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From the Bench to the Pharmacy: Protecting Innovation During Vaccine Development and Commercialization
Adam C Krol1, Muna Abu-Shaar2, Paul Brady3
1Biospark Intellectual Property Law, Cambridge, MA, USA.
Abstract:
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 description, enablement, novelty, and nonobviousness, by following a hypothetical vaccine development timeline that begins with the discovery of a previously unknown virus and ends with the commercial launch of a vaccine against the virus. Regulatory exclusivity, freedom to operate, and lifecycle management considerations are also discussed.
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