The patent relates to an agent for use in the prophylaxis or improvement of frailty in elderly person.
Brief outline of the case
The OD decided that claims 1 and 11 of the main request did not meet the requirements of Article 123(2). The same applied to AR1-7. Cl5 of AR8 was lacking clarity.
For the OD, AR 9 complied with Art 123(2) and 83. The indications of claims 9-14 were considered to be non-therapeutic, such that these claims did not contravene Art 53(c).
The board decided that the MR as well as AR 1-29, 17A-20A and 25A were not allowable under Art 53(c) and infringed Art 123(2). AR30-33 were either infringing Art 123(2) or not taken into account under Art 13(2) RPBA. The patent was thus revoked.
We will concentrate on the MR.
The various claims of the MR
Claim 1 relates to an agent for use in the prophylaxis or improvement of frailty in an elderly person, wherein the frailty is at least one kind of symptom selected from a group of symptoms.
Claims 11 and 17 relate to the non-therapeutic use of an agent, or a food or drink, – for the prophylaxis or improvement of frailty in an elderly person, wherein the frailty is at least one kind of symptom selected from a different group of symptions as in claim 1.
The proprietor’s point of view
Due to the presence of the term “non-therapeutic” in claims 11-18, any possible medical uses were excluded from the claims, such that these claims 11-18 could not be considered to be in violation of Art 53(c).
The uses defined in claim 11 cover non-therapeutic uses which can be distinguished, or separated, from therapeutic uses.
Furthermore, T 2275/18 clearly set out that all activities which may result in retaining health were not to be considered as therapeutic methods, in particular if they related to natural and common daily activities.
The insertion of the term “non-therapeutic” constituted an allowable undisclosed disclaimer in the sense of G 1/03, consistent with Art 123(2).
The opponent’s point of view
Claims 1 and 11 of the main request required the identical use, the prophylaxis or improvement of frailty, the identical compositional features, and the identical target group, i.e.an elderly person.
The patent did not discriminate between any therapeutic and non-therapeutic frailty symptoms, or use in the prophylaxis or improvement of frailty. To the extent that claim 1 of the main request was interpreted as a medical use claim in the sense of Art 54(5), the subject-matter of claims 11-18 was excluded from patentability under Art 53(c).
Furthermore, the application as filed did not disclose any “non-therapeutic” use, such that the subject-matter of claims 11-18 infringed Art 123(2).
The board’s decision
In claims 11 and 17, the expression “non-therapeutic” was introduced by way of an amendment as an undisclosed disclaimer in the sense of G 1/03.
In the board’s view, claims 11 and 17 do not generally relate to a non-therapeutic use. Instead, claim 11 and 17 explicitly relate to these conditions only in the context of the prophylaxis or improvement of frailty in an elderly person.
For the board, it is established case law that a prophylactic treatment, aimed at maintaining health by preventing ill effects that would otherwise arise, amounts to a method for treatment by therapy as referred to in Art 53(c).
Therapy is not limited to treatments which restore health by curing diseases which have already arisen. Both prophylactic and curative methods of treating diseases are covered by the word therapy, since both are directed to the maintenance or restoration of health.
The board considered that, even if the symptoms of frailty in elderly people are not necessarily considered an illness as such, the prevention of these symptoms necessarily aims at least at maintaining health in the patient.
The description makes clear that the prophylaxis of frailty is previous prevention of its symptoms from being developed, and the improvement of frailty includes bringing these symptoms to fall within a normal range, as well as preventing the progression or exacerbation of the disease.
It is also explained that the prophylaxis of frailty leads to the prevention or delaying of a transfer to a condition in need of nursing care and increases health expectancy.
The board added that, the proprietor’s argumentation on N and IS of claim 1 of the t rather contradicts their position regarding the non-therapeutic nature of the use of claim 11.
The proprietor submitted that claim 1 relates to the prophylaxis or improvement of frailty, and that the present invention is aimed at preventing and alleviating the ill effects that would otherwise arise in elderly populations, so as to maintain health, such that claim 1 should be considered to be a use limited product claim in accordance with Art 54(5).
Following this reasoning, in which the particular symptoms recited in claim 1 play no role, the same indication against frailty in claim 11 must also be regarding as therapeutic.
In T 2275/18, the board held that the claim at hand related to a non-therapeutic method of applying to human skin a personal care composition. Applying a UV-A sunscreen agent to human skin cannot be regarded as a therapy as otherwise even the most natural and common daily activities, such as washing or putting on clothes, would always be considered as therapeutic methods.
The present case has no relation with the situation underlying T 2275/18. The activity imagined by the proprietor would suppose, in the context of claim 11, that the patient taking a protein bar before going to the gym is an elderly presenting or developing symptoms of frailty. This can hardly be regarded as the most natural and common daily activity.
Contrary to the situation in T 2275/18, it is not possible to carry out the method of present claim 11 on a subject which is neither in a pathological state nor likely to develop one, because claim 11 precisely defines the subject as an elderly suffering from or likely to develop symptoms of frailty.
Claims 11 and 17 concern a use which is necessarily therapeutic/prophylactic and fall under the exclusion of Art 53(c)
In both T 1635/09 and in T 767/12, a disclaimer intended to restrict the claim to “non-therapeutic” methods was in analogous situations considered introducing a lack of clarity under Art 84. This is however a condition for allowing undisclosed disclaimers according to G 1/03.
Considering also that, in the present case, the undisclosed disclaimer “non-therapeutic” contradicts the original disclosure according to which the prophylaxis or improvement of frailty aims at maintaining health, this undisclosed disclaimer is also considered to infringe Article 123(2) EPC.
Comments
In the present case, the distinction “non-therapeutic” is purely arbitrary.
Where therapeutic aspects and non-therapeutic aspects are clearly distinguishable or easy to tell apart a claim seeking protection for the non therapeutic aspect is patentable, cf. T 144/83 or T 469/94. This is certainly not the case here, as the uses in claims 1 and 11 are clearly of therapeutic/prophylactic nature.
Older case law
Where therapeutic aspects and non-therapeutic aspects are indistinguishable or difficult to tell apart, the method should be considered as essentially therapeutic, cf. among a lot of decisions T 820/92 or T 438/91.
Contrary to the position of the board in T 2275/18, in T 1077/93, the board held that it is not possible to overcome the prohibition by a purely formal rewording of the claim, so as to qualify the purpose of the process as non-therapeutic, here cosmetic.
The compound used had an interaction with the cellular mechanism in the epidermis, with the purpose of preventing a pathological state (erythrema), it had thus a genuine therapeutic and not exclusively cosmetic purpose (filtering of UV).
T 2275/18 is thus highly open to critics. The OD was right in its evaluation of claim 14 of the MR. It clearly offends Art 53(c).
With T 1077/93, the fate of claims 11 and 17 could have been sealed quickly without a second thought.
All decisions cited in the comments might be quite old, but still applicable as the wording of Art 53(c) corresponds to that of Art 52(4) EPC1973.
https://www.epo.org/en/boards-of-appeal/decisions/t222074eu1
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