Time waits for no man: deciding when to file a patent application in Europe.

Author: Nina L White, Partner, Biotechnology & Life Sciences Group, Boult Wade Tennant.

Guidelines for would-be patent applicants in Europe's 'first-to-file' system

Deciding on the right time to file a patent application can be a difficult decision in any technical field, but it is particularly difficult in competitive and rapidly developing areas of biotech. Would-be patentees must make a decision whether to delay filing until a substantial amount of data have been accumulated to support the invention and risk being 'scooped' by a competitor, or alternatively file early to secure a filing date ahead of the competition and risk the patent application being rejected as lacking adequate experimental support. Choosing the right time to file is particularly difficult in jurisdictions such as Europe, which operate a 'first-to-file' rather than a 'first-to-invent' system.

Patent applicants have tried to circumvent this problem by filing early on the basis of limited experimental data to establish a filing date ahead of potential competitors, on the understanding that it may be possible to submit further experimental data at a later date to show that the invention did in fact meet all the requirements for patentability as of the filing date.

Various recent decisions of the European Patent Office (EPO; Munich) have cast doubt on the ability to rely on late-filed experimental data (that is, data submitted to the EPO after the filing date of the patent application) to support patentability. This article summarizes the effects of these decisions, and identifies the circumstances in which applicants should not expect to rely on late-filed experimental evidence to support patentability before the EPO.

Sufficient disclosure requirement
Biotech inventions must satisfy the basic patentability requirements common to all technical fields: that is, the invention must be novel and nonobvious in comparison to the prior art. The invention must also be supported by sufficient technical disclosure to enable one skilled in the art to practice the invention over the full scope claimed without undue burden.

It is well established in the case law of the EPO Boards of Appeal that in order to meet the requirement for sufficient disclosure (Art.83 EPC) the application as filed must disclose at least one way of carrying out the invention. If the claims are particularly broad, then it may be necessary to provide more than one example to ensure that the technical disclosure of the application is sufficient to enable a skilled reader to carry out the claimed invention over the whole range claimed.

If the technical content of the application is judged fundamentally insufficient as of the filing date, it is not possible to remedy the situation by submitting late-filed experimental evidence. This principle is illustrated in an EPO Technical Board of Appeal decision concerning a claim to use of a peptide having insulinotropic activity for the treatment of diabetes mellitus1. In this case, the peptide was defined as