Post Brüstle Developments in EU Biotech Patent Law at the CJEU
H.P. Brack (CH)
The Court of Justice of the European Union (CJEU) is expected to have an increasingly important role in patent matters in the future. This is because the EU countries and Parliament have agreed on a 'patent package' that lays the groundwork for the creation of unitary patent protection in the EU in the form of a European patent with unitary effect ('unitary patent') and a single specialized forum (the 'Unified Patent Court' or UPC) with exclusive jurisdiction for litigation relating to European patents and European patents with unitary effect.
The regulations on the unitary patent[1a] and on its language regime[1b] are legal instruments of the EU. Under Article 267 of the Treaty on the Functioning of the European Union it is a primary role of the CJEU to interpret the Union law. Furthermore the Agreement on a Unified Patent Court stipulates that the UPC is obliged, in the same way as a national court, to request preliminary rulings from the CJEU in order to clarify questions concerning the interpretation of EU law. Therefore it is clear that the CJEU will have an increasingly important role to play in patent matters in Europe, and it will be prudent for European patent attorneys to become familiar with its case law in the IP area.
As this case shows, national courts may unfortunately become bound to follow case law coming from the CJEU based on poor technical advice provided to the CJEU, or perhaps their lack of experience in the patent area, as some patent practitioners fear. Nonetheless this case also illustrates that such situations may be corrected by means of subsequent referrals to the CJEU.
Legal uncertainty resulting from CJEU case C-34/10 (Brüstle vs. Greenpeace): In an earlier paper on this topic in this journal, it was discussed how the CJEU in the case C-34/10 had provided clarification to the referring German Federal Court of Justice concerning the interpretation of several important aspects of the EU Directive 98/44/EC. In particular, the CJEU specified how the term "embryo" should be defined and also how several exclusions from patentability related to that term should be interpreted.
The Brüstle Court at the CJEU held that „any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a 'human embryo';". In balancing the interests of society, the CJEU was careful to err on the side of broader basic rights protection at the expense of narrower industrial property rights protection. Although their decision generally received positive reviews from practitioners and the industry, it nonetheless soon became clear that the Brüstle decision C-34/10 had created some significant legal uncertainty on one aspect.
In particular, it remained unclear whether human 'parthenotes' should fall under the definition of a human embryo according to Directive 98/44. It should be briefly noted that totipotent stem cells are the most versatile type of stem cell, and they are capable of developing into a complete, viable organism. In the case of parthenogenesis, chemicals are used to induce an egg to begin developing as if it had been fertilized, and the resulting egg (a parthenote) behaves like an early stage embryo. However because it contains no genetic material from a father, according to current scientific knowledge it cannot develop into a viable (human) fetus. Nonetheless the Brüstle court at the CJEU had equated human parthenotes with human embryos, and indicated that the definition of "human embryo" for the purposes of the Directive included human parthenotes. It will next be discussed how this apparent contradiction led to uncertainty in the interpretation of the Directive and a subsequent further referral to the CJEU from a national court for clarification.
Refusal of two GB patent applications - UK IPO BL O/316/12 (International Stem Cell Corporation): The issue in this decision of the UK IPO was whether the Patent Applications GB0621068.6 and GB0621069.4 complied with Schedule A2 of the UK Patents Act 1977, which was introduced into the Act in 2000 to implement articles
1-11 of Directive 98/44/EC.
The first ISCC patent application claims methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and stem cell lines produced according to the claimed method. The second ISCC patent application claims methods of producing synthetic cornea or corneal tissue involving the isolation of pluripotent stem cells from partenogenetically-activated oocytes as well as synthetic cornea or corneal tissue produced by these methods.
The UK IPO examiner's objection in his letter to the applicant was that the claimed methods of producing stem cell lines, or synthetic corneas or corneal tissue, and/or the stem cell lines or synthetic corneas or corneal tissue thus produced, constitute uses of human embryos for industrial or commercial purposes, and they are thus excluded from patentability under Paragraph 3(d) of Schedule A2 of the Act. The core of the examiner's argument was that the parthenogenetically-activated oocytes produced in step (a) of claim 1 of either application, and/or the parthenogenetic blastocyst-like structures derived from them in the subsequent steps, fall within the definition of a "human embryo" for the purpose of Schedule A2 of the UK Patent Act. The examiner had given two main reasons for this argument; firstly, the decision of the CJEU in case C-34/10 Brüstle and, secondly, the definition of the term "embryo" provided by the UK Human Fertilisation and Embryology Act 1990, as amended by the Human Fertilisation and Embryology Act 2008 (the "HFE Act"), which defines an embryo as including "an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo."
The UK IPO hearing officer, concluded that the clear and unambiguous statement of the CJEU that human parthenotes were encompassed by the definition of "human embryos" left no choice but for the UK IPO to refuse both patent applications from ISCC, as they both claimed methods in which an unfertilised oocyte is activated by parthenogenesis and caused to develop into a parthenogenetic blastocyst-like structure and that this parthenogenetic blastocyst-like structure is then used (and necessarily destroyed by the disclosed methods for the mechanical separation of the inner cell mass) to produce stem cells and/or corneal tissue. In particular, he noted that if the parthenogenetically-activated oocyte and the parthenogenetic blastocyst-like structure constitute human embryos, then the claims of both applications relate to the unpatentable commercial or industrial use of a human embryo. In addition, the hearing officer stated that since he had decided that the parthenogenetic blastocyst-like structure is a human embryo as defined in Article 6(2)(c) of the Directive, any product-by-process and omnibus claims to stem cells, synthetic cornea or corneal tissue produced from it are also necessarily not patentable. The hearing officer felt there was no inconsistency between his conclusion that the various cell types used by and produced by the methods of the two patent applications were not capable of developing into a human being and his decision that nonetheless all of the claims of both patent applications related to unpatentable subject matter according to the Directive, thus necessitating their refusal.
Referral to the CJEU - UK Patents Court, International Stem Cell Corporation v Comptroller General of Patents, Case No.  EWHC 807 (Ch): ISCC appealed the decision to refuse its patent applications to the Patents Court. ISCC argued in its appeal brief that the test adopted by the CJEU in C 34-10 (Brüstle) was intended to exclude from patentability only those organisms capable of commencing and actually completing the process of development which leads to a human being. ISCC cited as supporting evidence for this line of argumentation the wording of the CJEU's test and its similar treatment of fertilised ova and non-fertilised ova subjected to somatic-cell nuclear transfer, as well as the BGH's final judgment after the CJEU's ruling in Brüstle. Thus ISCC argued that parthenogenetically-activated human oocytes would therefore only be excluded from patentability to the extent that they are capable of producing human totipotent cells, which would then have the capability to develop into a complete human being.
The Comptroller General argued that the CJEU's ruling in Brüstle was not clear with respect to the question whether the term 'human embryo' covers organisms capable of commencing the process of development of a human being irrespective of whether the process could be completed. Furthermore the Comptroller General argued that it was equally unclear as to whether or not the CJEU had in fact relied on inferior submissions reflecting an inaccurate current scientific understanding of the subject matter of parthenotes in their decision on that aspect.
It is noteworthy that the referring UK Patent Court presented its own view on this question in stating that if the parthenogenetically-activated oocytes at issue are incapable of developing into a human being, they should not be regarded as human embryos. Futhermore Judge Carr indicated that the factual matrix in the case before him was quite different to that before the CJEU in Brüstle. In particular, genomic imprinting meant that in contrast to a fertilised ovum, there were no totipotent cells present in a parthenote, even in the first few cell divisions after activation. According to the current state of knowledge in the art, despite the superficial similarities in their initial development, parthenotes and fertilised ova were not identical at any stage. On this basis he felt there was clearly sufficient doubt as to the precise meaning of the ruling in Brüstle, and as to whether the CJEU would have come to the same conclusion as it did on parthenotes with the current facts, to justify making a further reference.
Therefore with his ruling on April 17, 2013 Judge Carr made a reference to the CJEU to clarify this issue by the following referred question:
Are unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, included in the term "human embryos" in Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions?
CJEU C-364/13, International Stem Cell Corp. v Comptroller General of Patents: Written observations were submitted in this case by the party ISCC, as well as the Member States FR, PL, PT, SE, and the UK and the Commission. A hearing was held on 29.04.2014 and ISCC, the UK, FR, SE and the Commission all made oral observations there.
The Opinion of the Advocate General (AG) from 17. July 2014: Pedro Cruz Villalón, the AG, stated that the preliminary considerations in his opinion included both better current scientific knowledge concerning the developmental capabilities of parthenotes and the possibility to perhaps change these capabilities by means of future genetic manipulation technologies. The AG noted first of all that all parties and the referring court unanimously agreed that according to current scientific knowledge "genomic imprinting" and the lack of paternal DNA prevented human parthenotes from developing proper extra-embryonic tissue and thus to term. The agreement on this point contrasted with the diverging opinions of the parties and the referring court in the earlier Brüstle case.
Villalón noted that the referring court and parties in the present case nonetheless also agreed that the barrier presented by genomic imprinting might be surmountable in the future by unforeseen developments in genetic manipulation technologies. In addition, the PT and the UK governments noted in their submissions that the "tetraploid complementation" method had been used already to obtain viable adult descendants from mice parthenotes. However the patent applicant, ISCC, stated that such genetic manipulation changed the very nature of the parthenote in question. Furthermore the FR government had noted that such manipulation of human parthenotes would be illegal there, and the UK High Court noted that the pending amended claims of the ISCC patent applications excluded the possibility of such genetic manipulations.
The AG opined that therefore a critical point to consider was that the CJEU in their judgement in Brüstle had intended to primarily focus on the inherent capacity of various cells and multicellular organisms to develop into a human being. The AG stated that a close look at the judgment shows that the Court at the CJEU meant to inquire as to whether an unfertilised ovum has the inherent capacity of developing into a human being or not. The AG's opinion then seemed to indicate that the CJEU in Brüstle had not been provided with the best current scientific knowledge on this issue. Villalón pointed out that in Brüstle the Court had established a functional equivalence between fertilised ova, non-fertilised ova subjected to somatic-cell nuclear transfer and parthenotes, even though parthenotes, as is now apparent, are the only organisms among those three that cannot develop into human beings. The AG opined that if the Court had actually been aware of the fundamental difference between parthenotes and non-fertilised ova subjected to somatic-cell nuclear transfer and nonetheless wanted to establish a functional equivalence between the two organisms, it would certainly have discussed this difference in their judgement. Villalón thus stated14: "It is hence reasonable to assume that the observations submitted at the time in Brüstle caused the Court to have the impression that all three organisms possess the inherent capacity to develop into a human being. ..." He contrasted that with the present ISCC case in which the referring court and the parties all unequivocally agreed that the submitted evidence on current scientific knowledge demonstrated that a parthenote does not, per se, have the required inherent capacity of developing into a human being and hence as such does not constitute a 'human embryo'.
AG Villalón proposed that the Court should answer the question referred as follows:
"Unfertilised human ova whose division and further development have been stimulated by parthenogenesis are not included in the term 'human embryos' in Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions as long as they are not
capable of developing into a human being and have not been genetically manipulated to acquire such a capacity."
AG Villalón emphasized that, in his view, even if human parthenotes are to be excluded from the concept of human embryos, the Directive does not prevent a Member State from excluding parthenotes or other organisms from patentability on the national level based on ethical and moral considerations.
The Decision of the ISCC Court at the CJEU from 18. December 2014: In their decision, the ISCC Court first specifically noted several aspects of the referral relevant to their answer to the referred question, as in the AG's opinion. First of all, that the referring court had stated that although a "parthenote" is capable of dividing and developing further, according to current scientific knowledge, human parthenotes can never develop to term because they lack paternal DNA. Second of all, the referring court had also stated that ISCC had amended its applications and their claims to exclude the possibility of using any method to overcome the inability of a parthenote to develop into a human being. Finally, according to the referring court, to exclude parthenotes from patentability does not strike an appropriate balance between encouraging biotechnology research by patent law and respect for the fundamental principles safeguarding the dignity and integrity of the person.
The ISCC Court then proceeded to reaffirm and clarify the key aspect of the earlier Brüstle decision in that "human embryos" meant being "capable of commencing the process of development of a human being". Firstly, the Court reaffirmed several points of the earlier Brüstle decision. The ISCC Court also emphasized that the concept of "human embryo" within the meaning of the Article 6(2)(c) of the Directive must be understood in a wide sense. The ISCC Court further stated that the Brüstle Court had specified that that classification must be applied to parthenotes because – although they are not strictly speaking the object of fertilisation – according to the written observations presented to the Court, parthenotes were just as capable of commencing the process of development of a human being as an embryo created by fertilisation of an ovum can do. Thus the ISCC Court concluded that it followed from the earlier Brüstle decision that a non-fertilised human ovum must be classified as a "human embryo" within the meaning of Article 6(2)(c) of the Directive in so far as the organism is "capable of commencing the process of development of a human being".
The ISCC Court went on to clarify however that the key aspect of "human embryos" was an "inherent capacity of developing into a human being" and that the term "human embryos" according to the Directive therefore excluded ovums lacking that capacity according to current scientific knowledge. Thus the ISCC Court concluded that the answer to the question referred is that Article 6 (2) (c) of Directive 98/44 must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenisis does not constitute a "human embryo", within the meaning of that provision, if, in the light of current scientific knowledge, that ovum does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine.
Grant of Patents, GB2431411B and GB2440333, by UK IPO on 4. November 2015 : The UK High Court made an Order on 22. January 2015 and a Consent Order on 29. April 2015 that resulted in both applications being remitted by the Comptroller to the Examiner for further examination, and they were both granted as patents.
Conclusion: This CJEU case, C-364/13 ISCC, illustrates how national courts may unfortunately become bound to follow case law coming from the CJEU based on poor technical advice provided to the CJEU, as was at least partially true concerning the alleged capabilities of pathenotes to develop into human beings in C-34/10 Brüstle. Nonetheless this case also illustrates that such situations may be corrected by means of subsequent referrals to the CJEU. Arguably the time required for such corrections is not overly unreasonable, as a total of slightly more than three years was required for a "correcting" judgment by the CJEU. Encouragingly the CJEU has also left considerable discretion to the national courts to determine what current scientific knowledge has to say concerning the ability of various types of organisms to develop into human beings or not.
After the EU patent package concerning unitary patent protection and the unified patent court comes into effect in the hopefully near future, it will be interesting to see whether or not there will be other examples of case law coming from the CJEU requiring correcting judgements as some patent practitioners fear.
Acknowledgement: Frederik Grever (NL) is thanked for his kind review of this manuscript.
- (a) Regulation (EU) No 1257/2012 of the European Parliament and the Council of December 17, 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection and (b) Council Regulation (EU) No 1260/2012 of December 17, 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements, OJ EU L 361 of December 31, 2012, p. 1 and p. 89.
- Consolidated version of the Treaty on the Functioning of the European Union – Part Six: Institutional and Financial Provisions - Title I: Institutional Provisions - Chapter 1: The institutions - Section 5: The Court of Justice of the European Union - Article 267 (ex Article 234 TEC), Official Journal EU C 115, of May 9, 2008, p. 164.
- Agreement on a Unified Patent Court OJ EU C 175 of June 20, 2013, p. 1.
- H.P. Brack, "The most important decisions of the EUEJ in patent matters", epi Information, 2/13, p. 54.
- Judgment of the Court (Grand Chamber) of 18 October 2011, Brüstle v Greenpeace, available on-line, accessed 07.01.2016 at http://curia.europa.eu/juris/liste.jsf?language=en&num=C-34/10
- Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ EU L 213, of July 30, 1998, p. 13.
- UK IPO Patent Decision of 16 August 2012, BL number O/316/12, available on-line, accessed 01.01.2016 at https://www.ipo.gov.uk/p-challenge-decision-results/p-challenge-decision-results-bl?BL_Number=O/316/12
- UK Patents Act 1977, available on-line, accessed 01.01.2016 at http://www.legislation.gov.uk/ukpga/1977/37/contents.
- The UK IPO Examination Report of 3. August 2010, availablew on-line, accessed 12.01.2016 at https://www.ipo.gov.uk/p-ipsum/Document/ApplicationNumber/GB0621069.4/GCG6C52Jdms/GB2440333-20100803-Exam%20report%20%20Standard.pdf.
- UK Human Fertilisation and Embryology Act 1990, available on-line, accessed 01.01.2016 at http://www.legislation.gov.uk/ukpga/1990/37/contents.
- UK Human Fertilisation and Embryology Act 2008, available on-line, accessed 01.01.2016 at http://www.legislation.gov.uk/ukpga/2008/22/contents.
- UK High Court Of Justice, Chancery Division, Patents Court, Judgement of April 17, 2013,  EWHC 807 (Ch), available on-line, accessed 01.01.2016 at http://www.bailii.org/ew/cases/EWHC/Ch/2013/807.html
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- Ipsum - Online Patent Information and Document Inspection Service, GB2431411 - Parthenogenic activation of human oocytes for the production of human embryonic stem cells, available on-line, accessed 12.01.2016 at https://www.ipo.gov.uk/p-ipsum/Case/PublicationNumber/GB2431411.
- Ipsum - Online Patent Information and Document Inspection Service, GB2440333 - Synthetic cornea from retinal stem cells derived from human parthenotes, available on-line, accessed 12.01.2016 at https://www.ipo.gov.uk/p-ipsum/Case/ApplicationNumber/GB0621069.4.
Der Gerichtshof der Europäischen Union (EuGH) erhält in der Zukunft im Bereich des Patentschutzes eine noch grössere Bedeutung. Grund dafür ist die Einigung der EU-Länder und des Europäischen Parlaments über das sogenannte Patentpaket, das die Grundlage für einen einheitlichen Patentschutz in der Europäischen Union in Form eines europäischen Patentes mit einheitlicher Wirkung schafft und die Errichtung eines Einheitlichen Patentgerichts (EPG) mit einer ausschließlichen Zuständigkeit für europäische Patente und europäische Patente mit einheitlicher Wirkung vorsieht.
Die Vorschriften über das einheitliche Patent und die Sprachregelungen sind Rechtsinstrumente der EU. Gemäss Artikel 267 des Vertrags über die Arbeitsweise der Europäischen Union ist der Gerichtshof der Europäischen Union für die Auslegung des Unionsrechts zuständig. Ausserdem sieht das Übereinkommen zur Schaffung eines einheitlichen Patentgerichts vor, dass das Einheitliche Patentgericht, wie jedes nationale Gericht, die korrekte Anwendung und einheitliche Auslegung des Unionsrechts sicherstellen muss, indem es den Gerichtshof der Europäischen Union um Vorabentscheidungen ersucht. Der EuGH wird somit eine immer wichtigere Rolle auf dem Gebiet der Patentsachen in Europa einnehmen, weshalb die European Patent Attorneys sich mit dessen Rechtsprechung im IP-Bereich vertraut machen sollten.
Wie der vorliegende Fall zeigt, müssen die nationalen Gerichte die Rechtsprechung des EuGH auch dann beachten, wenn ein Entscheid sich auf eine unkorrekte technische Begutachtung oder eine mangelnde Erfahrung im Patentbereich stützt. Dieser Fall veranschaulicht aber auch, dass solche Entscheide nachträglich, gestützt auf die Rechtsprechung des EuGH, berichtigt werden können.
La Cour de justice de l'Union européenne (CJUE) devrait avoir un rôle plus important en matière de brevets à l'avenir. En effet, les pays de l'UE et le Parlement se sont entendus sur un «paquet de brevet» qui établit les bases pour la création d'une protection par brevet unitaire dans l'UE sous la forme d'un brevet européen à effet unitaire («brevet unitaire») et un seul forum spécialisé («Unified Patent Court» ou UPC, tribunal pour les brevets unitaires) ayant compétence exclusive pour les litiges en matière de brevets européens et les brevets européens à effet unitaire.
Le règlement sur le brevet unitaire et sur son régime linguistique sont des instruments juridiques de l'UE. Conformément à l'article 267 du traité sur le fonctionnement de l'Union européenne, la CJUE a pour vocation d'interpréter les lois de l'Union. En outre, l'accord sur un tribunal pour les brevets unitaires stipule que l'UPC est obligé, de la même manière qu’un tribunal national, de saisir la CJUE de questions préjudicielles afin de clarifier les questions concernant l'interprétation des lois de l'UE. Il est donc clair que la CJUE aura un rôle plus important à jouer en matière de brevets en Europe, et il sera prudent pour les conseils en brevets européens de se familiariser avec sa jurisprudence dans le domaine de la propriété intellectuelle.
Comme cette affaire le montre, les tribunaux nationaux peuvent malheureusement être tenus de suivre la jurisprudence de la CJUE établie sur la base de mauvais conseils techniques qui lui ont été fournis, ou éventuellement de leur manque d'expérience dans le domaine des brevets, comme le craignent certains conseils en brevets. Toutefois, ce cas illustre également que de telles situations peuvent être corrigées à l'aide de références ultérieures à la CJUE.