Of Molecules & Medicine: Filing New Data at the EPO

By Iain Robertson, Attorney

Two recent decisions from the Boards of Appeal of the European Patent Office have highlighted the difficulties applicants and opponents can face when trying to reply on new experimental data to support their arguments.

In T 0235/13, the appellant tried to rely on post-published evidence to support the inventiveness of their application.

Claim 1 in both requests under appeal recited:

“A composition for use in a method of treatment of a patient with short stature but having no achondroplasia…

wherein the composition comprises type C natriuretic peptide (CNP) as an active ingredient and is administered by injection, wherein the CNP is CNP-53 from mammals, including human, or birds.”

The appellant argued that although the application only presented data for CNP-22, the application nevertheless disclosed that CNP-22 and CNP-53 are equally preferable, and that the prior art also considered CNP-22 and CNP-53 to be interchangeable. Therefore, they argued that the post-published evidence, which showed that CNP-53 has a longer half-life than CNP-22, confirmed a technical effect for CNP-53 which was foreshadowed by the application as filed, and so the post-published evidence should be taken into account when considering the inventiveness of the application, in line with previous Board of Appeal decisions T 1422/12 and T 440/91.

In T 1422/12 and T 440/91, it was decided that:

“any effects may be taken into account, so long as they concern the same field of use and do not change the character of the invention”.

In T 1422/12, the Board  of Appeal decided that the technical problem could be formulated to include the further technical effect of increased stability, despite this not being disclosed in the application in relation to the invention, because the background section of the patent application underlying T 1422/12 related to improving the performance characteristics of pharmaceutical products, and thus the new technical problem did fall “within the framework of the invention as disclosed in the application in suit“.

The Board of Appeal decided that T 1422/12 and T 440/91 did not apply in this case, because the application did not indicate any improvement to a therapy, let alone improved bioavailability of CNP-53 in comparison to CNP-22, and so this further effect, shown by the post-published evidence, did change the character of the invention. Therefore this further effect cannot be taken into consideration when considering inventive step. Consequently, the Board of Appeal found the application lacked an inventive step, and the appeal was dismissed.

It seems that the Board of Appeal in this case may have decided differently, at least when deciding whether to consider the further technical effect shown by the post-published evidence, if the application as filed had included a broad statement regarding the character of the invention which covered the improved bioavailability of CNP-53 in comparison to CNP-22.

In T 2469/17, an appellant-opponent tried to rely on experimental evidence to show that a patent lacked novelty over D1, D2 and D5.

The appellant-opponent re-produced a sample from an example in D1. The re-produced sample had a different bulk density and a different viscosity to those reported in D1.  Although claim 1 in this case did not define the claimed product by its bulk density or viscosity, the differences in these properties were enough for the Board of Appeal to conclude that the sample re-produced by the appellant-opponent was not, in fact, the same as that disclosed by D1, and so the re-produced sample was irrelevant to the novelty of the claims in this case.

D2 did not disclose all the information necessary to exactly re-produce the examples disclosed by D2, and so the appellant-opponent had to make some assumptions when trying to re-produce the examples from D2. They argued that these assumptions were based on an evaluation of what the skilled person would have done. However, the Board of Appeal decided that there simply was not enough information in D2 to re-produce the examples of D2, and so the Board decided that the sample produced by the appellant-opponent was not directly and unambiguously disclosed by D2.  Consequently, the sample did not affect the novelty of the claims in this case.

The appellant-opponent were the applicant for D5, and they performed measurements on a sample which they had stored from 2008. However, the Board of Appeal stated that there was no evidence that the sample from 2008 was the same as those disclosed in D5 (which had a filing date in 1994), or that the properties of the stored sample had not changed between 2008 and 2017 (when the properties of the sample were measured). Therefore, the Board of Appeal in this case could not draw any conclusions regarding the properties of the example disclosed in D5 based on the properties of the sample measured by the appellant-opponent, and so, once again, the measurements performed by the appellant-opponent did not destroy the novelty of the claims in this case.

As none of the experiments performed by the appellant-opponent were persuasive, the claims were found to be novel and inventive.

These two cases, T 0235/13 and T 2469/17, demonstrate some of the difficulties which can be faced when trying to reply on new experimental data at the EPO, either to show a technical effect, or to attack a claim. In the first case, drafting a patent application with a very broad statement regarding the nature of the invention may help catch as many technical effects within the “character of the invention” as possible, should you later need to rely on new experimental data to establish an inventive step. In the second case, wherever possible, it may be helpful to show that re-produced samples are as similar as possible to examples disclosed by the prior art, and to show that new measurements performed on old samples are relevant by demonstrating that the old samples have not deteriorated or changed over time.