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EPO to Follow EU Directive on Biotech Patents

The European Patent Office (EPO) [1] issued a report that several groups in the European Parliament have expressed about the grant of European patent EP 1257168 B1 [2].

In motions communicated to the EPO, Members of the European Parliament (MEPs) have stated that, in their view, the grant of this patent, which is entitled “Method of cryopreserving selected sperm cells”, constitutes a violation of the Directive on the legal protection of biotechnological inventions (98/44/EC).

The patent was granted to the US Company XY Inc. of Fort Collins, Colorado, in February 2005, although there is a nine-month period during which oppositions to the patent can be filed by third parties, which will terminate on 2 November 2005. The invention relates to a method for freezing sperm selected for a particular characteristic, as well as to a frozen selected sperm sample and methods of using such a sample. The invention is useful for preserving sex-selected sperm. Claim 1 is for:

1. A method for the cryopreservation of sperm comprising : (a) obtaining a selected sperm sample ; (b) cooling said selected sperm sample ; (c) isolating sperm from said selected sperm sample to produce isolated sperm ; (d) adding final extender to said isolated sperm to produce a suspension of sperm ; and (e) freezing said suspension of sperm.

The MEPs maintain that the patent also covers non-patentable human germ cells. They have therefore announced their intention to contest the grant of this patent by initiating an opposition procedure before the EPO. Other worries expressed in the motions concern the future development of the EPO’s practice in patenting human embryonic stem cells. Every year, around 5% of the patents granted by the EPO are contested in opposition proceedings. In two thirds of these cases, the patent is changed or even revoked in its entirety.

The EPO grants patents by applying the European Patent Convention (EPC) [3]. The EPC forms the legal basis for the Office’s institutional structure and its activities and operations. The EPC expressly stipulates that the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.

However, an element isolated from the human body or otherwise produced by means of a technical process may constitute a patentable invention, even if the structure of that element is identical to a natural element. Recital 16 of the Directive and the Guidelines for examination in the EPO state that such stages in the formation or development of the human body include germ cells. In 2004, the EPO received 6,581 patent applications in biotechnology and granted over 4,000 patents.

See the memo here [4].