Patent Opportunities In FDA Bispecific Antibody Guidance

Law360 (August 13, 2019, 1:28 PM EDT) -- In April 2019, the U.S. Food and Drug Administration published draft guidance entitled “Bispecific Antibody Development Programs Guidance for Industry” that provides “recommendations to assist industry and other parties involved in the development of bispecific antibodies.”[1] Based on three issues identified by the FDA as potentially important to regulatory approval of these products, companies may consider aligning their patent strategy with these regulatory requirements to acquire a competitive advantage. 

Bispecific Antibodies

Bispecific antibodies are proteinaceous molecules capable of binding to two different antigens. First reported in 1961, early versions were generated from mixtures of two monospecific antibodies (e.g., antibodies that bind to...

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