This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada. Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here. Part 2 will examine the patentability of diagnostic inventions in Europe.
Despite the challenges of obtaining patent protection for diagnostic inventions in the U.S., patent protection for diagnostic inventions is available in a number of jurisdictions outside of the U.S. Europe remains a pro-patentee jurisdiction as far as diagnostic inventions are concerned. At the European Patent Office (EPO), Article 53(c) of the European Patent Convention (EPC) does state that: “European patents shall not be granted in respect of … methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body…” (emphasis added). However, the EPO applies this exclusion narrowly. To be excluded, the method must be both diagnostic in nature and practiced on the human or animal body.
In G 1/04, the Enlarged Board stated that because neither the EPC nor the preparatory documents to the EPC provided a definition for the term “diagnostic methods”, according to established jurisprudence of the EPO, a diagnostic method must include at least the following steps:
(i) the examination phase involving the collection of data;
(ii) the comparison of these data with standard values;
(iii) the finding of any significant deviation, i.e., a symptom, during the comparison; and
(iv) the decision phase (attribution of the deviation to a particular clinical picture).
Thus, presenting claims lacking some of steps (i) to (iv) may avoid the exclusion.
Additionally, in G 1/04, the Enlarged Board further stated that for a claimed method to be considered a diagnostic method excluded from patentability under Article 53(c) EPC, the claim must contain the following features:
(a) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as purely intellectual exercise (i.e., decision step (iv), above);
(b) the preceding steps which are constitutive for making that diagnosis (i.e., examination, comparison and finding of significant deviation steps (i) to (iii) above); and
(c) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.
What is meant by feature c) above is that when determining whether or not the method is “practiced on the human or animal body”, only the recited steps that are a) preceding steps necessary for making a diagnosis, and, b) technical in nature, should be considered. The EPO has a consistent but very broad interpretation of what is meant by the term “practiced on the human or animal body”. If the performance of the respective step implies any interaction with the human or animal body, then the requirement is met. The interaction does not need to be invasive, involve any risk to patient safety or require a medical professional to be considered a step “practiced on” the body. Furthermore, a direct physical interaction on the body is not required; it is sufficient that the body is present and an interaction occurs. Moreover, a diagnostic method claim may be objected to as encompassing steps practiced on the human or animal body even if the practice is not positively recited. For example, EPO Examiners will consider the content of the description and dependent claims and, if it is considered that a step practiced on the human or animal body is encompassed by the claim, then an objection will likely be raised.
It is important to note that the exclusion of Article 53(c) EPC does not apply to in vitro diagnostic methods, such as for the testing or processing of samples derived from a subject. Even simple in vitro diagnostic method claims, straightforwardly based on the discovery of a correlation between a biomarker/ analyte and a disease state/clinical picture, are patent patentable at the EPO. In this regard, the subject-matter eligibility situation for diagnostics is much more positive at the EPO than at the U.S. Patent and Trademark Office.
To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions. You can register for the webinar at the following link: Link to webinar.
This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.