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 description, enablement, novelty, and nonobvi...

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Bibliographic Details
Published inMethods in molecular biology (Clifton, N.J.) Vol. 1404; p. 813
Main Authors Krol, Adam C, Abu-Shaar, Muna, Brady, Paul
Format Journal Article
LanguageEnglish
Published United States 01.01.2016
Subjects
Certification
Drug Discovery - economics
Drug Discovery - legislation & jurisprudence
Inventions - economics
Inventions - legislation & jurisprudence
Patents as Topic
Pharmacy
Social Control, Formal
Technology Transfer
Vaccines
Enablement
Written description
Obviousness
Regulatory exclusivity
Freedom to operate
Patent eligible subject matter
Supplementary protection certificate
Novelty
Patent term extension
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Summary: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.
ISSN:1940-6029
DOI:10.1007/978-1-4939-3389-1_53