Intellectual Property in Vaccine Innovation: Impact of Recent Patent Developments
This chapter examines the issues on patentability of microorganisms and human genes under the US laws and analyzes their influence on vaccine innovation. The analysis will focus on three aspects, namely, the naturally existing state, unmodified isolated f
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Introduction In 2015, three significant events on vaccine and patent law were commemorated. On the scientific front, it marked the 35th year of the declaration of a world freed from smallpox and the simultaneous cessation of its worldwide vaccination program [1]. Few may recall this devastating epidemic disease that spreads through many countries for centuries. Even fewer will recollect that it was Edward Jenner’s innovative contribution to immunization and the smallpox vaccine that made it possible to eradicate this dreaded disease. It is indisputably one of the greatest achievements of modern medicine. With respect to patent jurisprudence, two significant events are remembered: First, it coincidentally was also the 35th anniversary of the landmark decision of the United States (US) Supreme Court in Diamond v Chakrabarty (Chakrabarty) which held that human-made living matter was patent eligible subject matter. Not surprisingly, that decision galvanized a dynamic biotechnology industry into an era whereby “anything under the sun that is made by man” was regarded as being patentable. Second, it was only 2 years ago when another groundbreaking decision in Association for Molecular Pathology v Myriad Genetics (Myriad) [2] where the US Supreme Court, with an unusual unanimity, ruled that isolated genomic DNA, being “products of nature,” are not patent eligible unlike man-made complementary DNA (cDNA). This approach dramatically scaled back the concept of patentable subject matter and overturned several decades of the US Patent and Trademark Office (USPTO) practice in the granting of gene patents. The decision represents a departure from the international practice at that time.
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_54, © Springer Science+Business Media New York 2016
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Elizabeth Siew-Kuan Ng
As we celebrate the 220th anniversary of Edward Jenner’s outstanding contribution, it may be an opportune time to review the impact of intellectual property (IP) law on the development of vaccines. Although there are several aspects of IP rights that govern the protection of innovation in vaccines, this chapter will focus on the patent jurisprudence [3–5]. This chapter begins with a brief explanation of the role of patent law in biotechnology. It is then followed by an examination of the relevant US laws with respect to patent eligibility of microorganisms and human genes. The impact of these rules on vaccine innovation will be highlighted for further discussion. The analysis will address the patent eligibility of living organisms in three common categories that (a) exist naturally in nature, (b) have been isolated (i.e., merely extracted) from their natural environments in unmodified forms, and (c) have been modified/genetically engineered by man. The outcome of the analysis suggests that the patentability of those in categories 1 and 2 to the exclusion of category 3 will have a notab
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