EP 3 447 137 B1 relates to a liquid enzyme preparation and a method for preparing the same.
Brief outline of the case
The patent was maintained according to a new MR=MRn.
Claim 1 concerns a liquid enzyme preparation that has a basis in claims 1 and 3 of the application as filed, further amended by the introduction of the disclaimer “except a solution of 60 U/100 myl transglutaminase in 50% glycerol, 1 mM glutathione, 150 mM NaCl, 25 mM Tris-HCl, pH 8.0”.
The board decided that MRn was not compliant with Art 123(2) as it contained an undisclosed disclaimer under G 1/03, which was not an accidental anticipation for the subject-matter of claim1 as maintained. The disclaimer was based on a dissertation at the LMU, published in 2010.
In AR1, the disclaimer was deleted, but claim 1 lacked IS over D1, the same applied to AR2. AR3 in which the product claims were deleted was not admitted in the procedure under Art 13(2) RPBA.
The patent was thus revoked.
In the present blog entry we will discuss the undisclosed disclaimer.
The opponent’s point of view on the disclaimer
D1 does not qualify as an accidental disclosure. D1 discloses the enzymatic cross-linking of gelatine nanoparticles with a transglutaminase preparation that contained 60 U/100 myl transglutaminase in 50% glycerol, 150 nM NaCl, 25 mM Tris-HCl at pH 8.0.
It teaches that transglutaminase is a known non-toxic cross-linking agent routinely used to cross-link proteins in food chemistry and that therefore, it is a promising non-toxic and safe means for producing pharmaceutical gelatine nanoparticles for future application in humans.
The proprietors’ point of view on the disclaimer
The proprietors asserted that an accidental disclosure did not have to be unrelated to the invention at all, but that it was sufficient that the skilled person would not have taken it into account when making the invention. Otherwise, no disclaimer for an accidental disclosure was possible at all.
D1 was a large document concerned with the production of means for delivery of pharmaceuticals. It was not concerned with storage stability of transglutaminase at all. Instead, it merely contained a short description of a composition containing transglutaminase for immediate use.
However, the subject-matter of the patent was not the transglutaminase enzyme or its use but was a liquid transglutaminase composition that could stably be stored at room temperature. The skilled person would never have considered D1 when attempting to solve this technical problem as D1 did not give any pointers to storage stability.
The board’s decision on the disclaimer
The liquid transglutaminase preparation used in D1 for cross-linking gelatine nanoparticles falls under the definition of claim 1 of the MRn.
D1 is therefore concerned with the preparation and use of a liquid transglutaminase solution for non-toxic cross-linking of a product for use in humans. This is a similar purpose as that described in the patent for the claimed preparation which the cross-linking of proteins in food industry. The disclosure in D1 is hence not so unrelated and remote from the patent that a skilled person would never have taken it into account when working on the invention, as required by G 1/03.
As evident from Reasons 2.2.2 of G 1/03, the lack of a common problem alone in the patent and the prior art in question, here storage stability of a liquid transglutaminase preparation at room temperature for at least six months, is not decisive for a document being an accidental disclosure.
Instead, the disclosure in the prior art in question must be entirely unrelated from a technical point of view. This is not the case because D1 and the patent both concern transglutaminase enzyme preparations used for cross-linking products for future use in humans. The board therefore did not agree with the proprietors that the skilled person would not have taken D1 into account at all when making the invention.
As to the proprietors’ assertion that if the opponent’s arguments were followed, an undisclosed disclaimer could never be drafted, the board noted that an undisclosed disclaimer is indeed an exception that is allowable only under very particular circumstances. The conditions for qualifying as an accidental disclosure are therefore by its very definition rarely met. Hence, this argument was unconvincing.
The board therefore concluded that the teaching in D1 regarding the transglutaminase enzyme preparation does not qualify as an accidental disclosure in the sense of the definition in G 1/03.
In consequence, claim 1 did not meet the requirements of Art 123(2) because of the addition of an unallowable undisclosed disclaimer.
Comments
A quick search in the caselaw of the boards, shows that, from the 26 decisions relating to an undisclosed disclaimer based on an accidental anticipation, only 2 were actually considered as an accidental anticipation.
In T 2036/08, Reasons 2.2, last §, the board held that D7 is remote from the claimed invention and was regarded as an accidental disclosure in the sense of the decision G 1/03.
In T 1035/03 , Reasons 3, the board held that the technical information in D7 and D10 is so unrelated to and remote from the claimed invention, that the skilled person would never have taken it into consideration when making the invention. Neither document reports any pharmaceutical activity of the compounds disclosed therein.
It is thus difficult to say that in the present case D1 was remote from the field of the invention.
In T 0014/01, Reasons 1.6, the board held that, for an anticipation to be accidental it is necessary that the skilled person would have never taken it into consideration.
in T 0500/00, Catchword, the board held that the principle of good faith cannot be invoked against the application of the principles concerning the allowability of disclaimers laid down in G 1/03 to pending cases.
That applicants/proprietors would like to rely on accidental anticipations when filing a disclaimer is understandable, but accidental anticipations will remain a very rare exception.
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