This article focuses on five useful things to know about patenting the use of healthcare wearables in the field of diagnostics; an equivalent article on the field of treatment by surgery or therapy can be found here.
In recent years there has been an explosion in the field of healthcare wearables; high-tech devices now range from patches, rings, watches and scarfs to insoles, headbands, contact lenses and glasses. Their functionality encompasses everything from counting steps to diagnosing Alzheimer’s disease, tracking fertility to delivering wound sealant in the event of trauma. The wearable medical device market is expected to reach over US $74 billion by 2028 and the COVID crisis has only driven innovation in this area1.
Patenting this emerging technology is of paramount importance to many innovator companies. The devices themselves are patentable at the European Patent Office (EPO), provided the claims meet the usual patentability requirements including novelty and inventive step. However, claims to the use of these devices can fall foul of exclusions to patentability enshrined in the European Patent Convention (EPC). In particular, as healthcare wearables become increasingly sophisticated, use claims associated with such devices are more likely to contravene EPC provisions which prevent the patenting of methods of treatment by surgery and therapy, and methods of diagnosis practised on the human or animal body.
But that does not, by any means, preclude the allowance of all such claims. The way in which these exclusions are interpreted by the EPO can leave useful windows of patentability. It can also lead to the refusal of claims that would, at first glance, not appear to be excluded.
1. Methods of diagnosis are excluded from patentability at the EPO
Article 53(c) EPC recites that:
“European patents shall not be granted in respect of…diagnostic methods practised on the human or animal body”.
Therefore, while the devices themselves may be patentable, any claims to the use of such a device in a diagnostic method may be excluded from patentability. However, the relatively narrow way in which “diagnostic methods” are defined by the EPO can leave room for manoeuvre, as discussed below.
2. Method claims will not be excluded if any of the four “necessary phases” are missing
To be excluded from patentability as a method of diagnosis, a claim must include method steps relating to all of the following phases:
(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 attribution of the deviation to a particular clinical picture (i.e. the deductive medical or veterinary decision phase2).
If any of these steps are missing, the method will not be excluded under Article 53(c) EPC.
Example: Claims to the use of smart contact lenses that diagnose diabetes by measuring glucose concentration in tears might avoid the exclusion by claiming only the use of biosensors within the smart contact lenses to measure glucose concentration (step i), without claiming the subsequent analysis of the data and the diagnosis of diabetes (steps (ii) - (iv)).
Tips: If planning to avoid the exclusion by leaving one or more of steps (i) – (iv) out of the claim, it is important that the application is drafted in such a way that these steps are clearly not essential to the definition of the invention (i.e. that the invention is fully defined without these steps). If the claimed step(s) are only ever disclosed as part of a larger method of diagnosis, the EPO are likely to consider that the claimed step(s) cannot be isolated from this context so as to become the principle object of the invention3. In the above example, the invention could be framed as a method of data collection, and the description drafted to provide clear and unambiguous basis to claim this method without steps (ii) - (iv).
Furthermore, while the description can discuss the “missing steps”, for example the potential use of the claimed data collection method in a method of diagnosis (i.e. steps (ii) - (iv)), it is important not to include these steps in the dependent claims. Doing so can lead to an objection to the independent claim upon which these claims depend4.
One should also be aware that certain steps may be considered to be implicit. For example, steps relating to the comparison of data with standard values (step (ii)) may be considered to imply the finding of a significant deviation (step (iii))2,5.
3. Method claims may not be excluded if steps (i) to (iii) result in only an “intermediate finding” on the road to a clinical diagnosis
To be excluded from patentability, the method claim must include the final medical or veterinary decision phase, in other words, the diagnosis of “a particular clinical picture”2 (step (iv)).
Therefore, a claim relating to a method that stops short of actually diagnosing a particular clinical picture may not be excluded from patentability. Indeed, in one of the key decisions in the field of diagnostic methods, G1/04, the Enlarged Board of Appeal (EBA) confirmed that “intermediate findings” of diagnostic relevance must not be confounded with diagnosis for curative purposes and that a method for obtaining such findings did not constitute sufficient basis for denying patentability6.
Example: Claims to the use of sensors within smartphones and watches to detect gait speed, symmetry and stride length, which can be used by doctors to help diagnose Alzheimer’s disease, are likely to be patentable provided the step of diagnosing Alzheimer’s disease, or a medical condition which is indicative of Alzheimer’s disease, does not fall within the claimed steps of the method.
Tips: Take care when drafting the patent application as, if the diagnosis step would seem to be essential for the definition of the invention, simply leaving it out of the claim will lead to an objection from the EPO under Article 84 EPC on the grounds that an essential feature is missing2. This might arise if it is clear from the patent application as a whole that the results of the method would inevitably allow the attribution of the detected deviation to a particular clinical picture, even if that particular step is not claimed7,8.
It is important to note that the use of the language “attribution of the deviation to a particular clinical picture” in step (iv) does not imply that a specific disease needs to be diagnosed. The diagnosis may be of a broader nature than that and include “the determination of the nature of a medical or veterinary medicinal condition intended to identify or uncover a pathology”2... For example, in T1016/10, the detection of an “amyloidogenic disorder” was considered to represent a ”particular clinical picture”, even though amyloidogenic disorders include a wide range of different diseases and the claimed method did not allow the diagnosis of a specific one of these diseases9.
These days, healthcare wearables can detect and identify a wide range of physiological states beyond those directly related to diseases and medical conditions. As the Art.53(c) EPC exclusion applies only to the diagnosis of a particular clinical picture, such methods may be patentable.
Example: Claims to the use of healthcare wearables that monitor a women’s fertility for the purposes of aiding conception, by tracking physiological signals that act as markers for fluctuating hormone levels, are likely to be patentable.
Tips: Take care to draft the method claims using suitably specific language that does not include within its scope the diagnosis of diseases and medical conditions. For instance, considering the above example, monitoring a women’s fertility could theoretically be used for the diagnosis of a particular clinical picture.
To be excluded under Article 53(c) EPC, all of the steps of a technical nature which are necessary for reaching the diagnosis must be carried out on the human or animal body2.
Step (iv) is always considered non-technical, but the Art.53(c) EPC exclusion can be avoided if at least: (i) the collection of data; (ii) the comparison of the data with standard values; or (iii) the finding of a significant deviation (i.e. a symptom) is of a technical nature and isn’t carried out on the human or animal body2.
The proviso “carried out on the human or animal body” is interpreted to mean that the performance of the step “implies any interaction with the human or animal body, necessitating the presence of the latter”10. No specific type or intensity of interaction is required10.
In most cases, the collection of data inherently necessitates the presence of the human or animal body, and the comparison of the data with standard values and the finding of a significant deviation are considered non-technical mathematical methods. However, there are exceptions.
Example: There is case law indicating that the exclusion may be avoided, for example, if the steps of (ii) comparing the collected data with standard values or (iii) the finding of a significant deviation necessitate complex computation using data-processing devices11.
Tips: The technical step that isn’t carried out on the body must be one of: (i) the collection of data; (ii) the comparison of the data with standard values; or (iii) the finding of a significant deviation (i.e. a symptom). Other, intermediate steps will not be considered when assessing the diagnostic character of a method2,3. Therefore, this exclusion can’t be avoided by adding additional technical steps that are not carried out on the human or animal body, if those steps don’t form part of steps (i), (ii) or (iii)12,13.
As the proviso “carried out on the human or animal body” requires interaction with the human or animal body, a method step performed by a software program within a device that is simply designed to be worn on the human body, but does not require any interaction with it, should not be interpreted as “carried out on the human or animal body”.
In conclusion, the manner in which the EPO interpret the “method of diagnosis” exclusion under Art.53(c) EPC means that it is frequently possible to obtain claims to the use of healthcare wearables which function in the diagnostic space, provided the description and claims are drafted with the exclusion in mind. The exclusion of “methods of treatment by surgery or therapy” is, however, much broader in scope and is discussed in a separate article found here.
If you would like know more, please get in touch with Julia Venner, Nick Noble or your usual Kilburn & Strode advisor.
1. Mordor Intelligence “Wearable Medical Devices Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)” https://www.mordorintelligence.com/industry-reports/global-wearable-medical-device-market-industry
2. Guidelines for Examination in the EPO (G-II, 184.108.40.206)
3. T143/04 (section 2 of the Reasons for the Decision)
4. T125/02 (section 2 of the Reasons for the Decision)
5. T1197/02 (section 2.3 of the Reasons for the Decision)
6. G1/04 (section 6.2.3 of the Reasons for the Decision)
7. Guidelines for Examination in the EPO (F-IV, Annex, Example 6)
8. G1/04 (section 6.2.4 of the Reasons for the Decision)
9. T1016/10 (section 2.6 of the Reasons for the Decision)
10. G1/04 (section 6.4.2 of the Reasons for the Decision)
11. T1016/10 (section 2.7.2 of the Reasons for the Decision)
12. T1197/02 (section 2.2 of the Reasons for the Decision)
13. T143/04 (section 3.2 of the Reasons for the Decision)