From the Bench to the Pharmacy: Protecting Innovation During Vaccine Development and Commercialization
Patentable inventions may be made during the development of a vaccine, and patents on such inventions can help to protect the vaccine from competition. This chapter introduces several patent law concepts, including patent eligible subject matter, written
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Introduction A patent provides the patent owner with the right to exclude others from making, using, or selling the patented invention [1]. Vaccine development presents many patenting opportunities and challenges. The costs of researching and developing a new vaccine before it can be authorized for marketing are huge. Estimates for the cost of getting a medicine from the bench to the marketplace range from $1.5 billion to in excess of $1.8 billion [2, 3]. Although the cost of manufacturing a vaccine may be small, the profit margin on the sales price needs to be high in order to enable the massive cost of research and development to be recouped. Patents and other intellectual property rights are key to establishing market exclusivity and thus maintaining the necessary profit margin. To illustrate how patents can be used to protect inventions made throughout the vaccine development process and to provide an introduction to issues that might be encountered in the patenting process, this chapter follows a hypothetical vaccine development timeline (summarized in Appendix) for a newly discovered infectious virus from a United States (US) patent law perspective. The hypothetical timeline may appear oversimplified, and the time between events may not accurately reflect the speed of real-world vaccine development. However, the purpose of the timeline is to introduce several important patent law concepts that the reader may encounter in the real world. Key differences between the US and two other major patent jurisdictions, Europe and Japan, are noted where applicable.
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_53, © Springer Science+Business Media New York 2016
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2 Discovery of New Virus and Processes for Its Propagation, Inactivation, and Attenuation The timeline begins on January 1, 2016 with the discovery of the previously unknown Zoobug virus by scientists at Vacsotech Inc. In the 3 months following the discovery and isolation of Zoobug, the scientists at Vacsotech discover how to inactivate the virus using heat and radiation and discover how to propagate the virus in a human mesenchymal cell line, Zalex89. The scientists generate an attenuated strain of Zoobug (strain S1) by propagating Zoobug in mouse epithelial cell line MOG732. Vacsotech deposits the Zoobug-infected Zalex89 cell line with the American Type Culture Collection under the provisions of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (known as the “Budapest Treaty” for short). Following its discoveries and the deposit, Vacsotech files a patent application (Patent Application No. 1) in the US Patent and Trademark Office (USPTO) and the European Patent Office (EPO). The EPO grants European patents for nation states that are parties to the European Patent Convention [4]. Following the grant, a European patent may be vali
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