Recent Updates On Use Of Post-Filing Data As Evidence To Support Patentability

In a "first to file" patent system as exists in the United States and in most countries throughout the world, timing of when to file a patent application is critically important but must be balanced by patentability requirements such as nonobviousness and enablement. This is especially true in the life sciences, where data can be imperative for securing a patent but difficult to obtain as a result of long development cycles, clinical trial periods, and financial limitations. The submission of post-filing-date data can be a mechanism by which additional evidence in support of patentability can be provided once prosecution has begun.

The United States Patent Office (USPTO) has long allowed post-filing-date data in the form of an affidavit or declaration to provide objective evidence to demonstrate non-obviousness (e.g., by showing unexpected results) or for establishing enablement. To be accepted, the presented data must be commensurate in scope with the claims