|Date of decision:||25 September 1987|
|Case number:||T 0385/86|
|IPC Class:||G01N 24/08|
|Language of proceedings:||DE|
|Download and more information:||
|Title of application:||-|
Headnote1. 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. Methods providing only interim results are thus not diagnostic methods in the meaning of Article 52(4), first sentence EPC, even if they can be utilised in making a diagnosis.
2. A method involving interaction with the human or animal body is susceptible of industrial application if it can be used with the desired result by a technician without specialist medical knowledge and skills.
3. As an exclusion clause, Article 52(4), first sentence, EPC must be narrowly construed. A diagnostic method is practised on the human or animal body in the meaning of this provision only if both examination and establishing the symptoms on the basis of the examination results are performed on a living human or animal body.
|Relevant legal provisions:||
|Keywords:||Diagnostic method - interim results
Interpretation of legal provisions - exlusion clause
Summary of Facts and Submissions
I. European patent application No. 83 104 834.3 filed on 17 May 1983 and published as No. 0 095 124 was refused by the Examining Division on 3 June 1986. According to the main request the decision was based on original Claims 1 to 14, the two independent Claims 1 and 2 of which are worded as follows: "1. A method for the non-invasive determination of chemical and/or physical conditions inside a whole, intact, living animal or human body using magnetic resonance with a homogeneous, steady magnetic field and a high-frequency magnetic field, in which high-resolution magnetic resonance measurements are carried out on individual areas of the body and freely-selectable measuring points at any desired location within the living body are examined using local magnetic resonance (LMR) restricted to selectable areas of the body's volume, characterised in that the temperature within the selected areas of volume is determined from a parameter of the nuclear magnetic resonance spectrum measured.
2. A method for the non-invasive determination of chemical and/or physical conditions inside a whole, intact, living animal or human body using magnetic resonance with a homogeneous, steady magnetic field and a high-frequency magnetic field, in which high-resolution magnetic resonance measurements are carried out on individual areas of the body and freely-selectable measuring points at any desired location within the living body are examined using local magnetic resonance (LMR) restricted to selectable areas of the body's volume, characterised in that the pH value within the selected areas of volume is determined from a parameter of the nuclear magnetic resonance spectrum measured." ...
II. The main request was refused on the basis of Article 52(4) EPC, it being evident from the wording of the claims, the statement of the problem to be solved and other information given in the description that Claims 1 and 2 were in each case directed to a diagnostic method practised on the human or animal body which would reproduce the values measured on the living body under examination and thus reveal any deviations from the norm. ...
III. The applicants filed an appeal against this decision on 10 July 1986, at the same time paying the appeal fee, and submitted a statement of grounds on 2 October 1986. ...
Reasons for the Decision
3. The first question to be considered is whether the substance of independent Claims 1 and 2 falls under the first sentence of Article 52(4) EPC, which states that diagnostic methods practised on the human or animal body shall not be regarded as inventions susceptible of industrial application and are therefore not patentable.
3.1 As regards diagnostic methods, the travaux préparatoires for Article 52(4) EPC provide the following pointers as to its meaning and purpose: According to an initial proposal, processes used in the laboratory for the purpose of diagnosis were definitely not to be patentable where they involved treatment by doctors (see BR/135/71, page 48, point 93). The subsequent proposal of a general exclusion of all diagnostic methods brought objections from interested circles who claimed that advances in technology had indeed led to the evolving of diagnostic methods which were not of a specifically medical nature (see BR/169/72, page 9, second paragraph). Following a proposal from the French delegation, the term "diagnostic methods" was later defined more precisely by the addition of the words "applied to the human or animal body" (see BR/177/72, page 5, point 9c). Moreover, in the "Grounds given with regard to the ratification of international patent conventions" it is stated that the exclusion made by Article 52(4) EPC is in line with existing case law and literature and was ethically motivated (see R/1181/74, page 18, third paragraph). Finally, it was made quite clear at the Munich Diplomatic Conference by a change in the wording that the methods referred to in Article 52(4) were in fact inventions but were simply not susceptible of industrial application - see "Minutes of the Munich Diplomatic Conference for the setting up of a European system for the grant of patents" (Munich, 10 September to 5 October, 1973) published by the Government of the Federal Republic of Germany, page 28, and in particular point 24.
3.2 All this shows that the first sentence of Article 52(4) EPC is intended to exclude from the possibility of patent protection only methods of therapeutic treatment, so that no-one can be hampered in the practice of medicine by patent legislation. Like any exclusion clause, Article 52(4), first sentence, must be narrowly construed, a fact underscored by the statement in the second sentence that the exclusion from patentability does not apply to products for use in such methods. The Board is therefore convinced 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. This means that to answer the question whether amethod is a diagnostic method for the purposes of Article 52(4), first sentence, it is necessary to ascertain whether the method claimed contains all the steps involved in reaching a medical diagnosis. Methods providing only interim results are thus not diagnostic methods in the meaning of Article 52(4), first sentence, even if they can be utilised in making a diagnosis.
3.3 The systematic list of the steps leading to a diagnosis contained in the relevant literature includes recording the case history, observing, palpating and auscultating various parts of the body and carrying out numerous medical and technical examinations and tests - the examination and data gathering phases - and comparing the test data with normal values, recording any significant deviation (symptom) and, finally, attributing the deviation to a particular clinical picture (deductive medical decision phase) - cf. Brockhaus Enzyklopädie,
Vol. 4, 1968, page 684; The New Encyclopaedia Britannica, Macropaedia, 1977, Vol. 5, page 684; La Grande Encyclopédie Larousse, 1973, Vol. 7, page 3833. Even if only one of the last three steps is lacking, there is no diagnostic method but at best a method of data acquisition or data processing that can be used in a diagnostic method.
3.4 In the present case the result of the measures claimed is a quantitative expression of an isolated physical variable, namely the temperature or pH value within a given volume of a human or animal body. In the view of the department of first instance the fact that the product of the measures claimed are measurements of the body's own values which thus show up a divergence from the norm that can be used to make a diagnosis was sufficient to constitute a diagnostic method. For the reasons stated above the Board is unable to concur. On the contrary it is still necessary to consider whether the measurements obtained immediately indicate the diagnosis.
3.4.1 The measures claimed in Claim 1 result in the obtaining of a specific value for body temperature. While the department of first instance is correct in stating that such a value implicitly contains information which is of use in making a diagnosis, it is not a matter of the possibilities outside the scope of the claim that the value opens up. What is decisive is whether the nature of the disease is already immediately clear from that very value, which in the present case is not so. The presence or absence of a particular disease cannot be determined solely from the value of the body temperature as measured. For this it would first be necessary to establish whether the actual temperature measured differs significantly from a reference temperature value regarded as normal, i.e. non-pathological, and to what clinical picture the quantitative variance can be attributed. Only if these operations of differentiation and comparison were to be incorporated into the claim would the claimed method of measuring a physical variable (temperature) on the human or animal body become a diagnostic method in the meaning of Article 52(4), first sentence, EPC, and would then be so regardless of whether these operations were performed by a doctor or by computer.
3.4.2 The above arguments also apply to Claim 2. Here too the result of the procedure is simply a measurement giving information about the pH level inside a given area of the body's volume, but not about the presence or absence of a particular disease. Moreover, as the appellants have stated verbally, there is in the current state of clinical medicine no way of attributing pH values to a specific clinical condition.
3.5 The same answer is arrived at if, working on the assumption that the first sentence of Article 52(4) EPC is intended to prevent a doctor from being hampered in the practice of medicine by patent legislation, the characterising features of Claims 1 and 2 are examined to see whether they define methods which cannot be considered susceptible of industrial application because they can only be carried out by a doctor in the exercise of his healing skills.
3.5.1 The steady magnetic field and the high-frequency magnetic field used in the present case are natural forces which trigger the nuclear magnetic resonance. The effect on living matter is therefore of a technical nature. The impact of these technical measures with the body, i.e. the spin-flip in the living matter, does not constitute invasion of the living substance nor lead to any permanent changes in the body matter. Nor, so far as is known, do they leave any harmful side-effects. The Board is therefore convinced that a person skilled in nuclear spin resonance spectroscopy could implement the measures claimed in a commercial laboratory environment without specialist medical knowledge or skills.
3.5.2 The various steps for which protection is sought do not therefore include any measures having the character of medical treatment or requiring a doctor to carry them out. In fact it is a technician who, using the method claimed, is able, quite independently, to produce a working basis for the doctor's subsequent activity of diagnosis. Since the examination phase does not require the presence of a doctor who, moreover, has at his disposal a piece of equipment detached from the living body, the measures claimed are susceptible of industrial application, just like laboratory tests carried out on blood or tissue samples taken from the body. A method involving interaction with the human or animal body is susceptible of industrial application if it can be used with the desired result by a technician without specialist medical knowledge and skills. This is so in the present case.
3.6 For the reasons stated in points 3.2 to 3.5.2 above, the Board is satisfied that the features claimed in independent Claims 1 and 2 characterise not a diagnostic method but a technical method of measurement which might be useful inter alia in diagnosis.
3.8 This finding also accords with European Patent Office case law to date. Thus in the "second medical indication" decision of the EPO's Enlarged Board of Appeal dated 5 December 1984 (OJ EPO 1985, 64-66) point 22 of the reasons for the decision expressly states that the intention of Article 52(4) EPC is only to free from restraint non-commercial and non-industrial medical and veterinary activities. Furthermore, in its unpublished decisions T 61/83, T 208/83, T 18/84 and T 45/84, EPO Technical Board of Appeal 3.2.1 stated that a diagnostic method in the meaning of Article 52(4), first sentence, EPC must contain not only the method of examination providing the basis for the diagnosis, but also the result constituting the diagnosis.
3.9 The opinion of the Board set out above does not, moreover, conflict with a uniform interpretation of the law on the part of the Contracting States, since a comparison of the more recent case law there shows no such consistent interpretation of the term "diagnostic methods" to exist. While the Paris Court of Appeal construes the term "diagnostic methods" narrowly (PIBD, 1983, No. 329, page III -189), decisions of the Swiss Federal Supreme Court (GRUR International 1983, page 316), the German Federal Patent Court (GRUR 1985, page 278) and the Swedish Patent Appeal Court (cf. Törnroth et al. - Patentlagsstiftningen, 1980, page 54 and GRUR International 1985, page 617) apply a somewhat broader interpretation.
4. When issuing the contested decision the department of first instance only gave the reasons why in its opinion the claimed measures constituted a diagnostic method. It failed to explain in detail whether and why the method was "practised on the human or animal body", obviously assuming that this was the case because of the magnetic fields' effect on the body of producing magnetic resonance. Although the Board of Appeal does not see any diagnostic method in the methods claimed, it nevertheless considers it appropriate to consider whether the very interaction of natural forces with the living body involved in such a method of measurement fulfils the condition of being "practised on the ... body".
4.1 As explained above, since the first sentence of Article 52(4) EPC, is an exclusion clause, it must be narrowly construed. From the Board's point of view this means that where the facts show a particular subject-matter to be covered by the first sentence of Article 52(4), EPC both examination (measurement of actual value) and establishing the symptoms on the basis of the examination results - hence the deviation measured from the norm -must be carried out on a living human or animal body.
4.2 We now have to determine whether the temperature measured as claimed in Claim 1 or the pH value measured as claimed in Claim 2 are directly readable from parts of the body. In the case of the methods claimed in Claims 1 and 2 a steady magnetic field and a high-frequency magnetic field act on the part of the body concerned. If an energy quantum of the high- frequency magnetic field matches the energy difference between two adjacent nuclear spin orientations in the body matter (resonance), it is absorbed by the nucleus and produces a change in the nuclear spin orientation in the steady magnetic field. This spin-flip can be measured either as a line of absorption in the frequency spectrum of the high-frequency magnetic field after it has penetrated the body, or as an induced voltage signal in a coil placed outside the body. The nuclear environment tends to weaken the steady magnetic field at the site of the nucleus, shifting the resonance frequency by an amount characteristic of the temperature or of the pH value. The measures described in independent Claims 1 and 2 result in a measured value only visible outside the body in the high-resolution resonance spectrum that appears on a screen or plotter page in the final stage of the diagnostic apparatus. The data on temperature and pH value thus obtained is therefore visible on a data carrier detached from the body only after further technical measures which take place outside the body. Any further step which as a result of comparison with a norm reveals an abnormal deviation, does not require the patient's presence. The Board is therefore of the opinion that neither the features described in Claim 1 nor those in Claim 2 define a method "practised on the human body".
4.3 The practice of a diagnostic method on the human or animal body in the meaning of Article 52(4), first sentence, EPC presupposes that even a deviation from a norm that must be regarded as a symptom is directly discernible on the body itself.
4.3.1 If it were a matter of observing the spin-flip itself, the method would have to be considered as practised directly on the body. Typical examples of such methods are in the Board's opinion an allergy test in which the abnormal deviation can be detected from a change to the skin; a method for determining the patency of a body duct whereby liquid is injected into the uterus with a catheter and the pressure build-up in the uterus observed; a method in which scarlet-fever spots are directly observed or photographed; or an endoscopic examination carried out to ascertain liver damage.
4.3.2 On the other hand, it is not in the Board's opinion sufficient simply that an investigation into the state of a human or animal body be carried out for medical purposes (see Guidelines for Examination in the European Patent Office, Part C, Chapter IV, 4.3). The condition ascertained must of itself demonstrate the pathological deviation. A measurement of blood pressure is an absolute value which only reveals any irregularity when compared with a norm. It is only the comparison and the explicit indication of how great the deviation must be to be characteristic of a particular disease or group of diseases that make the measuring method a diagnostic one. Thus a radiographic examination with X-rays does not make the internal condition discernible on the body itself but only on a screen after the X-ray quanta have been converted into visible fluorescent light outside the body. And even then a pathological condition can only be ascertained when the density structure has been compared with normal values.
5. Since the Examining Division had already reached the opposite conclusion with regard to Claims 1 and 2, it did not go on to examine whether the application met the other requirements for patentability laid down in the EPC. This will now have to be done. The Board therefore considers it necessary to make use of the possibility open to it under Article 111 EPC and to remit the case to the Examining Division for further prosecution.
6. Given the circumstances, it was no longer necessary to consider the requests in the alternative. In particular, the Board sees no need to refer the matter to the Enlarged Board of Appeal. It does not view its conclusions as differing basically from the interpretation of Article 52(4), first sentence, EPC in earlier EPO appeal decisions relating to diagnostic methods.
For these reasons, It is decided that:
1. The contested decision is set aside.
2. The matter is referred back to the Examining Division for further examination on the basis of the original Claims 1 to 14.