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T 1303/18 - Disclosure of a compound, inherency for Art.54 and Art.123(2)

Key points

  • The question is whether the priority is valid.
  • "The appellant [proprietor] argued that there was no doubt that the claims as granted and the whole disclosure of [priority application] D49 concerned the same invention within the meaning of Article 87(1) EPC and opinion G 2/98, namely, polymorphic form II of rotigotine."
  • "In claim 1 as granted (point II above), the claimed compound is said to be polymorphic form II of rotigotine and is defined by at least one of four properties, namely: (a) a certain X-ray powder diffraction spectrum comprising four peaks with an error margin of ± 0.2, said to be measured with Cu-Kalpha irradiation (1.54060 Ã…); (b) a Raman spectrum comprising specific peaks with an error margin of ± 3 cm**(-1); (c) a DSC peak with a certain Tonset with an error margin of ± 2°C; (d) [a melting point of 97°C ± 2°C]."
  • The Board: "Comparing the definition in terms of property (a) given in claim 1 as granted with the above disclosures in D49 reveals the following differences. - The set of peaks defined for the X-ray powder diffraction spectrum in claim 1 as granted is a set of four peaks, while that in the above disclosures of D49 is a set of 14 peaks. 
  • The Board also considers property (b) (Raman spectrum), finding differences; the same applies for properties (c) and (d).
  • As to the melting point:  "The melting point is not disclosed [in D49]" ... "no basis exists in D49 for  a melting point of 97°C ± 2°C as defined in claim 1 as granted"
  • " in the current case, it is the subject-matter of claim 1 as granted that has to be directly and unambiguously derivable from D49. The appellant [proprietor] pointed out that the patent and D49 disclosed the same methods for characterising the mentioned polymorphic form and that the same figures resulted from this characterisation, thus demonstrating identity of the invention. However, the fact that the same characterisation methods like X-ray diffraction, Raman spectrum and DSC calorimetry are used to describe the disclosed compound in both the patent and D49 plays no role when assessing the above requirement. Also the fact that the patent and D49 share the same figures is irrelevant; what is decisive is whether or not, using common general knowledge, a compound as defined in claim 1 of the patent is directly and unambiguously disclosed in D49 as a whole."
  • " The appellant argued that identity between the claimed compound and the compound disclosed in D49 was already evident from the fact that the polymorphic form of rotigotine was designated as form II in both claim 1 as granted and D49. While alleged discrepancies in the definition of form II were merely due to the different sets of analytical data used for defining form II, this did not change the fact that the same compound was disclosed. A polymorphic form of a given compound remained the same regardless of the method used for characterising it."
  • "Contrary to the appellant's view, it is the set of analytical data chosen to characterise the compound that gives the skilled person the information necessary to identify the compound referred to. For the reasons set out above, the set of analytical data used in claim 1 as granted is not directly and unambiguously disclosed in D49. Therefore, it cannot be concluded that the compound defined in claim 1 as granted is the same compound as disclosed in D49."
  • "the appellant submitted that structural properties allegedly lacking in D49 were implicitly disclosed to the skilled person since they were inherent to polymorphic form II and accessible by using the disclosed analytical methods. "
    • As a comment, this argument may run foul of the rule that amendments may not add technical information (G2/10 r.4.5.1). Even if a compound inherently exhibits a  melting point of 97°C, adding a statement to that effect to a patent text may still violate Art. 123(2). However, this position may be controversial. A possible counter-argument could be that there is no change of subject-matter because there is only a single compound "rotigotine form II". This raises, in turn, the epistemological question of what is a compound? And what is the scope of a patent claim directed to a particular polymorphic form of a compound, and how this scope depends on the definition of the polymorphic form? 
  • "This argument is not convincing either. Priority has been claimed from a written disclosure (D49) and it is from this disclosure that the skilled person should have been able, at the relevant date, to derive directly and unambiguously, using common general knowledge, the subject-matter of claim 1 as granted. However, as set out above, D49 does not disclose the same compound as that defined in claim 1 as granted."
  • "Moreover, even assuming that the skilled person could have been in a position to analyse a sample of the rotigotine form II disclosed in D49, the skilled person would have obtained, inter alia, the whole X-ray powder diffraction spectrum and Raman spectrum (which are in fact represented in figures 1 and 5 of D49). However, for the reasons given above, these whole spectra do not constitute an adequate basis for the definition of the polymorphic form of rotigotine as given in claim 1 as granted. "
  • "the board sees no inconsistency in the way the opposition division assessed the validity of priority on one hand and the novelty of the claimed subject-matter on the other. In fact, in terms of novelty (see corresponding point below), the relevant prior art is a sample of a polymorphic form of rotigotine, which could have been analysed by the skilled person so as to obtain, inter alia, its whole X-ray powder diffraction spectrum and Raman spectrum. These whole spectra were found by the opposition division to anticipate the definition of the polymorphic form of rotigotine as given in claim 1 as granted."
  • "The application of one and the same standard for Articles 54 and 87 EPC does not, however, mean that the conclusions for novelty and validity of priority must necessarily be the same. More specifically, [] a priority application can directly and unambiguously disclose something falling within the scope of a claim of a subsequent application and thus anticipate the subject-matter of this claim while at the same time the latter still includes subject-matter not disclosed in the priority application, such that the priority is invalid."
    • In the case at hand, the priority application was not published and not cited as novelty-destroying, so the Board is considering a hypothetical novelty objection if D49 was prior art. Indeed, the compound disclosed in D49 would inherently have the melting point specified in claim  1 (leaving aside that claim 1 specifies four alternative features) and hence inherently fall within the scope of the claim even if D49 does not disclose the melting point.
  • The OD had found that: "The subject-matter of claim 1 of the main request and claim 1 of auxiliary requests 1 and 2 was not novel over the public prior use of rotigotine form II in commercial Neupro**(®) patches which occurred between the earliest and the subsequent priority date."
Partial priority / admissibility
  • The Board did not admit the argument based on partial priority:  "In its letter dated 21 August 2020 (point 1.2.1.3 on pages 11 to 14), i.e. after the filing of the grounds of appeal and replies and before the summons to oral proceedings was issued (6 December 2021), the appellant argued for the first time that, should the priority from D49 be considered invalid, the subject-matter of claim 1 as granted should at least be entitled to a partial priority from D49 in accordance with decision G 1/15." The Board: "Decision G 1/15 was published in the Official Journal of the EPO in 2017, i.e. before the oral proceedings held on 15 February 2018 before the opposition division. Therefore, the appellant's defence claiming a right to partial priority could and should have been presented before the opposition division or included at the latest in the statement of grounds of appeal, so as to comply with the requirement to present the complete case at the outset of the appeal proceedings."
  • " In its letter dated 21 August 2020, the appellant did not indicate any reason why the defence asserting a right to partial priority was only filed after its statement of grounds of appeal."
  •  "The appellant [proprietor] argued that this defence did not constitute an amendment of its appeal case. It only concerned interpretation of law by means of an argument based on a decision of the Enlarged Board of Appeal. Therefore, the appellant was allowed to make this defence at any point during the proceedings. "
  • " Contrary to the appellant's view, the defence by which a right to partial priority was invoked was not merely a presentation of a new argument pertaining to the interpretation of law but comprised a new allegation of fact. The appellant namely asserted that priority application D49 directly and unambiguously disclosed in an enabling manner part of the subject-matter of claim 1 as granted, and specifically that claim 1 as granted encompassed this part as an alternative subject-matter by virtue of a "generic "OR"-claim" within the meaning of decision G 1/15 (order). Therefore, the submitted defence would have involved a new factual assessment of the subject-matter of claim 1 as granted and of priority application D49, namely as to precisely which part of claim 1 it was that allegedly enjoyed partial priority and where it was disclosed in D49."
  • " As pointed out by the respondents, this new factual assessment would have been complex. This was evident from the fact that in some aspects the subject-matter of claim 1 as granted had been restricted as compared with the disclosure in D49 by inserting characteristics of the claimed compound such as a melting point and further Raman peaks which were not disclosed in D49. 
    • As a comment, as the public prior use is full prior art (Art.54(2)) for those parts of the claim for which the priority is invalid, the prima facie relevance of the arguments is not entirely clear. 
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.



source http://justpatentlaw.blogspot.com/2023/03/t-130318-disclosure-of-compound.html
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