Thursday, October 15, 2020 T 421/14 - Sufficiency for a composition with non-responders

No response for a subpopulation

How credible should evidence for a composition be? In this case, the opponent argued that the initial analysis of therapeutic efficacy lacked statistical significance. Only a post hoc analysis revealed a  significantly better response for a treatment group compared to a placebo group. Moreover, the effect only occurred in a subpopulation of responders, not for the general population. Is one allowed to claim a composition for a general group even if the majority are non-responders, or should one disclaim the non-responders?  

Another issue, was the public availability of two documents C30 and C31.  C30 was poster and C31 a slide show, both allegedly displayed at a public conference by the proprietor. Both were also included in the IDS statement for a corresponding US patent. Who should prove the public availability in this situation, and what is the appropriate standard?

A related case T 799/16 sharing some of its reasons with the present decision has also been decided. 

Monday, September 30, 2019 T 2239/15 - Private not the same as confidential

The patent application in this case was refused for lack of novelty based on MPEG standards-related documentation cited in the search report. In response to a previous complaint, regarding similar citations against earlier PCT applications, the EPO informed the applicants that examiners had been instructed that MPEG input documents did not constitute prior art and were not to be cited in search reports. In a later communication, however, they were informed that new facts were available regarding the public availability of a particular citation and that the European search report should mention those documents available to the EPO at the time of drawing up the ESR.

The appellants argued that the citation of the documents in the present case constituted a breach of legitimate expectations and further maintained their position that the cited documents were confidential working documents submitted to the MPEG working group in elaboration of a new standard. They also argued that the established procedures of MPEG required members to treat input documents as private, which was to be construed as 'confidential'. 

The Board considered the issue of confidentiality and the public availability of the documents cited in the present case based on the procedures of MPEG and drew a different conclusion. These procedures require, for example, that documents may be shared only with the permission of the authors and that draft documents are made available to meeting participants on a password-protected dedicated MPEG server. The procedures also specifically allow for the discussion at meetings to include consulting other experts with more specific knowledge on the topics addressed, but who are not actually present at the meetings. 

The Board concluded that the MPEG procedures could not guarantee, nor even expect, confidentiality but seemed to be designed to guarantee a certain privacy of data, by controlling access and transmission, while being sufficiently flexible to allow such transmission with other parties. In the absence of strict limitations,the cited documents were deemed to be have been made publicly available.

On the subject of legitimate expectations, the Board ruled that this principle applies to disadvantageous consequences resulting from the omission of procedural steps. It has no bearing on substantive law and cannot render patentable what would otherwise not be.

The appeal was dismissed.

Wednesday, May 02, 2018 T 1050/12 Public availability, enablement for medicines

Public availability
In this opposition appeal, a discussion took place on when a document was seen as being publically available when made available in a library. The opponent/appellant cited T 834/09 in support of arguments concerning the public availability of documents D3 and D7, The proprietor saw this decision as being divergent from the earlier case law and represented a conceptual shift by promoting the librarian to a member of the public (and not just a person making it available to the puiblic by putting it in the library at a possibly later moment). 

The board  comes to the conclusion that there is evidence on file supporting the conclusion that the document was made available to the public in general (i.e. the users of three libraries) before the priority date. This was the case regardless of whether or not the librarian was a member of the public. Accordingly, even if the board were to come to the conclusion that there was divergent case law as regards the status of a librarian as a member of the public, it would still be able to reach a decision in the present case without the need for an answer on this point from the Enlarged Board of Appeal.

Level of proof
The Board does not want to go into a discussion on which level of proof is most appropriate in this case ('on the balance of probability'  or 'up to the hilt') but applies the concept that what matters is whether or not the deciding body, is - having regard to all evidence and arguments put forward by the parties - convinced that the alleged facts, i.e. the public availability of the documents prior to the priority date, have indeed occurred.  

Enablement for medical use claims.

The proprietor argued that D3's disclosure was not enabling for the claimed medical use, because it only disclosed preliminary experiments for which it lacked many details, and it only hypothesised on a therapeutic effect. Contrary thereto, the patent provided data which made the therapeutic effect plausible. The board notes that enablement of disclosure for medical uses does not require that a therapeutic effect is demonstrated in vivo but rather that it is made plausible (T 609/02, reasons 9). The Board concluded that, while D3 does indeed not show that injected myoblasts as claimed do exert a therapeutic effect in the context of stress urinary incontinence, it nevertheless does provide data and information which render said therapeutic effect plausible. 

Catchwords:
Meeting abstracts published in a supplement to a regular volume of a scientific journal found to be publicly available before the priority date of the patent on the basis of library date-stamps and accompanying declarations of the librarians.

Sunday, February 12, 2017 T 1440/09 - Public availability of document submitted for standardisation

In the past several discussions took place whether or not documents submitted to a standardisation organisation were public. After submitting the document to the standardisation organisation, the applicant put the document on the Internet, and only then was a patent application filed. The Board had the impression that the applicant thought that since the submission to the standardisation organisation was to be regarded as confidential, that this gave protection for a later submission of the patent application (a form of priority). The Board destroyed this dream.

Tuesday, August 18, 2015 T 1279/10 - Deletion of reference to non-public DVD standard: problematic or OK?

The application contained several references to a (non-public) DVD standardization document including references with respect to certain terminology used, such as the term "video cell". The Examining Division required the applicant to delete the references to the (non-public) DVD standardization document. The Examining Division had subsequently refused the application after objections under Articles 83, 84 and 123(2) EPC, as the Examining Divison considered the skilled person to need non-public information to be able to understand the invention, the claims to be not supported by the description, and to extent the meaning of the term "video cell" beyond what was disclosed in the application as originally filed by its meaning no longer being defined by the standard document. The Board of Appeal assessed each of the objections and the assumed necessity of the standard document in detail in view of what is clear to the the skilled person from his common general knowledge and to what extent the invention is applicable to DVD only or broader.