Understanding the ECJ’s 2014 Decision on Human Embryonic Stem Cell Patents

On December 18, 2014, the Grand Chamber of the Court of Justice of the European Union (ECJ) lifted part of its more general 2011 ban on obtaining patents for human embryonic stem cells (hESCs), by ruling that hESCs made from unfertilized eggs can be patented. This landmark case is International Stem Cell Corporation v. Comptroller General of Patents, Designs and Trade Marks, in which the ECJ held that 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, or the Biotech Directive, does not cover “parthenotes,” the unfertilized human eggs produced by parthenogenesis (a term describing the reproduction from an ovum without fertilization, a normal process in some invertebrates and lower plants).

This case arose out of the refusal by the United Kingdom’s Intellectual Property Office (UKIPO) to grant two national patents to International Stem Cell Corporation (ISCC), holding that these two patents growing out of parthenogenesis fell within the definition of the term “human embryo” adopted by the Grand Chamber in their 2011 decision in Brüstle v. Greenpeace. ISCC appealed on the grounds that mammalian parthenotes can never develop to term due to a lack of paternal DNA and so the Brüstle decision did not apply. Thus, ISCC pointed out that it was crucial to establish what the ECJ meant by the expression “capable of commencing the process of development of a human being,” which, according to Brüstle, determines what might constitute a human embryo. ISCC argued that it should be interpreted narrowly, thus including only organisms capable of commencing the process, rather than broadly, which would include also organisms capable of commencing such process, yet incapable of leading to a fully human being. The ECJ opined that in order to be classified as “human embryo,” a non-fertilised human ovum must necessarily have the “inherent capacity” of developing into a human being. Because an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis lacks the “inherent capacity” to develop into a human being, it is not a “human embryo” within the meaning of the Directive and stem cells derived from it are, therefore, patentable. Reasoning that the issues at stake are questions of fact answerable with reference to the state of scientific knowledge at the time of decision, the Chamber thus allowed national courts to decide, on a case-by-case basis, whether parthenotes, in the light of “current scientific knowledge,” have the “inherent capacity” of developing into a human being and qualify for patent protection.

One may attribute the ECJ’s 2014 decision—at least in part—to economic globalization or the fear of brain drain by the EU, hence prompting the ECJ to rule in favor of hESC patenting. The decision can nonetheless be understood in the context of the globalization of law. The first question is: Did American laws and policies on hESC research and patent have any impact on the ECJ’s decision? The second question is: How might legal globalization affect the ways with which the ECJ will apply the “inherency” test to unexamined or new biotechnological inventions?

  1. ISCC in the Context of Legal Globalization

The topic of brain drain has emerged time and again as the EU and the US changed their policies with regard to stem cell research over the past decade. For example, the EU science ministers’ agreement in 2006 to allow part of the Union’s expanded budget to be spent on hESC research led to the prediction that American scientists, dissatisfied with President George Bush’s restrictive policy on hESC research, would flock to Europe. The funding boost to US research after President Obama’s 2009 executive order likewise sparked fear among the European research community about a possible brain drain across the Atlantic, only in the opposite direction. Reactions among European scientists to the ECJ’s ruling in 2011 were especially gloomy. While the fear of brain drain is not to be discounted, the 2014 decision can also be examined in the broader context of the globalization of law, including judicial globalization.

In the era of globalization, legal problems tend to arise in similar ways, especially in advanced societies and economies. Even legal problems in what were known as “First” and “Third” world nations are frequently compared due to the increased similarities of social debates. Whereas national governments used to respond to these problems independent of other nations, they now frequently look to one another, leading to the convergence of national laws. Judicial globalization refers to judicial interaction across borders. While the most active types of interaction can be found in processes like dispute resolution, a more passive and implicit form of interaction occurs in the form of the “cross-fertilization” of national judicial decisions, a product of globalization.

How exactly does “cross-fertilization” take place? Scholars have noted that judges cite foreign law and decisions for argumentation and for enriching their legal reasoning, and, more often still, they use foreign law without even quoting it. The U.S. Supreme Court, which almost never quotes other courts, has long been the main supplier of ideas and is the most quoted among the foreign courts. Because “courts don’t do what they say and they don’t say what they do,” the use of foreign case law in different ways—both direct and more subtle—is likely to be much more frequent than it seems.

In examining the possible impact of American law and its judiciary on the ECJ’s decision, one should note that hESC research and patentability in the U.S. were first approved through legislation, not by courts. The U.S. Patent Act holds that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” This broad grant was limited by a few judicially recognized exceptions, namely, “laws of nature, natural phenomena, and abstract ideas.” Later, the Supreme Court in Diamond v. Chakrabarty ruled that bioengineered living organisms were altered enough to deserve patent protection. Following Chakrabarty, the United States Patent and Trademark Office (USPTO) wrestled with the question of the patentability of other emerging forms of biotechnology, including those that are human-related. According to its “Quigg Memo” in 1987, it considers that “[a] claim directed to or including within its scope a human being will not be considered patentable subject matter under 35 USC 101.” The USPTO’s longstanding policy against the patenting of “entire” or “complete” human beings has allowed patents on living tissue, genetically modified cells, and other emerging forms of biotechnology, including isolated human genes.

With regard to hESC research, Congress banned the creation or destruction of human embryos for research purposes in 1996, and President George Bush signed an order in 2001 that barred the National Institutes of Health from funding research on embryonic stem cells beyond using 60 cell lines that existed at that time. Nevertheless, the Executive Order 13505 issued by President Obama in 2009, entitled “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells,” repealed Bush’s order and policy on the ground that such research was not ethically problematic. More recently, the America Invents Act (AIA) of 2011 imposes a statutory limitation on patentable subject matter through § 33(a), stating that “no patent may issue on a claim directed to or encompassing a human organism.” The Congressional Record states that this amendment “simply reaffirms current U.S. patent policy,” that it “would not interfere in any way with any existing patents with respect to stem cells,” and that it would “not forbid funding research on embryonic stem cells, because a human embryo is an ‘organism’ but a stem cell clearly is not.” The USPTO also issued a memorandum stating that it viewed the amendment as “fully consistent with USPTO’s policy on the non-patentabiliy of human life-forms.” Hence, § 33(a) codifies the already existing policy, narrowly tailoring the patent exception to only very rare circumstances.

The American judiciary has affirmed the above legislation and shown support for hESC research and patent. In early 2013, the Supreme Court refused to step into the heated debate over hESC research by declining to hear Sherley v. Sebelius, in which two scientists challenged Obama’s 2009 order. This lawsuit first arose in 2010, when James Sherley of the Boston Biomedical Research Institute and Theresa Deisher of Sound Choice Pharmaceutical Institute sued on behalf of “plaintiff embryos,” alleging that Congress had forbidden hESC research in 1996. When the U.S. Court of Appeals for the Federal Circuit upheld the lower court’s 2011 decision by ruling that the US National Institutes of Health can legally fund hESC research, plaintiffs appealed to the Supreme Court. The Supreme Court’s refusal to hear the case thus affirmed its support for Obama’s 2009 order that declared hESC research ethical. Most recently, the U.S. Court of Appeals for the Federal Circuit in Consumer Watchdog vs. Wisconsin Alumni Research Foundation rejected Consumer Watchdog’s attempt to strike down a long-contested hESC patent held by the Wisconsin Alumni Research Foundation, on the ground that the latter was not involved in work on hESC and therefore can’t challenge the patent in court. In late 2014, Consumer Watchdog petitioned the Supreme Court to overturn this ruling; in February 2015, the Supreme Court declined to hear to case. Although this case concerned the potential overreach of specific hESCs, rather than directly examining whether hESCs in general should be patentable, the lower court’s ruling in favor of defendant and the Supreme Court’s response affirmed that there is no ethical issue in hESC patents. Meanwhile, human stem cell patents in general do not go unchallenged, but their patentability has earned support from the USPTO and the judiciary.[1]

The general view that economic factors such as the fear of brain drain by the EU prompted the ECJ to hold in favor of hESC patenting does not offer the full picture. Although the issue of brain drain has emerged time and again as the EU and the US administered different policies over the past decade, the impacts of these policies have been overestimated. When the EU science ministers agreed in 2006 to allow part of the Union’s expanded £37 billion budget to be spent on hESC research, Lord Sainsbury predicted that American scientists would flock to the United Kingdom, but noted that such a brain drain would be a “limited” one. President Obama’s 2009 executive order and economic stimulus to stem cell research raised concern about the possibility of a reverse but fairly limited brain drain from Europe to America. Yet, critics noted that the interpretation of the ECJ’s 2011 ruling was unnecessarily gloomy. First, because the Directive did not prohibit all stem cell research, it had neither prevented European firms from developing technology platforms based upon non-embryonic human stem cells throughout the years, nor sparked a massive brain drain of European stem cell expertise to America or Asia. In addition, despite prior patent restrictions, firms that develop and sell human embryonic stem cell lines and their accompanying technology platforms have flourished and remained competitive.

Decisions of the ECJ in general “offer no direct clue as to whether they have been influenced by decisions of the U.S. Supreme Court” (or any other foreign court). Nevertheless, in certain important cases, the Advocates Generals made references to this court, which then bore direct relevance to the ECJ’s decisions that followed the Advocates Generals’ opinions, and alternatively, might have had a dialectic function when it does not follow such opinions. A good example can be found in the ECJ’s decisions on intellectual property. In Netherlands v. Parliament & Council, Netherlands brought an action for annulment of the Biotech Directive. Advocate General Francis Jacobs cited Diamond v. Chakrabarty to assure that the Biotech Directive would “leave untouched” the “classic requirements for a patent of novelty, inventive step, and industrial application,” thus quenching the anxiety that “any gene or gene sequence, or even the entire human genome” would “automatically be patented.” The ECJ finally ruled in favor of defendant by holding that the Directive was correctly adopted under Article 100a of the E.C. Treaty (now Article 95 E.C.).

Indeed, there is no direct evidence as to whether International Stem Cell Corporation was influenced by American laws or judicial decisions. Moreover, Advocate General Cruz Villalón did not mention any American case law or statutes in his opinion for this case. Nonetheless, that the ECJ had drew upon American cases in the past on intellectual property matters indicates that it may have considered the recent American court cases concerning hESC research and patents. Furthermore, even though AG Cruz Villalón addresses the issue of morality in paras 32-49 of his Opinion by stating that Article 6(1) and (2) of the Biotechnology Directive should be considered side by side, he does not go further to address the more fundamental question of whether hESC research in general is contrary to morality. While the ECJ’s decision does not fully converge with the U.S. policy and rulings, its partial lifting of the general ban on hESC patent indicates that it has made a progression towards the American jurisprudence on these matters.

The ECJ’s decision went hand in hand with the Court’s effort to further its role in championing human rights in the E.U. Scholars have noticed how the ECJ has embraced the U.S. Supreme Court’s role in the nationalization of American politics in its own contribution to the EU’s integration through judicial activism. For example, Elizabeth F. Defeis notes that throughout its fifty year history, the ECJ has held in a series of cases that fundamental rights of individuals such as non-discrimination, freedom of religion, association, and expression, were enshrined in the general principles of its Community law. The proclamation of the Charter of Fundamental Freedoms for the European Union in 2010 further reaffirmed the rights set forth in the European Convention on Human Rights (ECHR). Because the Charter is not legally binding on Member States, the ECJ effectively incorporated the Charter, along with provisions of the ECHR and the decisions of the European Court of Human Rights, into its human rights jurisprudence.

Whether in the U.S. or in Europe, hESC research and biotechnology in general have sparked fears that such innovations violate the sanctity of human life. Further, hESC patents raise concerns that patients’ access to the patented inventions will be limited by high costs as a consequence of monopolies. However, the right to conduct research and intellectual property right are also derived from basic human rights. American legislature and courts, by lifting the ban on the hESC research and patent, have strived to balance the right to conduct research and to own intellectual property with the right to access patented inventions. In contrast, until the ECJ’s 2014 ruling, the EU did not strike a similar balance. While the ECHR mentions neither human dignity nor intellectual property, Article 1 of its Protocol states that “[e]very natural or legal person is entitled to the peaceful enjoyment of his possessions.” The Charter addresses more directly these issues. Although Chapter 1, Article 1 states that human dignity is to be safeguarded and Article 3 prohibits eugenic practices and human cloning, Article 17 safeguards the right to intellectual property. By lifting part of its general ban on obtaining patents for hESCs, the ECJ thus addressed and accommodated the right to conduct hECS research and the right to patenting the products of such research, by balancing it with the right to access new inventions and the dignity of human life.

  1. Legal Globalization and the Likely Applications of the “Inherency” Test

Although the ECJ empowered national courts to decide whether parthenotes have the “inherent capacity to develop into a human being,” it did not provide proper guidelines for this test. As AG Cruz Villalón stated, member states might still decide to ban the patenting of hESCs derived from human parthenotes in accordance with the more general exclusion in Article 6 (1) of the Biotech Directive on the grounds of public order and morality.

Indeed, the hESC regulatory regimes in the EU countries are highly disparate. On the restrictive end, Germany prohibits embryo research and the importation of stem cell lines from other nations. Austria prohibits the procurement of cells from a human embryo for research purposes, but allows the use of pluripotent embryonic stem cells (those capable of developing into any type of cell or tissue except those that form a placenta or embryo) that have already been established in a lawful manner, for example, in other nations, or outside the territorial scope of its law. Similarly, Italy bans the derivation of hESC lines, but permits the use of imported ones for research. On the more permissive end, France allows hESC research so long as specific conditions are met. Portugal allows stem cell research and permits the use of frozen or surplus embryos created in-vitro for the derivation of hESC lines that would bring therapeutic and medical benefits to community. The U.K. and Sweden have remained the most aggressive promoters of hESC research: while forbidding reproductive cloning, both have comprehensive and well-established regulatory frameworks for stem cell research, and allow the use of IVF embryos, the destruction of these embryos to find new stem lines, and the creation of embryos through somatic cell nuclear transfer.

The responses of national courts to ECJ’s 2014 ruling are not difficult to predict. Because Germany permits no hESC research at all, it will not allow the patenting of hESCs, including those derived from parthenotes. Austria and Italy, which permit the use of imported hESC lines for research, will more likely than not permit the patenting of hESC research output derived from parthenotes. First, parthenotes lack the “inherent capacity” to develop into a human being according to current scientific knowledge in these two nations. Second, they have legalized abortion since 1974 and 1978 respectively, and therefore have little reason to prohibit, on the grounds of public order and morality, patenting hESCs made from unfertilized cells that have not even achieved the “embryo” status. Because France and Portugal allow hESC research under certain conditions, they should allow the patenting of parthenote-derived hESCs that are lawfully produced under these conditions. Finally, the U.K. and Sweden, both with progressive policies, would find no justification to ban the patenting of hESCs, which would only stimulate research.

The question concerning how the ECJ will apply the “inherency” test to unexamined or new biotechnological inventions is more difficult to answer. Because the ECJ’s 2014 decision possibly revealed an interaction between civil and common law features in the era of legal globalization, legal globalization may provide a framework for predicting how the ECJ may apply the “inherency” test to unexamined or new biotechnological inventions.

Scholars have attempted to lay out the major aspects of civil and common law systems, as reflected in the EU and the US legal systems respectively. For example, Charles H. Koch points out that the EU legal principles are largely based on the civil law model, which is founded upon “secular natural law,” the codes of which are the product of the “Age of Reason” and premised on the belief that life has an order. Hence, the overarching goal of the civil law system is legal certainty, and the drive for certainty and stability emphasizes systemic values focusing on definitions and categorizations. Although judges in both civil and common law systems are bound by the language of authoritative documents, the former is dominated by scholars’ and academic lawyers’ writings, whereas the latter is dominated by cases decided by practitioners-turned-judges. The former’s emphasis on categorization is often criticized as “insensitive” and “static” by U.S. commentators whose modern jurisprudence focuses on balancing, which “requires the explicit articulation and comparison of rights or structural provisions, modes of infringement, and government interests.” Yet, because the civil system by no means prohibits change, its categorization is an applied—not extreme—formalism that allows for certain degrees of creativity in interpretations and applications, especially in the age of globalization.

The ECJ’s 2014 decision, with its implicit balancing of rights and interests, possibly revealed the influences of the common law principles upon civil law principles. The ISCC, by tapping into the ambiguity of Brüstle’s criterion of a human embryo as one that is “capable of commencing the process of development of a human being,” points out, first, that there exist two interpretations, and second, that its narrow interpretation is preferable to its broad interpretation. AG Cruz Villalón and the ECJ did not expressly conduct this comparison. However, AG Cruz Villalón impliedly endorsed ISCC’s logic and argument for the narrow interpretation by redefining “human embryo” as necessarily containing the “inherent capacity” of developing into a human being. The ECJ did the same by following AG Cruz Villalón opinion. By refusing to blindly adhere to the definition in Brüstle, and by implicitly assessing two interpretations, the ECJ balanced the right to intellectual property and to conduct research with the right to access inventions and respect for human dignity.

Although the “inherency” test may seem easy to apply to parthenotes, recent technological advances may cause complications in its application. Scholars have mentioned, for example, the generation of hESCs from “non-viable” “triploid zygotes” (organisms whose cells contain a distinct membrane-bound nucleus, and are formed by fertilization between two gametes and containing three homologous sets of chromosomes): arising in approximately 5% of in-vitro fertilizations, these contain an extra set of chromosomes that prevent them from developing to term. Another instance is blastocysts (a structure formed in the early development of mammals, which possesses an inner cell mass subsequently becoming the embryo) created by abnormal nuclear transfer, which cannot be implanted into the uterus but are capable of generating customized embryonic stem cells. The same question arises concerning the patentability of hESCs created by using a discarded IVF (in vitro-fertilized) supernumerary, which is a fertilized egg.

How will the EJC apply the “inherency” test to unexamined or new biotechnological inventions? The examples concerning “non-viable” “triploid zygotes” and blastocysts, both fertilized cells, would urge the European Patent Office and the ECJ to consider whether the viability of the organism—or its potential to develop through gestation to birth—is a necessary condition to be classified an “embryo.” The ECJ and the AG will likely compare two options: that viability is a necessary condition for the “inherency” test, or that it is not. Given that with current scientific development, both “non-viable” “triploid zygotes” and “blastocysts” created by abnormal nuclear transfer cannot develop into human beings, the ECJ will likely consider hESCs derived from both patentable, and “viability” a necessary condition for the “inherency test.” The ECJ may even assess and balance the rights of different parties: because the fertilized cells cannot develop to human beings and therefore cannot be said to have human dignity, the right to claim property in hESCs derived from these new inventions would easily take over.

What about the use of a discarded IVF (in vitro-fertilized) supernumerary—a fertilized egg—to create hESCs? Because this method involves a viable fertilized egg, which would pass the inherency test, hESCs created through this method should not be patentable. Yet, a further complication may occur because many of these fertilized eggs, or pre-embryos, are in deep freeze, meaning that the post-thaw pre-embryos may be deemed “unviable” and thus lacking the inherent capacity of developing into a human being. The ECJ may consider the interests of various parties and tilt the balance towards unpatentability in this case as it applies the law to the scenario.

[1] For example, in Association of Molecular Pathology v. Myriad Genetics, the Supreme Court, through a unanimous decision, held that while a naturally occurring DNA segment is a product of nature and not patent eligible, a complementary DNA, or cDNA, which corresponds to the naturally occurring DNA sequences except that certain of its non-coding sequences (“introns”) are removed, is not naturally occurring and therefore patent eligible.

Leave a Reply

Your email address will not be published. Required fields are marked *