Introduction of Intellectual Property Rights and Vaccines

Gurpreet Bawa1, *, Ashish Jain1
1 Shri D. D. Vispute College of Pharmacy and Research Center, New Panvel, Mumbai, India

Abstract

The traditional discourse on the relationship between vaccines and intellectual property (IP) has primarily centered on patent rights. However, this conclusion advocates for a broader perspective that encompasses copyright, trademarks, patents, trade secrets, and potentially even plant breeders' rights in the context of vaccines. By recognizing the applicability of multiple IP rights to various facets of vaccines, a more comprehensive and robust protection framework can be established. This expanded discussion introduces novel considerations that have not been routinely addressed in relation to vaccines and IP rights. The argument emphasizes that the discourse should transcend the confines of a single IP right when discussing vaccines. Instead, it encourages a holistic approach, considering the integration and cooperation of multiple IP rights. Such an inclusive view not only broadens the scope of protection for vaccines but also facilitates the development of a strategic framework that leverages the synergies between different IP rights. The integrated perspective allows for a more nuanced strategy, enabling the evaluation of why specific IP rights should be included and how they contribute to the overall development and distribution of vaccines. In essence, the conclusion contends that a shift in the discussion from the application of individual IP rights to a comprehensive consideration of multiple rights is imperative. This evolved viewpoint enhances the productivity and conclusiveness of the strategy, emphasizing the need for a reformed discourse on vaccines and IP rights to adapt to the evolving landscape.

Keywords: Copyright, Intellectual property, Patents, Trademark, Vaccine.

* Corresponding author Gurpreet Bawa: Shri D. D. Vispute College of Pharmacy and Research Center, New Panvel, Mumbai, India; E-mail: gurpreet_bawa@ymail.com

INTRODUCTION

Vaccines come in a range of forms and components, including specific formulations, delivery systems, components, and distribution networks, and there are a variety of intellectual property (IP) rights available. Patent rights are frequently the starting and ending point of discussions over intellectual property

rights for vaccines. However, patent rights are not the sole form of intellectual property protection accessible to vaccinations. Other rights, including copyright, trademarks, plant breeders' rights, and trade secrets, may also apply to vaccinations.

For example, there is an ongoing debate about the ethical implications of awarding patent rights to innovations and items that improve public health, such as vaccines. This argument raises questions about whether patent rights have a good or detrimental impact on vaccine innovation and public access. Further doubts are raised about whether patent rights have a negative or good impact on the development of vaccine technology for diseases that primarily affect developing countries. This chapter admits that these discussions have been ongoing for many years and continue to be so. These are essential discussions; nevertheless, it is not the purpose of this chapter to add a voice to them.

This chapter explores how intellectual property rights impact vaccine development, use, and distribution. Right now, both ethical and practical discussions about intellectual property rights and vaccinations focus on patent rights. In the toolkit of intellectual property rights, patents provide owners with a major exclusive right, which has been utilised by various organisations to penalise those who attempt to imitate patented products. Patent rights have also been used to monopolise the market and justify exorbitant licensing costs for patent-protected products. These techniques can have a significant negative impact on the development of related technologies as well as access to patents. Thus, the scope and strength of patent rights have influenced the discussion of IP rights in general, so that the entire category of IP rights is considered as capable and culpable of the same exclusionary outcomes. In truth, patent rights are only one type of intellectual property right that may be applied to a vaccine, and the high prices and access constraints that result from the exercise of patent rights are only one option for an owner to use IP rights.

It is also noteworthy that the debate over intellectual property rights for vaccines is frequently overshadowed by the debate over pharmaceutical products and IP rights, which mostly focus on medications that do not contain vaccinations. Talking about vaccines in particular is crucial because they differ significantly from other medicinal products in terms of their characteristics and effects. Certain complications can arise in the formulation of vaccines (e.g., expert input is required for some vaccines), in their distribution (e.g., cold storage transit is required for many vaccines), and in their administration (e.g., professional transmission is required for injected vaccinations). Because of these complications, debates on intellectual property rights in relation to other kinds of pharmaceutical items might not apply entirely to vaccines.

Vaccines offer huge societal benefits that other pharmaceutical treatments cannot match. According to the World Health Organisation, "much of the debate on [IP rights] and public health has focused on the possible impact that patents on final products have on the prices paid in developing countries, and thus their affordability." The nature of vaccine development and production, as well as the structure of the ultimate market, may necessitate a distinct type of argument [1]. The report goes on to cite distinctions between pharmaceuticals and vaccines, noting the following: vaccines have much smaller markets; the public sector has a greater involvement in the production, pricing, and marketing of vaccines; vaccines as biological products are more complex and costly to produce; clinical trials may also be much more expensive for vaccines; and it may be much more difficult to copy a vaccine [2]. Although these distinctions make it evident that discussions concerning the influence of patents on vaccine accessibility and affordability may differ from those surrounding pharmaceuticals, it is nevertheless true that both types of drugs play an important role in public health. It has been said that "despite the 1.5% share that vaccines have in global pharmaceutical turnover in dollars, vaccines represent much more than 1.5% of the capacity to deal with global health problems because they have positive externalities" [3].

Vaccines have provided significant societal benefits, including the elimination of diseases from entire communities [4]. This chapter will focus on the unique challenges of intellectual property (IP) rights in relation to vaccines, rather than the broader connection between IP rights and pharmaceuticals. Various types of intellectual property rights apply to vaccines, each offering distinct advantages to the proprietor.

This chapter will address the types of vaccines that seek protection, as well as the many types of intellectual property rights that are applicable to vaccinations. We will begin by looking at the features and aspects of vaccines that may be subject to various intellectual property rights, as well as the IP rights that are applicable to them. After we have established the nature of the specific IP rights that apply to vaccines, we can look at the motivations for pursuing IP rights and some of the specific elements that influence the application of IP rights to vaccines. IP rights can be used in tandem to implement an IP protection strategy for vaccines that benefits both vaccine development and public availability. There are numerous rights in the IP toolbox, and they should all be evaluated in the context of vaccine development and deployment.

Applying IP Protection to Vaccines

A prevalent misperception is that intellectual property rights apply to vaccinations in a 1:1 ratio manner. For example, such a viewpoint assumes that if patent rights apply to vaccinations, the discussion about IP rights pertaining to vaccines will end. However, because vaccination may contain several elements and characteristics, each may be protected by a different intellectual property claim.

Vaccines, for instance, may consist of components such as a formulation, a means of administering the vaccination to a subject, a brand name that helps the public recognise the vaccine, etc. A review of the IP toolbox's tools reveals that: (1) the combination of medicinal ingredients that make up the formulation may be protected by patent rights; (2) the device, which could be a capsule designed to release the vaccine in a specific area of the body or some other type of vaccine delivery system, may also be protected by patent rights; and (3) the vaccine's brand name may be protected by trademark.

Furthermore, additional intellectual property rights may be used to safeguard the vaccine's components and features, depending on its...