Antibody Claims and the Evolution of the Written Description / Enablement Requirement

Abstract

Biologic patents are the basis of some of the most valuable technologies in the pharmaceutical industry. Biologic patents include patents to vaccines, antibodies as well as gene therapy and isolated blood products. This study focuses on the changing nature of a key biologic product, namely antibody patents.

Antibody technology has dramatically advanced in the past few decades. Initially, antibodies were only used as research and diagnostic tools. Currently, however, antibodies have been transformed into powerful therapeutic agents used to treat a panoply of diseases. Correspondingly, the scope of antibody patents has also changed as the technology has also developed.

In the early stages of development, antibody claims were granted broad scope, being defined only by the antigens that they bound to. Currently, antibody patents have been granted very narrow scope. The Federal Circuit and the PTO have used the written description and enablement requirements to narrow the scope of antibody patents, which mirrors the dramatic changes in antibody technology. This article outlines the changes in both Federal Circuit caselaw as well as PTO policy when it comes to antibody biologic products.

Keywords: antibody, patent, USPTO, patent examination, examiner, prosecution, written description, enablement, 35 USC 112(a)