Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the agency in evaluating the potential use of real-world evidence (RWE) in regulatory decisions involving drug and biological products.[2] The

In a recent decision, Ajinomoto v. ITC , the Federal Circuit addressed the issues of doctrine of equivalents and prosecution history estoppel as applied to patent claims reciting specific amino acid sequence of a biologic. On appeal, the Federal Circuit affirmed the decision by