Commercial Insight: Cytotoxic Therapies - Drug launches in rare indications to offset the decline in cytotoxic sales
- Published: July 2010
Patent Strategies - Effective Strategies for Extension of Product Lifecycles and Combating Aggressive Generics Markets
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.
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. SHOW LESS READ MORE >
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: GSK’s 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: Merck’s 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
“Patent Strategies - Effective Strategies for Extension of Product Lifecycles and Combating Aggressive Generics Markets” provides key data, information and analysis on the main patent protection strategies being implemented by pharmaceutical companies. The report provides information on the pre-patent expiry and post-patent expiry strategies, the reasons why companies implement patent strategies and the challenges faced by them. This report provides comprehensive analysis of five key patent strategies (new indications, formulation variants, extended/controlled released versions, Rx-to-OTC switches, and store brand generics) using case studies. It also reviews the factors determining the success and failure of the strategies, providing an understanding of how to ensure success for maintaining effective patent portfolios.
It is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by a team of industry experts.
Need for Robust Patent Portfolio in the Midst of Blockbuster Drugs Expiry
The pharmaceutical industry is going to experience major patent expiries during 2010-2014, of which 2010 to 2012 are expected to be peak years, with the loss of patents for drugs whose sales were more than $60 billion during 2009.
In 2010, major drugs like Lipitor, Cozaar, Advair, Arimidex, Flomax and Gemzar, with combined sales revenues of more than $24 billion, are expected to face generic competition. In 2011, nine drugs of six companies are going to experience a major impact of patent expirations. The drugs include Femara, Xalaton, Seroquel, Zyprexa, Almita, Aprovel, Plavix, Singulair and Zoladex, which together account for more than $20 billion sales revenue all over the world.
In contrast to 2011, 2012 is going to have less patent expirations, but the impact on sales is going to be greater than that of 2011; more than $15 billion for three drug expiries. Novartis’ blockbuster drug Diovan, with sales revenue above $6 billion; Bristol-Myers Squibb’s Avapro, with sales revenue above $6 billion; and Sanofi-Aventis’ Lovenox, with sales revenue of $3 billion, are expected to expire in 2012. Eli Lilly’s Cymbalta is the only major drug to face generic competition in 2013, with sales revenue of $3 billion all over the world. In 2014, Roche’s blockbuster drug Rituxan is going off-patent, creating impact on $6 billion of sales revenues. The full impact of patients shifting to lower-cost generic alternatives for all these products, as well as other brands in their therapy classes, will mostly be felt in 2012 and 2013, due to the timing and expected competitive intensity among generic entrants.