Enlarged Board Issues Decision on the Patentability of Stem Cells

In decision T 1374/04 dated 7 April 2006, four questions were referred to the Enlarged Board of Appeal of the EPO relating to the patentability of stem cells prepared by a method which involved the destruction of the human embryos. These questions have now been answered by the Enlarged Board in its decision G 2/06.

In summary:

- Rule 28(c) EPC (formerly Rule 23d(c) EPC) applies to all pending applications, including those filed before the entry into force of the rule;

- Rule 28(c) EPC (formerly Rule 23d(c) EPC) forbids the patenting of claims directed to products which - as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said, products are derived, even if the said method is not part of the claims.

- In this context, it is not of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos.

The WARF Application

The patent application from which this referral stems relates to cell cultures comprising primate embryonic stem cells and although the claims are silent as to the derivation of the cells, the only starting material disclosed in the application was pre-implantation (blastocyst) embryos (e.g. “spare” embryos arising from IVF procedures).

The Examining Division refused the application on the basis that the invention involved the direct and unavoidable use of human embryos, contrary to Rule 28(c) EPC.

Rule 28(c) EPC provides guidance on the interpretation of Article 53(a) EPC in connection with what is and is not considered to be contrary to morality in relation to biotechnological inventions:

“Rule 28 Exceptions to patentability

Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.”

In refusing the application, the Examining Division interpreted Rule 28(c) EPC broadly, concluding that it was not only relevant to the claimed subject matter (a cell culture), but to the whole disclosure (making the cell culture required the use of human embryos). In other words, they interpreted this provision so as to exclude not only uses of embryos, but also products derived from embryos, such as embryonic stem cells.

On appeal, the Technical Board of Appeal referred the matter to the Enlarged Board of Appeal of its own motion, stating that it considers “the question of the patentability of human embryonic stem cells and of the conditions therefor as being an outstandingly important point of law within the meaning of Article 112(a) EPC”.

The Enlarged Board’s Decision

Question 1

Does Rule 28(c) EPC apply to an application filed before the entry into force of the rule? (i.e. 1 September 1999)

Answer

Yes, Rule 28(c) EPC applies to all pending applications, including those filed before the entry into force of the rule. The absence of any transitional provisions can only be taken as meaning that the rule applies to all pending applications. Further, the rule merely further defines what is and is not considered to be contrary to morality (Article 53(a) EPC) in relation to biotechnological inventions and there is no indication that the exceptions to patentability specified in Rule 28 were ever regarded as patentable.

Question 2

If the answer to question 1 is yes, does Rule 28(c) EPC forbid the patenting of claims directed to products (here: human embryonic stem cell cultures) which - as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, if the said method is not part of the claims?

Answer

Yes, Rule 28(c) EPC forbids the patenting of claims directed to products which - as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims.

Thus, based on their interpretation of the intentions of the legislators, the Enlarged Board have concluded that Rule 28(c) should be construed broadly, thereby extending the exclusion to products whose isolation necessitated the direct and unavoidable use and destruction of human embryos. The term “invention” in Rule 28 is to be interpreted as relating to the technical teaching of the application as a whole as to how the invention is to be performed, and not merely to the invention as claimed.

The Board noted that in the context of Article 53(a) EPC, it is important to remember that it is not the fact of the patenting itself that is considered to be against ordre public or morality, but it is the performing of the invention, which, in this case, includes a step (the use involving its destruction of a human embryo) that has to be considered to contravene those concepts.

By answering question 2 in this way, the Enlarged Board appear to agree with construction given to this rule by the Opposition Division in the case of the Edinburgh patent (EP 0 695 351). In that decision, the Opposition Division concluded that only a broad interpretation of Rule 28(c) EPC could have been intended, based on the aims of the legislator, and so not only was the use of human embryos as such excluded from patentability, but also the human embryonic stem cells retrieved therefrom by destruction of human embryos.

Question 3

If the answer to question 1 or 2 is no, does Article 53(a) EPC forbid patenting such claims?

Answer

No answer is required since Questions 1 and 2 have been answered with yes.

Question 4

In the context of questions 2 and 3, is it of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos (here: e.g. derivation from available human embryonic cell lines)?

Answer

No, in the context of the answer to question 2 it is not of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos.

The Enlarged Board indicated that technical developments which became publicly available only after the filing date cannot be taken into consideration. Comparing the situation to an invention which is insufficiently disclosed in the application as filed, the matter cannot be rectified by the occurrence of subsequent technical developments, either by the applicant or by others. Any other conclusion would lead to legal uncertainty.

No Referral to the ECJ

The Appellant in this case had requested that questions be referred to the European Court of Justice (ECJ) on the basis that Rule 28(c) EPC is derived from Article 6(2)(c) of the European Community (EC) Directive 98/44/EC relating to biotechnology. Although the provisions of this Directive have been incorporated in the national laws of EC member states and, although not bound by EC law, the EPO has incorporated equivalent provisions into the EPC, there are some contracting states to the EPC which are not EC member states.

The Enlarged Board refused this request as inadmissible on the basis that it has no power to ask the ECJ for a preliminary ruling, firstly, because the EPO Boards of Appeal are not a court or tribunal of an EC member country, and secondly, since no such power is provided to it under the existing provisions of the EPC. In any case, decisions of the Enlarged Board are bound only by the provisions of the EPC and the provision in question is Rule 28(c) EPC, not Article 6(2)(c) of the Directive.

Summary and Advice

The EPO will now resume prosecution of any pending European patent applications to which the outcome of this decision was relevant.

It has been clarified that any inventions, the practice of which necessitates the destruction of human embryos, will be excluded from patentability by Rule 28(c) EPC, whether or not the invention as claimed specifies such destruction.

The interpretation of this provision is relatively broad in that not only are uses of human embryos for industrial or commercial purposes excluded from patentability, but also products derived from human embryos, when destruction of the embryo is unavoidable.

Accordingly, the EPO will not grant patents relating to inventions which necessitate the destruction of the human embryos in order to put the invention into effect.

It should be noted, however, that the national patent offices of some of EPC contracting states may take a different view. For example, prior to this decision of the Enlarged Board, the UK IPO would grant patents relating to human embryonic pluripotent stem cells because they do not have the potential to develop into an entire human body. This was in contrast to the previous position of the EPO, which will not grant claims relating to stem cells if it was necessary to use a human embryo to obtain those cells. The UK IPO have yet to issue a Practice Notice updating their policy and it will be interesting to see if they do so in due course.

Accordingly it may be advisable to file at national patent offices, rather than the EPO, if the destruction of the human embryos is required in order to put your invention into effect.

Helen Brearley
helen.brearley@elkfife.com
December 2008

Please click here to see Ms Brearley's previous article on the patentability of stem cells (dated 5 February 2008).