Out-Law News | 31 May 2012 | 11:54 am | 1 min. read
The IPO said it was changing its approach to the consideration for patentability of inventions in the human genetics field following a recent interpretation of EU laws by the European Court of Justice (ECJ).
In October last year the ECJ ruled that, under the terms of the EU Biotech Directive, inventions are said to have used human embryos if they require human embryos to be destroyed at any stage, including "long before the implementation of the invention", and even if the claims for the invention do not mention any use of human embryos at all, the IPO said.
The Biotech Directive states that an element isolated from the human body can be protected by a patent even if the structure of that element is identical to that of a natural element and its industrial application is disclosed in the patent. The Biotech Directive further states that "uses of human embryos for industrial or commercial purposes" shall be considered unpatentable.
The IPO updated its guidance on inventions involving human embryonic stem cells on the basis of the ECJ's findings. It said that because the UK's Patents Act implements the Biotech Directive, that the ECJ's interpretation of provisions of that Directive was binding on it.
"The Office practice will now recognise that where the implementation of an invention requires the use of cells that originate from a process which requires the destruction of a human embryo, the invention is not patentable according to [the Patents Act]," it said. "For example, where the implementation of the invention requires the use of a human embryonic stem cell line the establishment of which originally required the destruction of a human embryo, the invention is not patentable."
The IPO said that inventions that involve human stem cells that do not emanate from human embryos can still be patented, providing they "satisfy the normal requirements for patentability" and that the ECJ's ruling had also "confirmed that inventions that are for therapeutic or diagnostic purposes that are applied to and useful to the human embryo are not excluded from patentability."
The ECJ had been ruling on the meaning of the term 'human embryo' in its case last year. It said that any organism that is "capable of commencing the process of development of a human being" should be considered a human embryo and gave examples where both fertilised and non-fertilised human ovums would be said to constitute human embryos. It also left it to national courts to decide "in light of scientific developments" whether a stem cell obtained at the blastocyst stage, which is a very early stage of development, constitutes a human embryo within the meaning of the Biotech Directive.