Healthcare wearables – 5 useful things to know about patenting their use (part 2: treatment by surgery or therapy)

Healthcare wearables – 5 useful things to know about patenting their use (part 2: treatment by surge

This article focuses on five useful things to know about patenting the use of healthcare wearables in the field of therapeutic and surgical treatment; a corresponding article on diagnostic uses can be found here.

As we discussed in our first article, recent years have seen an explosion in the field of healthcare wearables and 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, Article 53(c) of the European Patent Convention (EPC) recites that:
 
European patents shall not be granted in respect of methods of treatment of the human or animal body by surgery or therapy”.
 
Therefore, while the devices themselves may be patentable, any claims to the use of such devices in a surgical or therapeutic method may be excluded from patentability.
 
This exclusion is interpreted more broadly than the exclusion covering diagnostic methods; a method claim is not patentable at the EPO if it includes even a single feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by surgery or therapy1. However, the way in which the EPO interpret “surgery” and “therapy” means that some claims to the use of healthcare wearables in methods of treatment are patentable...
 

1. Insubstantial physical interventions may not be considered “surgery”

Not all invasive physical interventions which may broadly be considered “surgery” will fall within the exclusion set out in Article 53(c) EPC.  The exclusion applies to:
 
“…substantial physical interventions on the body which require professional medical expertise to be carried out and which entail a substantial health risk even when carried out with the required professional care and expertise”2.
 
The degree of invasiveness or complexity of the operation performed can also determine if a procedure is considered surgical2. Simple, minor physical interventions, entailing little health risk, may escape the exclusion. Specifically, invasive techniques of a routine character which are performed on uncritical body parts and generally carried out in a non-medical, commercial environment are not excluded from patentability2. T2699/17 provides a useful discussion regarding exemplary criteria that may be taken into account when determining what health risk a method involves and whether it is considered substantial3.
 
Example: Claims to the use of a device comprising an adhesive patch with a needle or electrode which is inserted just under the skin to measure blood glucose levels are likely to be considered patentable.
 
Tip: Where a step requiring physical intervention with the body is an essential feature of the claimed method and cannot be left out to avoid the exclusion, it is important to ensure that the application as filed discusses the simple, routine, low risk nature of such steps (if applicable) to reduce the chance of them being considered excluded surgical steps.
 

2. Simply relieving discomfort (not providing therapy) is patentable

While Article 53(c) EPC excludes therapeutic methods from patentability, a line can be drawn between those methods that are truly therapeutic (in that they cure or prevent a disease or malfunction of the body) and those that merely relieve discomfort in a healthy subject. As stated in the Guidelines for Examination in the EPO4.
 
“When a method is directed to the treatment of a human or animal body that is in a normal, healthy state and, even if subject to some discomfort, not likely to develop a pathological state due to the discomfort, providing relief from the discomfort is not necessarily a therapy”.
 
As the use of the phrase “not necessarily” might suggest, the precise definition of “discomfort” is unclear, The fact that the subject is in a normal, healthy state is not sufficient to avoid the exclusion. For instance, pain is not considered “discomfort” (and its treatment patentable) irrespective of the state of the subject5. By way of example, the use of a device to administer transcutaneous electrical nerve stimulation (tens) in the treatment of menstrual cramps would likely be excluded from patentability, despite the pain occurring in a normal, healthy individual. In T81/84, the Board stated that whenever a person is suffering from the manifestations of a given condition, though natural, and whenever these manifestations overlap with or are indistinguishable from the symptoms of a disease or an injury, the treatment should be considered therapeutic6. On the other hand, case law suggests that the treatment of “hunger”7 and “fatigue”8 is patentable.
 
Example: Claims to the use of smart t-shirts comprising thermal devices which detect body temperature and automatically adjust the cooling/warming function depending on wearer preference and activity may be patentable. In T385/09, the EPO found that a method for cooling an animal subject in hot weather conditions is not excluded from patentability, as it does not cure or lessen the symptoms of any disorder or malfunction of the animal’s body, nor does it reduce the possibility of contracting any disorder or malfunction, since no such disorder or malfunction would normally occur if the animal were not cooled9.
 
Tip: While relieving discomfort is not considered therapy, treating the symptoms of a disease or disorder or preventing a pathological state would be. Therefore, in relation to the above example, the use of the smart t-shirt to cool a body to reduce fever or heat a body to treat hypothermia would be excluded from patentability. It may therefore be necessary to explicitly recite in the claims that the method is “non-therapeutic”. While it should be possible to insert such a disclaimer into the claims even without explicit basis in the application as filed10, it would be advisable to include such basis when the application is drafted, if possible. Otherwise, it is important that the patent application discusses uses which are non-therapeutic both in terms of their main purpose and any unavoidable side effects11.

 
3. Prophylatic treatment is not patentable

The exclusion to methods of treatment by therapy includes not only the curing of a disease or malfunction of the body but also prophylactic (or preventative) treatment. As stated in the Guidelines for Examination in the EPO4:
 
“Therapy…is concerned with bringing the body from a pathological state back into its normal, health state or preventing a pathological state” (emphasis added).
 
Example: Claims to the use of a scarf with an in-built filter to strain out airborn particulates and prevent the wearer from contracting diseases such as strep, flu, pneuomonia and tuberculosis are likely to be excluded from patentability.
 
Tip: Prophylatic treatments which are not therapeutic in nature are likely to be patentable. For example, as pregnancy is not a disease or pathology, claims to the use of contraceptive skin patches to prevent pregnancy will not fall under the exclusion in Article 53(c) EPC. Similarly, claims to the use of cooling caps to prevent hair loss are likely to be allowable.
 

4. Purely cosmetic treatment is patentable

Claims directed to purely cosmetic treatment are considered to be patentable. However, a cosmetic treatment that involves surgery or therapy is not1.
 
Example: Claims to the use of patches that use microcurrent technology to treat the signs of ageing, by providing superior penetration of water-based products into the skin to increase collagen and elastin production, are likely to be patentable.
 
Tip: Where the use of a healthcare wearable could provide both cosmetic and therapeutic effects, it may be necessary to explicitly recite in the claims that the method is a “cosmetic method”, in order to avoid the exclusion to therapeutic methods. Again, while it should be possible to insert such a disclaimer into the claims even without explicit basis in the application as filed10, it would be advisable to include such basis upon drafting, if possible.
 
Such disclaimers are unlikely to help avoid the exclusion to methods of surgery, however. The term “surgery” defines the nature of the treatment rather than its purpose2 and thus any claim to a cosmetic method which contains a surgical step will be excluded from patentability (see section 1, above, for a discussion of what is considered a “surgical step”). It is therefore important to ensure that the claims do not include surgical steps and/or that the application as filed provides explicit basis for a method claim without such a steps in order that they can be removed from the claims.

 
5. Methods only concerning the operation of a device are not excluded

The use of some healthcare wearables may, in practise, require a substantial physical intervention that would be excluded from patentability as a surgical method. Alternatively, their use may result in therapeutic treatment. However, if the essential features of the claimed method relate only to the operation of the device, it may be possible to fully define the invention without requiring the presence of the potentially surgical or therapeutic step.
 
This is the case where the method is concerned with the operation of a device without any functional link between the claimed method and the effects produced by the device on the body12. For instance, the method could involve obtaining information on the current working order of a healthcare wearable, provided the steps of the method do not affect the body of the person wearing the device.
 
Example: Claims to a method of measuring the flow of small quantities of liquid in a drug delivery device (to check the operation of the device), may not be excluded from patentability if there is no functional link between the claimed method steps and the dosing of the drug delivered by the device13. This is the case even if it is clear from the description that the device whose operation is being checked is a drug delivery device which administers a drug into the body through a pump in an invasive manner.
 
Tip: It is important to ensure that it is clear from the application as filed that the invention is associated exclusively with the production of an effect on the structure of the device and that it does not influence the effects produced by the device on the body. For instance, in relation to the above example, it would be advisable to ensure that it is clear from the description that the invention involves only measuring the volume of the drug solution flowing into the body per unit of time, and that the flow of the drug itself is not affected (for example, through a closed-loop in which the measured volume automatically influences future administration of the drug). It would also be helpful to ensure it is clear that these steps may be performed without any medical knowledge and that they have no therapeutic effect in themselves.
 

Summary

In conclusion, while the exclusion to “methods of treatment by surgery or therapy” may hamper the patenting of methods of using healthcare wearables with therapeutic effects, or those whose operation involves interventions of a surgical nature, it is not impossible. To be successful, it is important to understand the way in which the EPO interpret “therapy” and “surgery”, and how the claims and the description can be drafted in such as way as to minimise the chance of the claims falling with the exclusion. Obtaining advice from your European practitioner, before the patent application is filed, can be crucial in this regard.
 
If you would like know more, please get in touch with Julia Venner, Nick Noble or your usual Kilburn & Strode advisor.


1. Guidelines for Examination in the EPO (G-II, 4.2.1)
2. Guidelines for Examination in the EPO (G-II, 4.2.1.1)
3. T 2699/17 (section 1 of the Reasons for the Decision)
4. Guidelines for Examination in the EPO (G-II, 4.2.1.2)
5. Case Law of the Board of Appeal, 10th edition, 2022, Section 1B, 4.5.1 (page 65).
6. T 81/84 (sections 3 to 5 of the Reasons for the Decision)
7. T 385/09 (section 3.6 of the Reasons for the Decision)
8. T469/94 (section 4.2 of the Reasons for the Decision)
9. T 385/09 (section 3.4 of the Reasons for the Decision)
10. Guidelines for Examination in the EPO (H-V, 4)
11. T 385/09 (section 2 of the Reasons for the Decision)
12. Case Law of the Boards of Appeal of the European Patent Office, 10th Edition, , section 1B ,4.4.5 c)2022, (page 64)
13. T 245/87 (sections 3.1 and 3.2 of the Reasons for the Decision)

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