International Stem Cell Corporation v Comptroller General of Patents

Where the meaning of an exclusion from patentability under Directive 98/44/EC is unclear, and material scientific facts differ from those before the Court of Justice, a further reference may be required. The expression “capable of commencing the process of development of a human being” could mean either merely initiating development or initiating development capable of leading to a viable human being. Parthenotes were incapable of developing into viable human beings and contained pluripotent, not totipotent, cells. The court’s provisional view was that only processes capable of leading to a human being should be excluded.

International Stem Cell Corporation appealed against the Comptroller General of Patents’ decision, BL O/316/12, which rejected two patent applications concerning stem cells and corneal tissue derived from parthenogenetically activated human oocytes. The Hearing Officer considered the inventions excluded under paragraph 3(d) of Schedule A2 to the Patents Act 1977, implementing Article 6(2)(c) of Directive 98/44/EC.

The appeal concerned the proper interpretation of the Court of Justice’s ruling in Oliver Brüstle v Greenpeace eV [2012] 1 CMLR 41, particularly whether a parthenote must be capable of developing into a human being to fall within the term “human embryos”. The central issue was whether a further reference to the Court of Justice was necessary.

1. Further reference required. The appeal raised a question concerning the interpretation of Article 6(2)(c) of Directive 98/44/EC which was not sufficiently clear. The Court of Justice’s expression “capable of commencing the process of development of a human being” could refer merely to the commencement of development, or to commencement of a process capable of leading to a viable human being.
2. The factual findings in the present case materially differed from those before the Court of Justice in Oliver Brüstle v Greenpeace eV [2012] 1 CMLR 41. Parthenotes contained only maternal DNA, had no totipotent cells at any stage, were pluripotent only, and could never develop into a viable human being. They were therefore not identical to fertilised ova at any stage.
3. Those differences, together with uncertainty surrounding the reasoning and factual basis of Oliver Brüstle v Greenpeace eV, justified a further reference. The court did not finally determine whether parthenotes fell within Article 6(2)(c).
4. As a provisional view, the court considered that totipotent cells should be excluded from patentability, whereas pluripotent cells should not. Excluding processes incapable of leading to a human being would not properly balance the Directive’s objectives of protecting human dignity and encouraging biotechnology research.
5. The parties were directed to attempt to agree the terms of the reference within 21 days, with any unresolved issue to be referred back to the court.

1. High Court (Chancery Division): on appeal from the Comptroller General of Patents’ decision BL O/316/12, the court determined that a further reference to the CJEU was required and directed the parties to agree its terms.