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Case law 3 May 2021

Rabbit skin extract: animal suffering and exceptions to patentability

This decision relates to an invention directed to a pharmaceutical preparation comprising extract obtained from rabbit skin. The Examining Division refused the application under the exception to patentability as defined in Art. 53(a) EPC, arguing that the suffering of the rabbit could not be balanced by the benefit to mankind. Applicant lodged an appeal against this decision, citing the decision T19/90 (onco-mouse), stating the medical benefits obtained with the invention and the impossibility of obtaining the rabbit skin extract in another way. The Board agreed with the Examining Division and dismissed the appeal.
...animal suffering had to be weighed up against usefulness to mankind

Claim 1 of the main request reads as follows:

1. A pharmaceutical preparation comprising an extract of nucleic acids and amino acids from rabbit skin and pharmaceutically acceptable adjuvants, wherein the extract is obtainable by a method comprising the steps of:

  • a) providing a rabbit skin possessing kallikrein production inhibition activity;
  • b) extracting the rabbit skin with organic solvent;
  • c) processing with an acid and alkali; and
  • d) absorbing, eluting and concentrating the extract; wherein the rabbit skin is obtained by the process of vaccinating rabbit skin tissues with vaccinia virus by injecting subcutaneously 0.1-0.4 ml solution containing 10 6-10 9 viruses/ml at each site, to 100 to 250 sites per rabbit weighing 1.5-3 kg, feeding the vaccinated rabbit, killing the rabbit when its skin tissues are inflamed enough, peeling the rabbit, and freezing the rabbit skin at -18°C for storage, wherein the said vaccinia virus is Ikeda strain, Dairen strain, or EM-63 strain.

Claim 1 of auxiliary request (AR) 1 is identical to the claim above.
Claim 1 of AR 2 and 3 relates to a first medical use for the composition as defined in the claim above.
Claim 1 of AR 4 relates to a second medical use for the same composition directed to the treatment of symptomatic neuralgia, lumbago, acute pains from wound, burn and scald, and pains in surgery or postsurgery.2/2
Claim 1 of AR 5 is similar to the claim 1 of AR 4, but defining the rabbit as being a Japanese white rabbit.

The Examining Division refused the application on the basis of the main request and AR1-4, among others due to exclusion from patentability under Art. 53(a) EPC.

According to the Appellant (applicant):

"The patentability exclusion pursuant to Article 53(a) EPC had been applied very rarely and only in such cases where the invention, or its commercial implementation, was so abhorrent that the grant of patent rights would be inconceivable. This was not the case for the application, which was directed to pharmaceutical preparations and medical uses. (…)as set out by decision T 19/90, animal suffering had to be weighed up against usefulness to mankind, which was a broader test than the one used by the examining division."

Appellant asserted that that the use of rabbits in medical research is a well-accepted standard method and that the process to obtain the extract, as defined in claim 1 was necessary and could not be replaced by alternative processes.

In view of the examples of the application, the Board concluded that the yield of extract from the rabbit skin was very low. For instance, roughly 6 to 11 rabbits would be necessary to prepare an analgesic tablet or a volume of 1050 ml of “health food”. Thus, considering that the procedure involves provoking inflammation in the skin (see underlined feature in claim 1), it became clear for the Board that the commercial exploitation of the invention would lead to many rabbits having to undergo a painful procedure and be sacrificed. According to the Board, the amount of suffering caused to the animals is incommensurate with any benefits, or usefulness to mankind, that the invention may have. In this respect the Board considered that:

‘’The claimed pharmaceutical preparation does not have different mechanisms of action or target different pathways from other widely available compounds of the prior art: there are thus plenty of alternative medicaments on the market which achieve the same or a comparable therapeutic effect without involving the same amount of animal suffering.’’

In relation to T 19/90, the Board asserts that the onco-mouse of T 19/90 opened up new research avenues in the field of oncology at the cost of the suffering of a limited number of animals. Differently, the invention in question does not open up new avenues in the treatment of the claimed diseases. Furthermore, animal suffering is not limited to a given number of animals needed for testing, but rather is always present and involves a considerable number of animals every time that the composition is produced.

Therefore the Board considered that the subject-matter of claim 1 of the main request does fall under the exclusion of Art. 53(a) EPC. The Board also considered that the same reasoning also applied for AR1-AR5 and dismissed the appeal.

Read the full EPO decision via the link here below

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