Spain v Parliament & Council (C-146/13) – a giant step towards (dis)integration of the European patent system

Aurora Plomer

The green light for the introduction of a European unitary patent and a centralized patent court (UPC) was finally given by the CJEU in Spain v Parliament and Council (Case-146-3). This marks the end of longstanding but frustrated  efforts by the European Union to introduce a uniform patent system in Europe. Like its forerunners, the aim of the latest initiative in the form of the EU ‘patent package’,  is to create the legal conditions for a more secure, less complex  and less costly system for industry and investors to foster scientific and technological advances in the Union.  But whilst driven by the European Union,   the ‘patent package’   is a   mix of EU Regulations and an international Treaty  signed by twenty five out of the existing twenty eight Member States. The  ‘unitary patent’  or European patent with uniform effect (EPUE) across the twenty five signatories, has been created by means of Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection (OJ 2012 L 361, p. 1).  By contrast,  the centralized  ‘unified patent court’ (UPC),  with exclusive jurisdiction to enforce and revoke the EPUE,  is the product of an international treaty (the Agreement on a Unified Patent Court, signed at Brussels on 19 February 2013 (OJ 2013 C 175, p. 1.)  The  legal architecture of the patent package  is therefore complex  and raises important constitutional questions regarding the legal basis of the patent package under EU law, the delegation of powers to the European Patent Organization and the principles of autonomy and uniform application of EU law. These questions were raised by Spain in an application for annulment of the legal instruments creating unitary patent protection. The Grand Chamber’s decision of 5 May 2015, rejecting Spain’s application,  has removed the last legal objection to the implementation of the ‘patent package’.  Spain raised seven pleas, all rejected by the court, in a laconic judgment which leaves many questions open. Some of the most salient issues left open by the judgment are discussed below.

By way of background to the Court’s ruling, it is important to note that patents have historically been territorial in nature so their enforcement and validity is determined by national laws (Article 3 TRIPS).  Since the adoption of the European Patent Convention (EPC) in 1973, applicants have been able to obtain a European-wide patent granted by the European Patent Office (EPO) covering any designated Member State of the European Patent Convention (currently thirty eight). The EPC preserves the principle of territoriality, so the legal effect of a European Patent granted by the EPO is the same as if the patent had been granted by the national patent office of a Member State. The grant of a European Patent thus results in a ‘bundle’ of national patents whose validity and revocation post-grant stands to be determined under the national laws of each designated Member State. A large scale study of  9,000 patent suits from seven of the largest countries in the European Union during 2000-2010 shows that judicial outcomes of revocation and infringement proceedings post-grant diverge radically across the different countries and types of patented technologies in Europe, making for a complex, uncertain and costly legal environment.  In this light,  the creation of a centralized judicial system  with exclusive jurisdiction on enforcement  of the unitary patent (UPC) has undoubtedly, in theory, many attractions from an applicant’s perspective.  Whether the legal creature created by the EU will meet applicants expectations is less clear.

Under the patent package,  applications for a unitary patent will be processed and administered by the EPO (Article 9 of the Regulation) under the rules and procedures of the EPC (Article 2(a) of the Regulation). Once granted, the European patent with uniform effect (EPUE) shall have unitary effect amongst the participating Member States (Article 2(b)). Of the seven pleas raised by Spain and dismissed by the Court, three stand out.

Spain argued that the contested regulation should be annulled as contrary to the rule of law  in Article 2 TEU because the administrative procedure for the grant of the unitary patent has been delegated to  the EPO (under Article 142 of the EPC)  but the decisions of the EPO boards are not subject to any form of judicial review to ensure the correct and uniform application of EU law and the protection of fundamental rights. The Court’s dismissal of Spain’s argument simply reiterates AG Bot’s technical answer (18th November 2014) that the contested regulation in no way delimits the condition for the grant of European patents which are exclusively governed by the EPC and not EU law. Yet, the Court’s reasoning, whilst formally correct,  represents the EPO’s intervention as an ‘accessory’ administrative act of registering a European patent granted under EPC rules as a European Patent with Unitary Effect.   In so doing, the answer evades the critical point raised by Spain that the decisions of the  EPO boards,  at the grant stage of the European patent and its ‘accessory’ registration as a EPUE – are not subject to judicial scrutiny under EU law or indeed any other form of judicial scrutiny.  Neither is the point of purely academic interest as underscored by the case  Virgin Atlantic Airway Ltd v Zodiac Seats UK Ltd [2013] UKSC 46. As the result of an administrative error by the  EPO examiners, the applicant was exposed to a claim worth £49 million  in infringement proceedings in the UK. The UK Court held that the error could not be rectified at the post-grant stage unless the EPO corrected the error. The applicant’s request to the EPO to correct the error was originally refused prompting further appeals at the EPO and in the UK courts highlighting the shortcomings of the EPO tribunal system (the case has been extensively discussed in IP blogs; for example IP Copy). By contrast, in legal proceedings in national courts or administrative bodies where EU law is engaged, an applicant in similar circumstances could invoke Article 41 of the EU Charter. Not so with the EPUE and the EPO boards.  The recent dismissal of one of the EPO officials has further fuelled concerns about  the independence and fairness of the EPO tribunals, prompting an unprecedented intervention by Sir Robin Jacob (see letter and EPO response). Also, for a discussion of parallel proceedings in German Courts Dr. Stjerna’s article on the topic is available in PDF here. Continue reading

Case C-364/13 – Patentability of embryonic stem cells and parthenotes: Inherently Uncertain?

plomerAurora Plomer

On 18th December 2014, the Grand Chamber of the CJEU revisited the scope of the moral exclusion on industrial and commercial uses of “human embryos” in Article 6(2) (c) in Directive 98/44/EC on the legal protection of biotechnological inventions (Biotech Directive) and held that the exclusion does not cover unfertilized human eggs produced by parthenogenesis (parthenotes).

The referral followed the refusal of the UKIPO to grant two national patents to International Stem Cell Corporation (‘ISCO’) [2013] EWHC 807 (Ch) on the ground that the patents fell within the definition of the term ‘human embryo’ adopted by the Grand Chamber in Brüstle (EU:C:2011:669) .     The first patent, GB0621068.6, entitled “Parthenogenetic activation of oocytes for the production of human embryonic stem cells” covered both the methods for producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and the stem cell lines themselves.   The second application GB0621069.4 , entitled “Synthetic cornea from retinal stem cells” similarly included claims to methods and ‘product-by-process’. The UKIPO applied the Grand Chamber’s reasoning in Brustle that parthenotes were ‘capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so’ and therefore fell within the meaning of paragraph 36 of the judgment in Brüstle (C‑34/10, EU:C:2011:669). ISCO appealed on the grounds that, according to current scientific knowledge, mammalian parthenotes can never develop to term because, in contrast to a fertilised ovum they do not contain any paternal DNA, which is required for the development of extra-embryonic tissue (para 17). In this light, the High Court of Justice (England & Wales), Chancery Division (Patents Court), decided that the appeal “raised 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?” (At para. 3).

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Case Comment: Opinion of Advocate General Cruz Villalon in International Stem Cell Corporation (C-364/13)

Prof. Aurora Plomer

Three years after the landmark Brustle ruling, the CJEU is poised to revisit the scope of exclusion on industrial and commercial uses of “human embryos” in Article 6(2) (c) of the EU Directive on Biotechnological Inventions. This time, the referral is from a national court of first instance, the Chancery Division (Patents Court) of the UK High Court of Justice Court. In the Opinion of Advocate General Cruz Villalon, whilst the question raised by the UK court is “virtually identical” to the questions raised in the Brustle reference of the German Federal Court of Justice (BGH), the answer should be different.

One of the questions raised by the BGH in Brustle was whether the term ‘human embryo’ encompassed ‘unfertilised human ova whose division and further development have been stimulated by parthenogenesis’ (parthenotes). In Brustle, the Grand Chamber of the CJEU held that parthenotes fell within the scope of exclusion of Article 6(2) (c) because the term ‘human embryo’ had to be given an autonomous meaning in EU law and should be “be understood in a wide sense” to include any human ovum, as soon as fertilised “… since that fertilisation is such as to commence the process of development of a human being.” The criterion of whether an organism is “capable of commencing the process of development” (the ‘commencement’ test) was relied upon by the UK intellectual Property Office to reject two patent applications by International Stem Cell Corporation (ISC) relating to human embryonic stem cell lines produced by parthenogenesis activation of ova. In its appeal, ISC argued that the Brustle exclusion should not extend to parthenotes because such organisms are incapable of developing into human beings. In this light, the UK High Court raised the following question for a preliminary ruling: “Are unfertilised human ova whose division and further development has 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 on the Legal Protection of Biotechnological Inventions?”.

France, Sweden and the Commission submitted that, in the current state of science, parthenotes cannot be considered identical to embryos at any stage of their development and parthenogenesis cannot be regarded as a technique capable of commencing the process of development. Portugal expressed concern about the risks of further genetic manipulation and would have left the decision to national courts. The UK submitted that the critical factor was the capacity of the cell itself and not its capacities after genetic manipulation (para. 60). By contrast, Poland submitted that, even though parthenotes cannot develop into human beings according to current scientific understanding, nonetheless respect for human dignity requires that they should be treated as human embryos as they “initially undergo the same stages of development as a fertilised ovum (para. 60).

The analysis of Advocate General Cruz Villalon proposes to read into the Grand Chamber’s ‘commencement’ rule in Brustle a functional equivalence test, so that the decisive criterion which should be taken into account for determining whether an unfertilised ovum is a human embryo is “whether that unfertilised ovum has the inherent capacity of developing into a human being, i.e. whether it really constitutes the functional equivalent of a fertilised ovum.” (at para. 73). On this basis, the mere possibility that a parthenote could be genetically manipulated so that it can develop to term and into a human being does not change the fundamental character of the parthenote before manipulation. According to current scientific knowledge parthenotes do not have the capacity to develop into human beings but “where the parthenote is manipulated in such way that it actually obtains the respective capacity, it can no longer be considered a parthenote and it cannot be, consequently patented.” (at para. 77). Continue reading

Horizon 2020: EU funding of hESC research in the balance

Prof. Aurora Plomer

Stem cell research has the potential to bring important advances in our understanding and treatment of crippling diseases such as Parkinson’s, diabetes, stroke and heart disease. It has also attracted significant investment in a number of countries in Europe, notably the UK and Germany, which have established themselves as global market leaders in stem cell therapy and technology. The amount allocated to stem cell research under previous EU programmes has formed a relatively small portion of the overall budget but played a vital role in facilitating collaborations amongst EU researchers which would not have been possible through national funding alone.  Yet, the funding of embryonic stem cell research in Europe now lies in the balance.

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EU Accession to the ECHR – Latest Developments

Prof. Aurora Plomer

On Monday 30th of January I attended a conference organized by the European Academy of Law in Brussels on the latest developments on EU Accession to the ECHR. The meeting offered some illuminating insights into the contrasting perspectives of senior officials and judges from the CJEU and ECrtHR as well as members of the informal working group (CDDH-UE) charged with the drafting of the accession agreement. The final version of the draft legal instrument issued by the joint working group was released on 19th July 2011 for consideration and approval by EU and CoE institutions as well as Member States.

My overwhelming impression was that the process, particularly on the EU side, is unlikely to live up to the ‘rapid’ pace prescribed by Article 6 (2)(1) of the Lisbon Treaty. According to Luca de Matteis,  from the General Secretariat of the Council of the European Union, questions still open in relation to the draft accession instruments include the scope of EU’s accession and submission to ECtHR’s jurisdiction of violations deriving from EU’s Common foreign and security policy acts, “cases and conditions for unclenching the co-respondent mechanism” and voting arrangements for supervision of execution of judgments against the EU.

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EU Ban on Stem Cell Patents: Intended and Unintended Consequences

Prof. Aurora Plomer

The EU Court’s ban on embryonic stem cell patents and products derived therein continues to be the focus of attention and comments in scientific journals and newspapers, and will no doubt do so for a long time to come in the light of the unexpected and far-reaching scope of the ban. National patent offices in Europe and the European Patent Office have yet to analyze the implications of a judgment which requires the application of a uniform, judicially constructed definition of the human embryo across Europe, contrary to the existing diversity of legal definitions (see Asa Hellstadius, ‘A Comparative Analysis of the Implementation of the Directive’s Morality Clause’, in Plomer & Torremans, Embryonic Stem Cell Patents: European Law and Ethics, OUP, 2009) and the submissions of member States to the court.

Opponents of hESC research see the judgment as a ‘milestone’ and vindication of the rights of the embryo. But as legal definitions in this area have singularly been outstripped by the pace of scientific advance (see R v. SoS for Health ex parte Quintavalle),  the Court’s ruling is likely to invite future challenges and fuel the chronic legal uncertainty which has attended the interpretation of the scope of moral exclusions in the Directive. It is also possible that the ban may have unintended consequences and catch the work of scientists who have re-directed their research efforts to adult stem cells (including induced pluripotent cells or iPS cells) in the face of the persistent and powerful opposition of religious lobbies (see recent advances published in Nature only last month).

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