The EPO changed its guidelines in June 2012 and on the 24th of October 2012 the Norwegian Patent Office amended its patent guidelines. Here follows a brief outline of the amendments in Norway.

Brüstle

 Industry, research institutions and IP professionals waited to see how the EPO and national intellectual property offices would amend their practices after the Brüstle decision.

The guidelines before the amendments

Section 1 b Norwegian Patents Act excludes from patentability inventions whose commercial exploitations would run counter to public order and morality. The provision specifically mentions the use of human embryos for industrial or commercial purposes as excluded.

In the Norwegian Patents Guidelines, part C, chapter IV, item  2a7.1, there is a non-exhaustive list of excluded types of inventions. One of them is inventions that relate to the use of human embryos for industrial or commercial purposes. The guidelines explain that this "is a general exclusion of uses of human embryos from patentability". However, the provision does not apply to inventions that can be used on human embryos and be useful to them. This could for example be substances that are used for medical treatment of the fertilised egg cell.

The Norwegian rule mirrored the EPO's guidelines for examination, (C. IV. item 4.5) and to preamble 42 to the patent directive (Directive 98/44/EC): "The exclusion of the uses of human embryos for industrial or commercial purposes does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it."

The practice of the Norwegian patent office was aligned with that of the EPO after the Enlarged Board of Appeal's decision in March 2008 in case G0002/06. Under that practice, the use of stem cells cultivated from existing stem cells lines that had been stored in cell banks since 2003 and which did not, therefore, require destruction of further human embryos were not excluded, as long as the patent application was filed after May 2003.

Amendments to the EPO Guidelines and the Norwegian patent guidelines

In June 2012, the EPO guidelines were amended by inclusion in part G-II, 5.3 of the following:

"A claim directed to a product, which at the filing date of the application could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded from patentability under Rule 28 (c), even if said method is not part of the claim (see G 2/06). The point in time at which such destruction takes place is irrelevant. When examining subject-matter relating to human embryonic stem cells under art. 53 (a) and Rule 28 (c), the following has to be taken into account:

a) The entire teaching of the application, not only the claim category and wording, and

b) The relevant disclosure in the description in order to establish whether products such as stem cell cultures are obtained exclusively by the use, involving the destruction, of a human embryo or not. For this purpose, the disclosure of the description has to be considered in view of the state of the art at the date of filing.

Destruction of human embryos

An exemption from the patent ineligibility on the basis that further human embryos do not have to be destroyed, because the existing dispositive stem cells lines can be used , is no longer possible. However, there still maybe an opening for patents involving stem cells. In the same paragraph, the guidelines say that products which at the filing date of the application could be obtained exclusively by methods that necessarily involved the destruction of human embryos are excluded. This appears to allow for an interpretation to the effect that patents on products that at the filing date could be obtained by methods that do not necessarily involve the destruction of human embryos might be available.

Such methods have been developed in recent years, for example by obtaining stem cells from a blastocyst in a way that does not destroy it. Another method is by so called iPS (induced Pluripotent Stemcells), in which mature cells are re-programmed so as to assume the characteristics of embryonic cells. Patent applicants will argue that the availability of such methods at the time when they filed their applications means that the exclusion from patentability does not apply to their inventions.

Use of human embryos

In Brüstle the C JEU also stated that "an invention is excluded from patentability if the technical teaching which is the subject matter of the patent application requires the prior destruction of human embryos or their use as a base material,..." (authors' emphasis).

This appears to mean that even if the product in question does not require the destruction of human embryos, the invention can not be patented if the application requires the use of human embryos as "base material". "Use as base material" can mean any use of human embryos to obtain stem cells. However the expression could also be taken to mean the use of embryonic stem cells as feeder cells in co-cultures with the stem cells to be obtained.

Assuming that the latter is the correct interpretation, a patent application relating to an invention that neither requires the destruction of human embryos nor the use of embryonic stem cells as feeder-cells, would not be excluded from patentability.

Amendments to the patent guidelines in Norway

The amendment that has just been introduced reads:

Item 3 applies to inventions that destroy human embryos even if it occurred before the invention was made, as will be the case for inventions that use existing cell lines that have been obtained earlier by destruction of human embryos (ECJ C-34/10). This applies even if neither the claims nor other parts of the application refer to the use of human embryos. Hence it is irrelevant at what point in time the destruction of the embryo occurs. Nor is the exception in item3 contingent upon the question whether, after the filing date of the application, it is possible to obtain a required product without using a method that depends on the destruction of human embryos (G 0002/06).

The amendments, both those introduced in the EPO-guidelines and those introduced in the Norwegian patent guidelines appear to focus on the problem of the destruction of human embryos whereas the use of human embryos for industrial or commercial purposes, or, in the words of the CJEU, their "use as a base material" is not specifically dealt with in  the amendments of the two sets of guidelines.

Interestingly, in May 2012, the Norwegian Ministry of Justice sent on a round of consultations a report in which certain restrictive measures and legal provisions implemented in Norway when the EU's  biotech patent directive was implemented in 2003 were assessed. Commenting on the Brüstle decision, the MoJ said in its report that: "the judgment from the EU court will give guidance for the interpretation of section 1, 3rd paragraph no. 3 of the Norwegian Patents Act. It leads to a further narrowing of the latitude of the Patent Office's practice so that the grant of a patent would in practice not be an option for any form of embryonic stem cells. There is reason to expect that the judgment will be relied upon in the practice of the European Patent Office."

The MoJ report pre-dates the amendments in the EPO Guidelines and the Norwegian Patent Guidelines. The report does not deal with the question of interpretation of the expression "use as a base material" and the Ministry appears not to have been aware that for some years now it has been possible to obtain embryonic stem cells without destroying the embryo and without using embryonic stem cells in co-cultures to obtain stem cells. The Ministry's statement therefore appears to express a more restrictive view than the Brüstle judgment may warrant.

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