduction 50
5.7 Planning Rx-to-OTC Switch 50
5.7.1 Introduction 50
5.8 Store-Brand Generic 57
5.8.1 Introduction 57
5.9 Strategies That Failed 59
5.9.1 Introduction 59
5.10 Key Lessons 63
5.10.1 New Formulations, New Indications and Extended/Controlled Releases 63
5.10.2 Planned Rx-to-OTC Switch 63
5.10.3 Store-Brand Generic 63
5.10.4 Failed Strategies 64

6 Patent Strategies Post Patent Expiry Strategies 65

6.1 Introduction 65
6.2 Authorized Generics 65
6.2.1 Case Study: GSKs Paxil 65
6.2.2 Future of Authorized generics 65
6.3 Orange Book Listings and Delisting: New Controversies 66
6.3.1 Case Study: Mercks Zocor 66
6.3.2 The Future of Delisting Strategy 66
6.4 Conclusion 67

7 Patent Strategies Appendix 68
7.1 Market Definitions 68
7.2 Abbreviations 68
7.3 Research Methodology 69
7.3.1 Coverage 69
7.3.2 Secondary Research 69
7.3.3 Primary Research 69
7.3.4 Expert Panel Validation 70
7.4 Contact Us 70
7.5 Disclaimer 70
7.6 Sources 71
Table 1: Value of Drugs to go Off-Patent by Therapeutic Area, $m, 20102014 15
Table 2: Aricept Worldwide Sales,
Figure 1: Drug Discovery Process 8
Figure 2: Drug Discovery Research in R&D Value Chain 9
Figure 3: Revenues of Top 10 Drugs that Expire During 2010-2014 10
Figure 4: Decline in Patent Applications by Top 10 Pharmaceutical Patent Applicants at US Patent Office, 19952008 11
Figure 5: Company Patent Application Statuses During 1995-2008 12
Figure 6: Pharmaceutical and Biotech R&D Expenditure ($bn) vs. Number of NME/BLA Approvals, the US, 19952009 13
Figure 7: Total Value of the Drugs by Therapeutic Segment to Lose Patent Protection by 2014, $bn 14
Figure 8: Value of Drugs to go Off-Patent by Therapeutic Area, $m, 20102014 15
Figure 9: Top 20 Patent Expirations During 2010-2014, Based on US Sales in Dollars 16
Figure 10: Original Abbreviated New Drug Application (ANDA) Approvals from 2001 to 2009 17
Figure 11:Proportion of Life Cycle Management (LCM) Projects in the Late-Stage Development Pipeline by Therapeutic Area, 2010 19
Figure 12:Comparison of CAGR of R&D Expenditure vs. Turnover Over the Last Five Years for the Top Five Companies, 20032008 20
Figure 13: Decline in NME Approvals by the FDA, 19962008 21
Figure 14:Drug Lifecycle in Correlation with Patent Duration, Data Exclusivity and Market Exclusivity 24
Figure 15: Categorization of Key Patents to identify Generic Competition 25
Figure 16: Criteria for Obtaining Supplementary Protection Certificate (SPC) 26
Figure 17: Protection Conferred with Pediatric Exclusivity 27
Figure 18: FDA and EMA Benefits for Orphan Drugs 29
Figure 19: Hatch-Waxman Act Benefits for Branded and Generic Companies 30
Figure 20: ANDA Patent Certification Types and FDA Approval Processes 31
Figure 21: How Many Aspects can a Pharmaceutical Patent Encompass? 33
Figure 22: Aricept Worldwide Sales,