According to Article 52(4) of the European Patent Convention (EPC) diagnostic methods practised on the human or animal body are not regarded as inventions which are susceptible of industrial application within the meaning of Article 52(1) EPC.
In the past, different interpretations of this article have been used in the European Patent Office (EPO). In the strictest interpretation, this article was held to forbid method claims that involved a step performed on the human or animal body for the purpose of diagnosis.
In practice, this made patent protection impossible for inventions wherein application to the human or animal body during a diagnostic procedure was necessary to distinguish from the prior art. On the other hand, in the most lenient interpretation, Article 52(4) was held to forbid only method claims that included a step of reaching a diagnosis. The Enlarged Board of Appeal decision, which has final authority about interpretation of the EPC before the EPO, has now settled this point by siding with the more lenient interpretation.
The President of the EPO referred the point of law that arose from the contradicting Board of Appeal decisions T 385/86 and T 964/99 to the Enlarged Board of Appeal (G 1/04).
Referral to the Enlarged Board of Appeal
T385/86 stated that the only diagnostic methods to be excluded from patent protection are those whose results immediately make it possible to decide on a particular course of medical treatment. In other words, methods providing only interim results are not diagnostic methods in the sense of Article 52(4) EPC, even if the results could be used in making a diagnosis. The consequence of this interpretation of Article 52(4) EPC is that methods not containing all the steps involved in making a medical diagnosis would not be excluded from patentability (conclusion President).
In contrast, T 964/99 stated that the expression “diagnostic methods practised on the human or animal body” should not be considered to relate to methods containing all the steps involved in reaching a medical diagnosis. This Board considered that in accordance with the ordinary meaning to be given to the terms of the EPC-treaty in its context (good faith principle), Article 52(4) EPC
is meant to exclude from patent protection all methods practised on the human or animal body which relate to diagnosis or which are of value for the purposes of diagnosis. Essentially all that is needed to justify exclusion under Article 52(4) EPC is that the claimed method comprises one step which serves diagnostic purposes or is related to diagnosis.
Ratio of exclusion of diagnostic methods
The Enlarged Board of Appeal reminded that the exclusion from patentability of the abovementioned methods under Article 52(4) EPC seems to be based on socio-ethical and public health considerations. Medical and veterinary practitioners should be free to take the actions they consider suited to diagnose illnesses by means of investigative methods. According to established
jurisprudence, making a diagnosis as part of a medical treatment of humans or a veterinary treatment of animals for curative purposes includes at least four phases, viz.:
(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 phase (diagnosis for curative purposes stricto sensu).
The Enlarged Board argued that the deductive decision, phase (iv), as a purely intellectual exercise (unless it is carried out by a device), cannot be regarded as an invention within the meaning of another article of the EPC (Article 52(1)). In order to be an invention in the sense of Article 52(1)
EPC, the non-technical decision phase must necessarily be accompanied by preceding steps of a technical nature.
The Enlarged Board continued that according to Article 4(3) EPC, it is the general task of the EPO to grant European patents. Moreover, Article 52(1) EPC lays down the fundamental maxim of a general entitlement to patent protection to the effect that, as a matter of principle, a European patent is to be granted for an invention which meets the requirements of that provision. It is true that there are exclusion clauses from patentability provided for in the EPC. It is also true that the frequently cited principle, according to which exclusion clauses from patentability laid down in the EPC are to be construed in a restrictive manner, does not apply without exception. However, the Enlarged Board of Appeal considers that the principle of a narrow interpretation of such exclusion clauses is to apply in respect of the scope of the exclusion from patentability under Article 52(4) EPC concerning diagnostic methods. The wording of Article 52(4) EPC does not relate to particular steps in such methods. Thus, the text of the provision itself already gives an indication towards a narrow interpretation in the sense that, in order to be excluded from patentability, the method is to include all steps relating to it.
Further, it is difficult to define medical or veterinary practitioners on a European level for the sake of preventing them to be inhibited by patents in their diagnosis actions. From this it follows that, for reasons of legal certainty, which is of paramount importance, the European patent grant procedure may not be rendered dependent on the involvement of such practitioners: whether or not a medical or veterinary practitioner is involved in the method plays no role when deciding if the method is a diagnostic method in the sense of Article 52(4) EPC. Since a comprehensive protection of medical and veterinary practitioners may be achieved by other means if deemed necessary, the Enlarged Board is of the opinion that a narrow interpretation of the scope of the exclusion from patentability referred to above is therefore equitable. With regard to diagnostic methods involving method steps of a technical nature carried out by a device, such methods are in principle patentable if the technical method steps are not performed on the body. However, the Enlarged Board noted that recent developments in the field of diagnostics for curative purposes render these methods more and more complex and technically sophisticated, so that it is becoming increasingly difficult for medical or veterinary practitioners to have the means to carry them out. In this respect, they will hardly be hampered in their work by the existence of patents related to such methods.
Decision of the Enlarged Board
For a diagnostic method practised on the human or animal body to fall under the prohibition of Article 52(4) EPC, the claim must include features relating to:
(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that diagnosis, and
(iii) 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.
Whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC may depend neither on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medical or technical support staff, the patient himself or herself or an automated system. Moreover, no distinction is to be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it.
In a diagnostic method under Article 52(4) EPC, the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion “practised on the human or animal body”.
Article 52(4) EPC does not require a specific type and intensity of interaction with the human or animal body. A preceding step of a technical nature thus satisfies the criterion “practised on the human or animal body” if its performance implies any interaction with the human or animal body, necessitating the presence of the latter.
Consequences of the decision of the Enlarged Board
In the decision, the Enlarged Board opted for a formal test that allows the issue of exclusion from patentability under Article 52(4) EPC to be decided just by looking at the type of steps that the
claim contains. Several amici voiced concerns that such a formal approach would lead to a practice wherein Article 52(4) EPC could be flouted simply by deleting one type of step from a claim. The Enlarged Board played down such concerns, because it felt that EPO would force applicants to include such steps in method claims if they were essential to the invention (only to reject the claim as excluded under Article 52(4) EPC). It must therefore be expected that examiners will look very strictly whether applicants can be forced to include steps such as the diagnosis stricto sensu step and steps that interact with the human or animal body in their method claims, by arguing that these steps are essential for the invention. Applicants should be prepared to have arguments why
these steps are not essential for their invention. One way of arguing may be to formulate an object of the invention in terms of providing for a method to measure physical or chemical properties,
instead of an object in terms of diagnostic goals. Needless to say, European patent applications, where possible, should avoid statements that a diagnosis step stricto sensu or a step that interacts with the human body is essential. Claims without all these steps should preferably be included already on filing. Moreover, claims to a device that provides automated diagnosis should be included if relevant, as such claims are not expected to be rejected under Article 52(4) EPC. This leaves problems only for inventions wherein the diagnosis step stricto sensu by a human is an
inseparable part of the invention. It is to be noted that Article 52(4) EPC also applies to exclusion
from patentability of surgical and therapeutic methods.
Although not the subject of the present decision, it may be noted that with respect to methods of surgery or therapy, the Enlarged Board has endorsed the “single step” approach whereby a method claim falls under the prohibition of Article 52(4) EPC if it includes at least one feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by surgery or therapy. The Enlarged Board indicated that the restrictive interpretation of patent exemption for diagnostic methods does not amount to setting a different standard for diagnostic methods han that established for methods of surgery or therapy.