EPO decision limits patenting
of genetically modified animals
For the first time the EPO has revoked the parts of two patents directed to genetically modified animals for ethical reasons.
Generally, the patenting of genetically modified animals is not prohibited under the EPC and numerous patents on such subject-matter exist.
According to Art. 53(a) and R. 28(d) EPC, patents are not granted for processes for modifying the genetic identity of animals and also animals resulting from such processes which are likely to cause suffering to man or animal. However, exceptions are made in cases where there is evidence of substantial medical benefit.
The patents EP 1 456 346 and EP 1 572 862 were originally granted for a gene expression modulation system for establishing so-called gene switches in an organism as well as non-human organisms comprising such switches. The non-human organisms were selected from bacteria and fungi as well as from mammals such a mouse, rat, rabbit, cat, dog, bovine, goat, pig, horse, sheep, monkey, and chimpanzee.
Approximately a dozen ethical and nature conservation organisations opposed the patents. While the opposition was initially rejected, in a subsequent appeal procedure the Board of Appeal has revoked all claims on genetically non-human organisms. The Board of Appeal came for the first time to the conclusion that the required substantial medical benefit is non-existent.
It remains to be seen whether these remain singular decisions or the EPO will follow such an approach more frequently from now on. However, many researchers will still be permitted to conduct experiments on primates and other animals, even if they might no longer hold patents relating to their research in the future.