Composition of the Board: Chairman: U. Oswald Members: A. Lindner, L. Bhler

Patent proprietor/Appellant: Bayer Schering Pharma Aktiengesellschaft Opponent 01/Appellant:

STRAGEN PHARMA SA Opponent 02/Appellant:

Laboratorios Lon Farma, S.A. Opponent 03/Appellant:

Sandoz AG Opponent 04/Party to the proceedings: Helm AG Headword: Composition for contraception/BAYER SCHERING PHARMA AG Relevant legal provisions: Article: 53(c), 64(2), 83, 84 and 123(3) EPC Keyword: "Main request, auxiliary requests 1, 4, 5, 7, 8, 11, 12, 14, 15, 18, 19, 21, 22: therapeutic method (yes): prevention or reduction of pathological side-effects" "Auxiliary requests 2, 3, 6, 9, 10, 13: sufficient disclosure (no): invention cannot be carried out over the entire scope claimed; undue burden" "Auxiliary requests 16, 17, 20: sufficient disclosure (no): undue burden" "Auxiliary request 23: extension of protection (yes): conversion of use claim into Swiss-type' claim" "Auxiliary request 24: extension of protection (yes): conversion of use claim into purpose-related product claim"

Headnote I. Use as an oral contraceptive of a composition in which the claimed concentrations of the hormone content are selected at such a low level as to prevent or reduce the likely pathological side-effects of such an oral contraceptive is a therapeutic method excluded from patentability under Article 53(c) EPC.

II. Since the question whether or not a claimed use is therapeutic can be deter- mined only in the light of the activities carried out and/or the effects achieved in the course of that use, the exclusion from patentability under Article 53(c) EPC of a therapeutic use in which a non-thera- peutic use in the form of a contraceptive is inseparably associated with a thera- peutic use in the form of the prevention or reduction of pathological side-effects cannot be removed by limiting the claim to a "non-therapeutic use".

III. The conversion of a claim for the use of a substance or composition for a specific purpose into a Swiss-type claim or a purpose-related product claim within the meaning of Article 54(5) EPC results in an extension of protection.

IV. In assessing the reasonableness of any series of tests needed to reproduce an invention, account must also be taken of their avoidability. Time-consuming and ethically questionable tests are unrea- sonable if the claimed invention could have been defined, without any limitation of its scope, by features which would have rendered such series of tests superfluous for the purpose of reproducibility by the skilled person.

Summary of facts and submissions

I. European patent application No. 95 905 574.0 was granted as European patent No. 0 735 883 with 19 claims.

The independent claims granted were worded as follows:

"1. Use of an oral dosage form comprising an oestrogen selected from

2.0 to 6.0 mg 17-estradiol, and 0.015 to 0.020 mg ethinylestradiol; and a progestogen selected from 0.05 to 0.075 mg gestodene, 0.075 to 0.125 mg levonorgestrel, 0.06 to 0.15 mg desogestrel, 0.06 to 0.15 mg 3-ketodesogestrel, 0.2 to 0.3 mg norgestimate, >0.35 to 0.75 mg norethisterone, 0.1 mg of drospirenone to a drospire- none dose equivalent to 0.075 mg of gestodene, and 0.1 mg cyproterone acetate to a cypro- terone acetate dose equivalent to 0.075 mg gestodene; for contraception for a woman of fertile age who has not yet reached the preme- nopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

9. Combination product for oral contra- ception which comprises (a) 23 or 24 dosage units, each comprising an oestrogen selected from >2.0 to 6.0 mg 17-estradiol, and 0.020 mg ethinylestradiol;

and a progestogen selected from

0.25 mg of drospirenone to a drospire- none dose equivalent to 0.075 mg of gestodene, and 0.1 mg cyproterone acetate to a cypro- terone acetate dose equivalent to 0.075 mg gestodene; and (b) 5 or 4 placebo pills or other indica- tions in order to indicate that the daily administration of the 23 or 24 dosage units is to be followed by 5 or 4 pill-free or placebo pill days."

II. Four notices of opposition were filed against the grant of the patent. They were based on the grounds for opposi- tion in Article 100(a), (b) und (c) EPC, it being argued that the entire subject- matter of the patent was non-patentable under Article 52(1) EPC in conjunction

with Articles 54 and 56 EPC, owing to a lack of novelty and a lack of inventive step; that the patented subject-matter concerned methods excluded from patentability under Article 52(4) EPC 1973 and also not susceptible of indus- trial application within the meaning of Article 57 EPC; that the European patent did not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a skilled person; and that the patented subject-matter went beyond the content of the appli- cation as filed.

III. In its decision of 21 April 2009, the opposition division maintained the patent in suit in amended form on the basis of auxiliary request 10. On the merits, it concluded that the main request failed to meet the requirements of Article 123(2) EPC on account of the claimed dosage range for cyproterone acetate and drospirenone. The use claims in auxiliary request 8 concerned a method within the meaning of Article 53(c) EPC because therapeutic and non-therapeutic effects were inseparably linked in a significant number of the target group of women suffering from pre-menstrual syndrome (PMS). The invention defined in auxiliary request 9 did not meet the requirements of Article 83 EPC, because the skilled person would be unable to determine the doses of cyproterone acetate and drospirenone equivalent to 0.075 mg of gestodene which were claimed in claims 5 and 6.

As far as auxiliary request 10, which had been filed during the oral proceedings on 20 and 21 April 2009, was concerned, the opposition division concluded that the requirements of Rule 80 EPC and of Articles 84, 123(2) and (3) and 57 EPC were met. The disclaimer "non-thera- peutic" was not incompatible with the requirements of Article 123(2) EPC, because it was permissible to exclude non-patentable subject-matter by disclaimers. Through introduction of the disclaimer, the claimed use had been limited to direct, non-therapeutic contra- ception and therefore ceased to be a use within the meaning of Article 53(c) EPC. Moreover, the use now claimed was susceptible of industrial application because, unlike the vaginal cream used

in T 74/93 (OJ EPO 1995, 712), the oral dosage form did not have to be taken at the time of sexual intercourse. Given that the term "pre-menopause" was sufficiently well known in the prior art and that doctors at least could detect transitions from the "prior to the pre- menopause" phase to the "pre-meno- pause" phase, the invention defined in auxiliary request 10 was also sufficiently disclosed. Since this borderline area only affected a very small number of women, the possibility of distinguishing between them was unimportant, it being sufficient for the purposes of reproduci- bility that the invention could, essentially, be carried out over the entire scope claimed. The subject-matter claimed in auxiliary request 10 was also novel over the disclosure in document (6) (EP-A-0 253 607), because the target group of women of a fertile age who had not yet reached the pre-menopause had to be regarded as a distinguishing feature vis--vis the pre-menopausal women described in document (6). As far as inventive step was concerned, the opposition division, taking document (1) (Kuhl H., "Aktuelle Entwicklungen der hormonalen Kontrazeption", Gynkologe 1992, vol. 25, 231-240) as the closest prior art, considered that the problem to be solved was to provide a use for contraception for pre-menopausal women of a fertile age, such contracep- tion being intended to improve ovarian suppression. It was not obvious to solve this problem by administering a drug over 23 or 24 days because none of the available documents other than docu- ment (6) disclosed the claimed regimen for low-dose oral contraception, and as the opposition division had already observed in connection with novelty document (6) concerned a different target group. There, the time for which the contraceptive did not have to be taken had been reduced to prevent the incidence of hormone deficiency symptoms, and not to improve ovarian suppression as in the patent in suit. Accordingly, the skilled person would not seek to solve the problem defined above by applying the dosage regimen according to document (6) to the teaching in document (1).

IV. The patent proprietor (appellant- patent proprietor) and opponents 01 to 03 (appellant-opponent 01, appellant- opponent 02 and appellant-opponent 03) appealed against that decision.

V. Together with its statement of grounds of appeal of 23 October 2009, the appel- lant-patent proprietor filed a main request and 23 auxiliary requests. During the oral proceedings on 27 October 2010, it filed an additional auxiliary claim 24. The independent claims read as follows:

(i) Main request: "1. Use of an oral monophasic dosage form comprising 0.015 to 0.020 mg ethinylestradiol, and a progestogen selected from 0.05 to 0.075 mg gestodene, 0.075 to 0.125 mg levonorgestrel, 0.06 to 0.15 mg desogestrel, 0.06 to 0.15 mg 3-ketodesogestrel, 0.2 to 0.3 mg norgestimate, >0.35 to 0.75 mg norethisterone;

for contraception for a woman of fertile age who has not yet reached the preme- nopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

5. Use of an oral monophasic, ovulation- inhibitory dosage form comprising

0.020 mg ethinylestradiol; and a progestogen selected from 0.25 mg of drospirenone to a drospire- none dose equivalent to 0.075 mg of gestodene, and 0.1 mg cyproterone acetate to a cypro- terone acetate dose equivalent to 0.075 mg gestodene; for contraception for a woman of fertile age who has not yet reached the preme- nopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by

5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

7. Monophasic, ovulation-inhibitory combination product for oral contracep- tion which comprises (a) 23 or 24 dosage units, each comprising 0.020 mg ethinylestradiol; and 0.25 mg of drospirenone to a drospire- none dose equivalent to 0.075 mg of gestodene and (b) 5 or 4 placebo pills or other indica- tions in order to indicate that the daily administration of the 23 or 24 dosage units is to be followed by 5 or 4 pill-free or placebo pill days."

(ii) Auxiliary request 1: Independent claims 1 and 5 are identical to claims 1 and 5 of the main request, save for the following amendment: "Use of an oral ..." was replaced in each of those claims by "Non-therapeutic use of an oral ...". Independent claim 7 is identical to claim 7 of the main request.

(iii) Auxiliary request 2: "1. Use of a composition comprising

0.015 to 0.020 mg ethinylestradiol; and a progestogen selected from 0.05 to 0.075 mg gestodene, 0.075 to 0.125 mg levonorgestrel, 0.06 to 0.15 mg desogestrel, 0.06 to 0.15 mg 3-ketodesogestrel, 0.2 to 0.3 mg norgestimate, and >0.35 to 0.75 mg norethisterone;

to produce an oral monophasic dosage form for contraception for a woman of fertile age who has not yet reached the premenopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

5. Use of a composition comprising

0.020 mg ethinylestradiol; and a progestogen selected from 0.25 mg drospirenone to a drospirenone dose equivalent to 0.075 mg of gesto- dene, and 0.1 mg cyproterone acetate to a cypro- terone acetate dose equivalent to 0.075 mg gestodene; to produce an oral monophasic, ovula- tion-inhibitory dosage form for contracep- tion for a woman of fertile age who has not yet reached the premenopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle."

Independent claim 7 is identical to claim 7 of the main request.

(iv) Auxiliary request 3: The sole independent claim 1 is identical to claim 7 of the main request.

(v) Auxiliary request 4: Independent claims 1 and 4 are identical to claims 1 and 5 of the main request, respectively. Independent claim 7 of the main request was deleted.

(vi) Auxiliary request 5: Independent claims 1 and 4 are identical to claims 1 and 5 of auxiliary request 1, respectively. Independent claim 7 of auxiliary request 1 was deleted.

(vii) Auxiliary request 6: Independent claims 1 und 4 are identical to claims 1 and 5 of auxiliary request 2, respectively. Independent claim 7 of auxiliary request 2 was deleted.

(viii) Auxiliary request 7: Independent claim 1 is identical to claim 1 of the main request.

Independent claim 5 is identical to claim 5 of the main request, save for the following amendment: "Use of an oral monophasic ovulation-inhibitory dosage form comprising ..." was replaced by "Use of an oral monophasic dosage form comprising ...".

Independent claim 7 is identical to claim 7 of the main request, save for the following amendment: "Monophasic, ovulation-inhibitory combination product ..." was replaced by "Monophasic combi- nation product ...".

(ix) Auxiliary request 8: Independent claim 1 is identical to claim 1 of auxiliary request 1.

Independent claim 5 is identical to claim 5 of auxiliary request 1, save for the following amendment: "Non-therapeutic use of an oral monophasic ovulation- inhibitory dosage form comprising ..." was replaced by "Non-therapeutic use of an oral monophasic dosage form comprising ...".

Independent claim 7 is identical to claim 7 of auxiliary request 7.

(x) Auxiliary request 9: Independent claim 1 is identical to claim 1 of auxiliary request 2.

Independent claim 5 is identical to claim 5 of auxiliary request 2, save for the following amendment: "Use of a compos- ition comprising ... to produce a mono- phasic, ovulation-inhibitory dosage form" was replaced by "Use of a composition comprising ... to produce a monophasic dosage form".

Independent claim 7 is identical to claim 7 of auxiliary request 7.

(xi) Auxiliary request 10: The sole independent claim 1 is identical to claim 7 of auxiliary request 7.

(xii) Auxiliary request 11: Independent claim 1 is identical to claim 1 of the main request. Independent claim 4 is identical to claim 5 of auxiliary request 7.

(xiii) Auxiliary request 12: Independent claim 1 is identical to claim 1 of auxiliary request 1. Independent claim 4 is identical to claim 5 of auxiliary request 8.

(xiv) Auxiliary request 13: Independent claim 1 is identical to claim 1 of auxiliary request 2. Independent claim 4 is identical to claim 5 of auxiliary request 9.

(xv) Auxiliary request 14: Independent claim 1 is identical to claim 1 of the main request.

Independent claim 5 is worded as follows: "5. Use of an oral monophasic dosage form comprising 20 g ethinylestradiol and a progestogen selected from a cyproterone acetate dose equivalent to 75 g gestodene and a drospirenone dose equivalent to 75 g gestodene;

for contraception for a woman of fertile age who has not yet reached the preme- nopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle."

Independent claim 6 is identical to claim 7 of auxiliary request 7.

(xvi) Auxiliary request 15: Independent claim 1 is identical to claim 1 of auxiliary request 1.

Independent claim 5 is identical to claim 5 of auxiliary request 14, save for the following amendment:

"Use of an oral monophasic dosage form ..." was replaced by "Non-thera- peutic use of an oral monophasic dosage form ...".

Independent claim 6 is identical to claim 7 of auxiliary request 7.

(xvii) Auxiliary request 16: Independent claim 1 is identical to claim 1 of auxiliary request 2.

Independent claim 5 is worded as follows:

"5. Use of a composition comprising

20 g ethinylestradiol and a progestogen selected from a cyproterone acetate dose equivalent to 75 g gestodene and a drospirenone dose equivalent to 75 g gestodene; to produce an oral monophasic dosage form for contraception for a woman of fertile age who has not yet reached the premenopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle."

Independent claim 6 is identical to claim 7 of auxiliary request 7.

(xviii) Auxiliary request 17: The sole independent claim 1 is identical to claim 7 of auxiliary request 7.

(xix) Auxiliary request 18: Independent claim 1 is identical to claim 1 of the main request.

Independent claim 4 is identical to claim 5 of auxiliary request 14.

(xx) Auxiliary request 19: Independent claim 1 is identical to claim 1 of auxiliary request 1.

Independent claim 4 is identical to claim 5 of auxiliary request 15.

(xxi) Auxiliary request 20: Independent claim 1 is identical to claim 1 of auxiliary request 2.

Independent claim 4 is identical to claim 5 of auxiliary request 16.

(xxii) Auxiliary request 21: The sole independent claim 1 is identical to claim 1 of the main request.

(xxiii) Auxiliary request 22: The sole independent claim 1 is identical to claim 1 of auxiliary request 1.

(xxiv) Auxiliary request 23: The sole independent claim 1 is identical to claim 1 of auxiliary request 2.

(xxv) Auxiliary request 24: "1. Monophasic dosage form comprising

0.015 to 0.020 mg ethinylestradiol; and a progestogen selected from 0.05 to 0.075 mg gestodene, 0.075 to 0.125 mg levonorgestrel, 0.06 to 0.15 mg desogestrel, 0.06 to 0.15 mg 3-ketodesogestrel, 0.2 to 0.3 mg norgestimate, and >0.35 to 0.75 mg norethisterone;

for contraception for a woman of fertile age who has not yet reached the preme- nopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle."

VI. The following documents were also cited in the course of the opposition and appeal proceedings:

(21a) Oelkers W. et al., "Dihydrospi- rorenone, a New Progestogen with Antimineralocorticoid Activity: Effects on Ovulation, Electrolyte Excretion, and the Renin-Aldosterone System in Normal Women", J. Clin. Endocrinol. Metab. 1991, vol. 73, No. 4, 837-843

(24) Spona J. and Huber J., "Efficacy of Low-Dose Oral Contraceptives containing Levonorgestrel, Gestoden and Cyproterone Acetate", Gynecol. obstet. Invest. 1987, vol. 23, 184-193

(42) The North American Menopause Society (NAMS), "Menopause Practice: A Clinician's Guide. Section B: Normal Physiology", 2nd ed., 2007, 19-27

(43) Website: oralcontraceptives.com

(94) Rebar R.W. and Zeserson K., "Characterization of the new progesto- gens in combination oral contraceptives", Contraception 1991, vol. 44, No. 1, 1-10

(101) Kopera H. and Huber J., "Hormo- nelle Therapie fr die Frau", Springer, Berlin et al. 1991

(107) Spona J. et al., "Inhibition of ovula- tion by a triphasic gestodene-containing oral contraceptive", Adv. Contracept. 1993, vol. 9, No. 3, 187-194

(109) Oelkers W., "Effects of oral contraceptives on the renin-aldosterone system: overview and report on a new natriuretic progestogen", Adv. Contra- cept. 1991, vol. 7, Suppl. 3, 195-206

(111) Spona J. and Huber J., "Pharmaco- logical and endocrine profiles of gesto- dene", Int. J. Fertil. 1987, 32 Suppl., 6-14 (abstract)

(112) Andreasen E.E. et al., "Proges- terone and gestagen treatment. Pharma- cologic and clinical aspects", Ugeskrift Laeger 1987, vol. 151, 2021-2026 (abstract)

(113) "Declaration" of Professor T. Rabe of 12.10.2009

(120) Dsterberg B. et al., "Pharmacolo- gical features of gestodene in laboratory animals and man", in: Breckwoldt and Dsterberg (editors), "Gestodene, A New Direction in Oral Contraception", Carnforth, Lancs, Parthenon Publishing, 1988, 13-29

(121) Runnebaum B. and Rabe T., "New progestogens in oral contraceptives", Am J Obstet Gynecol, 1987, vol. 157, No. 4, 1059-1063

(122) Kuhl H., "Pharmacokinetics of oestrogens and progestogens", Maturitas 1990, vol. 12, 171-197

(131) "Joint proposed claim construction" filed with US District Court of Nevada

(132) E-mail correspondence between Sandoz' counsel (Steven Moore) and Bayer Schering Pharma's counsel (Paul Skiermont)

(133) Printout from www.medizin-telegramm.com

(134) Printout from www.fundinguniverse.com

(135) WHO Scientific Group, "Research on the Menopause in the 1990s", WHO Technical Report Series 866, Geneva 1996, 12-13

(136) WHO Scientific Group, "Research on the menopause", WHO Technical Report Series 670, Geneva 1981, 3-10

VII. The oral proceedings, culminating in pronouncement of this decision on the appeal, were held on 26 and 27 October 2010.

VIII. The appellant-patent proprietor's main arguments can be summarised as follows:

With regard to the exclusion from patent- ability under Article 53(c) EPC, the appellant-patent proprietor, citing docu- ment (43), observed that it had long been known that hormonal contracep- tion, in addition to its actual purpose

of preventing conception, had added beneficial effects which might indeed be therapeutic in nature, such as, for example, reduced incidence of certain kinds of tumour, lowering of LDL choles- terol levels and reduced incidence of PMS. However, in the past, methods of hormonal contraception had not been excluded from patentability under Article 53(c) EPC in the light of this knowledge. Whether or not a claimed method was therapeutic depended primarily on the intended purpose set out in the claim. The method of hormonal contraception at issue in T 820/92 (OJ EPO 1995, 113) was characterised by the administration of oestrogenic and progestational steroids, in addition to the contraceptive LHRH, with a view to preventing or alleviating the likely side- effects of applying LHRH, which was clearly a prophylactic treatment covered by the term therapy. By contrast, the intended purpose defined in the present claim 1 was exclusively non-therapeutic and so not excluded from patentability under Article 53(c) EPC. Rather, the present case resembled those settled in T 144/83 (OJ EPO 1986, 301) and T 36/83 (OJ EPO 1986, 295). In T 144/83, the board had allowed a method for cosmetic treatment, even though it had been impossible to distin- guish clearly between its therapeutic and cosmetic effects. The decision in T 36/83 was especially relevant to the present case because it had concerned parallel therapeutic and non-therapeutic uses and the board had allowed a claim to a non-therapeutic use even though the claimed cosmetic use might also incidentally involve a medical treatment. Thus, at least after introduction of the disclaimer to claim 1 of auxiliary request 1, methods covered by Article 53(c) EPC had been excluded from the claimed subject-matter. However, were the board to take the view that the subject-matter of claim 1 of auxiliary request 1 was also non- patentable under Article 53(c) EPC, the case should be referred to the Enlarged Board of Appeal under Article 112(1)(a) EPC because such a decision would run counter to that in T 36/83.

With respect to the sufficiency of disclo- sure of the claimed doses of the active substances drospirenone und cypro- terone acetate, the appellant-patent proprietor argued, in essence, that an invention was sufficiently disclosed, in principle, if the skilled person was shown at least one way of carrying out the invention. Although there was no infor- mation in the actual patent in suit as to how the dose of drospirenone or cypro- terone acetate equivalent to 0.075 mg gestodene was to be determined, the skilled person could define this without difficulty on the basis of the minimum ovulation-inhibitory dose. In that connec- tion, it stressed that it was usual practice to indicate the minimum ovulation-inhibi- tory dose for an individual substance (in this case: drospirenone or cyproterone acetate), and not for the combination of ethinylestradiol and a progestogen contained in the composition. As shown by documents (24), (94), (107), (111), (112), (120) and (121), the minimum ovulation-inhibitory dose for gestodene was known to be 40 g. Although docu- ments (1) and (101) disclosed a different minimum ovulation-inhibitory dose for gestodene, namely 30 g, those two documents were based on a single source, i.e. Table IV of the same author's document (122), which however contained no information as to how the 30 m dose had been established. Accordingly, the skilled person would undoubtedly identify 40 g as the correct minimum ovulation-inhibitory dose of gestodene.

The minimum ovulation-inhibitory dose for drospirenone was also known. Document (109) disclosed a pilot study, in which administration of 2 mg drospire- none over 21 days had been shown to have an ovulation-inhibitory effect, whereas this effect had not been achieved by applying 1 mg drospirenone. As for the opponents' argument that the minimum ovulation-inhibitory dose might be between 1 and 2 mg, tests of this kind were conducted in vivo and, for ethical reasons, it was unacceptable to conduct additional tests, which were very unpleasant for the test persons, for the sole purpose of defining the minimum ovulation-inhibitory dose more precisely. The administration of 2 mg drospirenone was the lowest dose shown in experiments to have the effect of inhibiting ovulation and therefore had to be accepted as the minimum ovula- tion-inhibitory dose. In this connection, the appellant-patent proprietor also cited document (113). Moreover, docu- ment (21a) contained a comparative study between a 2 mg dose of drospire- none and a 1 mg dose of cyproterone acetate. Since, according to docu- ment (24), the minimum ovulation-inhibi- tory dose for cyproterone acetate was 1 mg and comparative studies were generally conducted with equivalent amounts, the minimum ovulation-inhibi- tory dose of 2 mg for drospirenone could also be gathered from document (21a). The equivalent dose claimed in claim 5 of auxiliary request 2 could therefore be determined very easily, by first calcu- lating the ratio of 0.075 mg gestodene to the minimum ovulation-inhibitory dose for gestodene (0.075 mg: 0.040 mg = 1.875) and then multiplying the factor thus obtained by the minimum ovulation- inhibitory dose for drospirenone (2 mg x 1.875 = 3.75 mg). The equivalent dose for cyproterone acetate could be calcu- lated in the same way. The skilled person could therefore determine, without the need for any further inventive skill, which doses of the active substances had an ovulation-inhibitory effect, which was decisive for settling the issue of suffi- ciency of disclosure. The other objec- tions raised by the opponents, in parti- cular their argument that some of the embodiments covered by the claim did not have the desired effect, did not concern reproducibility, but rather the requirements under Article 84 EPC,

which were not at issue in the opposition and appeal proceedings.

With respect to the objections raised under Article 123(3) EPC to claim 1 of auxiliary request 23, the appellant-patent proprietor asserted that the situation as to a potential infringement had in no way been altered by the rewording of the use claim as a claim for further medical use. Consequently, this amendment should be allowed as far as Article 123(3) EPC was concerned.

As far as the admissibility of auxiliary request 24 was concerned, its filing during the oral proceedings on 27 October 2010 had to be considered a reaction to objections first specifically raised by appellant-opponent 03 during those proceedings. With regard to the requirements under Article 123(3) EPC, it was permissible under Article 54(5) EPC 2000, which applied to all pending applications, to claim compositions used for therapy in the form of purpose-related product claims. This claim form was equivalent to the original use claims and therefore allowable under Article 123(3) EPC.

IX. The appellants-opponents' main arguments can be summarised as follows:

With respect to the exclusion from patentability under Article 53(c) EPC, they submitted that the claimed method of contraception was inseparably asso- ciated with therapeutic effects. The crucial factor in deciding whether a claim was covered by the exclusion from patentability under Article 53(c) was not the intended use set out in the claim. Rather, as explained in T 820/92, the answer depended on the claimed

subject-matter as a whole. Since it was impossible to isolate the therapeutic effects from the method of contraception, the exclusion from patentability could not be countered by introducing the disclaimer "non-therapeutic".

On the question whether the doses of the active substances drospirenone and cyproterone acetate were sufficiently disclosed, the appellants-opponents submitted that an invention had to be essentially reproducible over the entire scope claimed, which was not so here, because the ovulation-inhibitory effect could not be achieved at the lower end of the claimed dosage range. There was also a lack of reproducibility at the upper end because the amounts disclosed in the prior art as the minimum ovulation- inhibitory dose of ethinylestradiol were inconsistent, whilst no amounts were disclosed for drospirenone. This meant that the doses equivalent to 0.075 mg gestodene had to be calculated by means of onerous tests which the skilled person could not reasonably be required to conduct.

With respect to the requirements under Article 123(3) EPC, they contended that conversion of a use claim into a claim for further medical use resulted in an exten- sion of the scope of protection.

Moreover, auxiliary request 24, which had been filed during the oral proceed- ings on 27 October 2010, had been filed belatedly and so could not be admitted into the proceedings because appellant- opponent 03 had already raised objec- tions under Article 123(3) EPC in its written pleadings of 19 March 2010.

X. The appellant-patent proprietor requested that the contested decision be set aside and the patent maintained on the basis of the main request or one of auxiliary requests 1 to 23, as filed with its grounds of appeal of 23 October 2009, or on the basis of auxiliary request 24,

as filed during the oral proceedings on 27 October 2010.

Appellants-opponents 01-03 requested that the contested decision be set aside and the patent in suit revoked.

Reasons for the decision

1. The appeal is admissible.

2. Admissibility of belated submissions:

2.1 Auxiliary request 24: Auxiliary request 24 was not filed until 27 October 2010 and so at a very late stage of the oral proceedings before the board. The appellant-patent proprietor justified this by arguing that auxiliary request 24 was a reaction to the objec- tions under Article 123(3) EPC first raised by appellant-opponent 03 during the oral proceedings. Appellant-oppo- nent 03 disputed this, citing its submis- sions of 19 March 2010, in which it had previously raised objections under Article 123(3) EPC.

Reference is indeed made to Article 123(3) EPC in the first paragraph on page 2 of those submissions of 19 March 2010, the wording being as follows: "With respect to the amend- ments made to the main request and to auxiliary requests 1 to 23 ..., we refer to the arguments already put forward with regard to Article 123(2) and (3) EPC in our statement of grounds of appeal of 23 October 2009, which apply by analogy to all versions of the claims".

The cited passage contains no specific reasons in support of the objections under Article 123(3) EPC. Nor are those objections rendered any more specific by the reference to the grounds of appeal of 23 October 2009, as Article 123(3) EPC is not addressed there either expressly or by implication. Thus, the appellant- patent proprietor was first confronted with a specific objection under Article 123(3) EPC during the oral proceedings on 26 and 27 October 2010.

The board nevertheless considered the objection admissible because, according to the decisions of the Enlarged Board of Appeal in joined cases G 9/91 and G 10/91, the boards must of their own motion fully examine any amendments made to the claims or other parts of a patent in the course of opposition or appeal proceedings as to their compat- ibility with the requirements of the EPC, in particular those of Article 123(2) and (3) EPC (see G 9/91, OJ EPO 1993, 408, and G 10/91, OJ EPO 1993, 420, Reasons 19 in both cases). Moreover, the appellant-patent proprietor was given sufficient opportunity to address the objection under Article 123(3) EPC. Its filing of auxiliary request 24 was thus a reaction to the objections first specifically raised during the oral proceedings. As such, the request was admitted into the proceedings in accord- ance with Article 13(1) and (3) of the Rules of Procedure of the Boards of Appeal ("RPBA"; OJ EPO 2007, 537).

2.2 Documents (131) to (136): Documents (131) to (136) were filed only at a very late stage of the appeal proceedings. Since they are irrelevant for the findings below in relation to Articles 53(c), 83 and 123(3) EPC, the board has decided not to admit them into the proceedings (Article 13(3) RPBA).

3. Main request Article 53(c): 3.1 Claim 1 in this case concerns the use of an oral monophasic dosage form comprising ethinylestradiol and a proges- togen, selected from a list of six specific compounds, for contraception for a woman of fertile age who has not yet reached the menopause. In deciding whether such use constitutes a non- patentable activity under Article 53(c) EPC, the board first of all observes that it is the settled case law of the boards that, since pregnancy is not an illness, its prevention is not a therapeutic method, not even when done prophylactically (T 820/92, Reasons 5.2 ff, confirmed in T 74/93, Reasons 2.2.3). However, the board must also bear in mind that the

intended use specified in claim 1 "for contraception for a woman of fertile age who has not yet reached the meno- pause" is not the sole factor relevant for deciding whether or not the exception to patentability under Article 53(c) EPC applies. Rather, it must be examined whether the subject-matter of the claim as a whole encompasses one or more therapeutic steps and/or therapeutic effects, because as explained in the decision in T 820/92, which the appel- lant-patent proprietor has cited non- patentability under Article 53(c) EPC (or Article 52(4) EPC 1973) applies even where such steps or effects are only part of the subject-matter covered by the claim (see Reasons 5.3).

When analysing claim 1, the board must consider that all active substances, both ethinylestradiol and each of the six progestogens, are characterised by indications of their concentrations, the selected ranges showing the product to be a low-dose contraceptive. It can be gathered from the description (see [0008] of the patent specification) that it was hoped that lowering the daily hormone dosage would reduce unwanted side-effects, and that epide- miological data confirm the desired trend of improving low-dose preparations in terms of any cardiovascular complica- tions. In addition, in [0009] of the patent specification, it is presumed, in particular, that there is a link between the level of the oestrogen dose and the incidence of cardiovascular conditions. In that connection, the board stresses that the reduction in the concentrations of the active substances in no way serves to improve contraceptive efficacy, but solely to prevent or reduce the secondary effects referred to above: in [0009] of the patent specification, for example, it is made unambiguously clear that an extreme reduction of the daily oestrogen dosage is incompatible with contracep- tive efficacy and jeopardises satisfactory cycle control. Thus, although the present claim 1 relates to a use which is per se

non-therapeutic, the selected concentra- tions of active substance defined in the claim simultaneously prevent the secondary effects likely to arise in the case of that per se non-therapeutic use. Such prevention which is affirmed in claim 1 by the indication of the concen- trations of active substance and which, in the light of the pathological nature of the secondary effects (e.g. cardiovas- cular or thrombolytic complications), must clearly be classed as therapeutic is inseparably associated with the per se non-therapeutic contraceptive process. Taken as a whole, therefore, the subject- matter of claim 1 of the main request encompasses a therapeutic method. Since, in accordance with the boards' settled case law, non-patentability under Article 53(c) EPC applies even where only part of the subject-matter covered by a claim constitutes a method of treat- ment of the human or animal body by therapy (G 1/04, OJ EPO 2006, 334, Reasons 6.2.1, confirmed by G 1/07 of 15 February 2010, Reasons 3.2, and G 1/08, OJ EPO 2010, 456, Reasons 5.6), the subject-matter of claim 1 of the main request is non-patentable under Article 53(c) EPC.

3.2 The decisions T 144/83 und T 36/83, which the appellant-patent proprietor cites in this connection, are irrelevant in this case for the following reasons:

3.2.1 T 144/83 (OJ EPO 1986, 301): In T 144/83, the board concluded that the wording of the main claim, which concerned a use of naltrexone for improving bodily appearance whereby naltrexone was repeatedly administered in a dosage effective to reduce appetite until a cosmetically beneficial loss of body weight had occurred, clearly covered a method of cosmetic use and was unrelated to therapy of a human or animal body. That a chemical product had both a cosmetic and a therapeutic

effect did not render the cosmetic treat- ment non-patentable (see Reasons 3 and 4).

Since naltrexone is categorised as an opioid antagonist and is a highly-effect- ive pharmacological substance, it cannot be ruled out that, in parallel to the non- therapeutic use claimed, it may have other effects which may indeed be of a therapeutic nature. However, that is irrelevant for the purposes of Article 53(c) EPC if those additional, potentially therapeutic effects can be clearly distin- guished from the non-therapeutic use and are not covered by the subject- matter of the claim. The fundamental difference between the use claimed in T 144/83 and that in the present claim 1 is thus that the scope defined by the wording of the former claim covered a non-therapeutic use only. An appropriate dose of naltrexone was repeatedly admi- nistered to persons not suffering from obesity until a cosmetically beneficial loss of body weight had occurred. Such a claim in any event cannot be regarded as relating to the prevention of obesity on a reasonable and objective reading.

By contrast, the scope defined by the wording of the present claim 1 encom- passes a use comprising a non-thera- peutic element which is inseparably associated with a preventive therapeutic element and that latter element is an essential part of the claimed method (see T 290/86, OJ EPO 1992, 414, Reasons 3.2).

3.2.2 T 36/83 (OJ EPO 1986, 295): In T 36/83, the board concluded that the disclosed uses of thenoyl peroxide were both therapeutic (treatment of acne) and cosmetic (comedolytic effect) in nature. On the admissibility of the claim directed to the cosmetic use, the board found that it was essential to establish whether the cosmetic indication was distinct from the therapeutic indication and held, in the

light of the information in the description, that this was so (see Reasons 6). Although the cosmetic treatment might also incidentally involve a medical treat- ment (see Reasons 6.1), it assisted in skin cleansing, which the board classed as non-medical body hygiene (see Reasons 6.2). The situation was thus analogous to that decided in T 144/83: a solely cosmetic and so non-thera- peutic effect could be achieved and indeed was exclusively claimed in the wording of the claim. Thus, in T 36/83 too, there was no inseparable link between a non-therapeutic and a thera- peutic activity, such as that identified in the present claim 1 of the main request.

3.3 In view of this fundamental differ- ence, the finding that the subject-matter of the present claim 1 of the main request is subject to the exception to patentability under Article 53(c) EPC is not inconsistent with the decision in T 36/83 and there are therefore no grounds for referring the matter to the Enlarged Board of Appeal under Article 112(1)(a) EPC, as requested by the appellant-patent proprietor.

4. The reasons given in point 3 apply mutatis mutandis to each of the claims 1 in auxiliary requests 4, 7, 11, 14, 18 and 21, which are identical to claim 1 of the main request and so likewise non- patentable under Article 53(c) EPC.

5. Auxiliary request 1: The wording of claim 1 of auxiliary request 1 differs from that of claim 1 of the main request in that the disclaimer "non-therapeutic" has been introduced. Such a disclaimer allows for the exclu- sion of therapeutic uses from a claim encompassing both therapeutic and non- therapeutic uses in such a way that they are substantively separable so that the remaining subject-matter is no longer covered by the exception to patentability under Article 53(c) EPC. However, such

a disclaimer cannot be employed to define as non-therapeutic a use which necessarily includes one or more thera- peutic steps, since the question whether or not a claimed use is therapeutic can be decided only in the light of the activ- ities carried out, or the effects achieved, in the course of that use. Since, as found in point 3.2.1 above, the subject-matter of claim 1 concerns a use comprising a non-therapeutic element which is inse- parably linked with a preventive-thera- peutic element and that latter element concerns essential features of the claimed use, the exception to patent- ability under Article 53(c) EPC also applies to the subject-matter of claim 1 of auxiliary request 1, despite introduction of the disclaimer "non-therapeutic".

Moreover, since the disclaimer "non- therapeutic" in this case is inconsistent with the subsequently defined use, which is therapeutic in substance, the subject- matter of claim 1 of auxiliary request 1 also fails to meet the requirements of Article 84 EPC.

6. The reasons set out in point 5 apply mutatis mutandis to each of the claims 1 of auxiliary requests 5, 8, 12, 15, 19 and 22, which are identical to claim 1 of auxiliary request 1 and so likewise non- patentable under Article 53(c) EPC.

7. Auxiliary request 2 Article 83 EPC:

The subject-matter of claim 5 of auxiliary request 2 concerns the use of a compos- ition to produce an oral monophasic, ovulation-inhibitory dosage form, the concentrations of the active substances drospirenone and cyproterone acetate being defined as follows:

0.25 mg drospirenone to a drospirenone dose equivalent to 0.075 mg gestodene, and 0.1 mg cyproterone acetate to a cyproterone acetate dose equivalent to 0.075 mg.

7.1 It is the boards' settled case law that an invention is sufficiently disclosed only if it essentially allows the skilled person to carry it out over the whole scope claimed. In this case, it transpired during the grant procedure that the concentra- tions originally disclosed for the active substances drospirenone and cypro- terone acetate, namely 0.1 to 0.3 mg and 0.1 to 0.2 mg (see claim 1 in the application as filed), had mistakenly been selected at a level which was too low by one order of magnitude (see the submissions of the appellant-patent proprietor and original applicant of 25 August 2003, section entitled "Amendments pursuant to Rule 88 EPC"), from which it can be inferred that neither drospirenone nor cyproterone acetate can be expected to have an ovulation-inhibitory effect in a dose of less than 1 mg. This means that the claimed use cannot be carried out over a considerable part of its scope, because an ovulation-inhibitory effect cannot be achieved in the entire lower concentra- tion range (0.25 mg to approx. 1 mg drospirenone and 0.1 mg to approx. 1 mg cyproterone acetate). For that reason alone, the subject-matter of the present claim 5 fails to meet the requirements of Article 83 EPC.

7.2 It should also be observed that the skilled person cannot establish whether or not a particular product has an ovula- tion-inhibitory effect without conducting time-consuming tests. The skilled person is not only confronted with the fact that the oral dosage forms at the lower end of the claimed range of concentrations of the active substances have no ovula- tion-inhibitory effects (see point 7.1 above), but will also find that it is indis- pensable to conduct tests to determine the upper threshold because, as will be shown below, the doses of drospirenone and cyproterone acetate equivalent to 0.075 mg gestodene cannot be deter- mined by a simple calculation, as asserted by the appellant-patent propri- etor (see point VIII above), even if it is assumed in the appellant-patent propri- etor's favour that the doses of those two active substances equivalent to 0.075 mg gestodene can actually be calculated proportionately on the basis of the minimum ovulation-inhibitory dose.

7.2.1 Minimum ovulation-inhibitory dose of gestodene: As shown by the appellant-patent proprietor (see point VIII), different amounts are disclosed in the prior art as the minimum ovulation-inhibitory dose of gestodene, namely 40 g daily in documents (24), (94), (107), (111), (112), (120) and (121) and 30 g daily in docu- ments (1), (101) and (122). The board cannot, however, accept the appellant- patent proprietor's argument that the skilled person would immediately recog- nise that the first set of documents, postulating a daily dose of 40 g gesto- dene, is a more reliable source for the minimum ovulation-inhibitory dose of gestodene than documents (1), (101) and (122). It is true that the latter docu- ments do not describe how the minimum ovulation-inhibitory dose was deter- mined, but this would not appear to be necessary given that, as the appellant- patent proprietor likewise asserts, the skilled person is entirely familiar with the method of doing so. Moreover, the skilled person is likely to pay particular attention to document (1) because it is recom- mended in the application as filed (see page 9, last paragraph) as a reference for determining the dose equivalents of various progestogen substances. Faced with the contradictory information to be gleaned from documents which must be regarded as equally plausible, the skilled person will conclude that the correct minimum ovulation-inhibitory dose of gestodene can only be determined by series of tests conducted to that end.

7.2.2 Minimum ovulation-inhibitory dose of drospirenone: Nor can the minimum ovulation-inhibitory dose of drospirenone be clearly identified from the prior art. It too must therefore be determined by way of series of appro-

priate tests. The appellant-patent propri- etor based its arguments on docu- ment (109) in particular, which shows that the administration of 2 mg drospire- none over the course of 21 days inhib- ited ovulation, whereas this result was not achieved by administering a dose of 1 mg over the same period (see middle of page 200). It cannot be inferred from that information that the minimum ovula- tion-inhibitory dose of drospirenone is 2 mg, but merely that a daily dose of 2 mg will definitely inhibit ovulation and that the minimum ovulation-inhibitory dose of drospirenone is somewhere between 1 mg and 2 mg. This conclusion is not called into question by "Study 2" in document (109), in which the effects of a daily administration of 2 mg drospire- none over the course of two monthly cycles are compared with those of the administration of 1 mg cyproterone acetate over the same period. Citing document (113) (see point 14), the appellant-patent proprietor argued that the minimum ovulation-inhibitory dose of cyproterone acetate was 1 mg and that a comparative study made sense only if it compared equivalents from which the skilled person could unambiguously conclude that the minimum ovulation- inhibitory dose of drospirenone was 2 mg. The same applied by analogy to "Study II" in document (21a).

In the board's view, it cannot be gathered unambiguously from either "Study 2" in document (109) or "Study II" in document (21a) that the minimum ovulation-inhibitory dose of drospirenone is 2 mg. The aim of both studies (Study 2 and Study II) was to investigate the effects of administering drospirenone as an ovulation-inhibitor in terms of the sodium, potassium and aldosterone-18- glucuronide concentrations in urine, the sodium and potassium concentrations in serum, the plasma renin activity and the plasma aldosterone concentration. To that end, it was appropriate to select a dose having the desired ovulation-inhi-

bitory effect, and the 1 mg dose, which did not have such an effect, was there- fore ruled out. Even though a compari- son was made with 1 mg cyproterone acetate, i.e. the minimum ovulation-inhi- bitory dose of that substance, that does not necessarily mean that, for reasons of equivalence, the minimum ovulation- inhibitory dose of drospirenone must be 2 mg. It is equally plausible that, not knowing the exact minimum ovulation- inhibitory dose of drospirenone, those conducting the two studies referred to above selected a dose which was bound to have an ovulation-inhibitory effect.

7.3 It follows that the minimum ovulation- inhibitory dose of both gestodene and drospirenone must be determined through experiments. Only the dose of 1 mg consistently defined for cypro- terone acetate in all of the various documents cited can be adopted (see e.g. document (1), table 1; docu- ment (24), table 3; or document (101), table 31).

As far as conducting these test series is concerned, the appellant-patent propri- etor observed, both at the oral proceed- ings and in writing (see third last para- graph on page 27 of its submission of 21 May 2010), that, since such tests had to be kept to a minimum for ethical reasons, the issue of reasonableness arose in this case.

Tests often have to be conducted to reproduce an invention where the claims are defined in terms of a function or by parameters, and the claimed subject- matter cannot be defined by specific structural features without unjustifiably limiting its scope. However, the subject- matter of the present claim 5 of auxiliary request 2 differs fundamentally from such a case because it defines a specific active substance (drospirenone) by a dosage range which is, in principle, specific. As a rule, third parties have no need in such a case to conduct tests in order to reproduce the invention. In the present claim 5, however, the upper

threshold for drospirenone is not defined as "x mg drospirenone" but as "a drospi- renone dose equivalent to 0.075 mg gestodene". This indirect definition which is by no means required for reasons relating to the scope of protec- tion, because it in no way alters the subject-matter compared with the direct definition as "x mg drospirenone" compels third parties to conduct time- consuming and ethically questionable experiments in order to reproduce the invention. The board considers that, in assessing the reasonableness of tests required for reproducibility, account must also be taken of whether they could be avoided. Time-consuming and ethically questionable tests are unreasonable if, as in this case, the applicant could have defined the claimed subject-matter, without any limitation as to its scope, by features which would have rendered such tests superfluous for the purpose of reproducibility by the skilled person. For this reason too, the invention defined in claim 5 of auxiliary request 2 fails to meet the requirements of Article 83 EPC.

8. Auxiliary requests 6, 9 and 13 Article 83 EPC: The reasoning set out in point 7 applies mutatis mutandis to each of the claims 5 in auxiliary requests 6 and 9 and to claim 4 of auxiliary request 13. Accord- ingly, the invention defined in these claims fails to meet the requirements of Article 83 EPC.

9. Auxiliary request 3 Article 83 EPC:

Claim 1 of auxiliary request 3 concerns a monophasic, ovulation-inhibitory combi- nation product, which comprises 23 or 24 dosage units, each comprising 0.25 mg drospirenone up to a drospire- none dose equivalent to 0.075 mg gestodene and 4 or 5 placebo pills.

9.1 The reasons set out in point 7.1 with respect to the lack of reproducibility apply mutatis mutandis to this claimed product because a monophasic, ovula- tion-inhibitory combination product, i.e. a monophasic combination product suitable to inhibit ovulation, cannot be manufactured with a 0.25 mg dose of drospirenone.

9.2 The reasons set out in point 7.2 with respect to the upper threshold for the drospirenone dose apply mutatis mutandis to the subject-matter of claim 1 of auxiliary request 3.

9.3 Accordingly, the invention defined in claim 1 of auxiliary request 3 fails to meet the requirements of Article 83 EPC.

10. The reasons given in point 9 apply mutatis mutandis to claim 1 of auxiliary request 10, which is identical to claim 1 of auxiliary request 3. Therefore, claim 1 of auxiliary request 10 fails to meet the requirements of Article 83 EPC.

11. Auxiliary request 16: Claim 5 of auxiliary request 16 differs from claim 5 of auxiliary request 2 in that the doses of drospirenone and cypro- terone acetate are limited to a single amount, namely the dose equivalent to 75 g gestodene. That, however, does not alter the fact that the tests described in points 7.2 and 7.3 are necessary to determine those equivalent doses, which means that the reasons given in those points also apply to the invention defined in claim 5 of auxiliary request 16. The requirements of Article 83 EPC are therefore not met.

12. Auxiliary request 20: The reasons given in point 11 apply mutatis mutandis to claim 4 of auxiliary request 20, which is identical to claim 5 of auxiliary request 16 and so likewise fails to meet the requirements of Article 83 EPC.

13. Auxiliary request 17: Claim 1 of auxiliary request 17 differs from claim 5 of auxiliary request 16 inas- much as cyproterone acetate has been deleted from the list of progestogens, so that drospirenone in a dose equivalent to 0.075 mg [gestodene] remains as the only progestogen. That, however, does not alter the fact that the tests described in points 7.2 and 7.3 are necessary to determine that equivalent dose, which means that the invention described in claim 1 of auxiliary request 17 likewise fails to meet the requirements of Article 83 EPC.

14. Auxiliary request 23 Article 123(3) EPC: 14.1 Claim 1 of auxiliary request 23 differs from claim 1 as granted in that the use claim originally granted has been converted into a Swiss-type claim, i.e. a claim directed to the use of a substance or composition for the production of a medicament for a specific therapeutic application. According to the boards' settled case law, account must be taken of the granted claims as a whole in assessing whether the scope of protec- tion has been extended by such an amendment. In this case, the granted set of claims includes, in addition to use claims 1 to 8, product claims 9 to 19. However, the subject-matter of claim 1 of auxiliary request 23, comprising an ethinylestradiol concentration of 0.015 mg to 0.020 mg, falls in terms of the ethinylestradiol concentration of 0.015 mg to < 0.020 mg outside the scope of protection conferred by product claims 9 to 19 as granted, in which the share of ethinylestradiol is limited to 0.020 mg.

14.2 The board must therefore examine whether it is compatible with the require- ments of Article 123(3) EPC to reword a claim directed to the "use of an oral dosage form comprising ... for contracep- tion ..." as a claim for the "use of a combination product which comprises ... to produce an oral ... dosage form for contraception ...". To do so, it is essential to establish whether the Swiss-type claim is to be construed as a claim

directed to (a) the use of a substance or composition for a specific purpose or (b) the manufacture of a medicament. Construction as a use claim cannot be reconciled with the decision of the Enlarged Board in G 1/83 (OJ EPO 1985, 60), according to which a claim directed to the "use of a substance or composition for the treatment of the human or animal body by therapy" is in no way different in essential content from a claim directed to "a method of treatment of the human or animal body by therapy with the substance or composition" (G 1/83, Reasons 13). The view that, when the invention concerns the employment of a substance or composition for therapy, a method claim excludes and a use claim includes at least the preparation of a pharmaceutical product, with instructions for use in the treatment of illness (which has been called in German the "augenfllige Herrichtung") was rejected by the Enlarged Board (G 1/83, Reasons 11, 17 and 18). By contrast, it considered that it was legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case in which the process of manufac- ture as such does not differ from known processes using the same active ingre- dient. It substantiated this finding by holding in the third paragraph of point 21 of the Reasons that, given the general exception to patentability prescribed in Article 52(1) EPC, "[i]t seems justifiable by analogy to derive the novelty for the process which forms the subject- matter of the type of use claim now being considered from the new thera- peutic use of the medicament and this irrespective of the fact whether any phar- maceutical use of the medicament was already known or not" [emphasis added]. In point 21 of the Reasons, the Enlarged Board therefore deemed the Swiss-type claim to be a process of manufacture the novelty of which, however, exceptionally arises from the intended use of the manufactured product, in a manner similar to the effect of the exception for the "first medical use" under Article 54(5) EPC 1973. It was only thanks to this approach that Swiss-type claims could be considered to overcome the excep- tion to patentability under Article 53(c) EPC (or Article 52(4) EPC 1973). Were a Swiss-type claim considered to corres-

pond in content to a use claim in that a substance or composition is used to achieve a given technical effect, and not to a process of manufacture, it would, in accordance with the ratio decidendi of the decision in G 1/83, continue to be deemed subject to the exception to patentability under Article 53(c) EPC (Article 52(4) EPC 1973) because it defines a method the claimed new use of which, i.e. treatment of the human or animal body by therapy, would constitute the essence of the invention, without being directed to the previous manufac- ture of the medicament.

Thus, the amendment made to claim 1 of auxiliary request 23 has resulted in a change of category from a claim restricted to a specific use of a product to a claim encompassing the preceding manufacture of that product.

In order to establish whether a change of claim category is in line with the require- ments of Article 123(3) EPC, the board must compare the protection conferred by the categories of claims in the patent before amendment with that conferred by the new category of claim introduced by the amendment (G 2/88, OJ EPO 1990, 93, Reasons 4.1). On the scope of protection conferred by a claim for a process of manufacture as opposed to a use claim, the Enlarged Board of Appeal, having regard to Article 64(2) EPC, held in G 2/88 as follows (see Reasons 5.1):

"Article 64(2) EPC is not directed to a patent whose claimed subject-matter is the use of a [product] to achieve an effect (this being the normal subject of a use claim): it is directed to a European patent whose claimed technical subject- matter is a process of manufacture of a product; the Article provides that for such a patent, protection is conferred not only upon the claimed process of manufac- ture, but also upon the product resulting directly from the manufacture.

Thus, provided that a use claim in reality defines the use of a particular physical entity to achieve an effect', and does not define such a use to produce a product', the use claim is not a process claim within the meaning of Article 64(2) EPC."

It follows from the above finding that the process of manufacture to which claim 1 of auxiliary request 23, in view of its content, is directed goes beyond the scope of protection conferred by the use claims as granted: in the case of claims directed to a process of manufacture, the effect of Article 64(2) EPC is to extend protection to the "product" obtained by such process (whatever it might be), whereas a use claim does not encom- pass the manufacture of the pharmaceu- tical product (G 1/83, Reasons 11), with the result that its scope of protection does not extend to the directly resulting product. Consequently, the requirements of Article 123(3) EPC are not met.

15. Auxiliary request 24: 15.1 In auxiliary request 24, the Swiss- type claim in claim 1 of auxiliary request 23 has been converted, with reference to Article 54(5) EPC 2000, into the corresponding purpose-related product claim. As far as the applicability of Article 54(5) EPC 2000 to the present case is concerned, the board recalls that the patent in suit was granted on 2 November 2006, i.e. before the EPC 2000 entered into force. However, under the transitional provisions for the EPC 2000, Article 54(5) EPC 2000 is inapplic- able to European patents already granted when the EPC 2000 entered into

force (see OJ EPO 2007, Special Edition No. 1, table on page 217). Irrespective of the fact that Article 54(5) EPC 2000 does not apply to the present case, so that a claim worded so as to provide purpose- related substance protection would only be allowable for the first medical indica- tion, the conversion of use claims 1 to 8 as granted into a purpose-related product claim constitutes an extension of the scope of protection prohibited under Article 123(3) EPC because the latter claim is directed to the actual product, so that manufacture of the product falls within the scope of its protection, which is not the case with a use claim (see point 14.2).

15.2 For its determination of the scope of protection conferred by product claims 9 to 19 as granted in comparison to that conferred by claim 1 of auxiliary request 24, with a view to assessing whether there has been an impermis- sible extension under Article 123(3) EPC, the board refers to the reasons it gave in point 14.1, which also apply to the subject-matter of claim 1 of auxiliary request 24.

15.3 Accordingly, the subject-matter of claim 1 of auxiliary request 24 fails to meet the requirements of Article 123(3) EPC.

16. Since none of the present requests can be granted, the board need not examine the other grounds for opposition or the other objections raised by the opponents.

Order

For these reasons it is decided that:

1. The contested decision is set aside.

2. The patent is revoked.

References: ar53; ar54;