News from the „Edinburgh-Patent“ (EP0695351) - T 1079/03

In the matter of the “Edinburgh-Patent” which has been controversially discussed in public during the last fourteen years, a final decision was made before an EPO Technical Board of Appeal by the Patentee.

Just to remember, the patent as initially granted related to a method of isolating and/or enriching and/or selectively propagating animal stem cells involving animal embryonic stem cells, and by way of definition in the specification human embryonic stem cells. In addition, it covered the use of embryonic stem cells for the preparation of a transgenic animal including transgenic humans also by way of definition and theoretical scope of protection.

During the opposition period thirteen parties, among them the governments of Germany, the Netherlands and Italy as well as Greenpeace and the German party Bündnis90/Die Grünen had opposed the patent. Objections raised under Article 100a) in conjunction with Articles 54 and 56 EPC were not justified as held by the Opposition Division during first instance’s opposition procedure in 2002.

However, Patentee’s claims were found not to be allowable on the ground of lack of sufficiency of disclosure of the invention (Articles 100b) and 83 EPC) and offence against “ordre public” and morality (Article 53a) EPC). This finally led to restricting the method for the genetic modification of stem cells by excluding embryonic stem cells and also eliminating the method claims for the preparation of a transgenic animal. This interlocutory decision of the Opposition Division of July 2002 was appealed by the Proprietor, the University of Edinburgh, as the sole Appellant.

Due to a pending procedure before the Enlarged Board of Appeal regarding the admissibility of claims concerning embryonic stem cells (G2/06), the Technical Board of Appeal decided only to discuss issues of Article 83 EPC rather than morality issues of Article 53a) EPC.

During the oral proceedings, the Board came to the opinion that none of the submitted requests filed by the Proprietor fulfilled the requirements of Article 83 EPC. As ultima ratio the Proprietor withdrew its Appeal with the consequence that no further legal actions are now possible before the EPO and the “Edinburgh-Patent” is finally valid in amended form as maintained before the Opposition Division in 2002.

It thus proved to be a strategic error that none of the opposing parties had filed independent Appeal which finally led to a premature termination of Proprietor’s Appeal by its withdrawal without a possibility of avoiding this by the Opponents. So we will have to wait for the decision of the Enlarged Board of Appeal (G2/06) for exciting ethical issues news of another embryonic stem cell case.

For further information please contact Dr. Juergen Kaiser.

Edinburgh-Patent as initially granted

Edinburgh-Patent in final form

Legal information

• A divisional application containing subject matter extending beyond the earlier application as filed is not "invalid". As such, there is no legal term as an "invalid" application. A divisional application can be amended at a later date, just like any other application, to remove inadmissibly added matter so as to comply with that requirement.
• EBA stated that an important principle of the European Patent Convention is that "the question whether or not an application complies with the substantive requirements of the EPC is to be decided on the text finally submitted or agreed by the applicant after any objections have been drawn to his attention and he has been afforded an opportunity to comment and also an opportunity to overcome the objection by means of an amendment."
• "A divisional application is a new application which is separate and independent from its parent application. Therefore, an amendment to remove added matter not disclosed in the parent application as filed is allowable irrespective of whether the earlier application is still pending or not."
• Divisionals are "to be treated in the same manner and subject to the same requirements as an ordinary application."
• "Third parties need to be aware that whilst any divisional application is still pending, any of its content as filed may yet be the subject of patent claims either in the divisional application itself, or in further divisional applications." EBA also held the opinion that a divisional can be directed by amendment to aspects of an earlier application also disclosed in the divisional application as filed but not claimed in the divisional as filed.
• In each of a sequence of further generation divisionals, the subject matter of a further divisional application must be contained in the predecessor application at the time the further divisional is filed. Thus, subject matter omitted on filing a member of the divisional series upstream the sequence cannot be re-introduced into that member or into further generation divisional applications.
• Furthermore no matter can be claimed, whether in a divisional or in a parent application, that has been unequivocally and definitively abandoned by that time.
• A divisional may be filed that is identical to its parent application. However, double patenting provisions prohibit the grant of such a ‘100% divisional’ which nevertheless forms a disclosure basis for the further generation divisional(s).

• G 0001/05
• G 0001/06