In a recent ruling by the Court of Justice of the European Union relating to genetically modified plants and seeds (Monsanto versus
the Court questioned the scope of protection conferred to genes. However, no principled analysis of the patentability of genes took place. Hence, in Europe, the patentability of genes still follows the statutory principle laid down in the EPC (Rule 29). But for how long? Will the AMP versus
USPTO verdict affect the situation in Europe? With respect to genetic diagnostic methods, will the CAFC's machine-or-transformation rule reach the European continent?
It is highly unlikely that those decisions will have such a far-reaching effect. However, history has shown that groundbreaking US Supreme Court decisions can influence patent law and practice all over the world. An example of this is the Chakrabarty decision, where it has been suggested that in the years following this case, the TRIPS Agreement (1994) sought ways to regularize and internationalize the technological and legal culture that flowed in that decision.21
In June 2010, the US Supreme Court reached a final conclusion on the CAFC's machine-or-transformation test in Bilski versus
The Supreme Court ruled that the machine-or-transformation test is a valuable clue to the question of process patent eligibility, but it held that this is not an exclusive test for process or method patents. The Court encouraged the CAFC to develop additional final criteria that would help define the kind of process claims that are patentable.12
Although it is highly unlikely that the machine-or-transformation test as interpreted by the Supreme Court will be applied in the appeal on AMP versus USPTO, it remains interesting to ask whether the machine-or-transformation test could ever become part of European patent law and practice. If so, then hundreds of genetic diagnostic method patents might be invalidated.
In Huys et al
we listed several method claims in European patents, which included (explicitly or implicitly) steps such as the isolation or sequencing of human DNA. These steps would lack any form of transformative character as defined in the Supreme Court decision Bilski versus
For instance, the in vitro
detection procedure of the Fragile X syndrome claimed in EP580621 (claim 14) (see Supplementary Information) comprises the steps of a treatment of a sample of genomic DNA, separating the fragments and visualizing and comparing the results obtained with control fragments (eg, by performing Southern blot or fragment analysis). Measuring and comparing gene fragments does not cause an alternation of the gene at hand. Taking the claim in its entirety, the essence of the claim is the act of comparing genes in normal and affected persons. Therefore, the claimed process is, in fact, a basic scientific principle, namely, that an alteration between the gene FMR-1
in normal and affected individuals indicates a mutation for Fragile X syndrome. Hence, a real transformation is arguably not present.
Other examples include claim 1 of EP885309 (Friedreich ataxia; see Supplementary Information) claiming a method of screening individuals for a mutation that leads to Friedreich ataxia, or claim 1 of EP0569527 (familial adenomatous polyposis; see Supplementary Information), which relates to ‘a method of diagnosing or prognosing a neoplastic tissue of a human', comprising only a step of detecting (read: sequencing) an alteration within a gene sequence. Illustrative is also claim 1 of EP696325 (Factor V Leiden; see Supplementary Information) on a method for screening for the presence of a genetic defect associated with thrombosis and/or a poor anticoagulant response to activated protein C, the said method comprising determination of the presence of a mutation in the nucleic acid. When applying the machine-or-transformation test, these methods would constitute nothing more than ‘data-gathering steps' that are not central to the purpose of the claimed process and hence would not qualify as transformations.
It remains also interesting to ask whether European standards from other technical fields could be applied to European genetic diagnostic method claims. Recently, the Enlarged Board of Appeal of the EPO formulated a new European standard for computer-implementing inventions, requiring a ‘further technical effect' for such inventions to be patentable.23
However, for the same reason of unrelated technicality, it is very unlikely that this new European requirement will be applied in the field of genetic diagnostic testing.
Whatever way it goes, whether in Europe the machine-or-transformation test will be applied to genetic diagnostic tests or not, or whether new European standards from other technical fields will be applied to genetic diagnostic methods, another important unsettled issue relates to the clarity of claims and to the sufficiency of disclosure in the patent description. In this respect, Article 84 EPC can become quite relevant, as it requires that in order to be patentable, an independent claim must recite all the essential features necessary for a clear and complex definition of a particular invention. Obviously, such features are mostly of a technical nature. Recently, the national court of an EPC member state considered in Eli Lilly versus
Human Genome the issue of ‘sufficiency' in relation to DNA patents, invalidating a genetic diagnostic patent because it was held to be insufficiently disclosed.24