In the present case, the patent proprietor and three of the four opponents filed appeals against the decision of the Opposition Division (OD) to maintain the patent in amended form.
The decision is somewhat lengthy; if you are happy with a summary, here is a translation of the headnotes provided by the Board:
1. The use of a composition for oral contraception, where the claimed concentrations of the hormons contained in the composition are chosen sufficiently low to avoid or reduce the pathological secondary effects that are to be expected in oral contraception, constitutes a method for treatment by therapy that is excluded from patentability pursuant to A 53 c).
2. As the question of whether a claimed use is therapeutic or non-therapeutic is to be decided exclusively on the basis of the actions carried out during this use and/or the effects obtained, the exclusion from patentability pursuant to A 53 c) cannot be overcome by limiting [the claim] to a “non-therapeutic use” in the case of a therapeutic method wherein a non-therapeutic use (contraception) is inseparably linked with a therapeutic use (avoiding or reducing the pathological secondary effects).
3. The transformation of a claim directed to the use of a substance or composition for a certain purpose into a Swiss-type claim or a purpose-limited product claim pursuant to A 54(5) leads to an extension of the scope of protection.
4. When considering whether series of trials needed for reproducing a claim may reasonably be expected (zumutbar), the question of whether they could have been avoided is also to be taken into account. One may not reasonably expect that time consuming and ethically questionable series of trials are carried out when [the applicant] could have defined the claimed subject-matter by means of features which would have made said series of trials – in view of reproducibility by the skilled person - unnecessary, without reducing the scope of the claim.
The decision provides some insight into the exclusion from patentability under A 53 c), possible ways to circumvent this problem and the scope of protection offered by the different types of claims that are used when further medical uses are to be protected. Let tribute be paid to the patent proprietor who greatly enriched this decision by fighting like a devil and proposing a great variety of claim alternatives.
*** Translated from the German (*) ***
Main request – A 53(c)
1. Use of an oral monophasic dosage form comprising
0.015 to 0.020 mg of ethinylestradiol;
and a gestagen selected from
0.05 to 0.075 mg of gestodene,
0.075 to 0.125 mg of levonorgestrel,
0.06 to 0.15 mg of desogestrel,
0.06 to 0.15 mg of 3-ketodesogestrel,
0.2 to 0.3 mg of norgestimate, and
> 0.35 to 0.75 mg of norethisterone,
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.
[3.1] Claim 1 under consideration concerns the use of an oral monophasic dosage form comprising ethinylestradiol as well as a gestagen, selected from a list of six specific compositions, for contraception for a woman of fertile age who has not yet reached the premenopause.
When considering the question of whether the use under consideration is an activity which is excluded from patentability pursuant to A 53 c), first of all it has to be taken into account that, according to the established case law of the Boards of appeal, pregnancy is not an illness and, as a consequence, that contraception is not a therapeutic treatment, not even within the meaning of prevention (T 820/92 [5.2 et seq., confirmed by T 74/93 [2.2.3])
However, it has also to be noted that the purpose of use given in claim 1 “for contraception for a woman of fertile age who has not yet reached the premenopause” is not the sole criterion for the existence or absence of an exclusion from patentability (Patentierungsverbot) pursuant to A 53 c). Rather, it has to be examined whether the subject-matter of the claim taken as a whole comprises one or several therapeutic steps and/or therapeutic effects, because, as has been stated in decision T 820/92 cited by the patent proprietor, there is an exclusion from patentability pursuant to A 53 c) (and A 52(4) EPC 1973, respectively) even though they concern only part of the claimed subject-matter (see [5.3]).
When analysing claim 1 it has to be noted that all active substances, the ethinylestradiol as well as each of the six gestagens, are characterised by indications of concentrations, wherein the chosen domains show that the product is a low-dose contraceptive. From the description (see paragraph [0008]) it can be seen that it is hoped that the reduction of the daily hormone dose reduces the undesirable secondary effects and that epidemiologic data confirm the desired tendency towards the improvement of low-dose compositions in view of cardiovascular complications. Moreover, paragraph [0009] of the patent specification presumes a link between the estrogen dose and the incidence of cardiovascular disorders.
In this context it has to be underlined that the reduction of the concentrations of active substances does not lead to an improvement of the contraceptive efficiency but exclusively to avoiding or reducing the above mentioned secondary effects. In the above mentioned paragraph [0009] of the patent specification it is unambiguously stated that an extreme reduction of the daily estrogen dose conflicts with contraceptive efficiency and makes a satisfying cycle control difficult. Thus claim 1 under consideration indeed claims a non-therapeutic use, but at the same time the choice of the concentrations of active substances as defined in the claim results in preventing secondary effects to be expected during the non-therapeutic use. This prevention, which is anchored in claim 1 via the indication of the concentrations of active substances and which clearly is to be classified as therapeutic because of the pathologic nature of the secondary effects (e.g. cardiovascular or thrombolytic complications), is inseparably linked with obtaining the contraceptive effect, which as such is non-therapeutic. Therefore, the subject-matter of claim 1 of the main request under consideration as a whole includes a therapeutic method. According to the established case law of the Boards of appeal a claim falls under the exclusion from patentability pursuant to A 53 c) even if part of the claimed subject-matter is a method for treatment of the human or animal body by therapy (G 1/04 [6.2.1], confirmed by G 1/07 [3.2] and G 1/08 (sic) [5.6]). Therefore, claim 1 of the main request is excluded from patentability pursuant to A 53 c).
[3.2] Decisions T 144/83 and T 36/83, which have been cited by the patent proprietor are not relevant for the present case, for the following reasons:
[3.2.1] In decision T 144/83 the Board came to the conclusion that the wording of the main claim, which was directed at the use of naltrexone for improving the bodily appearance, wherein the naltrexone is orally administered until a cosmetically beneficial loss of body weight has occurred, clearly encompassed a cosmetic method and did not concern a therapeutic treatment of the human or animal body. The fact that a chemical substance has both a cosmetic and a therapeutic effect cannot render the cosmetic treatment unpatentable (see paragraphs [3-4]).
It is true that naltrexone belongs to the group of opioid antagonists and is a pharmacologically highly active substance, so that one cannot exclude that there are further effects parallel to the non-therapeutic effect claimed, which further effects can indeed be of a therapeutic kind. However, this is irrelevant in the context of A 53 c) if the additional, potentially therapeutic effects can be clearly separated from the non-therapeutic use and are not covered by the claimed subject-matter. The essential difference with respect to the use claimed in claim 1 under consideration consists in that in case T 144/83 the wording of the claim encompasses only non-therapeutic uses. Naltrexone is administered to persons not suffering from obesity in sufficient doses until a cosmetically beneficial loss of body weight has occurred. Incidentally, if read in a reasonable and appropriate way, such a claim cannot be considered to correspond to the prevention of obesity.
In contrast, claim 1 under consideration is worded so as to encompass a use wherein the non-therapeutic part is inseparably linked to a therapeutic part and the preventive-therapeutic part is an essential part of the claimed method (cf. T 290/86 [3.2])
[3.2.2] In case T 36/83 the Board came to the conclusion that the uses disclosed for thenoyl peroxide were of both therapeutic (acne) and cosmetic nature (comedolytic effect). As far as the admissibility if the claim directed to the cosmetic use was concerned, the Board considered that the question of whether the cosmetic use can be distinguished from the therapeutic use was essential. Based on the indications provided in the description, the Board came to the conclusion that those uses could be distinguished (see paragraph [6]). Although the cosmetic treatment could sometimes comprise a therapeutic treatment (see [6.1]), the cosmetic application assisted in skin cleansing, which the Board regarded as clearly belonging to the field of non-medical body hygiene (see [6.2]). Therefore, this situation is analogous to the situation of decision T 144/83: an exclusively cosmetic and thus non-therapeutic effect is possible and this is all that the wording of claim 1 of the main request claimed. Therefore, in case T 36/83 there is no inseparable link of a non-therapeutic and a therapeutic step, such as the one found in claim 1 of the main request under consideration.
[3.3] Based on this fundamental difference the decision that the subject-matter of claim 1 of the main request under consideration falls under the exclusion from patentability pursuant to A 53 c) is not contradictory with decision T 36/83. A referral to the Enlarged Board of appeal pursuant to A 112(1), as requested by the patent proprietor, is not indicated. […]
Auxiliary request 1
1. Non-therapeutic use of an oral monophasic dosage form comprising
0.015 to 0.020 mg of ethinylestradiol;
and a gestagen selected from
0.05 to 0.075 mg of gestodene,
0.075 to 0.125 mg of levonorgestrel,
0.06 to 0.15 mg of desogestrel,
0.06 to 0.15 mg of 3-ketodesogestrel,
0.2 to 0.3 mg of norgestimate, and
> 0.35 to 0.75 mg of norethisterone,
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] The wording of claim 1 of auxiliary request 1 differs from claim 1 of the main request in that the disclaimer “non-therapeutic” has been inserted. In a claim that comprises both therapeutic and non-therapeutic uses which can be separated on a factual, and therefore objective (gegenständlich) level, such a disclaimer allows to exclude the therapeutic uses, so that the remaining subject-matter is not concerned by the exclusion from patentability pursuant to A 53 c). However, such a disclaimer cannot define a use which necessarily comprises one or several therapeutic steps to be non-therapeutic, because the question of whether a claimed use is therapeutic or non-therapeutic is to be decided exclusively on the basis of the actions carried out during this use, or the effects obtained, respectively. As has been stated above under [3.2.1] the subject-matter of claim 1 concerns a use where a non-therapeutic part is inseparably linked to a therapeutic part and wherein the preventive-therapeutic part concerns essential features of the claimed use. Therefore, the exclusion from patentability pursuant to A 53 c) also applies to the subject-matter of claim 1 of auxiliary request 1, despite the introduction of the disclaimer “non-therapeutic”.
Moreover, as the disclaimer “non-therapeutic” contradicts the use that is defined in the claim and which, when considered according to its content, is of therapeutic nature, the subject-matter of claim 1 of auxiliary request 1 does not comply with the requirements of A 84. […]
Auxiliary request 2 – A 83
5. Use of a composition comprising
0.020 mg of ethinylestradiol;
and a gestagen selected from
0.25 mg drospirenone up to a dose of drospirenone equivalent to 0.075 mg of gestodene, and
0.1 mg of cyproteron acetate up to a dose of cyproteron acetate equivalent to 0.075 mg of gestodene,
for the manufacture of a medicament for an oral monophasic ovulation inhibiting 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.
[7] The subject-matter of claim 5 of auxiliary request 2 concerns the use of a composition for the manufacture of a medicament for an oral monophasic ovulation inhibiting dosage form, wherein the quantities of active substances are as follows:
0.25 mg drospirenone up to a dose of drospirenone equivalent to 0.075 mg of gestodene, and
0.25 mg drospirenone up to a dose of drospirenone equivalent to 0.075 mg of gestodene, and
0.1 mg of cyproteron acetate up to a dose of cyproteron acetate equivalent to 0.075 mg of gestodene.
[7.1] According to the established case law of the Boards of appeal, an invention is sufficiently disclosed only if [the disclosure] allows to carry out the [the invention] over substantially the whole claimed domain. In the present case, it has become apparent during the grant proceedings that the quantities of active substances that had been disclosed for drospirenone and cyproteron acetate (i.e. 0.1 to 0.3 mg and 0.1 to 0.2 mg, respectively, see claim 1 of the application as filed) were chosen ten times too small, as the result of an error (see submission of the then applicant dated August 25, 2003, paragraph “Amendments pursuant to R 88”), from which it can be concluded that neither drospirenone nor cyproteron acetate may be expected to have an ovulation inhibiting effect below a dose of 1 mg. This means that considerable domains of the claimed use cannot be carried out because no ovulation inhibiting effect can be obtained in the whole lower domain of concentrations (0.25 mg to about 1 mg drospirenone and 0.1 mg to about 1 mg cyproteron acetate). For this reason alone the subject-matter of auxiliary request 5 under consideration does not comply with the requirements of A 83.
[7.2] Moreover it is to be noted that the skilled person is not able to determine whether a certain product has an ovulation inhibiting effect or not without carrying out time consuming trials. As a matter of fact, the skilled person not only has to face the fact that there is no ovulation inhibiting effect in the lower domain of the claimed concentrations of the active substances (see [7.1] above). He will also find that even for the determination of the upper limit trials will be required because, as will be shown hereafter, the dose of drospirenone and cyproteron acetate equivalent to 0.075 mg of gestodene, cannot be determined by simple calculation, as alleged by the patent proprietor, even if it is assumed, in favour of the patent proprietor, that the dose of both active substances mentioned above that is equivalent to 0.075 mg of gestodene can indeed be determined in proportion, based on the minimum ovulation inhibiting dose.
Minimum ovulation inhibiting dose of gestodene
[7.2.1] As explained by the patent proprietor […] the prior art gives varying values for the minimum ovulation inhibiting dose of gestodene, i.e. 40 μg per day in documents D24, D94, D107, D111, D 112, D120 and D121, and 30 μg per day in documents D1, D101 and D122. However, the Board cannot endorse the argument presented by the patent proprietor according to which the skilled person would immediately realize that, as far as the minimum ovulation inhibiting dose of gestodene is concerned, the first series of documents, which postulates 40 μg per day, were more reliable than documents D1, D101 and D122. It is indeed true that in said documents D1, D101 and D122 there is no description of how the minimum ovulation inhibiting dose was determined. However this appears not to be necessary because, as also pointed out by the patent proprietor, the method for its determination was well known to the skilled person. Moreover, the skilled person would take interest in document D1 because this document is recommended in the application as filed […] as reference for the determination of dose equivalents of several gestagene active substances. Faced with contradictory indications in documents that are equivalent as far as credibility is concerned, the skilled person would come to the conclusion that a series of trials was required in order to determine the correct minimum ovulation inhibiting dose of gestodene.
Minimum ovulation inhibiting dose of drospirenone
[7.2.2] The minimum ovulation inhibiting dose of drospirenone cannot be determined unambiguously from the prior art either and, therefore, also has to be determined experimentally by means of corresponding series of trials. In its argumentation, the patent proprietor relied in particular on document D 109 from which it can be seen that the administration of 2 mg of drospirenone over a period of 21 days did lead to an ovulation inhibiting effect, whereas this effect was not found when 1 mg were administered over the same period […]. It cannot be derived from this information that the minimum ovulation inhibiting dose of drospirenone is equal to 2 mg; it can only be derived that ovulation inhibition can certainly be obtained with a daily dose of 2 mg and that the minimum ovulation inhibiting dose for drospirenone is somewhere between 1 and 2 mg. Also, this conclusion is not rendered moot by “Study 2” presented in document D109, wherein the effects of a daily administration of 2 mg of drospirenone over a period of two monthly cycles were compared with an administered dose of 1 mg of cyproteron acetate over the same period. The patent proprietor referred to document D113 and argued that the minimum ovulation inhibiting dose of cyproteron acetate was found to be 1 mg and that a comparative study was meaningful only if equivalents were compared, from which the skilled person would unmistakably conclude that the minimum ovulation inhibiting dose of drospirenone was equal to 2 mg. The same would apply for “Study II” presented in document D21a.
The Board is of the opinion that it is not possible to unambiguously derive from “Study 2” of document D109 or from “Study II” of document D21a that the minimum ovulation inhibiting dose is 2 mg. The purpose of both studies (Study 2 and Study II) consisted in examining the effect of the administration of drospirenone as ovulation inhibitor in view of the concentrations of sodium, potassium and aldosterone-18-glucuronide in urine, the concentrations of sodium and potassium in serum as well as the plasma renin activity and the plasma aldosterone concentration. To this purpose, it was reasonable to choose a dose with ovulation inhibiting effect and to exclude the dose of 1 mg, which did not yield the desired effect. Even if the comparison was carried out with 1 mg of cyproteron acetate, i.e. the minimum ovulation inhibiting dose of cyproteron acetate, this does not mean that for reasons of equivalence the minimum ovulation inhibiting dose of drospirenone has to be 2 mg. It is equally plausible that in both studies mentioned above, as the precise minimum ovulation inhibiting dose of drospirenone was unknown, a dose had been chosen for which an ovulation inhibition effect was certain.
[7.3] It follows that for both gestodene and drospirenone the minimum ovulation inhibiting dose has to be determined experimentally. Only for cyproteron acetate the value that is uniformly defined to be 1 mg (see e.g. documents D1 […], D24 […] or D 101 […]) can be adopted.
As far as these series of trials are concerned, the patent proprietor has pointed out, both during oral proceedings and in written submissions […] that for ethical reasons the trials had to be reduced to a minimum, so that the question arises whether such trials can reasonably be expected (Frage der Zumutbarkeit).
In the context of reproducibility, it is often necessary to carry out trials when claims are formulated in terms of results to be obtained (aufgabenhaft) or defined via parameters and when it is not possible, without unduly limiting the claimed subject-matter, to define the subject-matter by means of concrete structural features.
However, claim 5 of auxiliary request 2 under consideration is fundamentally different from this situation because a concrete active substance (drospirenone) is defined with a concentration range (Mengenbereich) that is, in principle, concrete. In such a case third parties, as a rule, do not have to carry out trials as far as reproducibility is concerned.
However, in claim 5 under consideration, the upper limit of the concentration range (Mengenbereich) for drospirenone is not defined by “x mg of drospirenone” but by a “dose of drospirenone equivalent to 0.075 mg of gestodene”. By choosing this indirect definition, for which there is no necessity related to the scope of the claim, because it does not change the claimed subject-matter with respect to the direct definition via “x mg of drospirenone”, [the patent proprietor] forces third parties wishing to reproduce the claim to carry out time consuming and ethically questionable series of trials. The Board is of the opinion that when considering whether series of trials needed for reproducing a claim may be expected, the question of whether they could have been avoided is also to be taken into account. One may not expect that time consuming and ethically questionable series of trials are carried out when, as in the present case, the applicant could have defined the claimed subject-matter by means of features which would have made said series of trials – in view of reproducibility - unnecessary, without reducing the scope of the claim. For this reason also, the invention defined in claim 5 of auxiliary request 2 does not comply with the requirements of A 83. […]
Auxiliary request 23 – A 123(3)
1. Use of a composition comprising
0.015 to 0.020 mg of ethinylestradiol;
and a gestagen selected from
0.05 to 0.075 mg of gestodene,
0.075 to 0.125 mg of levonorgestrel,
0.06 to 0.15 mg of desogestrel,
0.06 to 0.15 mg of 3-ketodesogestrel,
0.2 to 0.3 mg of norgestimate, and
> 0.35 to 0.75 mg of norethisterone,
for the manufacture of a medicament for 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.
[14] Claim 1 of auxiliary request 23 differs from claim 1 as granted in that the granted use claim was rewritten in the so-called Swiss-claim form, i.e. as a claim directed to the use of a substance or composition for the manufacture of a medicament for a certain therapeutic application.
When examining whether this amendment has extended the scope of the claim, the established case law of the Boards of appeal requires that the whole set of claims as granted be taken into account. In the present case, the set of claims as granted comprises not only the use claims 1 to 8 but also product claims 9 to 19. However, as far as the concentration of ethinylestradiol of 0.015 mg to less than 0.020 mg is concerned, the subject-matter of claim 1 of auxiliary request 23, wherein ethinylestradiol is present with concentrations ranging from 0.015 to 0.020 mg, extends beyond the scope of product claims 9 to 19 as granted, where the part of ethinylestradiol is limited to 0.020 mg.
[14.2] Thus it has to be checked whether the reformulation of a claim directed to the “use of an oral dosage form comprising … for contraception …” towards a claim directed to the “use of a composition comprising … for the manufacture of … an oral dosage form for contraception …” is in line with the requirements of A 123(3). In this context it is of decisive importance whether the Swiss-type claim wording is to be understood as a claim directed to (a) the use of a substance or a composition for a certain purpose, or (b) to the manufacture of a medicament. An interpretation as a use claim is not reconcilable with EBA decision G 1/83. According to this decision, 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 [13]).
The opinion according to which a use claim included the manufacture of a pharmaceutical product, with instructions for use in the treatment of illness (“augenfällige Herrichtung”), whereas a method claim did not, was rejected by the EBA (G 1/83 [11,17,18]). Faced with this question, the EBA found it to be justified to admit patent claims directed to a substance or composition being used for the manufacture of a medicament, even though the method of manufacture as such does not differ from a known method, wherein the same active substance is used. This is justified as follows in the third paragraph of point [21] of the reasons:
“Based on the general order to grant patents anchored in A 52(1), it seems justifiable to derive the novelty of the manufacture of a substance or composition known as such from its new therapeutic use, irrespective of whether a pharmaceutical use of the substance or composition is known or not.” (emphasis by the Board)
NB: This is my translation of G 1/83 (which was issued in German). The English equivalent (G 5/83) has a wording that is somewhat different from the wording of its German counterpart.
Consequently, in point [21] of the reasons the Swiss-type claim form is understood as a method of manufacture, wherein, however - similar to the exceptional provision for the so-called first medical use pursuant to A 54(5) EPC 1973 – the purpose of use of the manufactured product exceptionally constitutes a feature that justifies the novelty of the method of manufacture. It was this way of looking at things alone that allowed the exclusion from patentability pursuant to A 53 c) (or A 52(4) EPC 1973) to be considered to have been overcome. If the Swiss-type claim form, considered according to its content, was equivalent to a use claim within the meaning that a substance or a composition is used in order to obtain a certain technical effect, instead of being equivalent to a method of manufacture, then, according to the ratio decidendi of decision G 1/83, it would still fall under the exclusion from patentability pursuant to A 53 c) (A 52(4) EPC 1973) because it defines a method wherein the core of the invention would reside in the claimed new use, i.e. the treatment of the human or animal body by therapy, without being directed to the previous manufacture of a medicament.
Consequently, in point [21] of the reasons the Swiss-type claim form is understood as a method of manufacture, wherein, however - similar to the exceptional provision for the so-called first medical use pursuant to A 54(5) EPC 1973 – the purpose of use of the manufactured product exceptionally constitutes a feature that justifies the novelty of the method of manufacture. It was this way of looking at things alone that allowed the exclusion from patentability pursuant to A 53 c) (or A 52(4) EPC 1973) to be considered to have been overcome. If the Swiss-type claim form, considered according to its content, was equivalent to a use claim within the meaning that a substance or a composition is used in order to obtain a certain technical effect, instead of being equivalent to a method of manufacture, then, according to the ratio decidendi of decision G 1/83, it would still fall under the exclusion from patentability pursuant to A 53 c) (A 52(4) EPC 1973) because it defines a method wherein the core of the invention would reside in the claimed new use, i.e. the treatment of the human or animal body by therapy, without being directed to the previous manufacture of a medicament.
Thus the amendment underlying claim 1 of auxiliary request 23 has resulted in a change of category from a claim that was limited to a certain use of a product towards a claim comprising the previous manufacture of this product.
When examining of a change of category of claims complies with the requirements of A 123(3), one has to compare the scope of protection offered by the claim category of the previous version of the claim to the scope of protection of the new claim category that has been introduced by the amendment (G 2/88 [4.1]) As far as the scope of protection of a manufacturing claim is concerned, as compared to [the scope of protection of] a use claim, the EBA has made the following statement in its decision G 2/88, considering in particular A 64(2):
“A 64(2) is not directed to a patent whose claimed subject-matter is the use of a process 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 manufacture, 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 A 64(2).”
It follows that the manufacturing method claimed in claim 1 of auxiliary request 23, considered according to its content extends beyond the scope of protection of the use claims as granted: Pursuant to A 64(2), when a claim is directed to a manufacturing method, the protection conferred extends to the “products” (of whatever kind they may be) of the method, whereas a use claim does not include the manufacture of the pharmaceutical product (G 1/83 [11]) and its scope of protection, therefore, does not extend to the product that is directly obtained by the method. Therefore, the requirements of A 123(3) are not fulfilled.
Auxiliary request 24
1. Monophasic dosage form comprising
0.015 to 0.020 mg of ethinylestradiol;
and a gestagen selected from
0.05 to 0.075 mg of gestodene,
0.075 to 0.125 mg of levonorgestrel,
0.06 to 0.15 mg of desogestrel,
0.06 to 0.15 mg of 3-ketodesogestrel,
0.2 to 0.3 mg of norgestimate, and
> 0.35 to 0.75 mg of norethisterone,
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.
[15.1] In auxiliary request 24 the Swiss-type claim form of claim 1 of auxiliary request 23 was transformed into the corresponding purpose-limited product claim (zweckgebundener Produktanspruch), with reference to A 54(5) EPC 2000.
As far as the applicability of A 54(5) EPC 2000 to the present case is concerned, it has to be taken into account that the opposed patent was granted on November 2, 2006, i.e. before entry into force of the EPC 2000. According to the transitional provisions applicable to the EPC 2000, A 54(5) is not to be applied to European patents that had been granted before the entry into force of the EPC 2000 (see OJ EPO 2007, Special edition n° 1, table on page 217).
Apart from the fact that A 54(5) EPC 2000 is not applicable in the present case, which means that a claim wording of the “purpose-limited substance claim” (zweckgebundener Stoffanspruch) type would only be admissible for the first medical use, the transformation of the use claims 1 to 8 of the patent as granted into a purpose-limited product claim corresponds to an extension of the scope of protection that is inadmissible pursuant to A 123(3). This is because the latter is directed to the product itself, which means that the manufacture of the product is comprised in the scope of protection of this claim type, which is not the case for a use claim (see point [14.2]).
[15.2] Concerning the determination of the scope of protection of product claims 9 to 19 as granted and its comparison with claim 1 of auxiliary request 24, which is needed for examining whether there is an inadmissible extension within the meaning of A 123(3), the Board refers to point [14.1], which also applies to the subject-matter of claim 1 if auxiliary request 24.
[15.3] Thus the subject-matter of claim 1 of auxiliary request 24 does not comply with the requirements of A 123(3). […]
The patent is revoked.
To read the whole decision (in German), click here.
To have a look at the file wrapper, click here.
(*) This decision is going to be published in the OJ, so a better translation will become available.
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