More IPO decisions on Vaccines - this time on HPV

Gardasil also played a role in the Intellectual Property Office's recent decision on eight applications for SPCs for single active ingredients on different strains of the L1 protein of the Human Papillomavirus (HPV). The applications were in the name of Georgetown University, one in the name of Loyola University of Chicago and one in the name of University of Rochester.

"One application concerned the recombinant L1 protein of Human
Papillomavirus (HPV) strain HPV6; one application concerned the recombinant L1
protein of Human Papillomavirus (HPV) strain HPV11; three applications concerned
the recombinant L1 protein of Human Papillomavirus (HPV) strain HPV16 and three
applications concerned the recombinant L1 protein of Human Papillomavirus (HPV)
strain HPV18. Although in the name of three applicants, these applications all
currently relate to a single licensee.

Two marketing authorisations were filed in support of these eight applications Gardasil (RTM) which comprises the recombinant L1 proteins of Human
Papillomavirus (HPV) strains HPV6, HPV11, HPV16 and HPV18 and Cervarix (RTM) which comprises the recombinant L1 proteins of Human Papillomavirus (HPV) strains HPV16 and HPV18. [...]

The eight SPC applications were found not meet the requirement under Article 3(b), because the marketing authorisations filed in support of each of these applications
comprises a further one or three active ingredients in addition to the active
ingredient listed in the product definition of that SPC application. Thus, in
each case, a valid authorisation has not been supplied to place the product (for
which an SPC has been applied) on the market as a medicinal product.
Since in accordance with Article 10(3) an opportunity to correct the irregularities
with these applications has been given, they were rejected under Article 10(4). "

Read the decision here.