EP 3 431 475 B1 results from Divisional application EP 2 958 916, filed as
WO 2014/128588. It relates to solid forms of a selective CDK4/6 inhibitor. The compound is known under palbociclib.
Brief outline of the case
The OD found that claim 1 as granted did neither infringe Art 123(2) nor Art 76(1), but lacked IS over a document classified A,D in the ESR. AR1-4 suffered the same defect, but the patent was maintained according to AR5.
The proprietor and opponents 1 and 4 (out of 4) appealed.
In appeal, the proprietor withdrew its appeal, but the board held that the patent as maintained infringed Art 76(1). The patent was thus revoked.
The board’s decision is based on aspects brought forward by opponent 4.
Claim 1 of AR 5 is derived from independent claim 19 of the parent application as filed.
Claim 1 of AR 5 essentially differs from independent claim 19 of the parent application as filed in that the specific surface area of <= 2 m2/g contained in independent claim 19 of the parent application as filed was omitted and instead the two characteristics of a powder X-ray diffraction pattern comprising peaks at diffraction angles (2ɵ) of 8.0 ± 0.2, 10.1 ± 0.2 and 11.5 ± 0.2 and a D90 value of from 30 µm ± 20% to 125 µm ± 20% were added into the claim.
Opponent’s 4 point of view
Opponent 4 objected that the parent application as filed could not provide a basis for the palbociclib free base defined by claim 1 of AR 5.
The reason was that claim 1 of AR 5 was not limited to a particular specific surface area, contrary to independent claim 19 of the parent application as filed.
The proprietor’s point of view
The proprietor submitted that the parent application as filed disclosed palbociclib free base having a large primary particle size, not having necessarily a specific surface area of <= 2 m2/g.
The parent application as filed explicitly indicated or even suggested that the particular specific surface area now omitted in claim 1 of AR 5 was not an essential feature of the invention disclosed in the parent application as filed. The proprietor relied on specific passages of the parent application as filed.
The board acknowledged that the passages relied on by the respondent disclose a crystalline free base of palbociclib, a powder X-ray diffraction pattern comprising peaks at diffraction angles (2ɵ) of 8.0 ± 0.2, 10.1 ± 0.2 and 11.5 ± 0, and a primary particle size distribution characterised by a D90 value of from 30 µm ± 20% to 125 µm ± 20%, i.e. the features characterising the palbociclib free base in claim 1 of AR 5.
For the board, the passages of the parent application as filed do not directly and unambiguously disclose that the specific surface area of <= 2 m2/g disclosed in independent claim 19 of the parent application as filed can be omitted in the characterisation of Form A of the free base of palbociclib.
On the contrary, the parent application as filed discloses that the specific surface area of <= 2 m2/g is an essential feature of the invention disclosed in the parent application as filed.
The independent claims of the parent application as filed (claims 1, 15 to 20) all require a specific surface area of <= 2 m2/g, either directly or by reference to another independent claim. Furthermore, in the summary of the invention, the parent application as filed refers, in a broad aspect, to a crystalline free base of palbociclib having a specific surface area of <= 2 m2/g.
Therefore, it is clear to the skilled person that the passages of the parent application as filed relied on by the proprietor refer to embodiments all having this specific surface area. These passages therefore disclose features characterising the crystalline free base of palbociclib in addition to the specific surface area of <= 2 m2/g.
The parent application as filed thus comprises no teaching that the specific surface area referred to in independent claim 19 of the parent application as filed is not an essential feature of the invention disclosed which can be omitted to characterise Form A of the free base of palbociclib.
Therefore, the board concluded that the omission of the specific surface area of <= 2 m2/g in claim 1 of AR 5 adds subject-matter beyond the content of the parent application as filed.
Reference to the CoA UPC
The board added that this conclusion is not in contradiction with the decision of the Court of Appeal of the Unified Patent Court UPC_CoA_382/2024 (Abbot/Sibio)
Claim 1 of said patent related to an on-body glucose monitoring device. The point of dispute was whether the omission of an elastomeric sealing member for sealing the coupling between the sensor assembly and the electronics assembly in the wording of this independent claim added subject-matter.
The CoA found out that the elastomeric sealing member was not an essential feature and therefore there deletion did not add matter.
The present board found that the CoA UPC used the same test as applied by the EPO as its gold standard, cf. G 2/10, OJ EPO 2012, 376.
Comments
The present decision does remind that a feature does not have to be declared as “essential” in the description to have this quality.
If all embodiments, here all independent claims of the parent application refer to a specific surface area of <= 2 m2/g, this feature is actually essential in view of the context.
A good representative would never state in the description that a feature is essential. However, any feature mentioned in an independent is by essence essential and its deletion or omission has always to be checked for compliance with Art 123(2).
Why quote the CoA UPC?
One wonders why the present board had to quote case law of the UPC.
In T 2646/11, Reasons 3.2, the board held that in the absence of any statements in the description that a feature is essential, the extraction of the feature of a through-hole as claimed from the drawings does not constitute an intermediate generalisation extending beyond the content of the parent application as published.
On the other hand, it was explicitly stated in the description that the holes 40 and 42 are “for engaging tools” and have specific shapes for this purpose. Claiming simply a “through-hole” without specifying this purpose would cover holes, which are not suitable for this purpose and which do not form part of the original disclosure.
The omission of this feature from claim 1 of the MR results in an impermissible generalisation and infringes Art 76(1).
There was thus no need to refer to a decision of the CoA UPC to find that the omission of an essential feature from the parent application infringes Art 76(1)!
There was case law inside the EPO, which was even better than that of the CoA UPC.
That harmonisation in Europe is a noble aim, does not mean the boards of appeal of the EPO have to get their instructions or have to refer to case law from CoA UPC.
Comments
2 replies on “T 1535/23 – Omission of features and added matter-UPC and Boards of Appeal”
Dear Mr Thomas,
It is my impression that the Board did not cite the UPC decision on own motion but had to comment on it as a reaction to a corresponding argument of the party. Unfortunately it is impossible for the reader of the decision to infer this since the document does not recollect the arguments of the parties in the facts and submissions section, as it has been usually the good practice of the Boards, and the “grounds” section does not explain either what was actually brought forward by the party in this respect.
Let’s hope this remains an isolated case and not the beginning of a new style.
Thanks for keeping this forum alive.
Dear O Tempora O Mores,
Thanks for your comments.
I had a look at the parties’ submissions. I could not find any reference to a UPC decision in any of them.
As the OP was cancelled, there are no minutes in which such a comment could have been brought forward by a party.
I checked the issuance of the present decision and that of G 1/24. The present decision was taken on 02.06.2025 and notified to the parties on 02.07.2025. G 1/24 was issued and notified to the parties on 18.06.2025.
The only conclusion is that the reference to a UPC decision has been introduced by the board on its volition. I do however not remember that a board has referred in a routine decision to a decision of a national jurisdiction.
It is not possible to know whether the reference to the UPC decision has been introduced before or after the issuance of G 1/24.
If the reference to the UPC decision has been introduced before the issuance of G 1/24, then it evidences a premature obedience of the board to decisions of the UPC. One wonders why?
If the reference to the UPC decision has been introduced after the issuance of G 1/24, then it evidences that the board wanted to please the EBA and show that it had well received the message from the EBA: harmonisation with the UPC has to be acknowledged.
In both cases, it is not good for the independence of the EPO.
I share your hope this remains an isolated case and not the beginning of a new style.
I might be getting old, (start in IP in 11. 1971), but I intend to stay active as long as possible.