Patenting Medical Methods
The medical industry is predicted to continue its impressive growth as the population enjoys greater longevity and innovation stimulates demand for new medical treatments. Patents are critical to investment in such innovation, especially where lead-times to market are long. The medical field of patents has its own set of exclusions to patentability for reasons of policy and ethics and the boundaries of patentability are constantly being tested.
Summary of Article
- G1/04; Patentability of diagnostic methods
- T1165/97 – ULTRAFEM / Feminine Hygiene Device
A Composition for Use in a Medical Method
First Medical Use Inventions
Second (or subsequent) Medical Use Inventions
Exclusion of Methods for Treatment
Exclusion of Diagnostic Methods
Products (Devices and Apparatus) for Use in Therapeutic and Diagnostic Methods
First (or subsequent) Medical Use of a Known Device or Apparatus
G1/04; Patentability of diagnostic methods
A claim must contain four steps of diagnosis before it will be excluded as a diagnostic method
Of the four steps, only the data gathering step will be regarded as technical and contributing to novelty and inventiveness of the claim
In BRUKER (T 385/86), four steps were identified as necessary and sufficient for exclusion as a diagnostic method:
i) a first examination phase during which data is gathered
ii) a further comparative phase, in which the data gathered is processed and compared with a normal value
iii) the recording of a significant deviation from this normal value when a comparison is made
iv) the attribution of the deviation to a particular clinical picture
This narrow interpretation of what constitutes an excluded diagnostic method established that even if only one of these steps were missing, the method was not to be regarded as diagnostic, but rather a method for gathering data which could be used for a diagnostic method. Methods which produced interim results such as X-rays or MRI imaging would therefore be patentable.
In a later Technical Board of Appeal decision (CYGNUS T 964/99 referred to in our Spring 2004 edition of Patent issues), a different approach was taken which suggested that step (i) alone could constitute an excluded diagnostic method. This very wide interpretation of ‘diagnostic method’ was contradictory to BRUKER and has now been overruled in the Enlarged Board of Appeal decision G1/04. The Enlarged Board confirmed that BRUKER, with its narrow exclusion, was the correct approach.
In G1/04, steps (i)-(iii) were described as ‘intermediate findings of diagnostic relevance’.
• Step (i) is usually technical and practised on the body, usually using some kind of device to collect data.
• Steps (ii)-(iii) are preliminary processing of data.
• Step (iv) is a diagnosis for curative purposes and as such is an intellectual exercise.
Only step (i) can be taken into account for the purposes of novelty and inventive step, although steps (ii), (iii) and (iv) will be allowable in a claim if essential to achieve the technical effect.
This approach was applied in July 2006 in AUSTRALIAN NATIONAL UNIVERSITY’S APPLICATION (T 1197/02). A test for early detection of glaucoma by presenting ‘zones’ to a patient and measuring contrast thresholds was held to be excluded as a diagnostic method.
In claim 1, various initial steps involved the examination of the patient and the collection of data. The court stated:
"in most cases, only . . . the collection of data can actually be of a technical nature and therefore (is) concerned with the criterion ‘practised on the…body.’"
These examination and data collection steps were held to constitute the “collection of data” phase - step (i) under G1/04).
Various further steps of claim 1 involved a calculation of a mean of the threshold values to determine which ‘zone’ produced the highest threshold level. These were regarded as preliminary processing in the sense of steps (ii)-(iii) of G1/04. The board held that these steps are not part of making the comparison per se and thus are of no relevance for making the diagnosis. In other words, steps (i)-(iii) do not constitute an excluded diagnostic method in the sense of Art. 52(4).
A final step in the claim involved a comparison of the collected thresholds with standard values exhibited by subjects with normal vision. This constituted the final diagnosis, or step (iv) under G1/04. All the elements required under the approach of G1/04 were therefore present in the claim and the method was excluded as diagnostic.
Unless the method to be claimed has novelty and inventiveness in an initial examination phase during which data is gathered from the body, an applicant trying to claim a diagnostic method is stuck between a rock and a hard place. Steps (ii)-(iii) are considered non-technical, so these cannot be relied upon for novelty and inventiveness. And, furthermore if the applicant tries to introduce novelty an inventiveness in a step (iv), the set of four steps is completed and the exclusion will apply.
AUSTRALIAN NATIONAL UNIVERSITY’S APPLICATION illustrates how, under Enlarged Board of Appeal Decision G1/04, a claim relating to a diagnostic method will only constitute patentable subject matter if it constitutes a novel and inventive way of collecting interim data from a patient which does not lead directly to a diagnosis.
T1165/97 – ULTRAFEM / Feminine Hygiene Device
· A method of using a vaginal discharge collector.
· Held not to be excluded as a method of diagnosis or treatment.
· Held to be industrially applicable, if the claimed method can be performed by a commercial enterprise.
The claims of concern related to a method of using a vaginal discharge collector and had been refused by the Examining Division on the basis of a lack of industrial applicability (Art 57 EPC). The Division’s refusal primarily relied on Decision T74/93 – BTG / Contraceptive Method (which held that a method of contraception which was to be applied in the private and personal sphere of a human being was not susceptible of industrial application). It was argued that even if the device were positioned by a medical professional rather than the patient, the claimed method would be excluded under Art. 52(4) EPC as a medical method, rendering the subject-matter unpatentable . Furthermore, the claimed steps of holding the collector in place and collecting the discharge were individually and personally performed by the woman in question and hence not industrially applicable. Finally, the claimed step of disposing of the discharge collector had no relation to any industrial applicability.
The applicant successfully appealed against this exclusion from patentability on the basis that the claimed method was in fact not a method for treatment or a diagnostic method. Furthermore, the Board held the invention to be industrially applicable because the claimed method could be performed by a commercial enterprise.
On the requirement of industrial applicability, the Board defined an invention as susceptible of industrial application if it could be made or used in any kind of industry. The claimed method could be performed by an enterprise aiming to assist women in collecting a sample of their discharge, such as for subsequent visual, chemical or bacterial inspection or for extraction of one or more of its components for use in industrial preparation of pharmaceutical compositions (NB it was considered irrelevant whether such an enterprise existed – what was significant was that there was the possibility that such a service could be offered by an enterprise).
Moreover, it could be foreseen that a professional in the service of an enterprise would perform application and retrieval of the discharge collector. Furthermore, this service would not be one satisfying only the strictly personal needs of the woman in question because the collection of a sample may be caused by external reasons, e.g. the advice of a medical practitioner to have such a sample taken for further diagnosis. In addition to this, the person taking the sample would generally not be acting on the instructions of the woman in question (c.f. the contraceptive method in BTG), but on the basis of instructions supplied with the collector itself.
The exclusion of industrial applicability under Art. 52(4) was held not to apply because there was no requisite act of surgery or preventative treatment of illness or any alleviation of the symptoms of pain and suffering. Also, there was no necessity of particular medical skills to work the invention. In this regard, the Board indicated that even if a medically trained person or doctor performed the claimed method, this would still not constitute a method of treatment of the human or animal body by surgery or therapy.
The claimed method was not considered to be a diagnostic method because the Board considered the exclusion only to apply to diagnostic methods of which the results make it directly possible to decide on a particular course of medical treatment, i.e. only methods that contain all the steps involved in reaching a diagnosis should be excluded (see below on this point).
Thus, the appeal was successful in respect of the method claims but the applicant was requested to make amendments to the description to remove references to methods of therapeutic treatment.
In order to prevent medical practitioners from being obstructed in their day to day duties by patents, the EPC expressly prohibits the grant of European Patents for medical methods. In particular, Art. 52(4) EPC states that “Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body (referred to hereafter as "medical methods") shall not be regarded as inventions susceptible of industrial application within the meaning of paragraph 1”. Paragraph 1 of Art. 52 EPC states that “European Patents shall be granted for any inventions which are susceptible of industrial applicability, which are new and which involve an inventive step”. Thus, a claim to a method of medical treatment or a claim to a diagnostic method (each discussed in greater detail below) would not be allowable under the terms of the EPC.
However, by virtue of the second sentence of Art. 52(4) EPC, this general prohibition does not apply to “products, in particular substances or compositions, for use in any of these methods”. Thus, claims to products for use in the methods referred to in the first sentence of Art. 52(4) are deemed patentable under the terms of the EPC.
As with any other invention, a claim to a product must be novel and inventive to be patentable. The requirements for novelty are set out in Art. 54 EPC, and for inventions in general they will be considered to be new if they “do not form part of the state of the art”. However, for products for use in medical methods, Art. 54(5) EPC provides a special concept of novelty that is not applied in any other technical field. Art. 54(5) EPC states that the general rules relating to novelty (as set out in Art. 54(1) to 54(4) EPC) do not “exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Art. 52(4), provided that its use for any method referred to in that paragraph is not comprised in the state of the art” (emphasis added).
In other words, Art. 54(5) EPC and the second sentence of Art. 52(4) EPC provide a particular form of product claim (a purpose-related product claim) which will be deemed novel, and hence patentable, by the EPO.
In considering the question of whether a composition for use in a medical method is patentable, one must have regard to:
(i) whether the composition is new,
(ii) whether the composition is known but has never before been used for a therapeutic application, and
(iii) whether the composition is known, a general or specified therapeutic effect is known, but a new specific therapeutic effect has been discovered.
Compositions falling within (i) or (ii) are referred to generally as “first medical use” inventions, and compositions falling within (iii) are referred to as “second (or subsequent) medical use” inventions.
In Board of Appeal Decision No. G5/83– EISAI / Second Medical Indication the Enlarged Board observed that the inventor of a "first medical indication" (i.e. an inventor who has discovered that a known product has a previously undiscovered medical use) could obtain “purpose-limited product protection for a known substance or composition, without having to restrict himself to the substance or composition when in a form technically adapted to a specified therapeutic purpose”. In other words, for a known compound X which has a novel and inventive therapeutic effect Y a purpose-limited product claim will meet the requirements of Art. 54(5) EPC, and hence will be deemed patentable.
In Technical Board of Appeal Case No. T128/82 – HOFFMAN-LA ROCHE / Pyrrolidine-Derivatives the Board of Appeal considered the question of a first medical indication (first medical use of a known substance) with regard to the breadth of the purpose-related product claim, and with particular regard to the fact that the specification disclosed only a few specified therapeutic uses whereas the claims were not limited to any of the therapeutic uses disclosed in the specification.
In this case the Board held that Art. 54(5) permitted a purpose-limited substance claim stating a general therapeutic purpose. In other words, the Board decided that if it is permissible within the terms of the EPC to grant protection in respect of a new chemical compound for use in therapy, then it must also be permissible and equitable to grant protection where for the first time a known compound is made available for therapy.
The Board noted that under Art. 54(5) the novelty of a compound which was known but not used therapeutically would be destroyed not only by the fact that the same specific therapeutic effect was already known in the art, but also by the disclosure of any other specific therapeutic application.
So, the practice of the EPO is to allow claims for first medical use inventions to the following (see summary point 3):
(a) “A (novel) compound X for use in therapy”; and
(b) “A (known) compound Y for use in therapy” (but only in circumstances where that compound has never before been proposed for any therapeutic application).
The exception to the novelty requirement set out in Art. 54(5) created a situation where claims to the first medical use of a substance were patentable, but the situation where a known therapeutic composition having a new therapeutic use (referred to above as circumstance (iii)) was less clear. To protect these compositions, applicants had been filing claims to “use of known substance X for a new therapeutic application Y” and the Examining Division had been rejecting these claims as being directed to a method of medical treatment prohibited by Art. 52(4).
The Enlarged Board confirmed in EISAI that claims directed to the use of a known substance X for a treatment of disease Y are not allowable, because such a claim would relate to a medical method that was not patentable under Art. 52(4). However, the Board also advised that claims directed to the "use of (known) substance X for the manufacture of a medicament for therapeutic application Y" would henceforth be considered to be patentable. Claims of this style were first advertised as being acceptable by the Swiss Federal Intellectual Property Office, and as a result are commonly known in Europe as “Swiss style” or “Swiss format” claims.
For example, if it turned out that aspirin could be used to treat, say, leukaemia then the composition prepared from aspirin and used to treat leukaemia could be patented so long as the claim was drafted in the Swiss style, namely “Use of aspirin for the manufacture of a medicament for the treatment of leukaemia”. (See summary point 4).
As explained above, Art. 52(4) EPC provides that various medical methods are not patentable. Even if a claimed method falls outside the therapy and diagnostics exclusion, it may still be unpatentable if it does not meet the general requirement of industrial applicability.
For example, in T 74/93 – BTG / Contraceptive Method, the Technical Board of Appeal considered a claim directed to the use of a contraceptive composition (e.g. a cream), for applying to the cervix of a female capable of conception. In the Board’s view, pregnancy was not considered an illness and hence its prevention was not therapy according to Art. 52(4) EPC. Therefore, the claimed method was not excluded as a method of treatment. Furthermore, the Board took the view that a method of contraception was not excluded per se from patentability in general. However, the specifically claimed contraceptive method was considered to be insusceptible of industrial application because it only satisfied the strictly personal needs of the woman in question. It did not matter that a nurse acting professionally could apply the method of contraception to a disabled person. This did not suffice to make the application of the method an industrial activity because, similarly, only the strictly personal needs of the disabled person would be satisfied.
Above, we looked at a case (T1165/97 – ULTRAFEM / Feminine Hygiene Device) where this exclusion was successfully overcome by arguing that a method was industrially susceptible if it was imaginable that the steps of the method could be carried out as a paid service (i.e. it was immaterial whether they actually were) and that they were not exclusively dependent for their execution on the instructions of the woman in question.
Therapy by treatment relates to the treatment of a disease in general or to a curative treatment in the narrow sense (T144/83 – DU PONT / Appetite Suppressant). Any claims to methods of this type are unpatentable, and include methods for pain reduction, improvement of physical condition, lethargy reduction, and all prophylactic or preventative methods such as vaccination.
However, claims directed to solely cosmetic effects have been found allowable. In DU PONT, a treatment causing a cosmetically beneficial loss of weight of a person not suffering from obesity in the medical sense was not necessarily beneficial to the health of that person, and consequently was not considered to be a method for treatment barred from patentability.
Conversely, it has been found that where a treatment has both therapeutic and cosmetic effects, a claim to such a method is not patentable (see T290/86 – ICI / Cleaning Plaque - cleaning plaque and/or stains from teeth was not patentable because plaque cleaning was considered to be at least prophylactic treatment). Moreover, if a single step in a method claim is excluded from patentability as a method of treatment, the whole claim will be excluded (T820/92 – GEN. HOSPITAL / Contraceptive Method).
Turning to diagnostic methods, case law has dictated that a method is only diagnostic if it leads to a concrete diagnostic result, indicative of a pathological condition. Thus, only diagnostic methods whose results immediately allow a decision on a medical treatment are excluded. Methods providing only interim or intermediate results have conventionally not been excluded even if they can be used in making a diagnosis. A further indicator that the exclusion does not apply is whether a medical practitioner is required to perform the method. Hence, if the method can be performed by a technically trained person without medical knowledge, the exclusion arguably does not apply.
The Technical Board of Appeal has previously attempted to define a diagnostic method by the steps it is required to include (T385/86 – BRUKER / Non-Invasive Measurement). There must be an examination phase and a phase establishing the symptoms from the results of the examination, and the method must be applied to living bodies. In BRUKER, the systematic list of steps leading to a diagnosis included: (i) recording the case history; (ii) 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); (iii) comparing the test data with normal values and recording any significant deviation (symptom); and (iv) attributing the deviation to a particular clinical picture (deductive medical decision phase). The Board held that even if only one of steps (ii) to (iv) was lacking, there was no diagnostic method, but at best, a method of data acquisition or processing that could be used in a diagnostic method.
Above, we also looked at a decision taken by the Enlarged Board of Appeal (G1/04) that has confirmed this position. In a subsequent Technical Board of Appeal decision (T 1197/02), the principles of G1/04 were applied. The decision further demonstrated that only step (i), the step of gathering data, is technical in nature. The novelty and inventive step of a claim must therefore be derived from this technical step rather than the processing (ii-iii) or diagnosis decision (iv) step.
The exclusions to patentability listed in Art. 52(4) EPC do not extend to products. However, a claim to the “use of device X in the treatment of condition Y” will not be patentable because, as indicated previously, such a claim is considered analogous to a method claim and would therefore be excluded from patentability as a method for treatment or a diagnostic method. It is therefore necessary to cast such a claim in the form of “device X for use in the treatment of condition Y” to escape the exclusion.
This begs the question as to whether a claim to a known device for the (unknown) treatment of a medical condition can be considered novel. Unfortunately, the special novelty provisions of Art. 54(5) EPC only apply to substances or compositions, and not to devices or apparatus. We therefore turn to case law outside the fields of therapy or diagnosis for guidance on claiming a known product for a new use.
In decisions G2/88 – MOBIL III / Friction Reducing Additive and G6/88 – BAYER / Plant Growth Regulating Agent, the Enlarged Board stated that the patentability of a second non-medical use of a product was already recognised in principle in EISAI (see above) which concerned the second medical use of a substance. However, in the latter case, the exclusion from patentability of therapeutic and diagnostic methods had caused the Enlarged Board to allow only a special type of claim. The Enlarged Board pointed out that a claimed invention lacked novelty unless it included at least one essential technical feature which distinguished it from the state of the art and took the view that the proper interpretation of a claim whose wording clearly defined a new use of a known compound would normally be such that the attaining of a new technical effect on which the new use was based was a technical feature of the claimed invention.
Thus, where the particular technical effect underlying such use was described in the patent, the proper interpretation of that claim would require a functional feature to be implicitly contained in the claim as a technical feature. It should be noted that just because a new use may previously not have been known (i.e. the new use is novel), it may still be considered obvious and consequently, unpatentable.
In principal, there is no reason why these decisions cannot be applied beyond a substance or composition to a device or apparatus. However, in T215/84 – BLACK CLAWSON / Oxygen Delignification of Pulp, a new use of a known apparatus (apparatus for continuous oxygen delignification) was held to be unpatentable because it was considered that the discovery that known equipment might be used in a new manner could not render the equipment novel. A similar decision was reached in T15/91 – LACH-SPEZIAL-WERKZEUGE / Abrichtwerkzeug, which went on to say that a hitherto unknown use of a known apparatus (a tool for the treatment of grinding wheels) did not substantiate novelty if no modifications to the technical design of the known apparatus were required. Moreover, one applicant has unsuccessfully tried to use a second medical indication or "Swiss-type" claim for a device, namely a surgical tool for intercepting laser energy (T227/91 – CODMAN & SCHURTLEFF / Second Surgical Use). This may, in part, be due to the specific formulation of the claim in question but does indicate that the European Patent Office is reluctant to consider that the purpose of a surgical use alone can convey novelty to the subject-matter of a claim relating to the use of the components of a known instrument for its manufacture, i.e. assembly. On the other hand, in T637/92 – KUFFERATH / Drainage fabric for presses in a paper machine, the Board held that the statement of purpose of a claimed device was to be interpreted as meaning that the device was suitable for the stated purpose. A known device that served another purpose but otherwise possessed all the features listed in the patent claim was not prejudicial to the novelty of the subject-matter of the claim if the known device was unsuitable for the purpose referred to in the claim.
In summary, claims to known devices for a new use (including medical uses) need to be considered on a case by case basis and extra care is required in drafting suitable claims.
1. “Use” claims in non-medical technical fields are considered by the EPO to be broadly equivalent to method claims, and as such are patentable. In the fields of therapy and diagnosis, however, a “use” claim is not appropriate for methods performed on the body, because such medical methods are excluded from patentability.
2. Use of a new composition for therapy or diagnosis is similarly unpatentable. However, in such cases, the composition can be claimed per se.
3. A “use” claim is not appropriate for a new or known composition with a new therapeutic effect (so called “first medical use inventions”). (But see point 5 below). In these cases, the claims should be phrased as: “a compound X for use in therapy”, “a compound X for use as an active therapeutic substance”, or similar, provided the composition has never before been proposed for any therapeutic application.
4. A “use” claim in the Swiss style is appropriate in the field of medical methods for the protection of known therapeutic compositions that have a new therapeutic effect (so called “second (or further) medical use inventions”). These claims should be presented as: “use of a compound X for the manufacture of a medicament for a therapeutic application Y”. It may also be beneficial to use such claims in an application for a first medical use invention to secure a fall-back position in the event that an earlier medical use for the particular composition subsequently comes to light.
5. A method of treatment that is not practiced on the human or animal body or that is not therapeutic is allowable, provided that it does not have both therapeutic and non-therapeutic effects, and provided it can be used in any kind of industry, e.g. it can be performed by an enterprise (other than a medical professional).
6. If a method or use claim has all four steps of a diagnosis method, the claim will be refused.
7. If a method or use claim has a single step involving treatment of the human body, the entire claim will be refused.