The present decision - which is from 2010 but has been published only now - has something to say on what “the same invention” means in the realm of biotech.
[2] Documents D1 and D8 are scientific publications dated 19 January 1996 and 12 March 1996, respectively. Document D9 is a European patent application published on 23 July 1997 claiming inter alia priority from US 08/639,501 (document D10), filed on 29 April 1996.
Thus, the publication dates of documents D1 and D8 and the priority date of document D9 lie between the filing dates of the second priority document P2 and the third priority document P3 of the patent in suit.
It is undisputed that the disclosure in documents D1, D8 and D9, if it belonged to the state of the art under A 54(2) or A 54(3), would be detrimental to the novelty of the subject-matter of claim 2 of the main request (and all identically formulated claims in [the patent proprietors’] auxiliary requests).
Documents D1, D8 and D9 would not belong to the state of the art under A 54(2) and A 54(3), if the claims were entitled to claim priority from P1 or P2, the first and second priority documents.
[3] The complete BRCA2 coding sequence is not depicted in any of the three priority documents, but only in the application as filed (figure 7). It encodes 3418 amino acids.
P1 and P2, respectively, contain partial BRCA2 sequences while P3 does not contain any coding sequence at all. The partial sequence of P1 as depicted in figures 1 to 3 (corresponding to figures 1 to 3 of the patent) encodes 544 amino acids (about 16% of the complete sequence). The partial sequence of P2 shown in figures 4 and 5 (corresponding to figures 4 and 5 of the patent) encodes 2329 amino acids (about 68% of the complete sequence).
[4] The Enlarged Board of Appeal (EBA) in the opinion G 2/98 came to the conclusion that the requirement for claiming priority in respect of “the same invention”, referred to in A 87(1), means that priority of a previous application in respect of a claim in a European patent application in accordance with A 88 is to be acknowledged only if the skilled person can derive the subject-matter of the claim directly and unambiguously, using common general knowledge, from the previous application as a whole.
When examining whether a narrow or strict interpretation of the concept of “the same invention” referred to in A 87(1) should be applied, the EBA considered that a narrow and strict interpretation of the concept of “the same invention”, equating it with the concept of “the same subject-matter” referred to in A 87(4), was entirely consistent with Articles 4F and 4H of the Paris Convention (points [2] to [5] of the reasons). This followed from the very aim and object of the right of priority: the protection from novelty destroying disclosures during a period of twelve months from the date of filing of the first application is satisfied only in case of the filing of a subsequent application relating to the same invention.
In point [8.3] of the reasons the EBA considered an issue that had been raised in decision T 73/88 which, in order to assess whether a claim in a later European patent application was in respect of the same invention as the priority application pursuant to A 87(1), made a distinction between technical features which are related to the function and effect of the invention and technical features which are not. This approach was said to be problematic because there are no suitable and clear, objective criteria for making such a distinction; it could thus give rise to arbitrariness. Different deciding bodies might thus arrive at different results when assessing these facts and circumstances. Furthermore, as pointed out in the referral of the President of the EPO giving rise to the opinion, it had to be borne in mind that the assessment by these different deciding bodies of whether or not certain technical features were related to the function and effect of the claimed invention might completely change in the course of proceedings. This was the case, in particular, if new prior art was to be considered, with the possible consequence that the validity of a hitherto acknowledged right of priority could be put in jeopardy. Such dependence would, however, be at variance with the requirement of legal certainty.
Finally in point [9] of the reasons the EBA stated:
“... an extensive or broad interpretation of the concept of “the same invention” referred to in A 87(1), making a distinction between technical features which are related to the function and effect of the invention and technical features which are not, with the possible consequence that a claimed invention is considered to remain the same even though a feature is modified or deleted, or a further feature is added (cf. point [8.3] supra), is inappropriate and prejudicial to a proper exercise of priority rights. Rather, according to that analysis, a narrow or strict interpretation of the concept of “the same invention”, equating it to the concept of “the same subject-matter” referred to in A 87(4) (cf. point [2] supra), is necessary to ensure a proper exercise of priority rights ...”.
[5] In application of G 2/98, the Boards of Appeal, in a number of decisions, have defined the concept of “the same invention” in the field of biotechnology and especially in connection with inventions referring to nucleotide sequences.
A summary of this case law of the Boards of Appeal is given in decision T 1213/05 [22-25] of this Board in a different composition.
[6] [The patent proprietors] have argued that this case law of the Boards of Appeal did not apply in the present case since, contrary to the technical situation underlying those decisions, the claimed nucleotide sequence was not defined by sequence information but by a process for obtaining it. The essence of the present invention was to be seen in the identification of the BRCA2 gene, whose identity had been confirmed by partial sequencing as disclosed in priority documents P1 and P2. Starting from this disclosure sequencing the rest of the gene (about 32% of the entire gene sequence not disclosed in document P2) was a matter of routine work that could have been done by a person skilled in the art without undue burden.
[7] In fact the [the patent proprietors] seek to distinguish between technical features which are related to the function and effect of the invention (and which according to [the patent proprietors] are disclosed in P1 and P2) and technical features which are not. This is exactly the approach which the EBA found to be inappropriate and prejudicial to a proper exercise of priority rights (G 2/98 [9]).
Documents P1 and P2 disclose partial sequences of the BRCA2 gene only. They do not refer to “the same invention”, in the sense of “the same subject-matter” referred to in A 87(4), as the patent, which discloses in figure 7 the complete BRCA2 coding sequence (see G 2/98 [2-5]).
[8] Yet further, the Board notes that claim 2 of [the patent proprietors’] main request is not directed to a method for identifying a gene, which according to [the patent proprietors] is the essence of the invention, but to “an isolated nucleic acid molecule consisting of the full length coding sequence or complete BRCA2 gene”.
[9] [The patent proprietors] referred to decision T 932/92 (NB: this should read T 923/92) wherein, as they argued, it was decided that a claim to a DNA isolate defined by a process for its production was entitled to claim priority from a priority document containing sequencing errors.
[10] In that earlier decision the Board decided that a claim referring to a process comprising the preparation of a protein which was defined by its function and by an amino acid sequence 1 to 527 as depicted in Figure 5, did not enjoy priority from the first and second priority documents which contained a Figure 5 that differed from Figure 5 of the patent in suit in respect of three amino acid positions 175, 178 and 191. It enjoyed priority only from the third priority document which disclosed the correct sequence (see T 923/92 [3-17]).
However, in point [46], the Board decided that claim 1 of subsidiary request 3 was entitled to claim priority from the first priority document. This claim was formulated such that it referred to a DNA isolate obtainable by probing a cDNA library with one or more of three defined hybridisation probes, isolating strongly hybridising clones and using them to produce a DNA sequence having a restriction pattern shown in figure 4 “for the putative mature tissue plasminogen activator sequence” encoding a polypeptide of 527 amino acids. The claim defined the N-terminal and C-terminal amino acid of the protein and specified the human t-Pa activator function.
[11] The first priority document disclosed the used starting material and hybridisation probes and it contained figure 4 in identical form as the patent. The nucleotides corresponding to amino acid residues 30 to 67, which were responsible for binding of the hybridisation probes, were identical in figure 5 of P1 and of the patent. Figure 5 of the first priority document and of the patent disclosed a polypeptide of 527 amino acids whose N-terminal and C-terminal amino acid were identical.
[12] The claim which was found to be entitled to claim priority from the first priority document in decision T 923/92 was formulated differently than claim 2 of the main request in the present case, which is directed to “an isolated nucleic acid molecule consisting of the full length coding sequence or complete BRCA2 gene”. Also the disclosure in the priority documents in that case was different than in the present case. Therefore, the passages of decision T 923/92 relied on by [the patent proprietors] do not apply in the present case.
[13] The issue of entitlement to priority has been dealt with in G 2/98, five years after the publication of decision T 923/92. The case law of the Boards of Appeal with regard to the entitlement to priority of a claim referring to a nucleic acid sequence is uniform and definite. The arguments presented by [the patent proprietors], therefore, have not persuaded the Board that there is anything in the present case which could justify a deviation from this case law. Accordingly, the Board arrives at the decision that the subject-matter of claim 2 of [the patent proprietors’] main request is not entitled to claim priority from P1 or P2.
Consequently, the claimed subject-matter lacked novelty and the patent was revoked.
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4 comments:
The OP lasted all of 25 minutes for 6 different requests. Why was it necessary to hold one at all, and to make all that fuss about whether to accept postponement? It wasn't a case involving two dozen parties from four continents, even though the presence of Myriad in combination with BRCAx gave it a certain profile. My feeling is that the board wanted to avoid any semblance of creating a precedent. The tone and the tenor of the appellant's letter would certainly have convinced me. DG3 isn't the only instance in Munich to provoke Kopfschütteln.
Because, according to the decision, oral proceedings were requested by both parties should the board not allow their requests. The board is not at liberty not to hold OP if the parties request one. Why the parties in spite of the clear situation nevertheless requested OP? That is a question one might ask in many more cases.
The board is not at liberty not to hold OP if the parties request one.
Agreed 100%. It was driven very early deep in my examiner's pea brain that the omission of a duly requested OP constituted a grave violation of Art. 113, and that the board would lose no time in throwing back the case at the first instance.
My concern was more about the postponement, and the fact that nothing in the written record foreshadowed the outcome of the OP.
Points 7 and 8 of the summons state:
The Board is of the preliminary opinion that several of the Opposition Division's decisions with regard to priority right (Art. 87 to 89 EPC) are not in line with the decision of the Enlarged Board of Appeal G 2/98 (OJ EPO 2001, 413). The attention of the parties is directed to the following recent and relevant decisions of this Board: T 1213/05 of 27 September 2007/ T 666/05 of 13 November 2008 and T 80/05 of 19 November 2008.
The parties at the scheduled oral proceedings will be heard on the issue of priority right (Art. 87 to 89 EPC). Depending on the outcome, the state of the art according to Art. 54(2) and (3) EPC will be determined and the issues of novelty (Art. 54 EPC) and inventive step (Art. 56 EPC) will be examined.
This passage still left room for a meaningful debate. The board cited a number of decisions, without indicating how their reasoning specifically applied to the present case.
I really wonder what could have happened in those short 25 minutes. Could there be an error in the minutes?
The EPO continues its very strict approach to sequence inventions. Whenever sequences are corrected in subsequent filings, the previous incorrect sequence should also be retained in the application to increase the probability of drafting a claim of worthwhile scope which is entitled to priority.
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