T 784/06: Where the Worlds of Computer-Implemented Inventions and Biopharma Meet

This article was included in our Winter 2010 edition of Inside IP magazine.

A recent decision of the Technical Board of Appeal (TBA) has indicated that European Patent Office case law previously developed in relation to the patentability of computer-implemented inventions is applicable to bioinformatics.

The decision also serves as a general warning to applicants for European patents regarding the importance of providing a “complete and sufficient” description of the claimed invention in the patent specification.  In this case, the TBA chose deliberately to ignore various steps of independent method claim 1 when assessing inventive step because the Board decided that the specification did not provide the skilled reader with the information needed to understand how to proceed with those steps.

The patent

The patent in question, EP0736107, had earlier been maintained in amended form following first instance proceedings before the EPO’s Opposition Division.  In the patent as maintained, independent method claim 1 was directed to a five-step method of determining the genotype at a locus within genetic material obtainable from a biological sample.  The first step (A) of claim 1 related to “reacting a genetic material to produce a reaction value”; in essence, this meant that the genetic material was treated in vitro in such a way as to indicate whether or not one or more nucleotides of interest were present in the genetic material.  The second to fifth steps (B to E) related to processing the data represented by the reaction value to determine the genotype at the locus in the sample.

In the subsequent appeal proceedings, the opponent and the patentee made submissions regarding whether the second to fifth steps of claim 1, which essentially involved the application of mathematical techniques to data obtained in the first step of claim 1, contributed to the technical character of the invention.  The patentee argued that they did, whilst the opponent argued that they did not.

The decision

There are two aspects to the decision.  The first relates to the applicability of previous case law to bioinformatics claims, whilst the second relates to the importance of providing a fully enabling disclosure of the invention in the patent specification.

1. In the TBA’s view, the method defined in claim 1 was a mix of “technical” and “non-technical” features because, although the reaction of a genetic material to produce a first reaction value in step A was deemed “technical”, the “mental activities performed based on the application of mathematical methods” defined in steps B to E were not.  According to the TBA, in order to decide whether steps B to E contributed to the technical character of the invention, the fundamental question to be answered was whether, in the light of the description of the patent specification, the “mental activities of steps B to E interact with the technical activity of step A so as to yield a tangible technical result”.

This reasoning is broadly consistent with previous EPO case law relating to computer-implemented inventions having amix of “technical” and “non-technical” features.  The decision therefore suggests that the case law for inventions which have a mix of “technical” and “non-technical” features is applicable to inventions in all fields, including bioinformatics, rather than being restricted to computer-implemented inventions.

2. It would normally be expected that the question of whether the “mental activities of steps B to E interact with the technical activity of step A so as to yield a tangible technical result” would be answered by assessing whether the combination of steps B to E with step A provides a “further” technical effect which goes beyond the normal physical interactions between the “technical” and “non-technical” steps.

However, in this case, the TBA never reached this stage of the analysis.  Instead, they reasoned that, although the specification included various equations and a portion of computer code for carrying out steps B to E, the description was not reasonably complete and sufficient for the skilled reader to understand how to proceed from the reaction value collected in step A through steps B, C, D and E.  At least part of the reason for this seems to have been because the Board decided that no informational content could be attributed to the constants, variables and functions mentioned in the equations and code.

Having determined that the description of steps B to E was insufficient for carrying out the invention, the Board decided that although the “non-technical” steps B to E could provide the claim with novelty, they should be ignored for the assessment of inventive step.  Since the only remaining step (A) was disclosed in the prior art, the patent was revoked on the ground of lack of inventive step.

This aspect of the decision highlights the importance of fulfilling the requirement for an enabling disclosure of the invention in a European patent specification, particularly when providing a portion of computer code.

John Chettle

Tanya Heare 29 Nov 2010

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