This very long – 123 pages – decision contains lots of interesting procedural aspects (it’s one of those decisions where the appellants are desperate enough to invoke Article 6 of the Human Rights Convention, which is never a good sign) and is well worth skimming through. The patent proprietor had filed an appeal after the Opposition Division (OD) had maintained its patent in amended form. The patent-in-suit was based on a divisional application; the patent proprietor apparently had chosen to have a patent delivered for a preferred embodiment and to cover the more general teaching by means of a divisional application. However, the OD had found claim 1 as granted to violate A 76.
In the following extract the Board answers the question of whether the main request (i.e. the patent as granted) did indeed extend beyond the content of the corresponding parent application. Claim 1 of this request read:
A controlled release oxycodone formulation for oral administration to human patients, comprising:(a) oxycodone salt in an amount equivalent to 10 mg to 160 mg of the oxycodone hydrochloride salt, and(b) a controlled release dosage matrix, other than an acrylic resin matrix selected so that the formulation provides pH-independent dissolution characteristics,(c) wherein said formulation provides, at steady state after repeated administration at 12-hour intervals, a mean maximum plasma concentration of oxycodone of 6 to 240 ng/ml at 2 to 4.5 hours after administration and a mean minimum plasma concentration of oxycodone of 3 to 120 ng/ml at 10 to 14 hours after administration.
In the discussion of the compliance of this claim with A 76 we once more meet our good old friend G 2/10.
[8.1] In its interlocutory decision the OD reached a conclusion on the issue of A 100(c) EPC 1973 for the set of claims as granted. Consequently, the assessment of the grounds pursuant to A 100(c) EPC 1973 is part of the legal framework of the present appeal proceedings.
[8.2] According to A 100(c) EPC 1973, opposition may be filed on the grounds that:
“the subject-matter of the European patent extends beyond the content of the application as filed, or, if the patent was granted as a divisional application or on a new application filed under Article 61, beyond the content of the earlier application as filed” (emphasis added).
The application underlying the patent in suit was filed as a divisional application of an earlier European application which was based on the international application published as WO 93/10765 (parent application P4).
Decision G 1/05 [3.6] states:
“Thus in opposition proceedings under A 100(c) it is a ground of revocation that the subject-matter of the European patent granted on a divisional application extends beyond the content of the earlier application as filed. A 100 does not state that it is a ground of revocation that the patent was granted on a divisional application whose subject-matter as filed extended beyond the content of the earlier application as filed. A 100 exhaustively sets out all the grounds of revocation that can be relied on, so the lack of any such ground of revocation suggests that the significant factor is the subject-matter at the time of grant and not whether the subject-matter of the divisional application as filed met the requirement of not extending beyond the content of the earlier application as filed.”
[8.3] The principles set out in decision G 2/10 with regard to the requirements to be met in order for amendments by the introduction of disclaimers for disclosed subject-matter to be allowable under A 123(2) also apply with regard to the requirements for divisional applications under A 76(1) (see decision G 2/10 [4.6]). They therefore also apply to the examination under A 100(c) EPC 1973 in the present case.
“1a. An amendment to a claim by the introduction of a disclaimer disclaiming from it subject-matter disclosed in the application as filed infringes Article 123(2) EPC if the subject-matter remaining in the claim after the introduction of the disclaimer is not, be it explicitly or implicitly, directly and unambiguously disclosed to the skilled person using common general knowledge, in the application as filed.1b. Determining whether or not that is the case requires a technical assessment of the overall technical circumstances of the individual case under consideration, taking into account the nature and extent of the disclosure in the application as filed, the nature and extent of the disclaimed subject-matter and its relationship with the subject-matter remaining in the claim after the amendment.”
In accordance with decision G 2/10, the disclosure of the parent application as filed has to be evaluated in comparison with the subject-matter remaining in the claim after the amendment.
[8.4] Claim 1 of the main request is identical to claim 1 as granted. The [patent proprietors] submitted that the disclaimer in claim 1 of the main request excluded subject-matter disclosed and claimed in the granted patent deriving from the parent application and referred to paragraph [0007] of the patent in suit (P1). Irrespective of whether or not this is the case, the following has to be considered. Such a procedural situation (which concerns the prosecution in a divisional application of the general teaching, whereas in the parent application the protection of a preferred embodiment is pursued) is reflected in decision G 2/10 [4.5.5, third paragraph]:
“The applicant may, for example, be interested in obtaining a first quicker protection for a preferred embodiment and pursue the general teaching in a divisional application. Whether or not and, if so, under what circumstances, in such a case a disclaimer would be necessary in order to avoid the so-called prohibition on double protection is a different matter. It is sufficient to say that such procedural behaviour is not abusive and even legitimate.”
[8.5] In order to assess what is the subject-matter claimed in claim 1 of the main request, the claim’s construction has first to be investigated.
[8.5.1] In accordance with Article 7(1), second sentence, of the Revision Act of 29 November 2000 and the decision of the Administrative Council of 28 June 2001 (Special edition No. 1, OJ EPO 2007, 197), revised A 54(4) is applicable, since the mention of the grant of the patent in suit was published in European Patent Bulletin before the entry into force of the revised EPC.
Oxycodone (as well as some oxycodone formulations) was known as a pharmaceutical drug before the effective date of filing of the patent in suit. Therefore, in accordance with A 54(4), claim 1 of the main request, which relates to “a controlled release oxycodone formulation for oral administration to human patients”, is a product claim in which the condition “for oral administration to human patients” merely expresses the suitability of the formulation for oral administration.
[8.5.2] Claim 1 of the main request relates to a controlled release formulation comprising oxycodone salt and a controlled release dosage matrix. The oxycodone salt is present in an amount equivalent to 10 mg to 160 mg of the oxycodone hydrochloride salt. The objective reading of the claim is that the oxycodone salt is included in the controlled release dosage matrix.
Moreover, the condition appearing in the definition of the controlled release dosage matrix “selected so that the formulation provides pH-independent dissolution characteristics” serves to define the controlled release dosage matrix as one that allows the formulation to release amounts of oxycodone (active compound) in a pH-independent manner. According to the wording in claim 1 of the main request, said condition must also apply to the matrix excluded from the claim by means of the disclaimer. Additionally, the expression “other than an acrylic resin matrix” excludes from the controlled resin matrices those which incorporate acrylic resins as suitable materials.
Therefore, the controlled release dosage matrix in the formulation according to claim 1 is any controlled release matrix which is not an acrylic resin matrix, and which allows the formulation to release oxycodone amounts without pH-dependent dose dumping.
[8.5.3] Additionally, claim 1 defines the formulation as providing, at steady state after repeated administration at 12-hour intervals, a mean maximum plasma concentration of oxycodone of 6 to 240 ng/ml at 2 to 4.5 hours after administration and a mean minimum plasma concentration of oxycodone of 3 to 120 ng/ml at 10 to 14 hours after administration.
These functional definitions require that the controlled release formulation comprising oxycodone salt in the lowest amount (i.e. an amount equivalent to 10 mg of oxycodone hydrochloride salt) be able to achieve (when administered at 12-hour intervals) at least the lowest values for the mean maximum plasma concentration and the mean minimum plasma concentration of the stated pharmacokinetic plasma profile at steady state conditions. By analogy, the controlled release formulation comprising oxycodone salt in the highest amount (i.e. an amount equivalent to 160 mg of oxycodone hydrochloride salt) must be able to achieve (when administered at 12-hour intervals) the highest values for the mean maximum plasma concentration and the mean minimum plasma concentration of the stated pharmacokinetic plasma profile at steady state conditions. Moreover, formulations comprising oxycodone salt within the range defined (i.e. amounts equivalent to 10 mg to 160 mg of oxycodone hydrochloride salt) and a controlled release dosage matrix, other than an acrylic resin matrix, must provide a pharmacokinetic plasma profile within the ranges defined in the claim (when administered at 12-hour intervals).
[8.5.4] From the foregoing it follows that claim 1 of the main request conveys that the particular pharmacokinetic plasma profiles at steady state, characterised by identifiable Cmax and Cmin at particular times, are attainable by means of any controlled release dosage matrix (as far as it does not cause pH-dependent dose dumping), without occurrence of acrylic resins.
[8.6] It has to be investigated whether or not the parent application (P4) discloses the product claimed in claim 1 of the main request and whether the subject-matter in said claim included technical information which is directly and unambiguously derivable from the parent application.
[8.6.1] The parent application (P4) discloses the general principle that “administering an oral solid controlled release dosage formulation comprising up to about 160 mg of oxycodone or a salt thereof … providing a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of up to about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from a mean of about 10 to about 14 hours after repeated “q12h” (i.e. every 12 hours) administration through steady-state conditions” reduces the range in daily dosages required to control pain in substantially all patients […]. However, the disclosure of this general principle does not suffice as a basis for the product claimed in claim 1 of the main request.
[8.6.2] The generic disclosure […] of the parent application P4 relates in general terms to “controlled release oxycodone formulations comprising up to about 160 mg oxycodone or a salt thereof, said formulations providing a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after repeated q12h administration through steady-state conditions”. This disclosure does not suffice either as an allowable basis for the product claimed in claim 1 as granted. In particular, the basis for the lowest value of oxycodone salt “in an amount equivalent to 10 mg of the oxycodone hydrochloride salt”, the lowest mean maximum plasma concentration of oxycodone of 6 ng/ml, and the lowest mean minimum plasma concentration of oxycodone of 3 ng/ml are lacking.
[8.6.3] The parent application P4 discloses controlled release formulations comprising a matrix. The matrix is defined in the parent application as “any matrix that affords in vitro dissolution rates of oxycodone within the narrow ranges required and that releases the oxycodone in a pH independent manner” […]. However, claim 1 of the main request does not require the controlled release dosage matrix to afford a particular in vitro dissolution rate. As a consequence, the definition of the matrix defined in claim 1 of the main request is broader in this respect than the definition given [… in] the parent application.
[8.6.4] The parent application P4 discloses generically the “materials” which are “suitable for inclusion” in a controlled release matrix by giving different broadly defined generic options […]. However, the particular options given for materials to be included in the matrix do not amount to a generic disclosure encompassing any thinkable controlled release matrix capable of achieving the plasma profile given in claim 1 of the main request. The list of suitable materials which may be included in a controlled release matrix appearing [… in] the parent application does not represent a complete and fully elaborated list of constituents covering each and every kind of controlled release matrices. Furthermore, the parent application does not disclose that the plasma profile defined in claim 1 of the main request is the immediate and direct result of any controlled release matrix just because it contains any of the materials listed on pages 9 and 10. Moreover, […] some particular suitable matrices are disclosed which, however, do not cover any possible suitable controlled release matrix of claim 1. Thus, it cannot be derived from the content of the parent application that any controlled release matrix is able to provide the pharmacokinetic plasma profile required by claim 1 of the main request, or that any controlled release matrix can achieve the plasma profile without the occurrence of an acrylic resin.
[8.6.5] The parent application P4 discloses controlled release matrices comprising hydrophilic polymers other than acrylic resins, namely it discloses suitable matrices comprising at least one water-soluble hydroxyalkyl cellulose and at least one C12-C36 aliphatic alcohol […]. However, this particular subgroup is not a sufficient basis for the generic definition in claim 1 of the main request. Moreover, the constitution of the “suitable matrix” in this particular embodiment only confirms that the “suitable materials” listed […] do not represent singularised subgroups of a “suitable matrix” but generic options for materials to be selected and included in order that a “suitable matrix” is built.
[8.6.6] Additionally, claim 5 of the parent application P4 explicitly requires a suitable pharmaceutical diluent to be present in the solid oral dosage form. Apart from the fact that this feature is lacking in claim 1 of the main request, claim 5 of the parent application does not give in its paragraph (b) any exhaustive list of all possible constituents forming a controlled release matrix. Moreover, claim 5 of the parent application does not teach that each and every constitution of the controlled release matrix is able to attain the pharmacokinetic plasma profile defined in claim 1 of the main request, or that said profile can be achieved by any combination of materials without the occurrence of acrylic resins.
The fact that claim 6 of the parent application P4 explicitly refers to a controlled release composition of claim 5, “wherein said controlled release matrix comprises an acrylic resin” (emphasis added) merely emphasises that controlled release matrices comprising an acrylic resin are preferred, but says nothing about the nature and effect of controlled release matrices without the occurrence of acrylic resins.
[8.6.7] For the above reasons, the board concludes that the subject-matter of claim 1 of the main request remaining after the introduction of the disclaimer extends beyond the content of the parent application P4.
[8.7] Turning now to the [patent proprietors’] arguments:
[8.7.1] The person skilled in the art is the notional skilled person working in the technical field at the effective date of filing. The notional skilled person is not represented by a particular scientific expert or specialist with almost twenty years of accumulated expertise and knowledge after the date of filing of the parent application.
Additionally, if an application requires additional technical information to interpret terms differently from an objective reading of them in the technical field, then the application as filed has to include explanations and/or citations of prior-art references to clarify those aspects. In the absence of such explanations and references in the parent application as filed, the terms and definitions employed are to be given their objective and generally accepted meaning. Nothing other than this has been done in the present case.
Moreover, as regards the [patent proprietors’] allegation that the pharmacokinetic plasma profile makes it possible for the person skilled in the art to identify a controlled release formulation as one according to the parent application P4, it has to be said that this is not the question to be answered for the assessment of added subject-matter. The question to be answered in the present case is whether the product claimed in claim 1 of the main request presents the skilled person with technical information which is not directly and unambiguously derivable from the parent application. As shown by the analysis above, the product claimed in claim 1 of the main request presents the skilled person with new technical information relating to the constitution of the controlled release matrix suitable for attaining the particular pharmacokinetic plasma profile defined in the claim.
[8.7.2] The [patent proprietors] also submitted that according to decision G 2/10 [4.5.4, fourth paragraph] the remaining subject-matter and the remaining general teaching will normally not be modified by excluding from protection, by means of a disclaimer, a group initially disclosed in the application as filed. However, decision G 2/10 also states in the same paragraph that a situation may arise in which the disclaimer has the effect of confining the subject-matter remaining in the claim to a subgroup of the originally claimed subject-matter which could not be regarded as disclosed in the application as filed even taking into account what the skilled person would have considered as implicitly disclosed.
In the present case there is an essential difference between what the [patent proprietors] subjectively consider has been disclosed in their parent application P4 and the objective assessment of what has actually been, be it explicitly or implicitly, directly and unambiguously disclosed. The board considers that the concept of implicit disclosure has to be applied with great care. Therefore, subject-matter is implicitly disclosed to the skilled person in an application as filed if this subject-matter is necessarily derivable from said application.
[8.7.3] The [patent proprietors] made use in their submissions of the expressions “technical contribution”, “technical information” and “technical teaching” as if they referred to the same concepts. However, when examining the subject-matter remaining after introduction of the disclaimer in the present case in the light of the principles set out in decision G 2/10, it has to be assessed whether the subject-matter claimed presents the skilled person with new technical information not directly and unambiguously derivable from the parent application as filed. On the other hand, the test relating to the technical contribution provided by a claim vis-à-vis the prior art does not apply to the present case, since the disclaimer was not introduced in view of any particular prior-art document. Moreover, the technical teaching in the patent in suit, which derives from the divisional application, is per se different from that in the parent application P4. This is due to the fact that the content of the divisional application as filed was restricted in comparison to the parent application P4. The fact that the content of a patent deriving from a divisional application is limited in relation to the parent application does not necessarily mean that there is a problem under A 100(c) EPC 1973. However, if the limitations cause the “singling out” of intermediate generalisations (such as particular subgroups of elements) involving new technical information, then there is added subject-matter within the meaning of A 100(c) EPC 1973.
Furthermore, the [patent proprietors] argued that the disclosure of a certain pharmacokinetic profile in the parent application P4 means that the parent application inevitably singles out each and every constituent and combination of constituents for the formulation. However, for the application of A 123(2) EPC, A 76(1) EPC 1973, or A 100(c) EPC 1973, the disclosure test does not relate to alternatives which are not directly and unambiguously derivable from the application as filed.
[8.7.4] Additionally, the [patent proprietors] cited the High Court’s decision D40 and the subsequent decision of the Court of Appeal D40a in support of their argument that the subject-matter claimed in claim 1 of the main request does not contain added subject-matter.
All the national decisions cited by the [patent proprietors] predate the referral decision T 1068/07 and decision G 2/10. Decision G 2/10 leaves no doubt that it has to be investigated in each individual case whether the subject-matter remaining in the claim after the introduction of a disclaimer includes technical information which is not directly and unambiguously derivable from the parent application as filed.
As regards the passages cited by the [patent proprietors] in said national decisions, it has to be stressed that the High Court in its decision D40 and the Court of Appeal in its decision D40a did not assess whether the subject-matter remaining in the claim after the introduction of the disclaimer was disclosed in the parent application as filed.
The same applies in relation to the decision of the District Court of The Hague (D78a).
Decision T 142/94 deals with the assessment of the requirements of inventive step in relation to a claim relating to a solid controlled release dosage form characterised inter alia by means of in vitro release profile and in vivo release profile. Therefore, decision T 142/94 is not relevant for the examination under A 100(c) EPC 1973. Decision T 1024/96 deals with the assessment of clarity of functional features under A 84 EPC 1973. However, claim 1 of the present main request is identical to claim 1 as granted. Therefore, A 84 EPC 1973 is not at issue (T 23/86). Decision T 1024/96 is thus not relevant for the present case either. Finally, it has to be pointed out that, in contrast to the circumstances of the decisions cited by the [patent proprietors], the product of claim 1 of the main request is not characterised by the in vitro dissolution rate.
[8.7.6] The [patent proprietors] also referred to their written submissions made in document D70. In document D70 the [patent proprietors] referred to decision T 1139/00, and submitted that by analogy to said decision claim 1 as granted had to be considered as allowable since the disclaimer excluded subject-matter disclosed in the parent application as filed. However, even if it is established that the disclaimer excludes subject-matter disclosed in the parent application as filed, the analysis to be made according to decision G 2/10 is whether the subject-matter remaining after introduction of the disclaimer is directly and unambiguously disclosed in the parent application as filed. Decision T 1139/00 was issued long before decision G 2/10, and thus only cites decisions G 1/03 and G 1/93. However, decision G 2/10 [4.3, last paragraph] makes it clear that neither decision G 1/93 nor decision G 1/03 intended to modify the general definition of the requirements of A 123(2). This finding is undoubtedly also applicable in the context of A 100(c) EPC 1973 (see point [8.3] above).
[8.7.7] The [patent proprietors] also cited decision T 1107/06 to support their arguments in favour of the allowability of a claim with a disclaimer for excluding subject-matter disclosed in the application as filed. However, decision T 1107/06 predates decision G 2/10, which stipulates that the investigation as to whether the subject-matter remaining in a claim after the introduction of a disclaimer is disclosed in the parent application as filed has to be decided in each case individually, after an objective investigation of the disclosure in the parent application as filed.
[8.8] For the above reasons, the main request fails under A 100(c) EPC 1973 since the subject-matter of claim 1 extends beyond the content of the parent application as filed.
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