CRISPR/Cas patents: ethical boundaries strengthened

22 February 2022 / Following an opposition filed by Testbiotech, the European Patent Office (EPO) has amended a patent on CRISPR/Cas (EP 3401400) gene scissors. The Nobel Prize laureates, Jennifer Doudna and Emmanuelle Charpentier, are named among the inventors in the patent. The claims covering human, animal and plant cells were deleted, and intervention in the human germline explicitly excluded.

Testbiotech filed the opposition because the patent did not exclud human germline interventions or the commercial usage of human embryos, and therefore failed to fulfil legal requirements. A further reason for filing the opposition were patent claims on genetic changes in animals that would have been likely to cause suffering. According to Testbiotech, this final point still needs further clarification after the decision.

“We are pleased that by filing our opposition, we were successfully able to strengthen the ethical boundaries in patent law. Patents on commercial uses of human embryos and interventions in the human germline are strictly prohibited in Europe. Patents on animals can only be granted if there is evidence of substantial medical benefit,” Christoph Then says for Testbiotech. “We expect the EPO to give more weight to these boundaries before they grant further patents.”

Three other oppositions have been filed against the patent. These oppositions call the requirement for criteria regarding inventiveness and technical disclosure into question. According to these opponents, there is considerable doubt as to whether all the relevant technical details were known and sufficiently described by the patent holder at the time of filing. While these questions have already been discussed in opposition procedures against very similar patents, it is the very first time that ethical questions have been brought up for discussion, and which need answers in the context of patents on CRISPR/Cas technology. It is likely that appeals will be filed against the decision.

Testbiotech has in the past successfully filed a number of oppositions at the EPO. Just recently, patent claims on genetically engineered animals, including chimpanzees, were revoked. There are further pending legal proceedings against a patent covering stem cells derived from human embryos, which was granted by the German patent office. This case has now been forwarded to the German Federal Court of Justice.

Contact:
Christoph Then, Tel +49 151 54638040, info@testbiotech.org