title: Intellectual property rights and challenges for development of affordable human papillomavirus, rotavirus and pneumococcal vaccines: Patent landscaping and perspectives of developing country vaccine manufacturers.
abstract: The success of Gavi, the Vaccine Alliance depends on the vaccine markets providing appropriate, affordable vaccines at sufficient and reliable quantities. Gavi's current supplier base for new and underutilized vaccines, such as the human papillomavirus (HPV), rotavirus, and the pneumococcal conjugate vaccine is very small. There is growing concern that following globalization of laws on intellectual property rights (IPRs) through trade agreements, IPRs are impeding new manufacturers from entering the market with competing vaccines. This article examines the extent to which IPRs, specifically patents, can create such obstacles, in particular for developing country vaccine manufacturers (DCVMs). Through building patent landscapes in Brazil, China, and India and interviews with manufacturers and experts in the field, we found intense patenting activity for the HPV and pneumococcal vaccines that could potentially delay the entry of new manufacturers. Increased transparency around patenting of vaccine technologies, stricter patentability criteria suited for local development needs and strengthening of IPRs management capabilities where relevant, may help reduce impediments to market entry for new manufacturers and ensure a competitive supplier base for quality vaccines at sustainably low prices.
authors.affiliation: Duke Global Health Institute, Duke University, Durham, NC, USA.
authors.forename: Subhashini
authors.initials: S
authors.lastname: Chandrasekharan
authors.affiliation: Initiative for Medicines & Access to Knowledge (I-MAK), New York, NY, USA.
authors.forename: Tahir
authors.initials: T
authors.lastname: Amin
authors.affiliation: Duke Global Health Institute, Duke University, Durham, NC, USA.
authors.forename: Joyce
authors.initials: J
authors.lastname: Kim
authors.affiliation: Gavi, the Vaccine Alliance, Geneva, Switzerland.
authors.forename: Eliane
authors.initials: E
authors.lastname: Furrer
authors.affiliation: Gavi, the Vaccine Alliance, Geneva, Switzerland.
authors.forename: Anna-Carin
authors.initials: AC
authors.lastname: Matterson
authors.affiliation: Gavi, the Vaccine Alliance, Geneva, Switzerland.
authors.forename: Nina
authors.initials: N
authors.lastname: Schwalbe
authors.affiliation: Gavi, the Vaccine Alliance, Geneva, Switzerland. Electronic address: ANguyen@gavi.org.
authors.forename: Aurélia
authors.initials: A
authors.lastname: Nguyen
mesh_terms: D001938:Brazil; D002681:China; D003906:Developing Countries; D004345:Drug Industry / Q000639:trends; D006801:Humans; D007194:India; D018973:Intellectual Property; D053918:Papillomavirus Vaccines / Q000191:economics* / Q000302:isolation & purification*; D022242:Pneumococcal Vaccines / Q000191:economics* / Q000302:isolation & purification*; D022243:Rotavirus Vaccines / Q000191:economics* / Q000302:isolation & purification*; D013678:Technology, Pharmaceutical / Q000191:economics / Q000379:methods
chemical_list: D053918:Papillomavirus Vaccines; D022242:Pneumococcal Vaccines; D022243:Rotavirus Vaccines
keywords: Developing country manufacturers; Gavi the Vaccine Alliance; Human papillomavirus vaccines; Intellectual property rights; Patents; Pneumococcal conjugate vaccines; Rotavirus vaccines; Trade; Vaccine manufacturers; Vaccines