EP 2 962 690 B1 is a 2d generation divisional and relates to (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline1,3-dione, or a pharmaceutically acceptable polymorph, salt, solvate or hydrate thereof, and to the (+) enantiomer for use as a medicament.
Brief outline of the case
The patent was maintained according to AR3.
The proprietor and opponents 1-8 and 11-14, out of 15, opponents appealed this decision.
Claim 4 of the MR infringed Art 123(2). The MR A was admitted in view of the deletion of claim 4.
However the MR A lacked IS and the MR B was not admitted under Art 13(2) RPBA.
The board thus decided revocation.
The case is interesting in view of the interpretation of claim 1 of “MR A” and the board’s comments about the Guidelines G-VI 6.1.2.
Claim 1 of “MR A” is formulated in the “compound for use” format of Articles 54(4) and 54(5).
The proprietor’s point of view
“MR A” corresponds to AR 10 as filed with the statement of grounds of appeal in which the stereomeric purity of the apremilast was defined in line with the amendment of AR 2 as expressly mentioned in the statement of grounds of appeal.
The claimed subject-matter related to a compound providing safe, well-tolerated and effective treatment of PDE4-mediated diseases following oral administration.
The board’s interpretation of MR A
Claim 1 of “MR A” is formulated in the “compound for use” format of Art 54(4) and 54(5), wherein the utility as a medicament is further specified as the use as a medicament which is administered orally.
The Guidelines G-VI 6.1.2 (2024), see example 2: “Composition comprising X for use in therapy by topical administration”, suggest with reference to T 51/93 that in a claim which only defines the mode of delivery, but no specific therapeutic effect, the definition of the mode of delivery is merely illustrative and not a limiting technical feature capable of establishing novelty.
Contrary to the suggestion in the Guidelines, T 51/93 actually recognizes without reference to any requirement regarding the definition of a specific medical condition that the definition of the mode of administration of a medicament represents a characterizing feature of a claim formulated in the so-called “Swiss-type” format as approved according to G 5/83 for defining inventions relating to new medical uses of known pharmaceuticals under the provisions of the EPC 1973, see T 51/93, Reasons 3.1.2.
In line with the considerations in G 2/08, see Reasons 5.10.3, the board therefore considered that the oral administration as defined in claim 1 of “MR A” represents, in accordance with Art 54(5), a characterizing feature of the claimed subject-matter.
The decision in T 51/93 further confirms that in a claim formulated as a “Process for making X for use Y comprising the steps of…” the definition of a specific medical purpose under Y illustrates what X can be used for, but does not further characterize the claimed subject-matter under the provisions of the EPC 1973, see T 51/93, Reason 2.2.2.
In line with the considerations in G 2/08, see Reasons 5.10.3, the board therefore considered that the oral administration as defined in claim 1 of “MR A” represents, in accordance with Art 54(5) EPC, a characterizing feature of the claimed subject-matter.
Comments
For the board it appears that, in view of T 51/93 and G 2/08, the mode of administration is a functional limiting feature for a second medical use claim.
The board thus disagrees with the Guidelines G-VI 6.1.2.
Have the Guidelines stuck to EPC 1973 in this example in the Guidelines?
Comments
Leave a comment