G 2/88 provides legal assessment for novelty of a non-medical use claim. G 2/88 allows acknowledging novelty of a non-medical use claim of an old compound for a particular purpose based on a previously unknown technical effect. The use, however, must be a truly new use that opens a new application of an old compound.
In Biogen’s European Patent EP 2 707 383, the claim was formulated as a non-medical use of pyruvate for achieving an effect of reducing the formation of trisulfide bonds in proteins. This technical effect was recited as the alleged “new purpose” of the non-medical use claim.
Two Oppositions were filed including Maiwald and Roche. Under substantive matters, Maiwald raised an objection for lack of novelty, inventive step and sufficiency of disclosure . On the other hand, Roche’s representatives from Mewburn Ellis raised objections for lack of inventive step and sufficiency of disclosure only. Biogen was represented by Mathys & Squire.
The prior art disclosed pyruvate in a process of protein purification but did not disclose the technical effect of reducing the formation of trisulfide bonds in proteins recited as the alleged “new purpose” of the non-medical use claim. Biogen argued that since the “new purpose” was unrecognized in the art, the use claim was novel in the sense of G 2/88. Maiwald argued that the Patent had only discovered a new technical effect of pyruvate (of reducing the formation of trisulfide bonds in proteins) that already underlay the known use of pyruvate in protein purification. Although the use claim recites the newly discovered technical effect as the “new purpose” of pyruvate, in effect the purpose remains the same as was known in the art, i.e., for protein purification, and therefore, not novel. This was not a situation of a truly new use that opens a new application of a known compound in the sense of G 2/88.
The Opposition Division decided that the non-medical use claim was novel.
The 3.3.04 Board led by the Chairwoman, M. Pregetter agreed with Maiwald as Appellant II, led by Dr. Regina Neuefeind and Asim Q. Akbani and overturned the Decision of the Opposition Division. The Board decided that the claimed non-medical use was not novel even though the alleged “new purpose” was not disclosed in the art. They reasoned that pyruvate would only and always achieve the alleged “new purpose” in the context of protein purification disclosed in the art (see catchword 3 and reason 13). Therefore, it was irrelevant whether the newly discovered technical effect now recited as the alleged “new purpose” was recognized in the art or not and could not render the non-medical use claim novel in the sense of G 2/88.
The 3.3.04 Board also noted that the formulation of the non-medical use claim in fact reflected a process claim (of protein purification) and noted that the exceptions applied to novelty of non-medical use claims in view of G 2/88 did not apply to process claims (see catchwords 1 and 2).
The Patent was revoked in its entirety for lack of novelty.
This Decision is also important because none of the Auxiliary Requests (filed already in the 1st instance) were admitted into the proceedings due to lack of substantiation (see catchword 4).
