Because No One is Immune to the Law
March 28, 2023 - United States, Asia, European Union, Litigation, Intellectual Property

Recent Updates on Use of Post-filing Data as Evidence to Support Patentability

MoFo Life Sciences

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 sought to be patented. For a showing of enablement, the objective evidence also must be consistent with the supporting teachings of the specification.

Last week, the European Patent Office confirmed that post-published evidence may be used to support a technical effect in the assessment of inventive step in the decision of the Enlarged Board of Appeal in G 2/21. The decision states that evidence submitted to prove the technical effect may not be disregarded solely because it had not been public before the filing date. However, for post-published data to be considered to establish inventive step, the skilled person must be able to derive the technical effect as being encompassed by the teaching and embodied by the originally disclosed invention.

Recent guidelines implemented by the Chinese National Intellectual Property Administration (CNIPA) in January 2021 also allow post-filing data to be considered in support of both inventive step and sufficiency of disclosure, if the technical effect to be proved by the supplementary data is obtainable by the disclosure of the specification. The Japan Patent Office’s Examination Guidelines also permit submission of post-filing data of experimental results to address inventive step, enablement, and written description, but such data may not be a substitute for the detailed description of the invention. Accordingly, in our experience, post-filing data in Japan is allowed as evidence if it supports and reinforces data already present in the originally filed specification.

While jurisdictions differ on whether and how post-filing data can be considered, data generated after filing may still be submitted in some cases when it is not possible to include at filing. However, to increase the likelihood that post-filing data will be considered, applicants should ensure that their patent specification includes teachings that provide a nexus between the claimed subject matter and the technical effect achieved. While this may not always require actual working examples, at least some in vitro data may be required and—for the case of therapeutic methods—in vivo animal model data may be necessary or helpful.