title: From the Bench to the Pharmacy: Protecting Innovation During Vaccine Development and Commercialization.
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.
authors.affiliation: Biospark Intellectual Property Law, Cambridge, MA, USA.
authors.forename: Adam C
authors.initials: AC
authors.lastname: Krol
authors.affiliation: Biospark Intellectual Property Law, Cambridge, MA, USA. muna@biospark-ip.com.
authors.forename: Muna
authors.initials: M
authors.lastname: Abu-Shaar
authors.affiliation: Abel & Imray, London, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Brady
mesh_terms: D002568:Certification; D055808:Drug Discovery / Q000191:economics / Q000331:legislation & jurisprudence*; D062069:Inventions / Q000191:economics / Q000331:legislation & jurisprudence*; D010330:Patents as Topic; D010604:Pharmacy; D012926:Social Control, Formal; D018581:Technology Transfer; D014612:Vaccines
chemical_list: D014612:Vaccines
keywords: Enablement; Freedom to operate; Novelty; Obviousness; Patent eligible subject matter; Patent term extension; Regulatory exclusivity; Supplementary protection certificate; Written description