Introduction to Adjuvant Patent Landscape 1

Adjuvants have been used since the early 20th Century to enhance an immune response to an antigen. The need for adjuvants as a component of vaccines is still acute, especially as newer antigens may be weak immunogens or have limited availability. Developing new adjuvants has great monetary value as well, as illustrated by acquisition of companies with adjuvant products. Regulatory approval of adjuvants however has been almost non-existent; no new adjuvant has been approved in the United States since the 1930s and only recently has the European regulatory agency approved three vaccines with a new adjuvant.

This patent landscape presents a first-pass overview of the adjuvant field and patenting trends in the field. A set of patent families with subject matter related to adjuvant compositions and uses was obtained. The set was analyzed with regard to what types of organizations are actively pursuing patents, who owns most of the patent families, and where are the patent applications filed. Briefly, companies are more active than non-profit organizations, the top 25 or so patent owners collectively own about 40% of the families, and about 80% of the patent applications are filed in high income countries.

The final section of this landscape provides information about some notable adjuvants, those that have been approved for new vaccines or commonly tested in clinical trials. Some key patents encompassing these adjuvants are shown along with the broadest claims. For this subset, in general broader claims were granted in Europe than in the United States.

This Patent Landscape is a dynamic work, and should not be viewed as definitive or comprehensive.

This draft is authored by Dr Carol Nottenburg, Cougar Patent Law, in collaboration with CAMBIA.

Funding for this Landscape has been provided through a grant from PATH Vaccine Solutions.