The Write Treatment: A Guide to Navigating Medical Device Claims in Europe
We review in this article some of the different claim formulations for medical devices for patent protection in Europe. Under European provisions, practitioners are constrained in their claim drafting by Article 53(c) EPC stating that “European patents shall not be granted in respect of… methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body”.
Typical allowable protection
The above exception to patentability relates to surgical steps, methods of treatment and diagnostic methods, but not to product claims, hence most medical device protection in Europe is afforded by an apparatus protection. The allowability is affirmed in the EPO Guidelines (G II 4.2.1):
“Claims to medical devices... which comprise subject-matter corresponding to that of a method for treatment of the human or animal body by surgery or therapy or to that of a diagnostic method practised on the human or animal body are not to be objected to under Art. 53(c), because only method claims may fall under the exception of Art. 53(c).”
An example of an apparatus claim might be “A medical device comprising: feature A and feature B”.
While Article 53(c) EPC states that the exception shall not apply to products (apparatus), a caveat is that the apparatus will fall under the exception if it can only be produced by performing a surgical or therapeutic step. This was the case in the decision of the Technical Board of Appeal T1731/12 which concerned a pulse generating apparatus for the treatment of Parkinson’s disease. The apparatus in question comprises two electrodes that are implanted into the brain and a control means that controls the electrodes to administer stimuli in order to desynchronise different areas of the brain. The Board decided that effect of the claim could only be achieved after the electrodes had been implanted because only then could the control unit be designed so that the effect is fulfilled, i.e. the apparatus could only be manufactured using a surgical step. The exception of a surgically defined apparatus is confirmed in the EPO Guidelines (G II 4.2):
“However, a method of manufacturing an endoprosthesis outside the body, but requiring a surgical step to be carried out for taking measurements, would be excluded from patentability under Art. 53(c) (see T 1005/98).”
This type of objection could be overcome by including during drafting other ways to non-surgically configure an apparatus, e.g. based on medical imaging and modelling.
Second medical use protection
In the example of the apparatus claim above, “a medical device comprising: feature A and feature B”, if the features A and B can be defined structurally (e.g. in terms of electrical or mechanical components, shape, internal configuration, moving parts, etc), usually these features will be effective as limitations for novelty against the prior art. Difficultly may arise when features A and B are defined in terms of functional features which reference a part of the body. Depending on the interaction with the body, the feature might be regarded as merely “suitable for”, or “ for use in a method” by the EPO, which can prevent these features A, B, which rely on their functional definition for novelty, from having that novelty recognised under the EPC.
Second medical use protection is sometimes cited by Applicants as a reason for allowing limitations to count against the prior art. Art. 53(c) EPC specifies that products, in particular substances and compositions for treatment are not excluded from patentability, and a further provision, Art. 54(5) EPC, explicitly states that a substance or composition can derive novelty from its intended new specific use in a method of treatment. As a medical device is typically formed from a substance or composition and used in a medical treatment, shouldn’t these two provisions make it possible to obtain a patent with claims for a known medical device for a new purpose-limited novel and inventive second or further medical use? Alas, not usually. Case law has set clear limits what can be considered a product for the purposes of Art. 54(5) EPC. The limits, extracted from the case law, have been summarised thoroughly in the literature (see for instance, Meyer et al, GRURInt, 2/2016), and a short summary is provided below. In order to derive novelty from its new medical use, a device, or parts thereof, should:
– be consumed during the treatment,
– be a finished product that on its own carries out its function,
– be in contact with the body during the treatment,
– have an active ingredient that carries out its function,
– not derive its function from its shape and position.
The EPO Guidelines for Examination (G-VI 7.1.1) give an example of a filler material which is injected between a first tissue targeted for radiation treatment and a second sensitive tissue which is desired to be protected from radiation. If the shielding effect of the filler material is achieved by a mere mechanical displacement of the sensitive tissue relative to the target tissue, due to the volume it occupies between the two tissues, the filler material qualifies as a device rather than a substance or composition. On the other hand, if the filler material produced a radiation-reducing effect on the sensitive tissue which could be attributed to its chemical properties, it would be considered as a "substance or composition" in the sense of Art. 54(5) EPC.
Method of manufacture
A method for the manufacture of a medical device could be patentable under European practice. If the medical device requires patient-specific data for its manufacture, and if that data does not require a surgical step to acquire, then there is typically no issue under Article 53(c) EPC. The EPO guidelines provide the following example (G II 4.2):
“For instance, a method of manufacturing insoles in order to correct the posture or a method of manufacturing an artificial limb is patentable. In both cases, taking the imprint of the footplate or a moulding of the stump on which an artificial limb is fitted is clearly not of a surgical nature. Furthermore, the insoles as well as the artificial limb are manufactured outside the body.”
However, if the method of manufacturing the endoprosthesis outside the body required a surgical step for taking measurements it would be excluded from patentability under Art. 53(c) for reasons similar to those mentioned in the T1731/12 decision discussed above.
Computer implemented inventions
A claim directed to a method of surgery, treatment or diagnosis cannot remedy an Article 53(c) EPC objection merely by reformulating it as a computer implemented method; such a claim will continue to fall under the exception, viz:
“If a surgical method claim is open to objection under Art. 53(c), this also applies to a corresponding claim directed to a computer-assisted surgical method. In other words, surgical methods for which European patents cannot be granted according to Art. 53(c) do not avoid exclusion merely through computer assistance.” (EPO Guidelines G-II 126.96.36.199)
“If a method claim directed to therapy is open to objection under Art. 53(c), this also applies to a corresponding claim directed to a computer-implemented therapeutic method (T 1680/08). In this respect, the same observations as in G-II, 188.8.131.52, for computer-implemented surgical methods apply.” (EPO Guidelines G-II 184.108.40.206)
However, non-surgical methods for collection data (without making a diagnosis) are not excepted from patentability:
“Accordingly, methods for merely obtaining information (data, physical quantities) from the living human or animal body (e.g. X-ray investigations, MRI studies, and blood pressure measurements) are not excluded from patentability under Art. 53(c)“ (EPO Guidelines G-II 220.127.116.11)
Further, a computer-implemented method claim excepted under Article 53(c) EPC, may be reformulated as a computer program or storage matter to overcome the exception, viz:
“Claims to ... computer programs and storage media which comprise subject-matter corresponding to that of a method for treatment of the human or animal body by surgery or therapy or to that of a diagnostic method practised on the human or animal body are not to be objected to under Art. 53(c), because only method claims may fall under the exception of Art. 53(c).” (EPO Guidelines G-II 4.2.1)
The maze that is device protection in Europe takes some understanding of the provision of Article 53(c) EPC and case law to safely navigate. A method claim that implies a surgical, treatment or diagnostic step on the body is excepted from patentability. While an apparatus claim does not fall under the exception, it can still be considered to contain surgical steps under certain conditions. The recognition of novelty for a second medical use of a medical device remains elusive for a majority of devices - unjustly inequitable with compositions used in medical treatments. A computer implemented method claim formulation does not remedy an Article 53(c) EPC deficiency, but a computer program or storage medium will succeed. It is clear that writing patents for medical devices in Europe requires an appreciation of the legal landscape and a careful consideration of the wording and format of the claims. However, with the right expertise and guidance, applicants can successfully navigate the maze and secure the protection they needed to bring their innovative medical devices to the market. If you have any questions about this article, or need advice concerning your idea, feel free to reach out to us at email@example.com. Our medical device team is ready to assist you!