Why don’t patent protections provide the same certainty for biologics that they do for small molecule drugs?
Generic copies of small molecule drugs must meet standards of sameness in order to rely on the innovator product’s data and clinical trials to receive FDA approval. For small molecule drugs, if the innovator product’s patent life has not expired, then competitors cannot legally bring generic versions of the product to market. Biologics are large, complex, molecules. This complexity, and because they derive from living matter, makes it impossible using current science for two biologic products to meet standards of sameness-that is, the two products would not be identical. Instead, biologics can only meet standards of similarity. Adhering to a standard of similarity for follow-on biologic products means it is possible for a competitor to attempt to rely on an innovator product’s data and clinical trials to receive FDA approval without infringing on the innovator product’s patent. In other words, the competitor product is similar enough to receive FDA approval but just different enough to
