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2012 05. 14.

European Patent Law

Cryopreservation of Sperm Cells

On May 3, 2012 oral proceedings were held at the EPO in Munich concerning the case T 1199/08 (“Cryopreservation of Sperm Cells”) resulting in a revocation of the patent by the Technical Board of Appeal. The decision of the Technical Board of Appeal has not been published yet, so it can only be speculated at present due to which reason the patent has been revoked. The revoked patent EP 1 257 168 owned by the US company XY was granted in February 2005 dealing with frozen sperm for in vitro fertilization. The granted patent claimed a method for the cryopreservation of sperm, a frozen selected sperm sample, as well as a second medical use of frozen selected sperm for artificial insemination. Oppositions filed by a member of the European Parliament belonging to the Greens, Greenpeace and Monsanto, who withdrew its opposition in appeal proceedings, argued that these claims are neither novel nor inventive and contravene Art. 53(a) EPC by defining subject matter the commercial exploitation of which would be contrary to "ordre public" or morality. Additionally, the opponents were of the opinion that the claimed subject matter should be regarded as an essentially biological process for the production of animals, the patentability of which is not allowed by Art. 53(b) EPC. The opposition proceedings led to a maintenance of the patent in amended form, wherein the claimed subject matter was restricted to a method for the cryopreservation of non-human mammalian sperm.

The member of the European Parliament belonging to the Greens as well as the patent proprietor filed an appeal against this decision. During the appeal proceedings various arguments were exchanged. The opponent argued that the patent in amended form still violated Art. 53(a) EPC and Art. 53(b) EPC. In addition many prior art documents were cited to show that the claimed subject matter was at least not based on an inventive step.  The case was shifted to a different Board of Appeal three years after the appeal proceedings started. The new Board of Appeal, which finally revoked the patent in appeal proceedings, is one of the most experienced boards of appeals in the EPO dealing with life science matters.

Two months after its appointment, the new Board of Appeal summoned to oral proceedings in November 2011. During the oral proceedings no decision on the revocation of the patent was made. The Board of Appeal had found in preparation to the proceedings a highly relevant prior art document which was introduced into the proceedings before the oral proceedings. This new prior art document and its impact on the assessment of inventive step was heavily discussed during the oral proceedings. During the oral proceedings, the patent proprietor filed a new main request claiming a method for the cryopreservation of sex-selected bovine sperm as well as a frozen sex-selected bovine sperm sample.  The Board of Appeal advised during the oral proceedings that it considers this new main request to fulfill all requirements laid out in the EPC except of inventive step. At the end of the oral proceedings, the Board of Appeal announced that the parties would receive new summons to attend oral proceedings. In the meantime, the parties were invited to provide their opinions in writing on the topic of inventive step, particularly in view of the new prior art documents cited by the Board of Appeal in preparation of the oral proceedings.

New oral proceedings were summoned for May 3, 2012. In preparation to the oral proceedings Microbix Biosystems Inc. filed a third party’s observation submitting allegedly highly relevant prior art documents. In this third party’s observation, it is argued that the patent as maintained in amended form should be revoked due to lack of novelty and inventive step in view of this cited prior art. The oral proceedings held on May 3, 2012 led to a revocation of the opposed patent. The minutes of the above oral proceedings are not published yet. Since the patent proprietor did not file any new requests in preparation to the oral proceedings scheduled for May 3, 2012, it is quite likely that the question whether the patent should be revoked or not was decided on inventive step. If lack of inventive step has led to the revocation of the patent, the reasons of the decisions will have to be studied carefully as to whether the Technical Board of Appeal in charge gives general guidance on the general patentability of germ cells or methods using germ cells in Europe.

Should you have any questions, please feel free to contact lenhard@mueller-bore.de

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