T 1031/00 - Novelty and phase III clinical trial announcement

Key points

• Perhaps I will post more than once a week.
•  An old decision today. Cited only once, not even for the point discussed below, which is still interesting in my view.
  
• " Claim 1 is directed to the first therapeutic application of (-) amlodipine, namely the treatment of hypertension." 
• " Thus for novelty purposes it has to be established whether or not a therapeutic application has already been disclosed in the available prior art for (-) amlodipine." 
• " [D3] shows the ability of racemic amlodipine and of (-) and (+) amlodipine to inhibit calcium ion influx into rat aorta tissue in vitro as indicative of their effectiveness in the treatment of hypertension and angina" 
• D3 " also discloses that amlodipine was then undergoing phase III clinical trials for hypertension and angina and that in vitro evaluation of the enantiomers of amlodipine shows the (-) isomer to be twice as active as the enantiomeric mixture in the rat aorta, the (+) isomer being 1000 times less active" 
• " the patent application in suit it is stated that the (-) isomer of amlodipine is an antihypertensive agent for treating human (claim 1). However, in spite of the numerous examples in the description, only one deals with hypertension but without going further than in vitro experiments. Therefore, the description provides no further evidence or data showing the actual antihypertensive effect of the (-) isomer of amlodipine in humans or animals than did the prior art document [D3]."
•  " in the absence, in the patent application as originally filed, of any data providing additional technical information in relation to the actual treatment of hypertension in humans or animals compared with the disclosure in the prior art document [D3], it must be concluded that the subject-matter of the patent application is anticipated by the disclosure in that document, ie document [D3] discloses the same "therapeutic application" as the present application." 
• " According to the appellant [applicant], only the disclosure of an actual therapeutic treatment in a prior art document could be novelty destroying for the subject-matter of a claim drafted in the first [or second] medical use form." 
• " In fact, the Board agrees with both authorities cited that the disclosure of an actual therapeutic treatment for a known substance in a prior art document would be novelty destroying for a claimed first medical use of the same substance. And the Board could also agree with the [applicant's arguments] for cases where, according to the particular circumstances the technical content of the prior art is limited when compared with that of the application in issue. In the present case however, [...]  the situation is different since the subject-matter of the patent in suit does not contain any technical information concerning the claimed therapeutic treatment going beyond that in document [D3]. Accordingly, the difference between that document and the application in suit resides merely in the words used but not in their technical content so that no novel technical feature can be recognised in the present case."
• " As to decision T 0241/95 [], also cited by the appellant during the oral proceedings, the ]Board considers that, if anything, it tends to contradict the appellant's submission that document [D3] does not disclose an actual treatment. In T 0241/95 it was stated: "It is a well-established and accepted principle that, for the purpose of patent protection of a medical application of a substance, a pharmacological effect or any other effect such as a behavioural effect observed either in vitro or on animal models is accepted as sufficient evidence of a therapeutic application if for the skilled person this observed effect directly and unambiguously reflects such a therapeutic application." (paragraph 4.1.2)." 
• In view of the foregoing, the Board considers that the subject-matter of claim 1 does not fulfil the requirements of novelty of Article 54 EPC.
• As a comment, this decision seems to propose as a principle that the level of enablement required for Art.83 and an anticipating disclosure ought to be the same, also for first and second medical use claims.

EPO T 1031/00 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t001031eu1.html

2.1. Main request

2.1.1. Claim 1 is directed to the first therapeutic application of (-) amlodipine, namely the treatment of hypertension.

This claim belongs to the family of claims not precluded under Article 54(5) EPC, which does "not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52, paragraph 4 [Methods for treatment of the human or animal body by ...therapy...], provided that its use for any method referred to in that paragraph is not comprised in the state of the art".

Thus for novelty purposes it has to be established whether or not a therapeutic application has already been disclosed in the available prior art for (-) amlodipine.

On the one hand, document (3), shows the ability of racemic amlodipine and of (-) and (+) amlodipine to inhibit calcium ion influx into rat aorta tissue in vitro as indicative of their effectiveness in the treatment of hypertension and angina (page 1696, left column, first paragraph; Table I compounds 17, 18 and 19 respectively).

It also discloses that amlodipine was then undergoing phase III clinical trials for hypertension and angina and that in vitro evaluation of the enantiomers of amlodipine shows the (-) isomer to be twice as active as the enantiomeric mixture in the rat aorta, the (+) isomer being 1000 times less active (page 1699, left column, lines 30 to 35).

On the other hand, in the patent application in suit it is stated that the (-) isomer of amlodipine is an antihypertensive agent for treating human (claim 1).

However, in spite of the numerous examples in the description, only one deals with hypertension but without going further than in vitro experiments. Therefore, the description provides no further evidence or data showing the actual antihypertensive effect of the (-) isomer of amlodipine in humans or animals than did the prior art document (3).

Accordingly, in the absence, in the patent application as originally filed, of any data providing additional technical information in relation to the actual treatment of hypertension in humans or animals compared with the disclosure in the prior art document (3), it must be concluded that the subject-matter of the patent application is anticipated by the disclosure in that document, ie document (3) discloses the same "therapeutic application" as the present application.

2.1.2. According to the appellant, only the disclosure of an actual therapeutic treatment in a prior art document could be novelty destroying for the subject-matter of a claim drafted in the first medical use form.

As support for this argument it pointed out to the decision T 128/82 (JO EPO 1984, page 164, paragraphs 9 and 13) and to the Manual of Patent Practice in the UK Patent Office, Fourth Edition, paragraph 2.53.

The relevant passages in decision T 128/82 read:

"9. Recourse to the travaux préparatoires for Article 54(5) EPC would in fact seem obvious. This article creates substantive patent law that does not go back to the Strasbourg Convention on the Unification of Certain Points of Substantive Law on Patents for Invention of 27 November 1963, and is also not modelled on concepts existing in the national patent laws of most countries represented at the Munich Diplomatic Conference of 1973. In addition to the general concept of novelty (Article 54(1)-(4) EPC) this article also introduces, in respect of substances and compounds used in surgical and therapeutic treatment and in diagnostic processes carried out on humans and animals (hereinafter referred to briefly as "therapy"), a special concept of novelty unknown in other technical fields

13. Attention is also drawn to the following points: Under Article 54(5) EPC a compound which is known but not used therapeutically is to be regarded as novel. Novelty, however, is not only destroyed by the fact that the same specific therapeutic effect is already known in the art, but suffers also from the disclosure of any other specific therapeutic application."

As to the Manual of Patent Practice in the UK Patent Office, it cannot be given more weight than to the Guidelines of the EPO, and neither can be binding on the Board which, nevertheless has considered the appellant's submission.

The relevant passage in the Manual reads:

"To provide evidence of a prior use of a substance or composition in therapy, actual disclosure of therapeutic use must be found. It is not sufficient for a research paper to disclose experiments which show an activity which would make the substance or composition suitable for use in therapy, or discloses in vitro testing for such use. The Section requires the use of the substance or composition in a method of therapy to form part of the state of the art."

In fact, the Board agrees with both authorities cited that the disclosure of an actual therapeutic treatment for a known substance in a prior art document would be novelty destroying for a claimed first medical use of the same substance. And the Board could also agree with the guidance given in both texts cited by the appellant for cases where, according to the particular circumstances the technical content of the prior art is limited when compared with that of the application in issue.

In the present case however, as explained under 2.1.1, the situation is different since the subject-matter of the patent in suit does not contain any technical information concerning the claimed therapeutic treatment going beyond that in document (3).

Accordingly, the difference between that document and the application in suit resides merely in the words used but not in their technical content so that no novel technical feature can be recognised in the present case.

As to decision T 0241/95 (OJ EPO 2001, page 103, paragraph 4.1.2), also cited by the appellant during the oral proceedings, the Board considers that, if anything, it tends to contradict the appellant's submission that document (3) does not disclose an actual treatment. In T 0241/95 it was stated: "It is a well-established and accepted principle that, for the purpose of patent protection of a medical application of a substance, a pharmacological effect or any other effect such as a behavioural effect observed either in vitro or on animal models is accepted as sufficient evidence of a therapeutic application if for the skilled person this observed effect directly and unambiguously reflects such a therapeutic application." (paragraph 4.1.2).

In view of the foregoing, the Board considers that the subject-matter of claim 1 does not fulfil the requirements of novelty of Article 54 EPC.