Thursday, 31 May 2012

T 1911/08 – Not Accidental

This appeal was filed against the revocation of the patent under consideration.

Claim 1 of the main request before the Board was a Swiss-type claim for a medicament for treating a great variety of disorders stretching from migraine to schizophrenia, Parkinson’s and stroke.  Claim 48 was directed at a compound for use as medicament. It contained a disclaimer which is referred to as “disclaimer (vi)” in the following passage where the Board examined  the allowability of the disclaimer under A 123(2):

[3.2] Disclaimer (vi) […] was introduced in response to a novelty objection raised under A 54(2) EPC with respect to document D6.

It is not in dispute that this disclaimer relates to an “undisclosed disclaimer” in the sense of decision G 1/03 [2, 1st §], that is, it does not have a basis in the application as filed. However, the parties disagree on whether document D6 can be viewed as being an “accidental anticipation” and, accordingly, as providing the basis for an allowable disclaimer under A 123(2), as set out in decision G 1/03 [hn2.1;2.2].

Therefore, in the present instance, it has to be decided whether document D6 is an accidental anticipation as defined in decision G 1/03, that is, whether “it is so unrelated to and remote from the claimed invention that the person skilled in the art would never have taken it into consideration when making the invention” (see [hn2.1]).

[3.3] The patent in suit relates heterocyclic compounds of general formula (I) that are effective as NMDA NR2B antagonists, and accordingly are disclosed as being useful in the treatment of a number of diseases associated with this pharmacological activity, namely, pain, migraine, depression, anxiety, schizophrenia, Parkinson’s disease, and stroke […].

Document D6 also relates to heterocyclic compounds of overlapping general formula (I), and a number of the specific compounds listed in Table 1 fall within this area of overlap. The compounds according to document D6 are disclosed as being well tolerated by plants and having favourable toxicity to warm-blooded species, and being highly suitable for controlling animal pests, for controlling endoparasites and ectoparasites in the field of veterinary medicine, and for controlling harmful fungi […]. Further details of the use in the field of veterinary medicine are disclosed […], including the possibility of oral administration to animals.

[3.4] The appellant argued that the biological pathway by which compounds acted should constitute the boundary between accidental and non-accidental anticipation, since, in modern mechanism-based research, the skilled person, that is, the medicinal chemist, would only take into account compounds interacting with the same receptor as a starting point for drug development.

The board cannot agree with this analysis for the following reason:

The ultimate aim of the pharmaceutical industry is the development of drugs capable of treating specific diseases. Therefore, in the present instance, where the patent in suit relates to the field of pharmaceuticals, the skilled person cannot merely be defined as being a medicinal chemist, but rather as being made up of a team covering the full range of disciplines required for drug discovery and development. High-throughput screening may be an important and integral part of this process. However, it will be equally important to establish whether candidate drug compounds have potentially favourable properties with respect to safety, toxicity, pharmacokinetics and metabolism. Therefore, the disclosure in document D6 that specific structures under consideration have favourable toxicity properties and are suitable for oral administration to animals would be considered to be valuable information to be taken it into consideration by the skilled person when making the present invention.

The board therefore agrees with the conclusion reached in T 134/01 [2.3], namely, that a further document belonging to the field of pharmaceuticals is not to be considered as being an accidental anticipation within the meaning of the decision G 1/03, that is, even if it does not relate to the same illness or biological pathway as the patent or application in suit.

In decisions T 739/01 [3.5], T 580/01 [2.4] and T 639/01 [3.2], the relevant prior art documents related to the treatment of the same illness as the patent or application in suit and were considered to be non-accidental anticipations. However, it does not follow that, had they related to a different illness, they would have been regarded as being accidental. Indeed, decisions T 739/01 [3.4-5] and T 580/01 [2.3-4] emphasise that “the patent in suit relates to the technical field of medicaments”, as does the relevant prior art.

[3.5] The further arguments advanced by the appellant are also not considered to be persuasive:

It is true that, for the purpose of patent protection of a medical application of a substance, a pharmacological effect observed in vitro may be accepted as sufficient evidence of a therapeutic application. However, this is only true if this observed effect directly and unambiguously reflects such a therapeutic application (cf. e.g. T 241/95 [4.1.2]). Indeed, as is further stated in decision T 241/95 [hn1], “the discovery that a substance selectively binds a receptor ... still needs to find a practical application in the form of a defined, real treatment of any pathological condition in order ... to be considered as an invention eligible for patent protection”.

Moreover, the appellant’s narrow problem-based approach to defining accidental disclosure focuses on an analysis of the problem to be solved. However, this was specifically rejected in decision G 1/03 [2.2.2]:
“Even less decisive, as an isolated element, is the lack of a common problem, since the more advanced a technology is, the more the problem may be formulated specifically for an invention in the field. Indeed, one and the same product may have to fulfil many requirements in order to have balanced properties which make it an industrially interesting product. Correspondingly, many problems related to different properties of the product may be defined for its further development. When looking specifically at improving one property, the person skilled in the art cannot ignore other well-known requirements. Therefore, a “different problem” may not yet be a problem in a different technical field.”
Finally, the appellant questioned the relevance of the disclosure of document D6 to pharmaceutical applications. As outlined above under point [3.3], the use in the field of veterinary medicine is disclosed in this document as one of three fields of application. Moreover, a whole section is devoted to dosages and formulations suitable for this use […], and an example is included relating to antiparasitic use […]. Therefore, it cannot be accepted that the disclosure of a veterinary use only qualifies as “a passing reference”. Moreover, since document D6 envisages oral administration to animals, there seems no basis for the contention of the appellant that the reference to a favourable toxicity in warm-blooded species was not of relevance to pharmaceutical applications. Finally, […] the diseases claimed in the patent in suit cannot be seen as being exclusively human-specific. Moreover, animal models are frequently used in research into human diseases. Therefore, information derived from the former is also of relevance to the latter.

[3.6] Accordingly, the main request […] must be rejected, since the incorporation of disclaimer (vi) into the respective claims 48 to 50 contravenes the provisions of A 123(2).

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