News

The EPO on Second Medical Use Claims, Witness Testimony and Oral Disclosures

13 March 2014

A recent far-reaching decision of a Technical Board of Appeal of the EPO (T2003/08) reviewed:

(i) whether means for achieving a therapeutic effect can be protected by a Swiss-style second medical use claim;

(ii) whether witnesses should be heard if they attend a hearing having not first confirmed receipt of a summons from the EPO; and

(iii) the level of evidence required to establish the content of an oral disclosure.

Second Medical Use Claims:

Claim 1 of the patent in question was a Swiss-style second medical use claim, which could be paraphrased as:

Use of a specific ligand in the manufacture of a column having said ligand coupled thereto for the treatment of a patient having a condition.

Only “substances and compositions” are eligible for second medical use protection in Europe (much to the consternation of medical device manufacturers).

The key question was therefore to determine whether the means used in the treatment of the condition of claim 1 constituted a “substance or composition” by establishing:

(a) the means by which the therapeutic effect is achieved, and

(b) whether that means is a chemical entity or composition of chemical entities.

In the present case the Board determined that the column was merely a carrier for the ligand and not a substance or composition. On the basis that the ligand provides the means by which the therapeutic effect is achieved, and is a chemical entity, the Board determined that the means used for achieving the therapeutic effect can be protected by a second medical use claim in the Swiss-style and the claim was allowed. Requests from both parties for a referral to the Enlarged Board of Appeal were refused.

If this decision is followed, a practical ‘test’ for whether or not a therapeutic treatment can be protected as a second medical use claim will be whether or not the therapeutic effect is achieved by means of a chemical entity or composition of chemical entities.

Witness Testimony

The appellant-opponent’s arguments for lack of novelty were based, at least in part, on an oral disclosure. In an interlocutory decision the Board decided it was necessary to hear testimony from two witnesses to the oral disclosure and appropriate summons were sent. Neither witness replied to the summons to confirm their attendance at the hearing.

The appellant-patentee requested the Board refrain from hearing the witnesses as it had been put in a disadvantageous situation. However, the appellant-patentee’s representative confirmed that he was prepared for both eventualities and he did not request a break for preparation or an adjournment of the hearing once it was clear that the witnesses were present.

The Board therefore concluded that the appellant-patentee’s rights had not been violated by hearing the witnesses. The Board also rejected the appellant-patentee’s argument that withholding confirmation of attendance was a deliberate ploy by the appellant-opponent to withhold certainty. The Board concluded that the appellant-opponent is not responsible for the actions of witnesses. Accordingly, the request not to hear the witnesses was refused.

Oral Disclosures

In relation to the oral disclosure of the witnesses, the Board argued that “an oral presentation is ephemeral” and therefore the standard of proof for ascertaining the contents must be high. What has been “made available to the public” has to be put beyond reasonable doubt.

Of the two witnesses at the hearing, one had given the alleged disclosure while speaking at a conference and the other was in the audience. Declarations from both witnesses were provided but neither was supported by contemporaneous notes. The Board held that the Declarations were not sufficient to establish the contents of the oral disclosure beyond reasonable doubt. In the view of the Board, the published “proceedings” from the conference cannot be automatically assumed to identically reproduce the lectures. This document was therefore also not held to be sufficient evidence of the contents of the oral disclosure.

Anyone considering relying on an oral disclosure at the EPO should be aware that the standard of proof remains high, contemporaneous notes are required, and written records made or published after the event are unlikely to be accepted as sufficient evidence of the content of disclosure.

Dr Helen Henderson
Life Sciences & Chemistry Group