The Condition of Industrial Applicability
Of course, any patent application directed to isolated genetic material must still meet all the requirements that any invention must meet in order for a patent to be granted. For example, the invention must be novel and comprise an inventive step. One such requirement is that the invention be “capable of industrial applicability.” This requirement is inherent in most fields of technology but is of particular relevance for patents claiming isolated genetic material.
It is required that “The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.” This mandate was introduced into the Biotech Directive to alleviate some of the ethical concerns raised during the 10 years in which it was being legislated. Indeed, this requirement was one factor underpinning the ECJ’s ruling that the Biotech Directive was consistent with principles of human dignity, as it distinguished the subject matter of a gene patent as being an invention rather than the simple discovery of a human gene sequence.
Unfortunately, what constitutes a valid disclosure of an industrial applicability is not entirely clear. Typically, the European Patent Office required that the disclosure must: provide an “immediate, concrete benefit,” be more than a speculative indication of possible objectives that may or may not be achievable by carrying out further research, and not be so vaguely defined that no practical application or profitable use can be envisaged.
However, a more recent decision by the European Patent Office found that only a “concrete benefit” was required and that it was enough to provide the first essential steps at the onset of research work into the function of the encoded protein. This has set the bar very low—so low, in fact, that when the same case came before the English Court of Appeal, it did not agree with the decision and instead used a test similar to that previously in place at the European Patent Office.
The English case is now the subject of an appeal to the U.K. Supreme Court. Hence, at least until that case is resolved and possibly even afterward, there will be uncertainty and divergence as to the industrial applicability requirement for gene patents in Europe. This is of some importance, given that pharmaceutical products that are underpinned by gene patents filed 10–15 years ago are now coming to market.
The requirement for industrial applicability is also relevant to the scope of the claims. The Biotech Directive states that “The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material...in which the product is incorporated and in which the genetic information is contained and performs its function.” A decision last year by the ECJ confirmed that this meant that a patent to a genetically modified soya plant could not be enforced against imported processed soy meal derived from such plants, even though the soya contained the claimed genetic construct.
This was because, where the patented product contains or consists of genetic information, patent rights do not extend to protect the patented product in circumstances where the patented product does not perform the function for which it has been patented—i.e., to confer herbicide tolerance to the soya plant. This was despite the fact that the product had previously performed its function and could do so again if extracted and inserted into a living cell. This requirement for a product to be present in circumstances in which it performs its function for it to be capable of infringing a patent on the product is unique to gene patents.
In summary, isolated genetic material is patentable in Europe and is likely to remain so. Nevertheless, ethical concerns first raised in the late 1980s have meant that specific conditions are placed on gene patents that are not imposed in relation to other areas of technology.