Brief outline of the procedure
The patent was revoked for lack of novelty, whereby the OD followed T 990/96.
The proprietor appealed.
The BA followed T 1085/13 and considered that the subject-matter of claim 1 was novel over D1-D3 and D15.
The BA remitted for further prosecution, notably for examination of inventive step.
The OD’s position
The opposition division concluded to a lack of novelty over D1-D3 and D15 despite accepting that the evidence on file demonstrated, at the effective date of the patent, that there was “no specific [oxycodone hydrochloride] preparation available on the market which would have met the claimed purity criteria”, i.e. “a pharmaceutical dosage form comprising oxycodone hydrochloride and less than 25 ppm 14-hydroxycodeinone”.
The OD followed T 990/96 and was of the opinion that the disclosure in D1-D3 and D15 of oxycodone hydrochloride made this compound available in all levels of purity before the effective date of the patent.
The exceptional situation whereby, according to T 990/96, novelty could be acknowledged where all prior attempts to achieve the claimed purity had failed, was not applicable to contested claim 1.
The proprietor’s position
With the statement of grounds of appeal, the proprietor contested the conclusion of the opposition division on novelty, in particular the conclusion that the exceptional situation in T 990/96 did not apply to the claimed subject-matter.
The proprietor submitted in appeal proceedings that according to decision T 1085/13, published after the contested decision was issued, the approach taken in T 990/96 contravened the established standards for the assessment of inter alia novelty, set out in Enlarged Board of Appeal decisions G 2/10 and G 2/88.
In view of T 1085/13, the decision of the opposition division was to be set aside, and novelty acknowledged.
The board’s position
For the board, claim 1 of the MR is to be interpreted such that the amount of 14-hydroxycodeinone in ppm is to be determined relative to the amount of oxycodone hydrochloride, and not to the amount of the pharmaceutical dosage form as a whole, i.e. including the pharmaceutically acceptable excipient.
The board agreed with the rationale and the conclusion of T 1085/13 in relation to the assessment of novelty. The claim at issue in T 1085/13 decision was directed to a specific compound in the amorphous form having a purity of at least 99.5% and containing less than 0.5% of the crystalline form. This situation was analogous to that of present claim 1, which defines oxycodone hydrochloride as having less than 25 ppm of a specific impurity.
To be in line with G 2/10, it was determined in T 1085/13, in the same way as for assessing compliance with Art 123(2), that in order to conclude a lack of novelty, there must be at least an implicit disclosure in the state of the art of subject-matter falling within the claimed scope.
For the board, a claim defining a compound as having a certain purity does not lack novelty if the disclosure of the prior art needs to be supplemented, for example by suitable (further) purification methods allowing the skilled person to arrive at the claimed purity.
In G 2/10, the board reminded that “the European Patent System must be consistent and the concept of disclosure must be the same for the purposes of Articles 54, 87 and 123 EPC”.
It was abundantly clear for the board that in the present case, the prior art D1-D3 and D15 would need to be supplemented with suitable further purification methods in order to (potentially) arrive at the claimed purity.
According to T 1085/13 this cannot lead to a lack of novelty of the claimed subject-matter, but is rather a matter to be considered in the assessment of inventive step.
As far as novelty vs. purity is concerned, there has been a change of paradigm with T 1085/13.
The present decision T 43/18 confirms T 1085/13.
It will be interesting to see whether further decisions of the same kind will follow.
Bringing the discussion from novelty over to inventive step reminds of deleting the criteria of “purposive selection” from novelty and transferring it to inventive step.
It took quite a while for the EPO to adapt the Guidelines in matters of selection inventions, cf. G-VI, 8(ii).
As far as purity vs. novelty is concerned, the Guidelines G-VI, 7 only refer to T 360/07 and state that “a known compound is not rendered novel merely because it is available with a different degree of purity if the purity can be achieved by conventional means”.
One could therefore consider that T 1085/13 and T 43/18 might deserve a mention in the Guidelines G-VI, 7.