International Stem Cell Corporation v Comptroller General of Patents
| Jurisdiction | England & Wales |
| Judge | Henry Carr |
| Judgment Date | 17 April 2013 |
| Neutral Citation | [2013] EWHC 807 (Ch) |
| Court | Chancery Division |
| Date | 17 April 2013 |
| Docket Number | Appeal Ref. CH/2012/0488 |
[2013] EWHC 807 (Ch)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building, Royal Courts of Justice
7, Rolls Building, Fetter Lane,
London, EC4A 1NL
Henry Carr QC
(sitting as a Deputy Judge of the High Court)
Appeal Ref. CH/2012/0488
On Appeal from the Comptroller General of Patents Decision No. Bl O/316/12
Mr Piers Acland QC (instructed by DLA Piper UK LLP) for the Appellant
Mr Tom Mitcheson (instructed by the Treasury Solicitor) for the Respondent
APPROVED JUDGMENT
I direct that pursuant to CPR PD para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Introduction
This is an appeal concerning two patent applications in the name of International Stem Cell Corporation ("ISCC"), both relating to human stem cells. In a decision dated 16 August 2012, the Hearing Officer, Dr Cullen, held that the inventions disclosed in the patent applications were excluded from patentability under paragraph 3(d) of Schedule A2 to the Patents Act 1977. This provides as follows:
"BIOTECHNOLOGICAL INVENTIONS
3. The following are not patentable inventions –
…
(d) uses of human embryos for industrial or commercial purposes;"
Paragraph 3(d) of Schedule A2 implements Article 6(2)(c) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions ("the Biotech Directive"). Guidance was given by the Court of Justice of the European Union ("the CJEU") as to the correct interpretation of Article 6(2)(c) in Case C-34/10 Oliver Brüstle v Greenpeace eV [2012] 1 CMLR 41. The Comptroller agrees with ISCC that this appeal turns on the reasoning of the CJEU in Brüstle.
This appeal raises a question of considerable importance. What is meant by the term "human embryos" in Article 6(2)(c) of the Biotech Directive? In particular, what was meant by the CJEU in Brüstle by the expression "capable of commencing the process of development of a human being"? Does that contemplate the commencement of a process which must be capable of leading to a human being? Or does it contemplate the commencement of a process of development, even though the process cannot be completed, so that it is incapable of leading to a human being?
The Hearing Officer decided that he was bound by Brüstle to reject the patent applications. At the time of his Decision, Dr Cullen had only been shown the UK Observations in Brüstle. The Comptroller maintains that the decision of the Hearing Officer, on the material before him and at that level of tribunal, was the correct one. Since then, ISCC has obtained the Observations of Prof. Brüstle, Greenpeace, Portugal, Sweden and the Commission. In the light of that further material, the Comptroller accepts that the issue of whether parthenotes (the meaning of which is explained below) are properly to be regarded as human embryos within Article 6(2)(c) of the Biotech Directive is not acte clair in the light of the current state of the art. Therefore, the Comptroller supports ISCC's request for a further reference to the CJEU on the central point in this appeal.
However, ISCC goes further. Its primary case is that the issue is acte clair in its favour and that the appeal should be allowed without a further reference to the CJEU. By the conclusion of the hearing, I had formed the clear view that a reference was required, and I informed the parties of this. This Judgment sets out my reasons.
The legal framework
The Biotech Directive came into force on 30 July 1998 and seeks to harmonise national patent laws concerning biotechnological inventions. The legal context of the Biotech Directive and the relevant Recitals and Articles are set out by the CJEU in the Brüstle decision at paragraphs 3–7. I reproduce below the parts of the Biotech Directive which are of most relevance to this Appeal.
The preamble to the Directive states as follows:
'…
(2) Whereas, in particular in the field of genetic engineering, research and development require a considerable amount of high-risk investment and therefore only adequate legal protection can make them profitable;
…
(16) Whereas patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented; whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot be patented;
(17) Whereas significant progress in the treatment of diseases has already been made thanks to the existence of medicinal products derived from elements isolated from the human body and/or otherwise produced, such medicinal products resulting from technical processes aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas, consequently, research aimed at obtaining and isolating such elements valuable to medicinal production should be encouraged by means of the patent system;
…
(20) Whereas, therefore, it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment;
(21) Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself;
…
(37) Whereas the principle whereby inventions must be excluded from patentability where their commercial exploitation offends against ordre public or morality must also be stressed in this Directive;
(38) Whereas the operative part of this Directive should also include an illustrative list of inventions excluded from patentability so as to provide referring courts and patent offices with a general guide to interpreting the reference to ordre public and morality; whereas this list obviously cannot presume to be exhaustive; whereas processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability;
(39) Whereas ordre public and morality correspond in particular to ethical or moral principles recognised in a Member State, respect for which is particularly important in the field of biotechnology in view of the potential scope of inventions in this field and their inherent relationship to living matter; whereas such ethical or moral principles supplement the standard legal examinations under patent law regardless of the technical field of the invention;
…
(42) Whereas, moreover, uses of human embryos for industrial or commercial purposes must also be excluded from patentability; whereas in any case such exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it;
(43) Whereas pursuant to Article F(2) of the Treaty on European Union, the Union is to respect fundamental rights, as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms signed in Rome on 4 November 1950 and as they result from the constitutional traditions common to the Member States, as general principles of Community law;
…'
It will be seen that these recitals express two competing policy considerations. On the one hand, that research in the field of biotechnology is to be encouraged by means of the patent system, and on the other hand, that patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; so that the human body, at any stage in its formation or development, cannot be patented. The Biotech Directive is to be interpreted in a way that balances these competing policy considerations.
The Biotech Directive then provides:
Article 5
1. 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.
…
Article 6
1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.
2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:
(a) …
(b) …
(c) uses of human embryos for industrial or commercial purposes;
(d) …
Technical Background
The following technical background is contained in the expert reports and exhibits of Dr De Sousa and Professor Ansell (referred to in paragraph [36] of the decision of Dr Cullen) and the Judgment of the Bundesgerichtshof in Brüstle. It is common ground between the parties.
Human embryogenesis
Development of a human being begins with fertilisation of the ovum. Strictly speaking, the unfertilised ovum is referred to as an oocyte. Penetration of a sperm cell induces the oocyte to mature into a fertilised ovum. The oocyte itself is haploid (it contains half the usual complement...
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