European law makes it clear that isolated DNA is patentable, and major changes are not expected.
In the U.S., the Myriad case has called into question whether isolated genetic material is itself patentable. In Australia attempts by Myriad’s licensee to enforce its patents have led to a similar questioning of the patentable nature of genetic material. In contrast, the European position is far more settled even if additional requirements are imposed on patents claiming genetic material.
The Myriad case resulted in a ruling that because isolated DNA is not markedly different from DNA as it exists in nature, it constitutes unpatentable subject matter; the decision is under appeal. The U.S. government has filed an amicus brief commenting that while man-made genetic constructs such as cDNA should be patentable, isolated DNA without further alteration or manipulation is not patent-eligible.
In Europe the same questions should not arise. This is because patentability of genetic material has been harmonized throughout the EU according to the “Biotech Directive.” This has been incorporated into the rules of the European Patent Office, which covers not just EU member states but also other European countries such as Switzerland and Norway.
The Biotech Directive provides that “biological material which is isolated from its natural environment or produced by means of a technical process” may be patentable “even if it previously occurred in nature.” Biological material includes genetic material. Thus, this provision can be relied upon as confirmation that in Europe isolated DNA and other genetic material is patentable subject matter, regardless of whether or not it is markedly different from native DNA.
Possibility of Change in Europe
There are indeed provisions relating to the human body, including the prohibition that “at the various stages of its formation and development…the simple discovery of one of its elements including the sequence or partial sequence of a gene cannot constitute patentable inventions.” This is qualified by the acceptance that “an 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.”
These provisions highlight the distinction in Europe between the unpatentablity of the genetic sequence as information and the patentability of a molecule comprising the genetic sequence. Therefore, the law in Europe is clear—isolated DNA is patentable subject matter.
It is nevertheless possible for new laws to be passed and old laws repealed. In Australia there are moves to do exactly that. A bill is being introduced to prevent the patenting of human genes and biological materials that are identical or substantially identical to materials as they exist in nature, regardless of whether they are isolated or purified.
It seems unlikely, however, that similar steps will be taken in Europe. The Biotech Directive was first proposed in 1988. In the face of extensive opposition from a number of groups, the European Parliament took 10 years to pass the bill. The legality of the Biotech Directive was then challenged by the Dutch government.
This resulted in the European Court of Justice (ECJ; the highest court in Europe) ruling, in 2001, that the patenting of genetic material isolated from the human body does not contravene any principles of human dignity. Given this and the difficulties that were faced in passing the Biotech Directive, it is doubtful that European legislature would have the desire to revisit the issue.
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.
Andrew Sharples is a partner at EIP in London and is the head of EIP Life, the life sciences patent group.