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.
Authors: Adam C. Krol, Muna Abu-Shaar, Paul Brady.
Methods Mol Biol. 2016; 1404: 813-34. Doi: 10.1007/978-1-3389-1_53.