No Patent–No Therapy: A Matter of Moral and Legal Consistency Within the European Union Regarding the Use of Human Embryonic Stem Cells

The European Court of Justice and its role and relevance within the European Union

The Court of Justice is the highest court within the European Union in matters of European Union law. Indeed, the court's jurisdictional power is limited to European Union law, whereas merely member state law cannot be a matter of the court's jurisdiction. However, once the court has delivered a judgment, this decision then binds all organs of the European Union, and all organs of the member states if they execute European Union law. Finally, judgments of the court are unappealable. ¹

Since the European Union consists of 28 member states, which are home to more than 500 million citizens, rulings of the Court of Justice can have an enormously economic impact. Therefore, it was no wonder that the court's ruling regarding the nonpatentability of inventions based on human embryonic stem cells was believed to have such a bearing on research and economy [1 –4], since patents are regularly an essential part of (re)financing research and development. Whether there is or whether there will be such an impact will have to be a subject matter of future empiric research.

The Brüstle v Greenpeace ruling of European Court of Justice

The ruling in the Brüstle v Greenpeace case ² followed a challenge by Greenpeace over a patent granted to German scientist Oliver Brüstle that concerns isolated and purified neural precursor cells, processes for their production from embryonic stem cells, and the use of neural precursor cells for the treatment of neural defects.

OPEN IN VIEWER

The main courtroom of the Court of Justice of the European Union.

Source: G. Fessy © CJUE.

The European Court of Justice's ruling held that processes requiring the prior destruction of human embryos, or their prior use as base material, cannot be patented in the European Union. This holding applies even if—as is the case with the questioned patent—the patent application describing the process does not refer to the use of human embryonic stem cells, but where the implementation of the invention necessarily requires the destruction of human embryos.

The court based its decision on Article 6(1) and 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of July 6, 1998, on the legal protection of biotechnological inventions ³ that stipulate that patents may not be granted for inventions whose commercial exploitation would be contrary to the European ordre public (public order) or morality, and that, in particular, patents may not be granted for use of human embryos for industrial or commercial purposes. Since the court came to the result that, because of the nature of a patent, a patent is always connected with industrial and/or commercial purposes, the court reasoned that the use of human embryos within the patent claims cannot be separated from the patent itself and the rights attached to it. The industrial and/or commercial use of a human embryo therefore would be such a violation of the European public order and/or morality.

The court utilizes the “doctrine of fruits of the poisoned tree” when it ruled that an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos or embryonic stem cells, but where the implementation of the invention requires the destruction of human embryos. In that case too, the view must be taken that there is industrial and/or commercial use of human embryos within the meaning of Article 6(2)(c) of the Patent Directive. The fact that destruction may occur a long time before the implementation of the invention is irrelevant. Not to include in the scope of the exclusion from patentability set out in Article 6(2)(c) of the Patent Directive technical teaching claimed, on the ground that it does not refer to the use, implying their prior destruction, of human embryos would make the provision concerned redundant by allowing a patent applicant to avoid its application by skillful drafting of the claim.

The embryo after the judgment: object or subject?

Neither the term “embryo” nor its legal definition already state any legal protection of such entities. Such legal status and protection rather come from the combination of the definition with certain protection acts to protect these entities, for example, against purposeful destruction. Since the European Court of Justice considered it immoral to purposefully destroy human embryos as well as to use embryonic stem cells out of such embryos or stem cells derived from embryonic stem cells for the benefits of others, one must also ask, beside the definition of an embryo and its legal protection, whether these embryos are legal subjects (so, legal persons) or just objects without their own rights governed by legal subjects. The court reasoned that the destruction of human embryos as well as the subsequent use of embryonic stem cells out of such destructed embryos are violations of the European Union's public order, because this is a violation of the safeguard of human dignity and the embryo is seen as a subject of such dignity. Therefore, if already early embryos enjoy the protection of human dignity just because of their totipotency, which is the definition of embryo made by the court, this speaks for the result that already an early embryo, comprised of a couple of cells, is a person in legal terms, and not an object.

Anyway, it is unfaithful to adjudge human dignity to the early embryo, but adjudge only a limited life protection to it since this allows the purposeful destruction of the embryo—maybe to gain stem cells—as long as the destruction is not a violation of human dignity. The embryo enjoys either full human dignity and the same life protection as a born person or none of each.

The necessity of officially sanctioned market access for stem cell–based therapies

Cell-based therapies need an officially sanctioned market access within the European Union. ⁴ On a regular base, this market approval is granted by the Commission of the European Union as the executive organ of the European Union after an evaluation of the relevant cell-based therapeutic product by the European Medicine Agency. Cell-based therapy products that are produced only small-scale and not industrial-like are granted by national authorities of the member states of the European Union. However, such exceptional granted therapy products have marketability only within that member state in which the product has been granted, whereas products granted by the European Commission have marketability within the entire European Union. Anyhow, in both situations, it is the European Union pharmaceutical law that governs the market approval process, once it is applied by the European Union itself, namely, by the European Commission, once by the regulators of the actual member state.

Same lawmaker–same moral

Both the European Union's Biopatent Directive and the market access law for cell-based therapies as well as the law governing clinical trials have been issued by the same lawmaker, namely, the European Union. Therefore, it should be expectable that this same lawmaker expresses the same moral understanding in all of its different statutes. Anyhow, it is not evident why and how with the patent law of the European Union there should be a different moral understanding regarding the commercial and/or industrial use of human embryos than in the European Union's pharmaceutical law. In the end, both fields of law deal with the same moral question when it comes to the use of human embryos for the benefits of others. Since stem cell–based pharmaceuticals need market approval regularly by the Commission of the European Union to enter the market, one must ask whether this European organ can have a different moral opinion on the European public order than the Court of Justice of the European Union. If the use of therapies based on human embryonic stem cells is permissible by official market approval, there would be a discrepancy between the moral value of human embryos in patent law and pharmaceutical law. On the one hand, techniques using human embryonic stem cells could not be patented; on the other hand, (same) techniques used to produce pharmaceuticals based on human embryonic stem cells could get official market approval.

Transfer of patent moral to pharmaceutical moral

First, the Court of Justice of the European Union reasoned that the purpose of the Biopatent Directive was to eliminate the possibility of patentability where respect for human dignity could thereby be affected. The court came to this conclusion since it referred to the preamble to the Patent Directive that states that although the directive seeks to promote investment in the field of biotechnology, use of biological material originating from humans must be consistent with regard for fundamental rights and, in particular, the dignity of the person. Recital 16 in the preamble to the directive, in particular, emphasizes that “patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person.” Since the court referred to the so-called “fundamental principles safeguarding the dignity and integrity of the person,” which are not just a matter of patent law, but also a matter of the entire legal system, such fundamental principles must also apply to pharmaceutical law. This is true all the more since both patent and pharmaceutical laws are laws of the same law maker.

Second, there is a technical relationship between the official market approval and the official patent granting. Both involve an official entity that grants either the patent or the market approval. The patent then gives to the patent holder a public-sanctioned monopoly for the industrial and/or commercial exploitation of the actual invention. The same is true for the market approval regarding pharmaceuticals. Here, the official entity, after evaluation of safety and quality of the pharmaceutical, grants at least indirectly the right to exploit the pharmaceutical industrially and/or commercially.

In conclusion, one must bring forward the argument that market approval for therapies based on human embryonic stem cells by European regulators must be linked to the Court of Justice's decision in the Brüstle case since both legal questions are governed by law of the same lawmaker, namely, the European Union, and refer to the same moral question, namely, the use of human embryos for the benefits of others. Therefore, it rather seems more consistent to expect the same moral standards in patent and pharmaceutical law. Finally, as long as inventions based on human embryonic stem cells cannot be patented because this is classified as a violation of the public order in terms of a violation of fundamental principles safeguarding the dignity and integrity of a person, namely, the embryo, the same must be true for pharmaceuticals based on human embryonic stem cells. Such pharmaceuticals may not be approved for the market—at least not as long as the safeguarding of the dignity and integrity of a person legally starts just with being a totipotent entity.

Future perspectives

If there will be therapies based on human embryonic stem cells to be approved for the market of the European Union, one must ask what would happen if the European Commission or a national regulator either grants or doesn't grant market approval with regard to moral considerations. Anyhow, the current situation for developers of such therapies is unclear whether they get market approval or not. Therefore, lawmakers are called to clarify whether therapies based on human embryonic stem cells are in compliance with current statutes or not. If such therapies are not in compliance with current law or if they will be prohibited, lawmakers must find a justification for this.

First, the Brüstle case made clear that there are nongovernmental organizations willing to file a suit to clarify the legal situation regarding human embryos. Second, the recent European Citizens' initiative “One of Us” showed that there is a civil movement to protect early embryos against any use for the benefits of others. ⁵ This initiative, formally supported by 2 million people in European Union, is the largest petition in European history. European Citizens' initiatives in general, which are guaranteed by European legislation, allow citizens of the European Union to call on the European Commission to propose legislation on matters of European Union competence. The initiative “One of Us” in particular aimed to juridical protection of the dignity, the right to life, and of the integrity of every human being from conception in the areas of European Union competence; therefore, the initiative demanded that the European Union no longer finances any practice that destroys human life before birth. On May 28, 2014, the commission vetoed this initiative. Amazingly, in its answer to the initiative, the commission did not say a word about future pharmaceuticals based on human embryonic stem cells.

However, if a therapy based on human embryonic stem cells gets market approval, it would a priori not be impossible that there would be attempts by a third party to get a judicial review up and running—potently again at the Court of Justice of the European Union. In that case, it would be amazing if the same court could have a different moral opinion on the purposeful destruction of embryos than it had before in patent law.

Way-outs?

Either one must accept a consistent public administration with same moral standards, which neither grants patents nor market approval for techniques, respectively, therapies based on human embryonic stem cells, or one must stand an opportunistic inconsistency, namely, having officially sanctioned market approval of therapies based on human embryonic stem cells, but no patents for this technology. This inconsistency will hardly be explainable to the public and inventors. Finally, it is society and the lawmakers who have to rethink the concepts of embryo definition and the legal protection of human embryos. As long as an embryo definition is solely based on the occurrence of totipotency in early embryos, as judged by the Court of Justice of the European Union, the above-mentioned consistency or inconsistency applies. Another consistent way-out to allow both patents and therapies based on human embryonic stem cells would be a consensual change in the understanding of when human life begins legally and its legislative implementing. This change would have to shift the current legal embryo understanding and/or embryo protection, which is based solely on the occurrence of totipotency, to the need of additional features occurring within the early development of human embryos, for example, implantation maturity or early neural differentiations.

Acknowledgment

The work presented in this paper was made possible by funding from the German Federal Ministry of Education and Research (BMBF 1315883).