Pages 196-199

NATIONAL JUDGES' PRESENTATIONS

NL Netherlands

NL Netherlands - Rian KALDEN - Vice-President, District Court of the Hague - Mundipharma Pharmaceuticals v. Sandoz/Allowability of disclaimer¹ - Mundipharma Pharmaceuticals B.V. v. Sandoz B.V., Added matter/Allowability of disclaimer, - District Court The Hague, The Netherlands, 7 April 2010, Case 340373 / 09-2029

Facts

The patent in suit related to formulations for the controlled release of oxycodone, meant for the relief of pain. The controlled release can be accomplished by means of a controlled release matrix or a release controlling coating. The patent concerned was based on a divisional. The parent application claimed the preferred embodiment being a controlled release acrylic resin matrix. To distinguish there - from and to prevent double patenting, the patent in suit contained a claim covering a controlled release dosage matrix other than an acrylic resin matrix.

Defendant's arguments

The validity of that claim was disputed on the basis that it constituted added matter. The argument was that the disclaimer as such was not disclosed in the application as filed, because – on the contrary – the disclaimed embodiment was actually presented in that application as part of the invention (also referred to as a "positive" disclosure) – even as a preferred embodiment – and not as something that must be excluded ("negative" disclosure).

The disclaimer should therefore be qualified as an undisclosed disclaimer, within the meaning of G 1/03. The disclaimer did not fall within the categories mentioned in the Enlarged Board decision G 1/03. The type of disclaimers mentioned in G 1/03 as being allowable are disclaimers in case of: Articles 54(3) and (4) (deemed prior art), 54(2) accidental disclosure and non-patentability for non-technical reasons. Preventing double patenting is not mentioned in G 1/03.

In addition, it was argued that the disclaimer has a technical meaning, as the teaching of the disclaimer is not to use an acrylic resin matrix, whereas the teaching of the application as filed is that an acrylic resin matrix is to be preferred.

Legal issue

There is controversy among several TBAs on how to interpret G 1/03. The question that divides the boards is whether a disclaimer that excludes subject-matter that is disclosed as part of the invention in the original application (referred to as positively disclosed) should be considered as an undisclosed disclaimer to which G 1/03 applies.

Decision

District Court The Hague held that there can only be an "undisclosed disclaimer" within the meaning of G 1/03 if neither for the disclaimer nor for the subject-matter of the disclaimer (i.e. that which is excluded) can a basis be found in the original application. In other words: only if the subject matter of the disclaimer has neither in positive nor in negative terms been disclosed in the original application can the disclaimer be qualified as "undisclosed".

The reasons for that decision are largely similar to those mentioned in the T 1107/06 and T 1139/00 decisions:

The EBA in G 1/03 addressed the issue of disclaimers in the framework of the questions put to it. The referrals to the EBA that led to the G 1/03 decision were made after it had been established that no basis could be found for a disclaimer in the application as filed – neither positive i.e. as an embodiment of the invention, nor negative, as not being part of the invention.

This is reflected in G 1/03 by the wording of the first answer which is worded closely to the question:

a disclaimer may not be refused for the sole reason that neither the disclaimer nor the subject-matter excluded by it from the scope of the claim have a basis in the application as filed;

District Court The Hague acknowledged that the introduction in a claim of a disclaimer – the subject-matter of which was previously positively disclosed – may alter the technical teaching of the application and thus infringe Article 123(2). It was decided that in this case – where the skilled person would understand that the subject- matter was disclaimed because this was covered by the parent application, of which this patent was a divisional. The disclaimer therefore had a pure legal reason and did not change the technical teaching of the patent as filed. As such, it could not be considered that by the introduction of the disclaimer the patent proprietor gained any unwarranted advantage, or that the interests of third parties were at stake. Thus it did not violate 123(2).

Parallel proceedings

A similar conclusion was drawn – based on slightly different considerations – by the UK Court of Appeal in the UK parallel proceedings.

In the case decided by the District Court The Hague, an appeal was also pending in opposition proceedings before the EPO in Munich. There, a request to refer to the EBA the question whether a disclaimer is allowable to delimit subject-matter of a divisional application from the subject-matter of a parent application, has been denied.

Referral to the Enlarged Board of Appeal

Very recently, a technical board of appeal has referred to the EBA the question whether a disclaimer infringes Article 123(2) EPC if its subject-matter was disclosed as an embodiment of the invention in the application as filed. We await the outcome of the case, G 2/10, with great interest.