|European Case Law Identifier:||ECLI:EP:BA:1995:T014394.19951006|
|Date of decision:||06 October 1995|
|Case number:||T 0143/94|
|IPC class:||A61K 7/06|
|Language of proceedings:||DE|
|Download and more information:||
|Title of application:||-|
|Applicant name:||Mai, Jutta|
|Opponent name:||Erwin Stückler|
|Headnote:||A claim directed to the use of a substance or composition for the production of a medicament for a therapeutic application does not conflict with Articles 52(4) or 57 EPC (see G 1/83, G 5/83, G 6/83), irrespective of the purpose (protection of a first medical use of a substance or composition, or protection of a further medical use) served by that claim (point 3.2). Accordingly, prior evidence of a further medical use is not required for this form of claim to be included in a patent application (point 3.2).|
|Relevant legal provisions:||
|Keywords:||Novelty - new form of administering substance with known use (yes)
Inventive step (yes) - non-obvious alternative form of administration
Summary of Facts and Submissions
I. European patent No. 0 289 639 was granted in respect of European patent application No. 87 106 650.2 on the basis of four claims.
II. The appellant (opponent) filed an opposition against the grant of the patent under Article 100(a) and (b) EPC, citing, among other things, public prior use of the claimed subject-matter and a number of documents.
III. The opposition was rejected by the opposition division under Article 102(2) EPC on 1 September 1993.
IV. The appellant filed an appeal against this decision. Oral proceedings were held on 6 October 1995. After the board had notified the parties of its provisional view that the contested patent appeared to have met the requirements with regard to disclosure under Article 83 EPC and that the facts contained in the opposition and appeal file gave the board no cause to arrive at an opinion different from that of the department of first instance with regard to the failure to substantiate the case for public prior use, the appellant elected not to pursue these arguments further. During the oral proceedings the respondent submitted a new main request and four auxiliary requests. Claim 1 of the main request reads as follows:
"1. Use of trigonelline for the production of an encapsulated agent which is to be administered perorally for reviving, and for stimulating and enhancing hair growth in living creatures."
This was followed by dependent claims 2 to 4.
V. In written proceedings and during the oral proceedings the appellant, among other things, stated that the therapeutic character of the use of trigonelline as an agent for reviving and stimulating and enhancing hair growth as claimed in the contested patent was no longer regarded as disputed. The feature introduced into the new claim 1 however, which was directed to the peroral administration of the preparation, had to be regarded as a method excluded by Article 52(4) EPC, and hence, given that the use of trigonelline in fenugreek seeds to prevent hair loss was known, for example, from
(41) Richard Willfort, "Gesundheit durch Heilkräuter", 1969, pp. 270/271,
the amended wording of the claim was inadmissible. At any rate a novel form of administering a treatment for one and the same illness could not be viewed as a further use within the meaning of decisions G 1/83 (OJ EPO 1985, 60), G 5/83 (OJ EPO 1985, 64) and G 6/83 (OJ EPO 1985, 67).
Irrespective of the fact that the new wording of the claim was demonstrably inadmissible, all the features of claim 1 had been described in prior-art publications in such a way as to be prejudicial to novelty.
In response to the restriction to the peroral administration of trigonelline, in addition to document (41), which also described internal, ie peroral, administration in the form of tea, a further document
(42) DE-A-3 225 056,
needed to be cited. Although this prior-art document related to an improvement of the liver function, ie to a different use, the preamble referred to fenugreek seeds as a known orally- administered, general restorative.
(43) FR-A-2 551 972,
supplementary to document (41), directly disclosed the topical use of fenugreek seeds to stimulate hair growth.
Apart from the lack of novelty shown, the form of administration could not be cited in support of inventive step, since a skilled practitioner would be aware from the known topical use of fenugreek seeds of the difficulty of conveying the active ingredients released therefrom to the desired site of action through the sebum surrounding the hair root, and hence would consider the solution of conveying trigonelline via the bloodstream by peroral administration as being obvious.
Finally, the addition of vitamins to a plant-based hair restorer was known from
(44) DE-A-3 300 491.
Moreover, two further textbooks and a passage from a lecture showed the advantageous effect of adding vitamins to hair restorers, as well as their foreseeable function, to be general knowledge in the art of dermatology. These were further reasons for denying the inventive step of the components listed in the dependent claims. Attention was drawn in particular to the fact that the use of vitamin B6 and of its individual components in hair restorers was standard practice and that calcium pantothenate was to be regarded as a standard hair care preparation. Furthermore, the standard means of obtaining the trigonelline mentioned in claim 1 was from fenugreek seeds in accordance with claim 4.
VI. The respondent also stressed that fenugreek seeds were a recognised medicament and consequently that the claimed use of trigonelline was therapeutic in character. With this knowledge of the prior art in mind, claim 1 of the main request had therefore been formulated in accordance with the form for a second medical use proposed in decisions G 1/83, G 5/83 and G 6/83 (op. cit.). In previous EPO board of appeal rulings, such as in T 289/84 of 10 November 1986, a distinction had indeed been drawn between different modes of application when assessing novelty and inventive step in the field of pharmacy, so that there could be no question of the claim as formulated being inadmissible.
As to the late-filed, allegedly novelty-destroying document (41) and the documents (42) to (44) subsequently cited, none of them made mention of trigonelline in encapsulated form for use in a specific therapeutic treatment, nor did any of them hint that the desired effect of fenugreek, which admittedly contained trigonelline, was attributable to this substance. None of them, moreover, contained any reference to the possibility of fenugreek having a positive effect on the hair by its being administered internally, ie perorally, via the alimentary canal instead of externally. The use of trigonelline capsules made it possible to "convey" trigonelline as far as was possible without it being broken down in the body and hence, surprisingly, to achieve the effect of enabling it to reach the hair roots. For the skilled practitioner, at all events, the most probable result would be an undefined breakdown of the active ingredients of the fenugreek seeds. In the light of these facts, all the other uses of fenugreek seeds cited in the new documents had no bearing on the decision.
If the board were to decide to refer the matter back to the department of first instance for further decision, it would be requested that the appellant be ordered to pay the costs.
VII. The appellant requested that the contested decision be set aside and European patent No. 0 289 639 revoked.
The respondent requested that the appeal be dismissed and the patent maintained on the basis of the main request and subsidiary requests 1 to 4 filed during the oral proceedings.
Reasons for the Decision
1. The appeal is admissible.
2. The board has examined the significance of the documents (41) to (44) first cited by the appellant during the appeal proceedings and has concluded that their depiction of the state of the art with regard to the pharmaceutical use of trigonelline and additives in hair tonics must be viewed as more relevant than the previously cited prior art when assessing the novelty and inventive step of the amended claims submitted during the appeal proceedings. The board has also taken account of the fact that in the proceedings before the department of first instance the parties primarily based their case on an argument of public prior use of the subject-matter of the contested patent which was not pursued further during appeal. The subsequently filed documents will therefore be admitted to the proceedings under Article 114(1) EPC.
3. The therapeutic character of the treatment of hair loss using trigonelline as an active ingredient was no longer questioned by the parties. Nor can the board find any justification for viewing the treatment of hair loss as an exclusively non-therapeutic measure. Article 52(4) EPC must therefore also be borne in mind when assessing the patentability of the subject-matter of claim 1 according to the main request. Hence the following can be said:
3.1 Under Article 52(4) EPC methods for the treatment of the human or animal body by therapy are not regarded as inventions which are susceptible of industrial application within the meaning of Article 57 EPC. Claims directed to the use of a substance or composition for the manufacture of a medicament for a therapeutic application do not however conflict with Articles 52(4) or 57 EPC (see Enlarged Board of Appeal decisions G 1/83 "zweite medizinische Indikation/BAYER" [OJ EPO 1985, 60], G 5/83 "Second medical indication/EISAI" [OJ EPO 1985, 64] and G 6/83 "deuxième indication médicale/PHARMUKA [OJ EPO 1985, 67], point 19, Reasons, in each case).
3.2 This applies even if the process for manufacturing the medicament does not per se differ from a known process using the same active ingredient. By the same token, such claims do not conflict with Articles 52(4) or 57 EPC, irrespective of the purpose (protection of a first medical use of a substance or composition, or protection of a further medical use) they serve. Hence no prior evidence of a further medical use need be submitted for this form of claim to be included in a patent application.
3.3 For the above reasons the wording of claim 1 and of the dependent claims 2 to 4 according to the main request does not run counter to the requirements [exclusions] of Article 52(4) EPC in conjunction with Article 57 EPC.
4. Claims 1 to 4 according to the main request also meet the requirements of Article 123(2) and (3) EPC. Claim 1 is based on the original claim 1 in conjunction with page 3, third paragraph, of the original disclosure. Claims 2 to 4 correspond to the original claims 9 and 12 and a combination of the original claims 3 and 4. By including the said features the application also clearly represents a restriction vis-à-vis the contested patent as granted.
5. Nor do the amendments made to the set of claims give the skilled practitioner considering the overall disclosure of the contested patent specification cause to question the use of trigonelline in any other than encapsulated form for the dosage required to achieve the intended pharmaceutical purpose. The board cannot therefore detect either insufficiency of disclosure within the meaning of Article 83 EPC in the documentation of the contested patent seen as a whole or any lack of clarity within the meaning of Article 84 EPC with regard to the protection sought in the wording of the claims as filed.
6. Since the appellant did not pursue the allegation of public prior use of the subject-matter of the contested patent any further in the appeal proceedings, and the board sees no obvious reason to deviate from the department of first instance's assessment of the facts, there is no need for further [detailed] comment on this issue.
7. In connection with the question of novelty of the subject-matter of claim 1 according to the main request vis-à-vis the prior-art publications the appellant cited documents (41) to (44). Of these documents only (41) and (43) relate to hair restorers.
7.1 According to its subtitle document (41) is to be regarded as a work intended for the general reader on the "recognition, effect and application of the most important native medicinal plants" ("Erkennung, Wirkung und Anwendung der wichtigsten einheimischen Heilpflanzen"). Section "67" on page 268 lists fenugreek (Trigonella Foenum graecum L.) as a species of clover. The part of the plant having healing properties is stated as being the seed, while the list of healing and active substances includes the alkaloid trigonelline (see p. 269 for the relevant paragraphs). In addition to a large number of external applications, eg in the breaking down of tumours, relief from neuralgia, open sores in the feet, etc. (see page 270, first and second paragraphs), the list of specific examples of fenugreek seed applications includes their internal use in the form of cold infusions to alleviate myxopoiesis, debility, rickets, various forms of tuberculosis, as well as general inflammation of the pharynx and the mucous membrane of the mouth in the form of a throat wash (page 270, third paragraph). External use of fenugreek seeds is also recommended in the form of an infusion in bath water to combat hair loss and favus. It is also said to be effective when rubbed into the scalp in pulverised form mixed to a paste with olive oil. The article goes on: "stops hair loss and stimulates new hair growth, provided the causes of hair loss are not more serious" (passage bridging the last paragraph of page 270 and the first paragraph of page 271). The pulverised seed can also be taken internally to aid in the treatment of a variety of diseases of the bone and weight loss (see page 271, second paragraph).
In addition to these healing properties, which are representative of its various modes of application, document (41) also lists a number of other effects which are attributed to components in fenugreek seed. Nowhere is a peroral preparation described for use in the treatment of hair loss, nor its use in encapsulated form.
7.2 Document (43) expressly describes the use of fenugreek seeds ("1 dose de fenugrec") in a compound containing ten plant substances in the form of a lotion for the topical treatment of hair loss and stimulation of hair growth. The said solution is rubbed into the scalp and allowed to take effect for several hours. Hair loss is described as being halted entirely and new hair growth stimulated after four applications (see page 1, lines 11 to 26 and 32 to 33).
Peroral, ie internal, administration of fenugreek seed in a form as claimed is not disclosed in document (43).
7.3 It follows from the foregoing remarks on the content of documents (41) and (43) that the position in decisions G 1/83, G 5/83 and G 6/83 (op. cit.), ie that novelty of the subject-matter claimed can only be based on a new therapeutic use, is different from the facts of the case in point.
The position is however the same as in decisions G 1/83, G 5/83 and G 6/83 (op. cit.) with regard to the content of document (42).
7.4 The assessment of what is regarded as the state of the art in the introduction to the description, page 3, of document (42), in addition to citing a large number of recorded instances of the use of fenugreek seeds, refers (final sentence of page 3, ending on line 3 of page 4) to page 603 of "Vidal", the French pharmacopeia, although neither the year of publication nor the number of the edition is indicated. According to this list the medicament is prescribed as an analeptic marketed under the name "Fénugrène" in the form either of capsules containing 1g powdered fenugreek seed, of coated tablets containing 0.147g dried extract of fenugreek seed, of an elixir containing 3g extract of fenugreek seed per 100g total weight, or of granules containing 9.1g powdered fenugreek seed per 100g total weight.
Based on the applications the document describes as known, the subject-matter of (42) relates to an orally administered medicament whose preferred embodiment takes the form of a freeze-dried product of fenugreek seed used to treat toxic damage to the liver and/or to improve the liver function or protection of the liver. One particular aim is to accelerate the breakdown of blood alcohol. The corresponding preparations can contain the additives, carriers, diluents, stabilisers and flavourings commonly employed by pharmacists. The claimed advantage of the invention lies in the fact that the administration of the pulverised seeds and the pharmaceutical preparations made from them is free from toxic side effects. According to the examples specified, the preparation is administered in the form of either a paste made from an aqueous powder of ground seed or a wet-ground and subsequently freeze-dried powder which is then mixed with water. Results of clinical tests on the serum from these examples reveal an improvement in the liver function. The results also indicate an acceleration in the breakdown of blood alcohol (see claims 1, 7 and 10; description, page 4, second and fourth paragraphs, page 5, second paragraph, page 5, final paragraph bridging page 6, first paragraph, and second and third paragraphs and examples 1 and 2).
Document (42) makes no mention of the use of a solid and/or pulverised fenugreek seed product as a medicament in connection with hair growth problems.
7.5 With regard to the foregoing description of the content of document (42), with a so-called first medical use of fenugreek seeds as a pharmaceutical ingredient, it is also immediately apparent why the contested patent is rightly based on an independent claim 1 according to the wording proposed in decisions G 1/83, G 5/83 and G 6/83 (op. cit.), so that a reasoned discussion of the claimed features is possible without the need to repeat formal explanations regarding what was said under point 3.
7.6 Document (44) is directed to further developing a topical preparation based on menthol, camphor and amino-acetic acid in the form of an emulsion intended to stimulate hair growth and prevent dandruff. Among the additional active ingredients enumerated are vitamins B1 and B2.
Neither trigonelline (or fenugreek seed) nor its peroral administration whether or not in encapsulated form is known from document (44).
7.7 Since none of the other documents cited during examination, opposition or appeal proceedings anticipates all the features of claim 1 according to the main request, the requirements of Article 54 EPC have been met.
8. Although both document (41) and document (43) describe a topical use of trigonelline, or rather of fenugreek seed, in the treatment of hair growth problems, document (41) merely describes this use in the context of a textbook alongside a number of other, entirely different applications. The board therefore views document (43), which is specifically directed only to the treatment of hair loss and the stimulation of renewed hair growth, as a more suitable starting point for its assessment of inventive step.
8.1 Vis-à-vis the closest prior art as depicted in document (43) which, as shown in detail above under point 7.2, describes a topical preparation for the treatment of hair growth problems, the problem addressed by the contested patent can be viewed in providing an alternative mode of administering such a preparation using trigonelline, or more specifically fenugreek seed.
According to claim 1 of the main request this objective is achieved by using trigonelline for the production of an encapsulated peroral preparation for reviving, stimulating and enhancing hair growth in living creatures.
In view of the experiment cited as an example in the contested patent (column 2, lines 10 to 17), which indicates that even unencapsulated extract of fenugreek seed administered perorally in liquid form shows a positive effect on the scalp, and in view of the fact that the respondent's further assertion that trigonelline has an effect on the hair root was not disputed by the appellant - indeed, the appellant expressly included the therapeutic character of using trigonelline to treat hair loss in his arguments - the board is convinced that the problem underlying the invention has indeed been solved.
9. The only issue remaining is therefore whether the solution claimed involves an inventive step.
9.1 Document (43) clearly points to the advantageous effect of fenugreek seed on hair growth (see point 7.2 above). Nor is this disputed by the respondent. However, in view of the very positive results of topical application described in this document - "la chute des cheveux est arrêtée complètement" (hair loss is stopped entirely) - and in the absence of any indication of there being possible disadvantages in the method used or of advantages to be gained from other modes of application, and in view of the desired effect, there is nothing to indicate why the skilled practitioner would be dissuaded from pursuing such a promising teaching.
9.2 The teaching of document (41) can clearly be viewed in the sense of confirming the effect, particularly stressed in document (43), of the topical use of fenugreek seed containing the active ingredient trigonelline on hair growth problems. Here again, and using virtually the same wording, stress is laid on the fact that hair loss is stopped and hair growth stimulated, provided there is not a deeper underlying cause for the hair loss.
In contrast to document (43), however, document (41) describes, in addition to said use of fenugreek seed in combatting hair growth problems, an extremely broad spectrum of further and - as far as symptoms are concerned - fundamentally different uses. The mere restriction to internal forms of administration, simply cited as examples and not exhaustively in the above remarks under 7.1, creates the impression that the active ingredients of fenugreek seed are a panacea and in particular that the applications described exhaust all the available possibilities.
Since it lists internal and external applications separately and expressly mentions any instances of where both possibilities can be considered - for example, as infusions and warm poultices for tuberculosis of the skin or diseases of the spleen - and since it points out that homeopathic tinctures can be used both internally and externally (see pages 270 and 271), document (41) gives no indication as to what might prompt the skilled practitioner to administer an embrocation of fenugreek seed in olive oil, expressly intended for external (topical) treatment, in peroral, encapsulated form for the same purpose.
The appellant's further submission in connection with document (41) to the effect that anatomical knowledge of the fact that the hair roots are surrounded by sebum and that this clearly hinders the active ingredient in reaching them with the result that the skilled practitioner would directly consider the far easier method of peroral administration, cannot convince the board. This is contradicted by the commonly acknowledged fact that peroral administration of a medicament runs the risk of the active ingredient being broken down during its passage through the alimentary canal. It cannot possibly be predicted a priori that a medicament, even one protected by a capsule - and document (41) makes no provision whatsoever for such a form of administration - will reach the site of action without being broken down.
For these reasons, and in the light of the problem addressed, document (41) cannot, either alone or in combination with the skilled practitioner's general knowledge or with the teaching from document (43) discussed above, lead the skilled practitioner to the claimed solution to the problem.
9.3 The state of the art on which document (42) is based, which includes the general statement that fenugreek seed products can be used as a restorative, and the further development of this knowledge in (42) to conclude that fenugreek seed products can be used therapeutically to influence liver functions and to bring about a more rapid breakdown of blood alcohol, clearly indicate to the skilled practitioner the teaching that the active ingredients of this plant product have the potential to influence the metabolism of internal organs in both the human and the animal body. However, since the appellant was unable to go on and demonstrate under what conditions the skilled practitioner would, directly and without knowledge of the invention, have been able to establish an obvious link between hair growth problems on the one hand and improving the liver function or a generally restorative effect on bodily functions on the other, it is not evident which facts from document (42) could be used to deduce that a peroral form of the medicament would have any other site of action than the liver, or at least other internal organs.
9.3.1 Furthermore, even if the prior art taken as the starting point of document (42) is considered in isolation - ignoring the fact that this document furnishes no proof that the French pharmacopeia "Vidal" discloses the existence of a fenugreek seed medicament in encapsulated form, and if so in which of the many editions published up to the filing date of this document - corresponding reference to such a mode of administration, recommended by document (42) without any indication of its specific advantages in addition to coated tablet, elixir and granulate for an unspecific and hence vague use as a restorative, would not so much as suggest the solution claimed, which is restricted to a specific form of administration for a specific use and a clearly defined site of action.
9.4 Both parties agree that document (44) relates solely to preferred embodiments of the subject-matter of claim 1 according to the main request with a view to possible additives in plant-based hair restorers (see point 7.4 again).
The large number of other documents cited during examination, opposition and appeal proceedings are even less relevant to the teaching of the contested patent than those discussed above and therefore require no further elaboration.
9.5 From all the above it follows that the subject-matter of claim 1 according to the main request involves an inventive step within the meaning of Article 56 EPC. The same applies to dependent claims 2 to 4 according to the main request, which merely relate to further embodiments of the subject-matter of claim 1.
10. In view of the above it was not necessary to consider auxiliary requests 1 to 4.
11. Concerning maintenance of the patent on the basis of the set of claims which the board has held above to be grantable, the board would add that the still-to-be-adapted description should at all events include an assessment of the prior art first raised during the appeal stage.
For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The case is remitted to the department of first instance with the order to maintain the patent with the claims according to the main request and a description which remains to be adapted.