Case note: Brüstle v. Greenpeace

By: Francisco Campoamor Valderrama

Introduction

The case Brüstle v. Greenpeace[1] is monumental due to the far-reaching implications the holding may have that go beyond the scope of the preliminary question presented to the Court of Justice of the European Union (hereinafter, “E.C.J.” or “the Court”). The determination made by the Court sets forth a moral agenda that permeates not just European Union (“E.U.” or “Union”) patent law, but notions of morality and ethics at a E.U.-wide level. Because of the powerful potential that stem cell research has to heal and treat neurological disorders, we are confronted with a case that impacts not just E.U. citizens, but also the collective human patrimony. In an analysis that will extend beyond patent law, this paper will explore and come to understand just how far-reaching the consequences of the Brüstle decision really are.

Factual and Legal Background

The legality concerning stem cell research in Europe is fragmented in terms of how far Member States can go, and the fact that stem cell research itself is not illegal under E.U. law.[2]Member states like Belgium, Sweden, Spain, and the United Kingdom are enthusiastic proponents of research in the field, all having passed domestic legislation that allows therapeutic cloning of stem cells and encourages scientific investment in the matter.[3] However, other States have applied more restrictive policies. Italy, for example, does not allow the domestic cloning of stem cells, but does allow for the importation of biological material from foreign states where that process is legal.[4] Indeed, some states like Germany, with a particular cultural aversion to medical experimentation on human tissue stemming from the horrors of World War II, have completely outlawed the creation of stem cells.[5] However, for the most part, research can be conducted as long as certain conditions are met, like Italy’s requirement for the external procurement of such cells, or like Germany’s allotment of the importation of stem cells for research as long as they were produced before May 1st, 2007.[6]

As it is in the usual course of things regarding scientific discovery, such research is often accompanied by the application of patents to the methods and discoveries involved in the matter. Patents play an important part in scientific research because they allow for the time-limited monetization of technologies, which in turn serve as an incentive for important economic investors to supply financial aid to these projects.[7] In other words, capital investors invest in scientific research based on the premise that they will be able to charge for their use as a way to regain their investment. Without the promise of economic gain, scientific research tends to dry up and development consequently stalls.

Recognizing the huge potential behind stem cells and their medical use, the E.U. acted relatively quickly in order to provide a healthy environment for research to happen across the Union. Accordingly, in 1998, Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions (hereinafter “Biotech Directive”) was passed, with the intention of encouraging investment in the field, and harmonizing the differences among the laws and practices of Member States regarding the biotech industry.[8] Article 1(1) of the Biotech Directive calls for Member States to protect biotech inventions under national patent law.[9] While understanding the ethical intricacies of the field, the Directive also set limits on what is patentable and what is not. Therefore, inventions that are new and require an inventive step are patentable, as well as biological material isolated from its natural environment.[10] On the other hand, the Biotech Directive also states that the human body, throughout the various states of its development, cannot be patented.[11] It is, however, Article 6 of the Directive that is of concern to us, as it is the clarification of this article that is being sought in the questions before the Court. Article 6 states that any invention whose commercial use would be contrary to ordre public shall not be patentable, specifically, “uses of human embryos for industrial or commercial purposes.”[12]

It is with this backdrop that we analyze the E.C.J.’s 2011 Grand Chamber judgment in Oliver Brüstle v. Greenpeace e.V. The Brüstle case is not one where the legality of research regarding stem cells is questioned; instead, the Court must decide if this research is patentable under European Union law.[13] Dr. Oliver Brüstle is a German neuropathologist from the University of Bonn who, in September 1997, successfully applied for a patent regarding the isolation and production of neural precursor cells, as extracted from embryonic stem cells originating from Israel.[14] In 2004, the environmental activist group Greenpeace filed suit challenging the validity of the patent, claiming that because the stem cells extracted by Dr. Brüstle originally came from human embryos, such practice went against notions of ordre public as codified in E.U. and domestic law.[15]

The technologies patented by Dr. Brüstle held significant promise in the treatment of patients with neurological disorders like Parkinson’s diseases or Alzheimer’s syndrome, mainly through the transplantation of neural cells into the nervous system of those afflicted.[16] Moral and ethical concerns are raised, however, due to the process by which this treatment was ordinarily brought about. In order to acquire these neural precursor cells, they had to be extracted from the cerebral tissue of human embryos, a process that destroys the embryo as a whole.[17] Nevertheless, Dr. Brüstle offered a new approach, as the technology that he patented allowed for the extraction of such cells from pluripotent embryonic stem cells. Because pluripotent cells are those that have the biological potential of developing into any kind of specialized cell,[18] Dr. Brüstle’s method offers a way to resolve the problem of producing a practically unlimited quantity of neural precursor cells, without the destruction of cerebral tissue from a developed embryo.[19]

Greenpeace challenged the patent in question before the German Federal Patent Court, which ruled that the patent was invalid regarding the use of precursor cells obtained from human embryonic stem cells and the processes used to obtain them, according to national German law.[20] This determination was subsequently appealed by Dr. Brüstle before the German Federal Court of Justice, which in turn applied for a preliminary reference before the E.C.J.

The Legal Questions

Before the Court, three questions were presented, all seeking greater clarity regarding the interpretation of the Biotech Directive. The first question presented to the Court was about the meaning of the term “human embryo” as stated in Article 6(2)(c) of the Biotech Directive, and how wide of an interpretation it must be afforded.[21] The Court noted the importance of settling a uniform definition of a legal term when Member States have not been delegated the responsibility to do so, which is the case here.[22] Further, it is important considering the harmonizing intention behind the directive; if different interpretations of the meaning of “human embryo” were to exist among the Member States, the smooth functioning of the internal market would be hampered with different patent standards across the E.U.[23]

Seeking such a standard definition is, however, complicated, as the moral implications of the issue conflict with the fact that Member States have different opinions as to when life begins. It is interesting to note that both the Advocate General Bot (hereinafter “A.G.” or “Bot”) in his opinion,[24] and the Court in its judgment, warn that this will be an objective legal analysis without any moral determination.[25] However, this determination is anything but moral. How the Court can pretend that this determination exists in a vacuum is troubling, since defining the concept of life is inherently a moral imposition, especially considering that both the A.G. and the Court achieve this notion based on the premise that there is a lack of consensus regarding the starting point of life in the scientific community.[26]

The Court thus finds that the concept of “human embryo” begins at the moment a human ovum is fertilized, because it has commenced the process of developing into a human being.[27] This definition is further applied to a “non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis.”[28] Regarding stem cells obtained from human embryos at the blastocyst stage, that determination is left up to Member States.[29] The A.G. makes an interesting observation regarding exactly what is being asked. Rather than discussing the different theories about the beginning of life, he instead delves into analyzing when the human body begins to develop, for it is the human body that demands respect and protection.[30] Further, he states that science can give us an understanding of the biological processes surrounding human conception, but it cannot tell us “when the human person truly begins.”[31] Assertions such as these are concerning because no doubt the scientific community would disagree. Furthermore, it is a bold step for the Court to claim this, as it is a purely scientific determination, when instead the Court should be limited to legal findings.

The second question before the Court is in regards to the meaning behind the phrase “uses of human embryos for industrial or commercial purposes,” and if an exception exists for scientific research.[32] As stated earlier, the granting of patents is important from a research point of view, as they often guarantee a source of funds for scientific discovery. The Court, rightfully so, states that a grant of patent is clearly demonstrative of an industrial or commercial intent,[33] and that despite any scientific research purposes, the subject matter of a patent cannot be separated from the rights a patent confers.[34] However, the Court does not seem to give a satisfying argument as to why this must be, and the A.G. only offers the contention that a grant of patent inherently implies the mass production of stem cells, and thus the destruction of large numbers of embryos.[35] It is surprising then that the Court did not take the opportunity to establish a scientific research exception, especially when one considers that the invention offered by Mr. Brüstle reduces the number of embryos needed to begin with. Moreover, encouraging such research can only contribute towards the development of future technologies that reduce the destruction of embryos even more.

The third question before the Court essentially asks if an invention is non-patentable even if it does not directly utilize human embryos, but rather, involves materials or ingredients obtained by the prior destruction of human embryos.[36] The Court finds that an invention must be ruled as non-patentable if any of the necessary steps regarding its implementation result in the destruction of human embryos, or if the invention is used in the destruction of future embryos.[37] This last conclusion is the logical result of the Court’s answer to the first two questions. By answering as such, the Court prevents a loophole by which applicants could evade the terms of patentability as set forth above through the ingenious wording of the patent application.

Analysis

The Opinion of the Advocate General

The judgment of the Court closely followed the preliminary determination put forward by Advocate General Bot in his Opinion, who explained in deeper detail, relative to the final judgment, the reasoning behind his findings. Thus, they are worth noting.

In a preemptive strike against future potential counterarguments that the scientific community might have, A.G. Bot dismisses notions of creating technology gaps between the E.U. and its closest technological rivals, the United States and Japan, as irrelevant to matters at hand.[38] Bot further notes that patentability and research are not intertwined concepts, and a negation of one would not foreclose the other.[39]These, however, are observations that fall too deeply into the realm of the ideal, and escape the reality that without the economic advantages that patents provide, scientific research on the matter will surely fall behind as investors prove reluctant to invest funds in a sector that will provide no returns. Any possible counterarguments Bot might have towards this position are met with the fact that he himself found the controversy at hand to be mired in notions of ordre public, as the relevant Biotech Directive clearly stated in its recital 16.[40] Indeed, Bot expressly relies on the notion that the E.U. is not just a market to be regulated, but one that has values worthy of being expressed.[41]

The political evolution of the Union has certainly reflected this supposition, not to mention countless Union-wide legislation, case law and constitutional provisions that have extended the E.U.’s purview far beyond economic interests. This is a positive factor, for Europeans and the global order as a whole stand to benefit from the collective expression of European will. However, it is interesting to note the Brüstle decision creates a roadblock for significant scientific progress, instead choosing to place a higher value on perceived notions of collective morality in sacrifice of the objective scientific good.

Notions of Common European Morality

Through this ruling, the Court takes upon itself the difficult task of laying down a Union-wide definition of “human embryo.” Because there is no agreed definition of what that means among Member States, nor is there a consensus as to the moral status of such definition, this is a difficult proposition to make.[42] Member States do not agree as to when an embryo gains full moral status as a human, opinions varying from holding that it does so either from conception or some time afterwards; nor is there consensus regarding the degree of rights conferred on the embryo depending on the elapsed time.[43] A previous Court case concerning the Biotech Directive took this into consideration, when in Netherlands v. European Parliament and Council[44] it was held that Article 6(1) of the Directive allowed Member States a wide margin of appreciation when it came to applying the exclusion, in order to take into account the difficulties regarding a uniform application of the definition when each state had a different social and cultural context.[45]

A.G. Bot however, in his opinion, does seem to lay the foundations for a common European concept of morality regarding this determination, finding that the creation of embryos for the sole purpose of being destroyed would not be consistent with the concept of ordre public and morality as shared by all Member States of the Union.[46] In reaching this conclusion, he cites Articles 1 and 3(2) of the Charter of Fundamental Rights, which state that human dignity is inviolable and should be protected against any potential use for financial gain.[47] In other words, the A.G. held that inventions involving the destruction of human embryos are immoral, and therefore against E.U. law. This is a blatantly moral stance.[48] This position also goes against standard industry practices, which usually allow such research on embryos as long as they are 14 days old or younger.[49]

The Brüstle judgment is also difficult to analyze due to its mercurial approach and its failure to sustain its moral stance on notions of Fundamental Rights, as Bot did in his opinion. To deny that it is entering a moral discussion in its decision, but failing to engage with current scientific information, all the while under the pretext of it being “a purely legal analysis,” can be problematic. Furthermore, failing to engage with any relevant legal authorities that might have been of use, like notions of human dignity as referred to in E.U. constitutional ideals, or relevant jurisprudence from the European Court of Human Rights, also seems contradictory.[50] Instead, the Court seemed content with the judgment and its decision that a Union-wide definition was needed based on the doctrine that “terms of E.U. law which do not reference the law of a specific Member State must be given an independent and uniform interpretation throughout the European Union, and that the term ‘embryo’ . . . is such a term and so falls within this general rule.”[51] We are thus left with a decision that applies the concept of “human dignity,” another term hardly discussed by the Court in its decision,[52] to the collections of cells that in no way resemble human beings.

European Patent Law

Patent law has traditionally been seen as an objective field of law in which scientific understanding of the matter at hand rules the decision-making processes. This encapsulates the theory that patents do not offer positive rights, i.e. the right to use your invention.[53] Rather, patents hold a negative right, in that they grant you use of an invention at the total exclusion of others.[54] Consequently, merely holding a patent says nothing about the holder’s intent to use it; instead, it serves as a signal to the world that no one can profit from the same technology as protected by that patent law. In other words, having a patent does not inherently imply its use. As such, it is not for the patent system to evaluate the moral and ethical concerns raised by its protection, as that is something best delegated to the legislature, who can indeed rule that the use of some piece of technology is illegal.[55] However, even if a government states that using a particular technology is illegal, the patent remains in place and that technology remains protected. Scholar Enrico Bonadino disagrees with this statement, holding that patent officers should evaluate the moral aspects of the inventions presented to them, as patents should reward innovations useful to our society.[56] Such views do not move this author, as these are determinations that are better left to a more direct interpreter of the will of the people, like elected officials that can better serve as social barometers regarding public notions of what is right and what is wrong.

The Brüstle decision appears to signify a departure from this traditional notion of patent law. The ruling implies that patent law can no longer remain isolated from the ethical concerns raised by the invention, and further, patent officers are now tasked with evaluating the moral and ordre public considerations of these inventions.[57] This raises further questions, as it is not clear what should guide patent officers from coming to such conclusions. Furthermore, the ruling seems to suggest that the inception of an invention should be evaluated when judging its morality, as is the case at hand when it was concluded that such patents are illegal only if they entail the prior destruction of human embryos. However, the ruling tells us nothing of how “far back” one must go in applying this analysis to other inventions. For example, a product manufactured through illegal child labor in a faraway land. Surely, child labor is seen as reprehensible in the E.U. and elsewhere, but we doubt the technology would be refused a patent based on the workplace conditions the local manufacturers face; otherwise industries involved in clothing and accessories would collapse. The A.G. came to the same observations as well.[58] Nonetheless, they were not cited or considered in the final judgment. Hence, we are again reminded that this is a case that offers more questions rather than answers.

Comparative Analysis Biotech Patents in the United States

The stakes are high for Europe, as the Brüstle decision leaves the region in a perilous position in terms of the Union’s potential to be a leader in the field. Stem cell research is not only an area where serious scientific advances can be made, but it is also a highly profitable one. It is predicted that the overall global market for stem cell technologies will reach $7.3 billion in 2014.[59] As a result, understanding the particularities of the stem cell market after the Brüstle decision in comparison with the Union’s largest competitor, the United States, is of particular importance.

As we have seen, the human body, at any stage of its development, cannot be patented under European law. In the United States however, these patents are subject to a much more lenient interpretation. 35 U.S.C. §101 tells us 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.”[60] It can then be inferred that there are four categories of patentable material: processes, machines, methods of manufacturing, and composition of new matter.[61] Supreme Court jurisprudence has further narrowed down exceptions in relation to the laws of nature, natural phenomena, or abstract ideas.[62] These exceptions were laid out in an even plainer manner in 1980, when the Supreme Court stated: “Congress intended statutory subject matter to ‘include anything under the sun that is made by man.’”[63] Because §101 makes no mention about ordre public, nor any other legislation or case law, stem cell and human cloning inventions are considered patentable in the United States.[64]

The only other avenue for ordre public considerations to be entertained in the United States is through the Manual of Patent Examining Procedure (hereinafter “MPEP”), which contains the following clause: “[I]f the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. §101 must be made indicating that the claimed invention is directed to nonstatutory subject matter.”[65] However, it does not seem that U.S. Patent Officials view stem cells as falling under these guidelines, although that might change with future potential amendments to the patent code.[66]

In terms of public financing, under the previous Bush administration, the executive branch placed strong restrictions on stem cell funding that seriously curtailed research in the field during the eight years of his presidency.[67] However, under the Obama administration, the federal government has enacted a full reversal, and by virtue of an executive order given in 2009, all federal restrictions on stem cell research have been lifted, allowing funding levels to substantially rise.[68] Thus, what was once Europe’s scientific garden, enjoying the advantage of state support for research, as well as a patent system favorable to scientific discovery, has now turned barren. Europe, not having the competitive edge in the field, has now fallen behind as an industry and research leader in an area that holds much promise in the development of cures and medicines for afflictions that have traditionally been hard to treat. Because the research in question does indeed have the potential to aid all those around the world and not just Europeans, this must not be seen as a negative incident, as the research is still being done. The problem lies in the fact that while the United States holds no such restrictions on stem cell research, this is subject to change at the whim of Congress, which currently holds a particularly conservative composition. If and when such legislation happens in the United States, stem cell research might then come to a considerable halt, as the two biggest contributors to sciences will not have the legal bases to adequately serve as leaders in the field.

Conclusion

            As we have seen discussed above, the European Court of Justice, in the Brüstle case, handed down a judgment of imperative legal consequences. For the first time, it was being asked to interpret the definition of “human embryo” as defined by the Biotech Directive. As a result, the Court decided that such a concept applies from the moment a human ovum is fertilized. Further, any invention that necessitates the prior destruction of human embryos cannot be patented under E.U. law. Unfortunetly, the purpose of such patents, be it an academic or scientific pursuit, is not enough to exclude them from this provision, effectively curtailing the scientific community’s preferred way of guaranteeing economic investment in its development.

            This decision has had far reaching ramifications. Despite the judgment’s warning to the contrary, it set a uniform moral standard regarding the issue of stem cell research across the Union, imposing a definition that does not hold a majority view, and making unpatentable what has been recognized to be legal in many Member States. It further failed to establish a scientific inquiry exception to European patent law, instead turning the Patent Officer into a moral arbiter for society, a determination that should be in the hands of representatives closer to the people. Finally, but not exhaustively, it put Europe at a significant disadvantage as an economic and scientific leader in an area of great promise in terms of health services and capital creation. This is a tenuous position to be in, because while the United States remains a comfortable place to conduct stem cell research, the passage of adverse federal legislation might eliminate the patentability of stem cell technologies. The E.U. has taken a dangerous turn, and this author only hopes that A.G. Bot’s promise,[69]regarding the reversibility of the decision in light of further scientific advances relating to the determinations herein laid out, turns out to be genuine.


[1] Case C-34/10, Oliver Brüstle v. Greenpeace e.V., 2011 E.C.R. I-9849 (hereinafter “Brüstle”).

[2] For an overview on the different policies amongst the Member States, see Euro Stemccell, About Stemcell: Regulation of Stemcell Research in Europe, EURO STEMCELL, http://www.eurostemcell.org/stem-cell-regulations, (last visited on April 11, 2015); Also see Council Directive 1998/44 of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, 1998 O.J. (L 213) 13 (EC)

[3] Michelle Ralston, Stem Cell Research Around the World, Pew Research Center – Religion & Public Life Project (July 17, 2008), http://www.pewforum.org/2008/07/17/stem-cell-research-around-the-world/.

[4] Id.

[5] Id.

[6] Id.

[7] For a discussion on this dynamic, see World Intellectual Property Organization, Economic Deveopments and Patents, WIPO, http://www.wipo.int/patent-law/en/developments/economic.html, (last visited on April 4, 2015).

[8] Council Directive 1998/44 of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, 1998 O.J. (L 213) 13 (EC) [hereinafter Biotech Directive], ¶ 3-5.

[9] Id. art. 1(1), at 18.

[10] Id. art. 3, at 18.

[11] Id. art. 5, at 18.

[12] Id. art. 6(2)(c), at 18.

[13] Brüstle, 2011 E.C.R. I-9849, ¶ 40.

[14] Verdict in the Brüstle vs. Greenpeace Case, Stem Cell Network North Rhine Westphalia (Dec. 18, 2012), http://www.stammzellen.nrw.de/en/latest-news-press/latest-news/details/article/urteil-in-der-streitsache-bruestle-vs-greenpeace.html.

[15] Id.

[16] Brüstle, 2011 E.C.R. I-9849, ¶ 16.

[17] Id. ¶ 17.

[18] Id. ¶ 18.

[19] Opinion of Advocate General Bot, Case C-34/10, Oliver Brüstle v. Greenpeace e.V., 2011 E.C.R. I-9825, ¶ 31 (hereinafter “Opinion of the Advocate general Bot”).

[20] Brüstle, 2011 E.C.R. I-9849, ¶ 19.

[21] Id. ¶ 23.

[22] Id. ¶ 26.

[23] Id. ¶ 28.

[24] Opinion of Advocate General Bot, Brüstle, 2011 E.C.R. I-9825, ¶ 45.

[25] Brüstle, 2011 E.C.R. I-9849, ¶ 30.

[26] Opinion of Advocate General Bot, Brüstle, 2011 E.C.R. I-9825, ¶ 47.

[27] Brüstle, 2011 E.C.R. I-9849, ¶ 35.

[28] Id. ¶ 36.

[29] Id. ¶ 37.

[30] Opinion of Advocate General Bot, Brüstle, 2011 E.C.R. I-9825, ¶ 72-73.

[31] Id. ¶ 80.

[32] Brüstle, 2011 E.C.R. at I-9849, ¶ 23.

[33] Id. ¶ 41.

[34] Id. ¶ 43.

[35] Opinion of Advocate General Bot, at I-9846, ¶ 114.

[36] Brüstle, 2011 E.C.R. at I-9874, ¶ 47.

[37] Id. ¶ 49.

[38] Case C-34/10, Opinion of Advocate General Bot, Oliver Brüstle v. Greenpeace e.V., 2011 E.C.R. I-9825, 9834, ¶ 41.

[39] Id. ¶ 44.

[40] Id. ¶ 45.

[41] Id. ¶ 46.

[42] Shawn H.E. Harmon & Graeme Laurie, Case Comment, Dignity, Plurality and Patentability: The Unfinished Story of Brüstle v. Greenpeace, 38 Eur. L. Rev 92, 95 (2013).

[43] Id.

[44] Case C-377/98, Netherlands v. European Parliament and Council, 2011 E.C.R. I-07079.

[45] Harmon & Laurie, supra note 42 at 96.

[46] Enrico Bonadino, Case Comment, Biotech Patents and Morality after Brüstle, 34 Eur. Intell. Prop. Rev. 433, 435 (2012).

[47] Charter of Fundamental Rights of the European Union arts. 1 and 3(2), 2000 O.J. (C 364) at 9.

[48] Bonadino, supra note 46.

[49] Id.

[50] Harmon, supra note 42.

[51] Id.

[52] Id. at 96 – 97.

[53] Bonadino, supra note 45.

[54] Id.

[55] Id.

[56] Id. at 436.

[57] Bonadino, supra note 45, at 435.

[58] Opinion of Advocate General Bot, at I-9844, ¶ 106.

[59] Ulrich Storz, The Limits of Patentability: Stem Cells, in Limits Of Patentability: Plant Sciences, Stem Cells And Nuclear Acids, Springerbriefs In Biotech Patents 9 (Springer Berlin Heidelberg 2013).

[60] 35 U.S.C. §101.

[61] Storz, supra note 59 at 12.

[62] O’Reilly v. Morse, 56 U.S. 62 (1853).

[63] Storz, supra note 59, at 13 (citing Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980)).

[64] Id. at 13.

[65] Id. at 19.

[66] Id. at 20.

[67] Id. at 22.

[68] Id. at 23.

[69] Opinion of Advocate General Bot, at I-9835, ¶ 48.

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