T 1710/09 – Taking A Can For A Must

T 12/81 has made the following statement on selection inventions :

[12] A substance selection can come about in various ways, e.g. if an unmentioned compound or group of compounds having a formula covered by the state of the art is found, in the absence of any information as to the starting substance or substances. The present subject-matter does not involve a selection of that kind in an area which, although marked out by the state of the art, is nonetheless virgin territory.

[13] However, the disclosure by description in a cited document of the starting substance as well as the reaction process is always prejudicial to novelty because those data unalterably establish the end product. If on the other hand two classes of starting substances are required to prepare the end products and examples of individual entities in each class are given in two lists of some length, then a substance resulting from the reaction of a specific pair from the two lists can nevertheless be regarded for patent purposes as a selection and hence as new. (my emphasis)

There is some disagreement between the Boards on the interpretation of the verb “can” here. Some time ago, we have seen T 783/09 where Board 3.3.04 stated:

[5.6] However, given the term “can” in the citation from decision T 12/81, the absence of a direct and unambiguous disclosure for individualised subject-matter is not a mandatory consequence of its presentation as elements of lists. Thus, the “disclosure status” of subject-matter individualised from lists has to be determined according to the circumstances of each specific case by ultimately answering the question whether or not the skilled person would clearly and unambiguously derive the subject-matter at issue from the document as a whole […].

In the present decision, Board 3.3.02 comments this approach.

The patent proprietor had filed an appeal after the Opposition Division had revoked the opposed patent (17 oppositions had been filed!)

Claim 1 of the requests on file read:

Main request (amendments with respect to claim 1 as granted underlined):

Use of alendronate in the manufacture of a medicament for treating osteoporosis in a human in need of such treatment, where said medicament is orally administered to said human in the form of a tablet as a unit dosage comprising about 70 mg of the alendronate compound, on an alendronic acid active weight basis, according to a continuous schedule having a once-weekly dosing interval.

First auxiliary request (amendments with respect to claim 1 of the main request underlined):

Use of alendronate monosodium trihydrate in the manufacture of a medicament for treating osteoporosis in a human in need of such treatment, where said medicament is orally administered to said human in the form of a tablet as a unit dosage comprising about 70 mg of [deleted: the] alendronate monosodium trihydrate [deleted: compound], on an alendronic acid active weight basis, according to a continuous schedule having a once-weekly dosing interval.

Second auxiliary request (amendments with respect to claim 1 of the first auxiliary request underlined):

Use of alendronate monosodium trihydrate in the manufacture of a medicament for treating osteoporosis in a human in need of such treatment, where said medicament is orally administered to said human in the form of a tablet as a unit dosage comprising about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active weight basis, according to a continuous schedule for at least one year and having a once-weekly dosing interval.

Main request; A 76(1)

[3.1] This claim 1 relates to the

• use of alendronate …
• for treating osteoporosis … orally administered … in the form of a tablet
• as a unit dosage comprising about 70 mg of the alendronate compound ……
• according to a continuous schedule having a once-weekly dosing interval.

[3.2] A combination of claims 6, 7 and 8 as originally filed in the earlier application provides for a combination of these features with the exception of the “form of a tablet”, which is missing. Moreover, the active ingredient “alendronate” is disclosed only in the form of the specific salt alendronate monosodium trihydrate and not as alendronate in general. Thus, regarding original claims 6 to 8, the teaching of claim 1 of the main request is at least generalised in an unallowable manner with respect to the active ingredient.

Looking at the description, the missing feature “in the form of a tablet” is found to be mentioned in example 2 together with “alendronate”. However, example 2 refers to examples 7 and 8 defining the “alendronate” as monosodium salt trihydrate, because the text in example 2

“Alendronate tablets or liquid formulations … are prepared (see Examples 7 and 8). The tablets … are orally administered …” (emphasis added by the Board)

leaves no freedom of interpretation that example 2 could relate to another alendronate than the monosodium salt trihydrate actually used […].

If, as an alternative, page 19, lines 18 to 27 are referred to in order to provide a basis for the feature “in the form of a tablet” in claim 1 of the main request, prima facie there would be no problem of unallowable generalisation. In these lines 18 to 27, the “form of a tablet” is correlated to bisphosphonates in general. However, in these lines alendronates as the particular embodiment of bisphosphonates are not disclosed for formulation as a tablet. In addition, the form of a tablet is mentioned as only one possibility of various oral forms, together with capsules, elixirs, syrups … or powder.

To provide a source for allowing the selection of alendronate from bisphosphonates, lines 7 to 14 on the same page could be cited disclosing

• preferred bisphosphonates, inter alia alendronate,
• more preferred alendronate, pharmaceutically acceptable salts thereof, and mixtures thereof (potentially meaning the same as alendronate in general) and, however,
• most preferred alendronate monosodium trihydrate.

The only information that is given for answering the question as to what level of preference might be combined with which member of the group of oral forms, e.g. with elixir, powder or in fact tablets, could be that “most preferred” prevails, but in this case the already described problem of unallowable generalisation reappears and claim 1 of the main request is still in breach of A 76(1).

[3.3] As an alternative, an attempt to find a disclosure of the features of claim 1 of the main request could be started from page 20, line 28 to page 21, line 19 of the description as filed in the earlier application:

a) The teaching set out there relates to the

• use of alendronate …
• as a unit dosage comprising from about 8.75 mg to about 140 mg of the alendronate compound … (page 20, lines 30 to 32)
• according to a continuous schedule having
• a once-weekly dosing interval (page 20, line 33 to page 21, line 4) or
• a twice-weekly dosing interval (page 21, lines 5 to 11) or
• a biweekly (page 21, lines 12 to 19) or
• a twice-monthly dosing interval (page 21, lines 12 to 19)
• for
• osteoporosis prevention or
• treating osteoporosis

with differing unit dosages, namely 35 mg for “prevention” or 70 mg for “treatment” (see page 21, lines 1 to 4, lines 7 to 11 and lines 14 to 19).

The feature “in the form of a tablet” is missing here too.

b) For adding this feature, again example 2 could be referred to:

The teaching of example 2 on pages 29 and 30 of the original application reiterates the two alternatives as being treatment (with 70 mg of alendronate) or prevention of osteoporosis (with 35 mg of alendronate) and in addition discloses two further alternatives as the basis for orally administering 70 mg of alendronate to a human patient once-weekly, namely

• tablets or
• liquid formulations

as exemplified in examples 7 and 8.

c) Thus, reading these sources of disclosure relevant for the subject-matter as requested in claim 1 of the main request, the skilled person is free in principle to combine different variations of the elements being suggested as features of the claim with respect to

• dosage (e.g. 70 mg),
• dosing interval (e.g. once-weekly) and
• form of the formulation (e.g. in the form of a tablet),

with no recognisable preference for the features as actually represented in this claim [underlined].

d) Reference to page 19 instead of example 2 also cannot solve the problem of providing for the feature “in the form of a tablet” (and not as a syrup or elixir etc.) clearly connected to alendronate in general (not to monosodium trihydrate) and at the same time clarifying the preference of “once-weekly” and the dosage of 70 mg, as can be seen from the arguments under point [3.2], fourth paragraph et seq. above.

[3.4] As a consequence, a unit dosage of 70 mg of alendronate in the form of a tablet for a once-weekly dosing interval for treating osteoporosis is not individualised in the description as originally filed in the earlier application, and the subject-matter of claim 1 of the main request cannot be derived directly and unambiguously.

First and second auxiliary request; A 76(1)

[3.5.1] The considerations and conclusions under point [3.3] above apply mutatis mutandis to claims 1 of the first and second auxiliary requests because, as the core amendment, they differ only in restriction from alendronate to monosodium trihydrate (with the additional wording that the medicament was orally administered to the human “for at least one year” in the second auxiliary request). These considerations in particular are valid for starting from pages 20 and 21 of the description as originally filed.

[3.5.2] With respect to the claims as originally filed in the earlier application as the basis for the original disclosure, it is to be stressed that they equally reflect

a) the structure of the teaching of pages 20/21,

b) the structure of the description and

c) the structure of the examples.

In these three cases a), b) and c), the alternatives for

• the dosage,

• differ in relation to the use, mostly

• 35 mg (osteoporosis prevention) or
• 70 mg (treating osteoporosis) […]

• the alternatives for the dosing interval are

• a once-weekly dosing interval (see claims 8 and 14 or see page 20, line 33 to page 21, line 4 or example 2) or
• a twice-weekly dosing interval (see claims 9 and 15 or see page 21, lines 5 to 11 or example 3) or
• a biweekly (see claims 10 and 16 or see page 21, lines 12 to 19 or example 4) or
• a twice-monthly dosing interval (see claims 11 and 17 or see page 21, lines 12 to 19 or example 5). 

This teaching is to be supplemented for the form of the formulation

• from the examples representing as alternatives,

• tablets or
• liquid formulations […]

• or from page 19 presenting, as alternatives,

• tablets, capsules, elixirs, syrups, effervescent compositions, powders, and the like or
• tablet, capsule, or powder, respectively […].

In all cases, the alternatives are of equal weight, no preference is indicated by specific words or in any other directly recognisable way and their singling out for reasons of original disclosure is not allowed.

[3.5.3] Therefore, also when starting from the claims as originally filed, the particular combination of features in claim 1 of the first and the second auxiliary requests is not to be found in individualised form in the earlier application as originally filed and the provisions of A 76(1) are not fulfilled.

[4] Under these circumstances, the additional arguments of the appellant cannot hold.

[4.1] Applying the principle of direct and unambiguous derivability gives rise to a clear and unequivocal conclusion in the present case. There is no room for any question as to what the skilled person would seriously contemplate.

[4.2] The “form of a tablet” as well as “70 mg of alendronate once-weekly for treatment of osteoporosis” as preferred features in view of the overall content of the earlier application could not be seen by the Board, and specific and convincing arguments for this opinion were not presented.

For instance, it is not apparent why the structure of the experiments of example 1 would indicate particular weight being attached to a once-weekly dosing: on page 27, lines 10 to 14 of the description of the earlier application it is set out that considerably less oesophageal irritation was observed from the administration of a single high concentration of alendronate on a weekly basis (Group 5) or twice-weekly basis (Group 6) versus administration of low concentration dosages on consecutive days (Group 2) (emphasis added by the Board), giving once-weekly the same weight as twice-weekly.

With respect to the other arguments of the appellant, it is to be stated that in view of example 8 the tablet form is not the primarily exemplified form of the medicament in the application as originally filed, and the mentioning of the word “alendronate” in example 7 does not alter the fact that only the “monosodium salt trihydrate” is specifically used in this example.

[4.3] Coming to its conclusion, the present Board duly considered decision T 783/09 cited by the appellant in support of its line of argumentation concerning the disclosure in its originally filed application of the features currently claimed.

With respect to T 12/81, the following is emphasised in T 783/09 [5.6]:

“… given the term “can” in the citation from decision T 12/81, the absence of a direct and unambiguous disclosure for individualised subject-matter is not a mandatory consequence of its presentation as elements of lists. Thus, the “disclosure status” of subject-matter individualised from lists has to be determined according to the circumstances of each specific case by ultimately answering the question whether or not the skilled person would clearly and unambiguously derive the subject-matter at issue from the document as a whole” (underlining by this Board).

While it is stressed in T 783/09 that the circumstances of each specific case are decisive for the outcome of the assessment of the “disclosure status”, it follows from points [3.3] and [3.5] above, in particular point [3.3 c)], that the specific circumstances of the present case are different from those considered in T 783/09 and nothing has been submitted during the proceedings that might justify a statement to the contrary.

Thus, complying fully with the issue “disclosure status” to be uniformly assessed in all cases of entitlement to priority or original disclosure of an amendment on the one hand and novelty of a claimed subject-matter on the other hand in answering to the question “whether or not the skilled person would clearly and unambiguously derive the subject-matter at issue from the document as a whole”, the present Board considers it inappropriate to expand all the reasonings and conclusions with respect to the particular subject-matter of decision T 783/09 to the present case.

The present Board adheres to the meaning of the sentence in seminal decision T 12/81

“If on the other hand two classes of starting substances are required to prepare the end products and examples of individual entities in each class are given in two lists of some length, then a substance resulting from the reaction of a specific pair from the two lists can nevertheless be regarded for patent purposes as a selection and hence as new.” (underlining by this Board)

taking “can” for a “is to” as the therefrom following standing jurisprudence did. In view of the implications of freely interpreting this word “can”, there is deep concern that in this way the uniformity of the disclosure assessment process cannot be warranted. […]

The appeal is dismissed.

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