What's the use?!

Mattew Spencer, Partner, Boult Wade Tennant

This article first appeared in the August 2009 issue of Bio-Science Law Review. Click here to read this article in PDF format.

It may seem an odd concept for patent applicants to file an application directed to a new product when they are not sure how they might use it. But this is the type oif patent application that the European Patent Office (EPO) has been dealing with more and more frequently in recent years. The UK High Court has also recently attempted to get to grips with a patent describing a range of possible uses for a new product based solely on speculation.

Traditionally, biological research was carried out by starting with a useful activity and then working out the structure responsible. Such research meant that a patent application was generally only filed at the point at which both the structure of the molecule and its function had been characterised. As the amount of genetic information available increased rapidly during the 1990s, however, bioinformatics tools permitted would-be patentees to discover family members of known proteins based upon sequence alignment alone. Many patent applications were filed based upon such an in silico discovery, often with limited or no functional characteristation of the protein, even by in vitro testing.

In the absense of a functional characterisation, patent applicants postulated uses for their new protein, typically based upon the functions of other members of the family. This lack of functional characterisation has raised doubts about the merits of these 'inventions', from the Examining Divisons of the EPO, through the Opposition Divisions and Technical Boards of appeal and into the national courts. The varied and sometimes imaginative manner in which the various statutory requirements for patentability have been applied when assessing these applications suggests that the statute was not written to deal with the issue. This article reviews primarily the requirement of industrial application, which has been shaped (almost to breaking point) to deal with the issue of speculative uses for an invention.

The Staute
Article 57 EPC states: 'An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture'. This sounds fairly harmless - the invention simply needs to be one which can be made or used in some form of industrial context. The statute does not appear, on the face of it, to impose a requirement that the invention has actually been put into practice. Traditionally, this requirement was viewed s perhaps the least onerous of all the patentability requirements.

However, specifically in relation to inventions concerning biological material, the Biotech Directive¹ attempted to clarify what types of invention should be considered to be susceptible of industrial application. Whilst '[t]he human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions',² the Biotech Directive, as implemented into Rule 29 EPC state that '[a]n element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.'³ Thus, isolated genes and proteins are not excluded from patentability.

Rule 29(3) EPC adds the requirement that '[t]he industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.' This suggests than an explicity, or perhaps implicit, disclosure of how to make or use the invention in industry is needed in the application as filed. The statute does not, however, indicate the level of technical or experimental evidence that is needed to support such a statement.⁴ Perhaps an inferred industrial application may suffice in certain circumstances?

Article 164 EPC⁵ confirms that the EPC Rules which implement the Biotech Directive should not make the requirements for industrial applicability more burdensome than those specified in Article 57 EPC. However, Rule 26(1) EPC explicity indicates that the Biotech Directive 'shall be used a supplementary means of interpretation'. With this in mind, recital 23 of the biotech Directive has cuased some concern for would-be patentees. This recital reads: 'Whereas a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention', and it has been interpreted as importing certain requirements for an indication of function to be supplied in order to acknowledge industrial applicability.

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1. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.
2. Rule 29(1) EPC.
3. Rule 29(2) EPC.
4. In similar fashion to Rule 29(3) EPC, Rule 42 EPC requires that '[t]he description shall: (f) indicate explicitly, the way in which the invention is industrially applicable.'
5. 'In case of conflict between the provisions of the Convention and those of the Implementing Regualtions, the provisions of the Conention shall prevail.'