SUMMARY OF THE REFERRAL TO THE ENLARGED BOARD OF APPEAL BY THE PRESIDENT OF THE EPO CONCERNING THE INTERPRETATION OF THE TERM “DIAGNOSTIC METHOD PRACTICED ON THE HUMAN OR ANIMAL BODY” IN ARTICLE 52(4) EPC

In the Referral, dated December 29, 2003, the President of the EPO referred several points of law to the Enlarged Board of Appeal based on two divergent decisions in the field of diagnostics. The Referral is mainly based on the divergence between the interpretation of the term “diagnostic method practiced on the human or animal body” in the context of Article 52(4) EPC in decisions T 385/86 and T 964/99, both of the Technical Board of Appeal 3.4.1.

The following points of laws are referred (literal translation):

1a) Do only those methods constitute “diagnostic methods practiced on the human or animal body” within the meaning of Article 52(4) EPC (in the following “diagnostic methods”) which comprise all steps necessary for establishing a medical diagnosis, i.e. the examination phase including data gathering, the comparison of the data obtained with the normal values, the establishment of a significant deviation (of a symptom) by this comparison, and finally the attribution of the deviation to a certain clinical picture (the deductive medical decision phase), or

1b) is a “diagnostic method” already present if the claimed method comprises only one method step which is of value for diagnostic purposes or relates to diagnosis?

2) If the question in 1b) is affirmed: Must the claimed method be exclusively applicable for diagnostic purposes or be exclusively related to diagnosis? Which criteria are needed to obtain a judgment?

3a) Is a “diagnostic method” already present, if

(i) the claimed method contains at least one step which is regarded as a fundamental step of a “diagnostic method”, requiring the personal presence of a physician (alternative 1), or

(ii) the claimed method, although not requiring the personal presence of a physician, requires that a physician assumes the responsibility (alternative 2), or

(iii) all method steps can be practiced even or also by medical or technical help, by the patients themselves, or by an automated system (alternative 3)?

3b) If the participation of a physician (through physical presence or by assuming responsibility) is decisive, must the physician then participate in that method step which is practiced on the body, or must the physician participate in only any of the steps regarded as a fundamental step of a diagnostic method?

4) Does the requirement “practiced on the human or animal body” means that the steps are carried out in direct contact with the body, or can only those steps which are directly practiced on the body attribute a diagnostic character to a method, or is it sufficient if at least one of the method steps is directly practiced on the body?

Reasons for the Referral

I. Introduction

In the reasons, the President provides arguments supporting a deviation between the two decisions with regard to the interpretation of the term “diagnostic methods practiced on the human or animal body” in the meaning of Article 52(4) EPC. First, he elaborates on the intention of Article 52(4) EPC, noting that according to sentence 1, “diagnostic methods practiced on the human or animal body” would not be considered industrially applicable, similar to the “methods of surgery or therapeutic treatment of the human or animal body” (in the meaning of Article 52(1) and 57 EPC). The basis for the exemption in Article 52(4) EPC would be legal, socio-ethical and cultural considerations with regard to human health, in particular, persons using surgical, therapeutical or diagnostic methods as part of a medical treatment of humans or animals should not be hampered by patents.

II. Decisions T 385/96 and T 964/99

In this section, the two decisions are summarized and briefly commented upon. In decision T 386/86, OJ EPO 1988, 308 ff. (“Non-invasive determination of measure values”/BRUKER; related to pH and temperature measurements in the body using magnetic resonance), the Technical Board of Appeal requested that Article 52(4) EPC be narrowly construed, similar to other exemptions. Accordingly, a “diagnostic method” in the meaning of Article 52(4) EPC must allow an immediate decision on a particular course of a disease and methods providing only interim results would not constitute a “diagnostic method”. To fulfil this criterion it would be necessary that the claimed method contains all steps involved in reaching a medical diagnosis (1. examination phase, 2. establishing of symptoms, 3. deductive medical decision phase, see item 3.3 of the reasons). Further, the Board pointed out that both phases (examination and establishing of symptoms) must be carried out on a living human or animal body (see item 4.1 of the reasons). In the case under decision these prerequisites were not fulfilled and therefore the claimed method was regarded as patentable. Moreover, a medical doctor must be involved in at least one of the steps of a “diagnostic method” (see item 3.5.2. of the reason).

The President notes that several earlier decisions would be in accordance with the interpretation of the term “diagnostic method” in T 385/86 and that later decisions would have confirmed that view (e.g. T 83/87, T 400/87, T 775/92, T 530/93, T 1165/97, T 629/98, T 1038/00, T 807/98). The narrow interpretation of the term “diagnostic method” would not only be confirmed in the above case law but would also be applied in the practice of the European Patent Office as stated in the “Guidelines for Examination in the EPO” (C-IV, 4.3, October 2001).

When the above case law was established and practiced for several years, decision T 964/99 (OJ EPO 2002, 4 ff. – CYGNUS, INC., related to a method for sampling a substance from the living body and analysis of its concentration) came up, which, in view of the President, would not be in accordance with decision T 385/86. He held that the Board in T 964/99 had stated that an interpretation of the term “diagnostic method” as used in T 385/96 would go against the spirit of Article 52(4) EPC, because it would allow patent protection for “manual procedures” of physical examination (e.g. palpation) (see item 3.5. of the reasons), since these methods would not comprise all steps necessary for a “diagnostic method” according to T 385/86. Further, in the Board’s reasoning in T 964/99, decision T 385/86 would have set a different standard for diagnostic than for surgical or therapeutic methods (see item 3.6 of the reasons). Following a semantic analysis of the terms “diagnosis” and diagnostic”, the Board then concluded that Article 52(4) is meant to exclude from patent protection all methods practiced on the human or animal body which relate to diagnosis or which are of value for diagnosis (see item 4.4 of the reasons), thus methods should be excluded from patent protection even if they comprise only a single diagnostic step. In the Board’s view it would be further immaterial if the claimed methods could also be performed by a patient himself (see item 6.1 of the reasons). In the case under decision these prerequisites were fulfilled and therefore the claimed method was excluded from patentability.

III. Divergence between the decisions

In this section, three main differences between decisions T 385/86 and T 964/99 are revealed concerning a) the interpretation of the term “diagnostic method”, b) the interpretation of the term “practiced on the human or animal body” and c) the necessity of the presence of a physician in “diagnostic methods”.

a) The term “diagnostic method” – all steps required for diagnosis versus one step only required

According to the Referral, the term “diagnostic method” was narrowly construed in T 385/86: the Board in T 385/86 had equated the term “diagnostic method” with “diagnosis” since all steps involved in reaching a diagnosis are required in order to constitute a “diagnostic method”, whereas methods comprising only a single diagnostic step are not excluded from patentability. In contrast, the Board of Appeal in decision T 964/99 had explicitly stated that the term “diagnostic method” should not be considered to relate to methods containing all steps involved in reaching a medical diagnosis. Instead, in the Board’s view, it would be sufficient for an exclusion from patentability under Article 52(4) EPC if the claimed method comprises only one step which serves diagnostic purposes or is related to diagnosis (see items 5.1, 5.2 and 6.1 of the reasons).

In the President’s opinion, it appears to be justified to treat diagnostic methods in the same manner as surgical and therapeutic methods as exempted by Article 52(4) EPC which would mean that only a single step with diagnostic character in a claimed method would render same non-patentable under Article 52(4) EPC. The basis for this wide interpretation of surgical and therapeutical methods would be that “ for a given patient, the optimal or only available treatment could not be administered if even a single part or step thereof – and most treatment comprise several steps – were covered by patent protection” (see item 7 in the reasons of decision T 35/99). In view of the President, “a member of the help care professions could not carry out a diagnostic method on a patient if even a single necessary method step would be protected by patents” (page 17, last sentence). He considers that, depending on which approach of the two decisions further decisions will be based, methods related to diagnosis may or may not be patentable. He supports this argument by demonstrating that the non-allowed method claimed in T 964/99 would be patentable by applying the principles developed in T 385/96 since the step of attributing the measured deviation to a particular disease would be missing.

b) Participation of a Physician – mandatory versus not mandatory

The President notes that, according to the Board in T 385/86, a method involving an interaction with the human or animal body would be susceptible to industrial application if it could be used with the desired result by a technician without specialist medical knowledge and skills (see 3.5.2 of the reasons). Further, from T 385/86 he draws the conclusion that a method could also be considered as a diagnostic method if it contains at least one step (in our view contradictory to the previous statements) which could only be carried out by a doctor (p. 21, last paragraph). Criteria for this requirement might be whether the claimed method would be characterized by an invasion on the living substance or would lead to any permanent changes of the body matter.

In contrast, according to decision T 964/99, it would be immaterial for a decision upon a “diagnostic method” whether the method claimed could be performed only by the patient himself, a technician or by a physician, if the method contained at least one step of an essential diagnostic activity.

In view of the President it would be in agreement with the definition of “therapeutic methods” in the meaning of Article 52(4) that it should not be decisive who the method practices in order to judge about the presence or absence of a “diagnostic method.” While, according to T 385/86, it would have to be analyzed if the method claimed include at least one step which had to be practiced by the doctor himself, it would, according to T 964/99, be the character of the diagnostic activity which should be decisive. In the view of the Technical Board of Appeal, it would appear to be sufficient if there is one step for which the doctor takes the responsibility. The President then provides another example, decision T 655/92, in which, according to his view, it was decisive that the method would contain at least one step which only can be carried out by medical staff or under the responsibility of a physician (see item 5.3 of the reasons, emphasis added).

c) All steps versus one step “practiced on the human or animal body”

The President held that the Board in T 385/86 interpreted Article 52(4) EPC such that all steps of a claimed method must be practiced on the human or animal body themselves to characterize the method as a diagnostic method. According to the Board, the actual values and deviations from the norm that are regarded as symptoms should be directly readable from parts of the body and must be directly discernible on the body itself (see item 4.2 and 4.3 of the reasons). Typical examples would include an allergy test and a method in which scarlet-fever spots are directly observed. In the case discussed in T 385/86 the data would only be visible outside the body and also the pathological deviation was not directly discernible on the body. If only one step of diagnostic character would be practiced outside the body, the criterion “practiced on the ... body” would not be fulfilled.

According to the Technical Board of Appeal in T 964/99, only those methods should be excluded from patentability, which are practiced on the living human or animal body, while extra-corporal laboratory tests would be patentable (see item 4.3 of the reasons). However, since in the claimed method, being the basis for this decision, only the sampling step was performed on the body which (which at the same time was the step with diagnostic character) the President’s concluded, that “obviously not all steps must be practiced on the body in order to exclude a method from patentability.”

Summary and Outlook

The differences between the two cases discussed may be briefly summarized as follows: a) according to T 385/86 a method only constitutes a “diagnostic method” if it comprises all steps necessary for a medical diagnosis, in contrast, in T 964/99, one step with diagnostic character could be sufficient to regard the method as “diagnostic method”, b) whereas in T 385/86 a physician must be involved in at least one step of the “diagnostic method” this is not a prerequisite in T 964/99 and c) both the examination phase and the phase in which the symptoms are established must be practiced on the body according to T 385/86, in contrast, only one step with diagnostic character practiced on the body is sufficient in T 964/99 to regard a method as a “diagnostic method.”

According to established case law of the EPO, methods are excluded from patent protection if they comprise only a single step of a surgical or therapeutical nature (see for example T 775/97, T 1005/98, T 35/99, T 606/96, T 820/92). Importantly, the President states that “it appears to be justified to treat the diagnostic methods as equal with surgical and therapeutical methods. In view of the case law in the field of therapy which is exempted by Article 52(4) and the fact that the legal, socio-ethical aspects apply not only to therapeutic and surgical but also to diagnostic methods there are good chances that the Enlarged Board of Appeal will interpret the term “diagnostic method practiced on the human or animal body” according to T 964/99, thereby raising the bar for obtaining patents in the field of diagnosis.

For more details please refer to the English translation of the full text of the Referral.

ANNEX

Article 52

Patentable inventions

(1) European patents shall be granted for any inventions which are susceptible to industrial application, which are new and which involve an inventive step.

(2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1:

(a) discoveries, scientific theories and mathematical methods;

(b) aesthetic creations;

(c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;

(d) presentations of information.

(3) The provisions of paragraph 2 shall exclude patentability of the subject-matter or activities referred to in that provision only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such.

(4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Article 112

Decision or opinion of the Enlarged Board of Appeal

(1) In order to ensure uniform application of the law, or if an important point of law arises:

(a) the Board of Appeal shall, during proceedings on a case and either of its own motion or following a request from a party to the Appeal, refer any question to the Enlarged Board of Appeal if it considers that a decision is required for the above purposes. If the Board of Appeal rejects the request, it shall give the reasons in its final decision;

(b) the President of the European Patent Office may refer a point of law to the Enlarged Board of Appeal where two Boards of Appeal have given different decisions on that question.

(2) In the cases covered by paragraph 1(a) the parties to the appeal proceedings shall be parties to the proceedings before the Enlarged Board of Appeal.

(3) The decision of the Enlarged Board of Appeal referred to in paragraph 1(a) shall be binding on the Board of Appeal in respect of the appeal in question.

Guidelines for Examination at the EPO (C-IV, 4.2.1, Dec. 2003):

“Diagnostic methods likewise do not cover all methods related to diagnosis. Methods for obtaining information (data, physical quantities) from the living human or animal body are not excluded by Art. 52(4) if the information obtained merely provides intermediate results which, on their own, do not enable a decision to be made on the treatment necessary. Generally, such methods included X-ray investigation, NMR studies, and blood pressure measurements.”