Patenting human biological materials and data: balancing the reward of innovation with the <i>ordre public</i> and morality exception

Esra Demir is a PhD candidate at Erasmus School of Law and junior fellow at the Jean Monnet Centre of Excellence on Digital Governance. Evert Stamhuis is a full professor at Erasmus School of Law and senior fellow at the Jean Monnet Centre of Excellence on Digital Governance. The availability of human biological materials and data plays a key role in promoting biotechnological innovations and conducting biomedical research. While the function of patent rights in promoting innovation is widely discussed, there are still overarching concerns in patenting human biological materials and data, including triggering commercialization and commodification of the human body, precluding affordable access to the products or services and inducing interest extraction by patent holders to recoup investments and make excessive profits. This article aims to analyse the extent to which the ordre public and morality exclusion can protect the human being whose bodily material has been taken and prevent legal and ethical exploitation. We argue that the concept of ordre public and morality needs to be modified, sparking a new governance approach to better protecting human beings in a patent system that is more participatory, accountable and transparent in patent assessment. The patent system as a regulatory intervention of the state promotes the commercialization of a certain type of technology.1 Upon grant, the patent holder acquires exclusive rights to the commercial use of a technical invention for a period of up to 20 years.2 The focal point of the patenting process, which is a strictly technical process, is the question of whether the invention sufficiently fulfils the requirements for patentability to qualify for a limited monopoly.3 However, the patent system and its technical structure have been challenged by biotechnological inventions and their commercial application, and in particular, the debate on patentable material has become increasingly controversial. Historically, patenting human genetic materials dates back to the 1980s, yet the legitimacy of patentability and commercialization of these materials and data are still under debate.4 On the one hand, it is often put forward, although not without opposition, that the role of patents in the field of biotechnology stimulates innovation and promotes biomedical research and scientific progress for the benefit of society and mankind.5 As the physical embodiment of information about human nature, these materials and technologies have a wide range of applications in biomedicine today, such as next-generation sequencing, therapeutic companion diagnostics and prenatal diagnostics.6 On the other hand, numerous legal and ethical questions arise, putting the patentability issue on the public agenda.7 A clear answer must therefore be given to the question of whether patent rights can be granted on human biological material and data and, if so, to what extent safeguards to protect humans need to be in place. The goal is to arrive at a fair innovation atmosphere that balances patent rights with existing concerns such as the commodification and commercialization of the human body, fair and equitable access to technologies and so on.8 This topic is a matter of serious concerns that needs to be resolved as the number of patent applications related to human biological materials and data has steadily increased and continues to increase.9 This article aims to analyse the ordre public and morality exclusion in patent law to understand the extent to which such exclusion can protect the human being whose bodily material has been taken in the course of the R&D that led to the invention and thereby prevent legal and ethical exploitation. To this end, this article begins with an analysis of the patentability of human biological material and data under European patent law. It then analyses the ordre public and morality exclusion as a tool to prevent ethical and legal exploitation. Finally, it looks at the role of such exclusion in creating a balance between rewarding innovation and protecting human rights and values. Using legal doctrine, we argue that the concept of ordre public and morality needs to be modified and that there is a need for a new governance approach to better protect human beings in a patent system that is more participatory, accountable and transparent. In Europe, the patentability of human biological materials has been handled at the legislative level by the European Patent Convention (EPC) and Directive 98/44/EC on the legal protection of biotechnological inventions (Biotech Directive).10 The EPC, accepted on 5 October 1973, provides the general provisions on substantive patent law on what are patentable inventions, the exceptions to patentability and further patentability criteria.11 With biotechnological innovations on the rise in the last quarter of the 20th century, the patentability of certain inventions attracted public attention. As a result, the European Union (EU) started to get involved in the European patent area in order to ensure legal certainty around new (biotechnological) inventions.12 Therefore, the Biotech Directive was approved by the European Parliament and of the Council on 6 July 1998. The aim of this Directive is to provide effective and harmonized protection on biotechnological innovations through patent law.13 With this Directive, the protection of the inventions related to biological materials and the living matter has been brought into the field of patent.14 With the Biotech Directive regulating and protecting sensitive issues related to genetic inventions such as gene patents and human embryonic stem cells patents, the discussion about the scope of patentability has been stimulated.15 For example, in 2005, the EU Parliament passed a resolution on patenting biotechnological inventions, calling on the Commission to revise the Biotech Directive to consider human germ cells, human stem cells, human embryos and gene sequences as unambiguously unpatentable subject matter.16 However, this call has remained unanswered to date. The following subsections provide information on the general criteria for patentability in Europe and discuss the distinction between discovery and invention. These criteria play a crucial role in ensuring that the patent is granted on the basis of human ingenuity, and we will show further down that they are not available to absorb the concerns with ethics and human right that are central in this paper. In general, patentability criteria have been handled by both the EPC and the Biotech Directive.17 According to Article 52 EPC and Article 3 Biotech Directive, European patents shall be granted for any inventions, in the field of technology, which are new, involve an inventive step and are capable of industrial applicability. To meet the requirement of novelty, the invention must not have previously been disclosed to the public. In other words, if the invention does not form part of the state of the art, it can be considered as new.18 To meet the requirement of inventiveness, the patent applicants must be able to show that the invention is not obvious to the skilled person, a person well-informed and experienced about the subject matter.19 To meet the requirement of industrial applicability, the invention may be considered as industrially applicable if it can be made or used in any kind of industry.20 More specifically, the Biotech Directive states that inventions that meet aforementioned requirements shall be protected by patent law, even if they concern a product consisting of or containing biological material or a process for the production, processing or utilization of biological material.21 With respect to biotechnological inventions, identifying the distinction between discovery and invention is of great importance to ensure that the patent is granted on the basis of human ingenuity and not on the basis of nature itself.22 In general, discoveries are accepted as unpatentable because they are signified as a law of nature or product of nature that is found and described by researchers or scientists without a technical effect.23 This rule is enshrined in Article 5 of the Biotech Directive. According to this provision, The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.24 As can be seen, the mere discovery of the human body and bodily tissue such as gene sequence is excluded from patent protection.25 Accordingly, when the subject matter of patent protection is abstract in nature (discoveries) or non-technical in nature (scientific theories or methods for performing mental acts), it cannot be considered as an invention.26 Although, in theory, this distinction between discovery and invention looks clear, it may not be drawn clearly in the field of biotechnology.27 In principle, a previously unrecognized substance found in nature is a mere discovery, so it is not patentable material. However, according to the EU patent law, the substance may be accepted as a patentable subject matter if the technicality is revealed. For example, as mentioned in the European Patent Office (EPO) Guideline, if a gene, discovered in nature, has a technical effect, that effect may be patentable, eg, the use thereof in gene therapy.28 This issue is also clarified in the preamble of the Biotech Directive. According to Recital 21, the element isolated from the human body or produced is not excluded from the patentability. This is because these biomaterials are obtained by the technical processes used to identify, purify and classify them. Furthermore, the techniques used to reproduce them outside of the human body cannot be accomplished by nature itself.29 Human gene sequences are considered as a patentable subject matter as long as they are isolated or produced by using a technical process.30 However, non-isolated forms of genes cannot be the subject matter of patent protection.31 Furthermore, again in the same text, it is stated that a mere DNA sequence without indication of a ‘function’ is not assessed to contain any technical information, but accepted as mere essence found in nature, so it is not a patentable subject matter.32 Therefore, technicality is an essential precondition in Europe for characterization as a patentable invention, and furthermore, the technical effect of the invention needs to be disclosed in the patent application.33 In practice, one of the prominent cases related to drawing the line between discovery and invention involves the patents on BRCA genes, which have been hotly debated in both the EU and the USA. After the discovery in the 1990s of the precise location and sequence of two human genes, namely, BRCA1 and BRCA2, on chromosomes 17 and 13, mutations of which significantly increase the risk of breast and ovarian cancer, Myriad Genetic Inc. has been granted several patent rights. With this, Myriad has had exclusive rights to isolate an individual’s BRCA1 and BRCA2 genes and to synthetically create complementary DNA.34 In Europe, between 2001 and 2004, the EPO granted patents to BRCA genes.35 After obtaining patent rights, Myriad Genetic Inc. reached out to the European healthcare providers to suggest them licences. However, the licensing terms required that European healthcare providers send the DNA samples to Myriad’s laboratories rather than allowing licensees to perform the tests by themselves.36 Therefore, the oppositions against the BRCA patents started to arise in Europe, in the early 2000s, and many scientists and laboratories filed oppositions against the EPO.37 The grounds for these oppositions essentially focused on the question of whether it was a mere discovery and thus not an invention. In other words, it was a question of whether the general patentability criteria were met, particularly with regard to the requirements of inventive step and industrial applicability.38 In addition, there were concerns about access to diagnostic tests at fair and reasonable prices and also about the difficulty of confirming test results and finding low-cost (alternative) tests, given Myriad’s monopoly position in the market.39 This has resulted in Myriad Genetics holding only a handful of very narrow patents in Europe.40 Likewise, on 13 June 2013, the US Supreme Court held that a naturally occurring DNA segment is not patent-eligible material.41 The case of the BRCA genes shows the difficulty in drawing the distinction between discovery and invention in the patent procedure. In addition, given the current state of biotechnology and its impact on the function of identifying specific genes, it is increasingly difficult to meet general patentability requirements, in particular, the criteria of involving an inventive step and being susceptible to industrial application.42 From the above, it can be concluded that the key question here is whether the subject matter is indeed an invention and not just a discovery.43 However, the complexity of determining patentable subject matter creates legal uncertainty.44 This issue remains particularly important because inventions involving human biological material and data have been the subject of ongoing patent disputes over the ownership of such technologies.45 Therefore, it is important to analyse the protection mechanisms embedded in the normative framework against legal and ethical exploitation. 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