Vaccines and IP Rights: A Multifaceted Relationship

Just as there are many forms of vaccines and components to vaccines—particular compositions, delivery systems, components, and distribution networks—there are a variety of intellectual property (IP) protections applicable for vaccines. IP rights such as p

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Introduction Just as there are many forms of vaccines and components to vaccines—particular compositions, delivery systems, components, and distribution networks—there are a variety of intellectual property (IP) protections applicable for vaccines. Often a discussion of IP rights for vaccines begins and ends with patent rights. However, patent rights are not the only IP protection applicable to vaccines. Other rights such as copyright, trademarks, plant breeders’ rights, and trade secrets may also be applicable to vaccines. For example, there is an ongoing debate regarding the ethical implications of granting patent rights for technologies and products that offer public health benefits, such as vaccines. In this debate questions are raised regarding whether patent rights have a positive or negative effect for vaccine innovation and public availability. Further questions probe whether patent rights have negative or positive effects for the development of vaccine technologies for diseases that affect the developing world in particular. This chapter acknowledges that these debates have been ongoing for years and continue to date. These are important conversations; however, it is not the aim of this chapter to add a voice to these dialogues. This chapter will consider the types of IP rights that can play a role in the development, use, and distribution of vaccines. Right now both the ethical and practical conversations regarding IP rights and vaccines tend to concentrate on patent rights. In the toolbox of IP rights, patents grant owners a significant exclusive right that has been used by many organizations to penalize parties who attempt to copy the patented inventions. Patent rights have also been used to monopolize the market and to justify charging high fees for patent-protected products. These tactics can have

Sunil Thomas (ed.), Vaccine Design: Methods and Protocols, Volume 2: Vaccines for Veterinary Diseases, Methods in Molecular Biology, vol. 1404, DOI 10.1007/978-1-4939-3389-1_52, © Springer Science+Business Media New York 2016

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Karen Durell

substantial negative effects for development of related technologies and access to the patented inventions. Thus, the scope and strength of patent rights have colored the discussion of IP rights generally, so that the entire category of IP rights is viewed as being capable and culpable of the same exclusionary results. In fact, patent rights are but one IP right that can be applied to a vaccine, and the high fees and limitations on access that occur due to the wielding patent rights is but one choice for the usage of IP rights by an owner. It is further notable that the discussion surrounding IP protections for vaccines is often lost amidst the discussion of pharmaceutical products and IP rights, which generally concentrates on medicines that do not include vaccines. It is important to engage in a discussion directed to vaccines specifically, as vaccines have properties and outcomes that cause them to differ in important ways from other pharmaceutical produ