European Parliament agrees resolution on biotech patents 28/10/05. By the Public Health Genetics Unit Patents on human DNA should be granted only for 'concrete applications', argues a resolution from the European Parliament.

The European Parliament (EP), in its latest sitting, has agreed the text of a resolution on patenting biotechnological inventions . The resolution confirms Parliament's rejection of research on human embryos and calls for the European Patent Office (EPO) and Members States to grant patents on human DNA only for a 'concrete application' and for the scope of the patent to be limited to that application.

It also calls for the European Commission (EC) to file a notice of opposition to patent EP1257168 , which covers a method for cryopreserving sperm cells that would enable the sex of the child to be chosen during the artificial insemination process. The EEP-ED Group within the European Parliament has dubbed this the 'designer baby patent'.

In August the EC published their second report looking at Member States' implementation of the Directive on the legal protection of biotechnological inventions (98/44/EC). The report noted that some States have granted patents on DNA sequences that cover the original disclosure in the patent application as well as possible future uses of the sequence.

Other countries have taken a more conservative approach, only granting a patent for the specific application, while France has totally banned patenting of DNA sequence. The EP, in this resolution, has given its support to the more restricted 'purpose-bound protection.'

The contentious patent was awarded to a US company, XY Inc. , in November 2002. According to an EPO press release , some Members of the EP claim that the patent, entitled 'Method of cryopreserving selected sperm cells', violates the Directive as it covers non-patentable human germ cells. The Directive states "Inventions shall be considered unpatentable where their commercial exploitation would be contrary to order public or morality."

The EPP-ED Group believes that "…the spirit of the Directive opposes patents on embryonic stem cells." The European Patent Convention , which incorporates relevant portions of the Directive into European patent law, confirms that the human body and its elements cannot be patentable inventions. But "…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."

The EPO, while acknowledging the right of anyone to oppose a patent, "…emphasises that it follows an extremely cautious approach in patenting biotechnological inventions." The EPO had agreed in June 2005 to stop making decisions on patent applications involving human embryonic stem cell technologies [Schubert, S. Nature (2005) 435:720-1].

The EP will contest the grant of the patent by initiating an opposition procedure. The EPO's Technical Board of Appeal is expected to make a first decision on the subject on 18 November. However, this Board is able to refer the issue to the Enlarged Board of Appeal, the EPO's highest instance, for a definitive legal ruling.

Article courtesy of the Public Health Genetics Unit .