Patent Protection Strategies: Maximising product Revenues : Market Research Report

Patent Protection Strategies: Maximising product Revenues

Published: Aug. 1, 2007 - 151 Pages

PATENT PROTECTION STRATEGIES
Executive Summary: The need for patent protection; Current patent protection mechanisms; Offensive strategies; Case Histories; Optimizing Revenue Returns; Future outlook
Chapter 1 The need for patent protection: Summary; Introduction; The costs of drug development; The drug lifecycle; The need to optimize returns from successful drugs; The dependence on blockbuster revenues; The impact of generics; Aggressive generic companies
Chapter 2 Current patent protection: mechanisms; Summary; Introduction; Patent basics; Requirements for a therapeutic patent; Four types of pharmaceutical patent; Legal patent frameworks; United States; Europe/PCT; Japan; Other markets; Patent term extensions; US patent term extensions; Supplementary Protection Certificates; Japanese Patent term extensions; Pediatric exclusivity; Orphan Drug legislation; Regulations for market entry of generics; United States; Europe; Japan; Biological Products and Biosimilars; United States; Europe; Freedom to operate
Chapter 3 Offensive strategies: Summary; Introduction; Filing strategies; Early or late filing?; Overlapping claims; Broad claims or narrow claims?; Exploitation of term extension legislation; Product patents; Subsidiary patents; Crystalline form patents; Salt and solvate patents; Enantiomer patents; Prodrug and antedrug patents; Process patents; Formulation patents; Improved formulations; Drug Combinations; New delivery routes; Method of Use patents
Chapter 4 Defensive strategies: Summary; Introduction; Patent infringement suits; Mechanism; Authorized generics; OTC switches; Orange Book delisting; Research Disclosures
Chapter 5 Case Histories: Summary; Introduction; Prozac; Losec and Nexium; Epogen v Dynepo; Plavix
Chapter 6 Optimizing Revenue Returns: Summary; Introduction; Lifecycle initiatives; Franchise development
Chapter 7 Future outlook: Summary; Introduction; Changes in drug development; Impact of technology; Tougher project goals; Legislative issues; KSR International Co. v. Teleflex Inc (US Supreme Court); Biologicals
Appendix: Glossary; References; Index
List of Figures: Figure 1.1: Novel Therapeutic Entities Approved by the FDA, 2000-2006; Figure 1.2: Schematic drug revenue life cycle; Figure 1.3: Dependence of major companies' 2006 revenues on blockbuster products; Figure 1.4: US Sales of Prozac and generic fluoxetine, 2000 - 2006; Figure 1.5: Quarterly US sales of Zocor 2005-2006; Figure 1.6: Quarterly US sales of Plavix 2005-2007; Figure 1.7: US sales of OTC and Prescription Claritin, 2000-2006; Figure 2.8: Variation in number of SPCs granted in EU countries, 2003; Figure 2.9: Variation in number of SPCs granted in EU countries, 2003; Figure 3.10: Impact of offensive strategies on drug revenue life cycle; Figure 3.11: Primary claims of two key patents relating to paroxetine; Figure 4.12: Impact of defensive strategies on drug revenue life cycle; Figure 4.13: Timeline for Paragraph IV ANDA filing; Figure 4.14: US sales of Paxil, an authorized generic and a competing generic August 2003- June 2004; Figure 4.15: US Sales revenues of Schering-Plough's major anti-histamines 2000-2006; Figure 5.16: Revenues from AstraZeneca's antiulcer franchise 1999-2006; Figure 6.17: US Sales of Wellbutrin and generic bupropion 1999-2006; Figure 6.18: Global sales of Adalat formulations 1975-2000
List of Tables: Table 1.1: Drugs generating 2006 revenues in excess of $3 billion; Table 2.2: Possible term extensions in major markets; Table 2.3: Selected high revenue generating Orphan drugs; Table 2.4: Orphan drug legislation in the major markets

Abstract

Business Intelligence for the Pharmaceutical Industry

Business Insights' portfolio of healthcare management reports are designed to help you make well informed and timely business decisions. We understand the problems facing today's pharmaceutical and healthcare executives when trying to drive your business forward, and appreciate the importance of accurate, up-to-date, incisive product, market and company analysis. We help you to crystallize your business decisions. The strength of our healthcare research and analysis is derived from access to unparalleled databases and libraries of information and the use of proprietary analytic techniques. Business Insights reports are authored by independent experts and contain findings garnered from dedicated primary research. Our authors' leading positions secure them access to interview key executives and to establish which issues will be of greatest strategic significance for the industry. Our healthcare portfolio of reports can be used across a wide range of business functions to assess market conditions and devise future strategy. Our reports cover key areas including strategy, industry analysis, market outlook, new business opportunities and strategic insight.

Some key findings from this report...

ANDA reviews are most effectively delayed by pursuing litigation for patent infringement.
A recently established US Supreme Court ruling will extensively influence future patenting strategies, having been formed in the April 2007 US Supreme Court ruling on patentability involving KSR International Co -v- Teleflex Inc.
Contingency plans can effectively counter failed or defective patent strategies, as shown in the Claritin and Prozac case studies.
Successful patent protection strategies can vastly enhance the sustainability of product franchise revenues, significantly exceeding the lifetimes of basic patents. Prominent examples include AstraZeneca’s Losec and Nexium, and Amgen’s epoetin alfa.
Holistic investigation of a firm’s ‘Freedom to Operate’ is necessary prior to resource commital in product development or commercialization.

Patent Protection Strategies

As new drug developments continue to necessitate increasingly high investments, successfully protecting revenue sustainability from the threat of low cost substitutes is reliant upon fully harnessing the efficacies of the patent system. In a market environment where competition from generics companies is becoming increasingly aggressive and the patenting of therapeutics is continually subject to impending legislative change, understanding how to effectively reassess, develop and exploit patent protection strategies is essential in facilitating enhanced market exclusivity and revenue returns over the lifecycles of new drugs. Patent Protection Strategies: Maximising product revenues is a new report published by Business Insights, examining the need for optimising and sustaining the patent protection of novel products. The report explores the best methods of exploiting legislation to maximise revenue generation and protecting the considerable investments associated with innovations. It will also examine the both the offensive and defensive tactics that can develop product lifecycle strategies, through the refinery of organisational patent protection in tandem to encumbering the market entry of generic substitutes. Use this report to understand how to successfully develop and apply patent protection strategies, exploit legislation effectively and secure the lifecyles of your innovations to maximise revenue returns...

Top five reasons to order your copy today

Strengthen product protection by tailoring patent options to the individual specifications of your products more effectively.
Create a multi-strategy approach to defend your products and their revenues, as detailed within this report.
Enhance the efficacy of your patenting policy and opportunity management with explicit insights into the impending legislative
Integrate your patent protection and product lifecycle strategies with greater fluency, and reap the long term revenue benefits that improved synchronicity will afford.
Improve your current patenting practises by benchmarking case histories, and augment your organisation’s approach to achieve effective and successful strategy application.

Key issues examined in this report...

Recouping drug development costs. The acute importance of sustainable market exclusivity for new drugs, through the use of patents and other legislative methods, in relation to recovering development costs and optimising revenue returns.
US Supreme Court ruling. The scope of product patentability and patent protection strategies in general are widely expected to experience drastic changes as a result of the April 2007 ruling.
Growing market prevalence of authorised generics. An industrywide debate has been evoked over the increasing use of authorized generics, based upon concerns over validity and consumer benefit.
Biosimilar legislation. In June 2007, American Congress established a legal framework concerning the market admission of biosimilar products.
Implications of declining NCE’s. Diminishing NCE’s highlight the importance of maximising patent protection for new drug entrants.

Your questions answered...

How can the nominal 20 year period of patent protection be most effectively extended?
What frameworks can be applied to formulate a holistic market strategy incorporating patent and product lifecycle considerations?
How can the market entry of generic substitutes be delayed?
Do significant differences exist between the patenting methods practised across the major markets?
How may legislative changes impact upon future patent strategies and what areas of new legislisation are currently under discussion?
What are the most effective patenting techniques and how can they be applied to maximise the sustainability of product revenues?

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Patent Protection Strategies: Maximising product Revenues

Table of Contents

Abstract