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.

Development and Validation of Two Optimized Multiplexed Serologic Assays for the 9-Valent Human Papillomavirus Vaccine Types

“…Including assay modernization as a key part of vaccine life cycle management has intrinsic benefits, including increased method robustness, cost reduction, and decreased risk of assay failure ( 24 ). Vaccine assays, such as the HPV-9 cLIA assay, are a key part of vaccine development and life cycle management, and they may help to extend the overall vaccine life cycle by bridging clinical findings across trials, thereby lengthening the time on patent ( 15 , 20 – 23 , 25 ). Because vaccine assays may be used for many years beyond the initial clinical studies for which they were developed, assay modernization is important to ensure that they continue to be fit for purpose throughout the vaccine life cycle.…”

10. Public-private partnership enabled use of anti-tick vaccine for integrated cattle fever tick eradication in the USA

“…National agencies ensure that veterinary vaccines meet purity, safety, and efficacy regulations required for market authorization (Banks 2014;Henderson and Lewis 2014). Because economic context drives corporate investment in their commercialization (BBSRC 2015; Benfield 2016), the protection of intellectual property for vaccine-based innovations through patents ensuring freedom to operate is an important consideration to make in the decision making process to develop vaccines (Durell 2016;Farmer and Grund 2014;Krol et al 2016).…”