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Intellectual property strategies for pharmaceutical development

 

This report provides an introduction to the intellectual property strategies involved in the development of pharmaceuticals from the discovery of an NCE, through to its launch, with details and advice on the appropriate decisions and actions. The report also deals with the different types of inventions that may occur.

According to Tufts University in 2003, a new chemical entity (NCE) costs on average US$897 million to develop, including cost of post-approval research (rising from US$803 M in 2001). An NCE can often be copied very easily once it is on the market.

Lesser, but still considerable costs apply to the development of new forms of an NCE, and to new formulations and uses of existing NCEs. To justify such investments the research-based industry, including those who develop new formulations and uses, needs exclusive rights for a reasonable period. This exclusivity allows the investors to recoup their costs, and, if they are lucky, the costs of their failed developments. If they are very lucky and skillful they may make a considerable amount of money.

Without the protection provided by various forms of intellectual property, mainly patents and regulatory exclusivities, investments in this highly risky business would be unlikely.

• Patent attorneys who are in either industrial or private practice and who deal with pharmaceutical inventions
• Research workers and managers in the pharmaceutical industry
• Business executives and lawyers who will be dealing with the licensing of pharmaceutical inventions
• Individuals and companies involved in the development of straight generic products, and those developing innovative products based on existing compounds (so called 'branded generics' or 'super generics') who are trying to find ways through the protections put up by the research based industry
• Pharmaceutical and biotechnology investors
• Researchers, business development managers and technology transfer officers in universities and institutions
• Similar people in the agrochemical industry will find much of relevance to their business in the report (though the report does not deal directly with agrochemical inventions)

 

Table of Contents

1. Introduction

2. Types of IP in pharmaceutical development

2.1. Copyright

2.2. Designs

2.3. Trade Marks

2.4. Patents

2.4.1. New

2.4.1.1. Searching for prior art

2.4.1.2. Searching and watching for 'freedom to use'

2.4.2. Technically useful

2.4.3. Unobvious

3. To get a patent

3.1. Filing the initial application

3.2. The Patent Office search

3.3. The complete specification

3.3.1. The decision whether to go to a complete specification

3.3.2. How to file the complete specification

3.4. Where is protection required?

3.4.1. The national/regional phase

3.4.2. Whether to oppose or not?

3.4.3. The national phase in the EPO

3.5. Litigation 3.6. Strategies for NCEs

3.6.1. The chemistry

3.6.1.1. Identification of NCEs

3.6.1.2. When and what to file

3.6.1.3. Who controls the R&D process

3.6.1.4. The scope and content of the application

3.6.1.4.1. Divisional applications

3.6.1.4.2. Defensive NCE patents

3.6.2. The other parts of an NCE patent application

3.6.2.1. Description

3.6.2.2. Formulation

3.7. Subsequent inventions

3.7.1. New forms of the known compound

3.7.2. New chemical processes for making the known compound

3.7.3. New formulations

3.7.4. New medical uses

3.7.5. Active precursors and/or metabolites of the compounds

3.7.6. New dosages

3.7.7. Mixtures

3.7.8. Devices

4. General Strategy

4.1. Lots of patents

4.2. Close contact between patent advisors and R&D

4.3. The brainstorm

4.4. The costs

4.5. Know-how and regulatory exclusivities

4.6. Orphan Drug Status

4.7. Patents and Regulatory Authorities

5. Conclusion

6. Appendices

6.1. Glossary

6.2. Resources

 

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