27 April 2020
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Case 6 – T 1262/04 (EPO Board of Appeal, 13 July 2012)      

 

Should an assessment of patentability turn on whether the animal is transgenic? This case considered a delicate ethical balancing act.

With one of the strongest life sciences’ patent teams in Europe, we’ve always played an active role at the EPO – and in some of the most important legal decisions of the Boards of Appeal cited in the “White Book” or in the EPO Guidelines for Examination. In this series, we’re reviewing the ones we feel are most memorable in terms of making the law.

At the EPO, patents are not granted for inventions considered to be contrary to “ordre public” [public order] or morality (Article 53(a) EPC). For biotechnological inventions which involve genetically-modified animals (known as transgenic animals), it will be contrary to morality if the invention is “likely to cause them suffering without any substantial medical benefit to man or animal” (Rule 28(d) EPC).

It was the interplay between Article 53(a) and Rule 28(d) EPC that was discussed during this decision.

The primary question being: For biotechnological inventions which involve only non-transgenic animals, is the test under Rule 28(d) still applied?

The claims in the application concerned methods for detecting tumour cells in mouse models of human disease, where these methods involved measurement of photons emitted by light-generating proteins. Some of the claims covered non-transgenic mice to which tumour cells containing light-generating proteins were administered.

Life Sciences Partner Simon Kiddle acted as representative for the applicant and argued that Rule 28(d) was not relevant for claims that didn’t apply to transgenic animals. The Board of Appeal agreed, noting that a highly related but not wholly identical test under Article 53(a) needs to be applied to such cases.

Balancing act

The latter test depends largely on a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention's usefulness to mankind on the other. In this case, the suffering of animals resulting from the deliberate introduction of tumour cells was balanced against the use of methods requiring fewer animals overall and enabling accelerated drug discovery due to better imaging techniques.

This case highlights the subtle differences between transgenic and non-transgenic animals when assessing whether an invention is contrary to public morality.

In practical terms, however, it seems an invention should in principle be patentable where the benefit to mankind is sufficient to outweigh the suffering caused to an animal – whether that animal is transgenic or not.

Find the decision here.

This blog was drafted by Daniel Yin.

Simon is a Partner and Patent Attorney at Mewburn Ellis. He also heads up the firm’s Life Sciences practice group and is a member of our management board. Simon has nearly 30 years’ experience in original patent drafting, patent strategy European oppositions and appeals, including complex multi-party proceedings, and due diligence work, across the life sciences field for both large and small molecule therapeutics. He has worked on the portfolios covering many top selling biologics and has been at the forefront of patenting in the field of precision medicine and life cycle management for therapeutics.
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