E-News No.45

E-News No.45

Survey on the Use of Post-Filing Data in Patent Prosecution and Invalidation Proceedings by John Todaro (Merck – U.S.A.)

The AIPPI Standing Committee on Pharma and Biotech (“Pharma Committee”) was formed in 2015 to address matters of concern to pharmaceutical practitioners, and has over 50 members.   The Committee includes the former Biotech Committee, which has been reorganized as a subcommittee within the Pharma Committee.

One project the Pharma Committee has undertaken this year is a survey of national laws and practices on whether patent applicants or patentees may rely on post-filing data (data obtained after the filing date of the patent application) in support of patentability.   This is an important issue in chemical and pharmaceutical practice, which may arise either during prosecution or post-grant, in defense of an invalidity proceeding.   The Pharma Committee members have discussed differing approaches to post-filing data around the world. For example, the Chinese Patent Office frequently refuses to accept post-filing data during prosecution. In contrast, the European Patent Office and U.S. Patent and Trademark Office have been more accepting of post-filing data.

The Pharma Committee survey proposes a hypothetical situation which would be familiar to any patent practitioner in the chemical field. An applicant is pursuing claims to novel compounds of genus A, which inhibit Enzyme 1, and are useful for treating various diseases which have been linked to Enzyme 1.

In a first scenario, the claims are rejected by the patent office on inventive step grounds over compounds of genus B.   The survey question is whether the applicant may submit to the patent office data developed after the filing date, which shows that the compounds of genus A are either more efficacious than the compounds of genus B, or that they have some other unexpected favorable property as compared to genus B compounds. The survey also asks whether similar data can be used in defending the validity of granted claims to genus A upon a validity challenge before the patent office or a court, based on the genus B disclosure.

In a second scenario, the claims to genus A are rejected by the patent office on lack of sufficiency or lack of utility, or similar grounds.   The survey question is whether the applicant can submit to the patent office data developed after the filing date, which shows that the compounds are effective in inhibiting Enzyme 1.   The survey also asks whether similar data can be used in defending the validity of granted claims to genus A upon a validity challenge before the patent office or a court, based on the lack of sufficiency or utility.

The Pharma Committee hope to provide a report on the results of the survey in our Annual Report.