T 0621/11 - A or the, an inescapable trap

EPO T 621/11

For the decision, click here

Key points

• The invention relates to a medicament for treating or preventing a metastasis of a tumor.The patent is stuck in the inescapable trap (Art 123(2)/(3)) by changing "the step of inoculating a tumor in the patient" in the application as filed into " suitable for inoculating the tumor in a patient", because " the"  tumor is the primary tumor (according to the Board), and inoculating this specific tumor is not disclosed in the application as filed. Reverting back to " a tumor" extends the scope of protection. 
• The Article 123(3) objections was admitted, even though late filed,  "given the nature of the objection".

Summary of Facts and Submissions

I. European patent No. EP1003533, based on European patent application No. 98939886.2, published as WO 99/07394 (hereafter referred to as "the application as filed") and entitled "Use of herpes vectors for tumor therapy", was granted with 17 claims.

II. Claim 1 of the application as filed reads:

"A method of eliciting a systemic antitumor immune response in a patient who presents with or who is at risk of developing multiple metastatic tumors of a given cell type, comprising the step of inoculating a tumor in the patient with a pharmaceutical composition consisting essentially of: (A) a herpes simplex virus (HSV) that infects tumor cells but that does not spread in normal cells, wherein the genome of the herpes simplex virus comprises at least one expressible nucleotide sequence coding for at least one immune modulator, and (B) a pharmaceutically acceptable vehicle for the virus, such that an immune response is induced that is specific for the tumor cell type and that kills cells of the inoculated tumor and of a non-inoculated tumor."

III. Claim 1 as granted reads:

"1. Use of a composition comprising a herpes simplex virus (HSV) that replicates in dividing cells and exhibits attenuated replication in non-dividing cells, and that comprises one or more expressible nucleotide sequences encoding one or more cytokines or at least one other immune modulator, and a pharmaceutically acceptable vehicle for the virus for the preparation of a medicament for treating or preventing a metastasis of a tumor of a given cell type by eliciting a systemic antitumor immune response in a patient who presents with or who is at risk of developing multiple metastatic tumors of a given cell type, wherein the medicament is suitable for inoculating the tumor in a patient."

Reasons for the Decision

1. The appeal is admissible.

2. Main request

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2.2 Article 123(2) EPC

2.2.1 Claim 1 relates to the use of a composition comprising a mutated herpes simplex virus and a pharmaceutically acceptable vehicle for the preparation of a medicament for treating a metastasis of a tumour of a given cell type by eliciting a systemic antitumour immune response in a patient who presents with multiple metastatic tumours of a given cell type, wherein the medicament is suitable for inoculating the tumour in a patient; the claim is thus drafted in the format of a Swiss-type claim.

2.2.2 Article 123(2) EPC stipulates that a European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed. It is the established case law of the Boards of Appeal that the content of an application comprises the disclosure directly and unambiguously derivable from it.

2.2.3 The application as filed discloses a method of eliciting a systemic antitumour immune response in a patient, which method comprises the step of inoculating a tumour in the patient with a mutated herpes simplex virus (see page 7, lines 16-21; claims 1, 17, 28, 30 and 31 of the application as filed). There is no disclosure in the application as filed of any such method which need not comprise the step of inoculating a tumour. However, claim 1 of the main request merely requires that "the medicament is suitable [original emphasis] for inoculating the tumor in a patient"; the claimed use does not comprise the step of "inoculating a tumor in the patient" as an obligatory feature. Therefore, the claimed use extends beyond the content of the application as filed.

2.2.4 Furthermore, claim 1 refers to the preparation of a medicament for treating a metastasis of a tumour and states that the medicament is suitable for "inoculating the [original emphasis]tumor in a patient". This means that the medicament is suitable for inoculating the primary tumour giving rise to the metastasis to be treated.

However, the application as filed refers only to methods comprising the step of "inoculating a [original emphasis]tumor in the patient" (see for instance page 7, lines 16-21; claim 1 of the application as filed), without stating that the (primary) tumour giving rise to the metastasis to be treated is to be inoculated. Whereas several passages of the application as filed make a distinction between the inoculated tumour and non-inoculated tumours (e.g. page 7, lines 16-24; page 10, line 34, to page 11, line 2; page 11, lines 4-6; page 16, lines 4-10), there is no teaching that the inoculated tumour is the primary tumour giving rise to the metastasis. 

Therefore, the information that the medicament is suitable for inoculating the primary tumour giving rise to the metastasis, rather than for inoculating any one tumour of the patient presenting with multiple metastatic tumours of a given cell type, is not directly and unambiguously derivable from the application as filed.

The appellant-proprietor pointed out that the examples section of the application as filed [...] For this reason alone, the information that the primary tumour is to be inoculated cannot be directly and unambiguously derived from the disclosure of the subcutaneous tumour model in the application as filed.

2.2.5 Consequently, claim 1 of the main request does not meet the requirements of Article 123(2) EPC.

3. Auxiliary request 1

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3.2 Article 123(3) EPC

3.2.1 The appellant-proprietor requested that the Article 123(3) EPC objection raised by the appellant-opponent should not be admitted into the proceedings as being late-filed; he had become aware of this new objection only a few days before the oral proceedings and could thus not deal with it without the adjournment of the oral proceedings.

3.2.2 Amendments to the claims or other parts of a patent made in the course of opposition or appeal proceedings are to be fully examined for compatibility with the requirements of the EPC, e.g. with regard to the provisions of Article 123(2) and (3) EPC (see G 9/91, OJ EPO 1993, 408, 19).

3.2.3 In the present case, the board considers the objection under Article 123(3) EPC raised by the appellant-opponent in its letter of 6 May 2015 with respect to auxiliary request 1 filed by the appellant-proprietor one month before the oral proceedings to be fundamental and highly pertinent.

It is true that the appellant-opponent could in principle have raised this objection earlier, since the claim under consideration had already been filed as claim 1 of auxiliary request VII on 18 October 2011.

However, given the nature of the objection, the board considers that the time available for the appellant-proprietor to consider the objection and prepare counter-argumentation, i.e. at least five days, was sufficient. The appellant-proprietor could thus be expected to deal with the objection without adjournment of the oral proceedings.

Therefore, the board admits this objection into the proceedings.

3.2.4 Article 123(3) EPC stipulates that the claims of a patent as granted may not be amended in such a way as to extend the protection conferred. In order to decide whether or not an amendment of the patent in suit satisfies that requirement, it is necessary to compare the protection conferred by the claims before amendment, i.e. as granted, with that of the claims after amendment. It is the established case law of the Boards of Appeal that a very rigorous standard, namely that of "beyond reasonable doubt", is to be applied when checking the allowability of amendments under Article 123(3) EPC, such that the slightest doubt that the scope of the patent as amended could cover embodiments not covered by the unamended patent would preclude the allowability of the amendment.

3.2.5 Claim 1 of auxiliary request 1 is directed to the use of a defined composition for the preparation of a medicament for treating a metastasis of a tumour of a given cell type, wherein a tumour (i.e. any tumour) of the patient is inoculated with the medicament.

Claim 1 as granted is directed to the use of a defined composition for the preparation of a medicament for treating a metastasis of a tumour of a given cell type, wherein the medicament is suitable for inoculating the tumour (i.e. the primary tumour which gave rise to the metastasis to be treated) in a patient.

This means that according to the use of claim 1 of auxiliary request 1, the medicament only has to be suitable for inoculating a tumour (i.e. any tumour) in the patient, but does not necessarily have to be suitable for inoculating the primary tumour which gave rise to the metastasis to be treated, contrary to the use of claim 1 as granted. Hence claim 1 covers uses of medicaments not covered by claim 1 as granted.

Therefore, the scope of the claims as granted has been extended.

3.2.6 The appellant-proprietor argued that the scope of the claims as granted had not been extended, because the appellant-opponent's objection was merely hypothetical and not based on any documentary proof.

The board cannot follow this argument and considers that documentary evidence disclosing embodiments covered by the amended claim and not covered by the claims as granted is not required in order to arrive at a finding of contravention of Article 123(3) EPC, because the extension of protection is apparent from a comparison of the amended claim with the claims as granted, as set out above.

3.2.7 The appellant-proprietor further submitted that the scope of the claims as granted had not been extended, because additional limitations had been introduced into claim 1 of the first auxiliary request, i.e. the features that a tumour of the patient is inoculated with the medicament and that the composition induces an immune response that is specific for the tumour cell type and that kills cells of the inoculated tumour and of a non-inoculated tumour.

The board is not convinced by this argument, because the additional features introduced into claim 1 of auxiliary request 1 do not limit the medicament to one that is suitable for inoculating the primary tumour giving rise to the metastasis to be treated, and thus cannot remedy the extension of protection set out above.

3.2.8 The board concludes that claim 1 of auxiliary request 1 has been amended in such a way that the extent of protection conferred has been extended, contrary to Article 123(3) EPC.

[...]

8. It follows from the above that none of the admissible claim requests fulfils the requirements of Article 123(2) and (3) EPC.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.