22 April 2021

Application of Article 53(a) EPC – Considering the morality of pharmaceutical inventions

The European Patent Office (EPO)’s Technical Board of Appeal 3.3.01, in recent decision T 1553/15, has provided guidance on the patentability exclusion under Article 53(a) EPC, which prescribes that inventions cannot be patented when their commercial exploitation would be contrary to “ordre public” or morality. The decision considers the balance between the suffering of animals and the benefit to mankind as set out in previous case law. In the present case, the availability of alternative compounds that act by the same mechanism was a key factor in the Board’s decision to reject the patent application.

The patentability exclusion of Article 53(a) EPC has been applied rarely, and there are only a few decisions at the EPO that set out under what conditions animal suffering would be considered as contrary to “ordre public” or morality. In seminal decision T 19/90, the Board considered the provisions of Article 53(a) EPC in the context of a transgenic animal model for cancer. The Board concluded: “The decision as to whether or not Article 53(a) EPC is a bar to patenting the present invention would seem to depend mainly 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 T 19/90, the Board considered that the transgenic animal model “opened up new research avenues in the field of oncology at the cost of the suffering of a limited number of animals”.

The decision in T 1553/15 concerns a pharmaceutical preparation containing an extract of nucleic acids and amino acids from rabbit skin. According to the application, the rabbit skin is obtained by sacrificing vaccinia-virus-infected rabbits, and 5ml extract solution (corresponding to 200g rabbit skin) is used to prepare a volume of around 305ml analgesic injection solution, or 50ml extract solution (corresponding to the skin of roughly 6 to 11 rabbits) is used to prepare an analgesic tablet or around 1050ml of “health food”. The resulting preparations were claimed to have analgesic, anti-allergic, anti-ulcer and sedative effects.

The appellant argued that the suffering of the rabbits was reduced as far as possible and was clearly balanced against the usefulness to mankind because there was no other way to produce the pharmaceutical preparation.

Although the Board accepted that the pharmaceutical preparation was new, it noted that it does not have different mechanisms of action or target different pathways from other widely available compounds of the prior art. The Board therefore held that there are plenty of alternative medicaments on the market that achieve the same or a comparable therapeutic effect without involving the same amount of animal suffering. This reasoning applies even if rabbit skin is the only way of producing the pharmaceutical preparation. The Board also noted that the animal suffering involved is not limited to a given number of animals needed for testing, but rather is always required when the pharmaceutical preparation is produced.

The Board therefore concluded that the suffering of animals is not commensurate with any benefits to mankind brought by the claimed invention according to the balancing test of T 19/90. This decision thus provides further insight into the factors to be considered when assessing whether inventions involving animal suffering can be balanced against the invention’s benefit to mankind and thus comply with Article 53(a) EPC.