Personalised Medicine Patents at the EPO
A 2019 decision of the European Patent Office’s (EPO) Boards of Appeal regarding “functionally defined patient group” provides Applicants with further certainty to how subject matter for claims can be carved out for healthcare inventions, particularly those in the “personalised medicine” space. We here review briefly how the EPO considers medical use claims, before looking more closely at patenting personalised medicines at the EPO.
Background and Second Medical Use claims
The EPO does not permit “method of treatment” type claims – “methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body” are not patentable according to Article 53(c) of the European Patent Convention (EPC). This is based on an underlying principle that medical and veterinary practitioners should be free to use their skills and knowledge of the best available treatments to achieve the utmost benefit for their patients, uninhibited by any worry that the treatment might be covered by a patent (G1/07, 3.3.6, see also G 5/83 and G 1/04).
The EPO permits claims directed to the “first medical use” of a substance or composition, when the substance or composition itself is novel, or when it has never been utilised for medical purposes before. For example:
“Compound X for use in medicine/a therapy/treating a human/surgery” or
“Compound X for use as a medicament”
At the EPO, under Articles 53(c) and 54(5), it is also permissible to claim new, clearly defined, further medical uses of a known medicament which already have one or more known medical uses. Claims to any second, or further, uses must be novel and inventive. These claims are in the form of “product for use” claims, also known as “second medical use claims”. For example:
“Compound X for use in the treatment of disease Y” or
“Compound X for use as a disease Y agent”.
On a side note, the EPO no longer allows “Swiss-type” claims, i.e. (“The use of Product X for the manufacture of a medicament for the treatment of cancer/leukaemia“).
Personalised medicine: tailored treatments
“Personalised medicine” aims to stratify healthcare by assessing a patient as an individual to prescribe them the right treatment, at the right dose, at the right time, with the minimum possible side/adverse effects. This could be through, for example, genotyping the patient’s genetic polymorphisms, current gene expression analysis or looking at the genetic or epigenetic make-up of a patient. It can also involve looking at specific biomarkers in a patient, such as those related to a specific disease pathology. For example, using the monoclonal antibody Trastuzumab (Herceptin) to specifically treat breast and stomach cancers which are HER2 receptor positive, or genotyping women for the CYP2D6 gene and thus not using Tamoxifen for breast cancer treatment.
Whilst this approach is still considered as in its infancy, the concept of personalised medicine, or personalised healthcare will be a large part of the future of healthcare.
Personalised medicine and patents
When protection for second medical use claims has already been sought, there are a number of different ways that further, follow-up, protection can be sought in the same space. We explore some of these approaches below.
Novelty can be established by reciting new and inventive routes of administration, as established in Decision of the Board T51/93. A patent may be granted to a new and inventive administration of a known medicament administered by a different route. In T51/93, the second medical use claim was directed to the previously undescribed subcutaneous administration. However, it must be proven that the new administering route contributes to the solution of the identified problem allegedly solved by the claimed invention. There must be an acknowledged technical effect achieved by the new administration route.
In the landmark case G2/08 the Enlarged Board of Appeal at the EPO ruled that a new use of a medicament is patentable if the treatment was new due to a new dosage regime. The particularly claimed dosage regime must not be known and must have a technical effect in order to render the claim novel and inventive over the prior. For example:
“Compound X for use in the treatment of disease Y, wherein the compound is administered according to a specific dosage regime (e.g. specific amounts/timing of administration)
New routes of administration and new specific dosage regimes could both be forms of personalised medicine. However, decision G2/08 did not deal with stratifying medicine based on patient grouping, such as using biomarkers or lifestyle choices to group patients.
In the earlier decision of T233/96, patients were considered grouped by way of being “unable to exercise adequately”, and upon interpreting previous decisions T19/86 and T893/90, the Board established the following criteria for claims to a treatment or diagnosis of the same disease with the same compound:
- i) the treatment/diagnosis is carried out on a new group of subjects which is distinguished from the former by its physiological or pathological status;
- ii) the group chosen doesn’t overlap with the group previously treated; and
iii) the choice of the new group isn’t arbitrary, where no functional relationship exists between the particular physiological or pathological status of this group of subjects and the therapeutic or pharmacological effect achieved.
However, this test has been inconsistently applied in follow-up hearings. For example, in T1399/04 claims were considered novel to a grouped patient population when the population overlapped with a previously known population (i.e. not satisfying ii) of the above test). This Board particularly noted that the situation of T233/96 did not apply to the facts of the case in question, due to the much more clearly defined “functional relationship between the feature distinguishing the patient group of the claim from the patient group treated according to the prior art” along with a “pharmacological effect achieved by the active compound of the manufactured composition”.
In T 734/12 the Board also ruled that “experiencing an inadequate response to a TNF alpha-inhibitor” was sufficiently distinguishable from the patient group of the prior art by its physiological and pathological status, and consequently, according to the established case law of the Boards of Appeal (citing decisions T 1399/04, T 19/86 and T 893/90) “represents a new therapeutic application”.
These decisions indicate that as long as the new patient group is not explicitly disclosed in the prior art, and its choice is not arbitrary and possesses some kind of technical effect (i.e. the above identified “functional relationship”), then claims directed to this new patient grouping can be considered novel over the prior art. This is even if the patients already known to be treated in the prior art may actually inherently be a part of the newly identified grouping, e.g. if they possess a biomarker not before identified and were receiving treatment anyway.
This principle has been cemented in the recent 2019 decision T694/16, which re-iterated that, in points 5.1-5.21 of the reason for the decision:
“If a claim is directed to a known compound or composition for use in a therapeutic method of treatment or prevention of a disease, and the claim specifies that the subject to be treated displays a clearly defined and detectable marker, which is not displayed by all subjects affected by or likely to develop that disease, then the purposive selection of the patients displaying the marker for the specified treatment is a functional feature characterising the claim.”
The decision also cites T1399/04 and agreed that T 233/96 related to a special case:
“namely one where the patient selected for treatment was characterised by the feature that the patient, “… is unable to exercise adequately”, which was considered vague, unsuitable for properly defining the claimed subject-matter, and not related to the purported therapeutic effect”, and concluded “Accordingly, novelty may not be denied on the ground that the claimed patient group is embedded and necessarily overlaps with a larger population of previously treated patients”
In conclusion, this decision provides further confirmation that the EPO is willing to allow patents directed to patient groupings, which will be welcome news to applicants looking to protect intellectual properly in the “personalised medicine” space.