Earlier this month, the Australian High Court unanimously ruled that an isolated gene code was not a ‘patentable invention’ (D’ARCY v Myriad Genetics Inc & ANOR  HCA 35). It echoed the US Supreme Court decision in Myriad in 2013. In this case the genetic diagnostic patent BRCA 1 was decided invalid, yet BRCA 1 has long been used exclusively by Myriad Genetics in the genetic diagnostic testing market for detecting breast cancer and ovarian cancer. From the 1980s, the US courts have been adopting a broad ‘everything-under-the-sun-is-patentable’ approach to granting biotech patents after the Diamond v Chakrabarty case. It is after the Myriad case, in conjunction with Mayo v Prothemeus and the Alice case, that we observe a shift towards narrowing down the scope of patentability, all suggesting a need to redress the imbalance between individual monopolistic rights and social responsibilities in the intellectual property (IP) system. In an East Asian Confucius setting the individual’s responsibilities have been hailed as paramount to their intrinsic value and their contributions to society. It is from within the family or the community that an individual is shaped and thus, when considering the role and the rights of an individual, the impacts or implications on the community would need to be reflected upon. I still remember an old slogan: ‘Ask not what your nation has done for you; but ask yourself what you have done for your nation’. Against this backdrop the rights of an individual are never absolute. As an immigrant to the UK myself, one of the major cultural shocks has been the comparative wide array of ‘rights’ as opposed to ‘responsibilities’ in the Western world. Due to the fact that balance and equilibrium have been embedded in my philosophy, I am at times disoriented with the over-emphasis of ‘rights’ and the absence of corresponding associated ‘responsibilities’ towards society. Various alleged rights could be claimed under the heading of human rights and human dignity. Most of the time the alleged rights are sensible, while others do require a bit of imagination. In this post I will be delineating the contour of IP responsibilities particularly in the context of patents and 3D printing health technologies. I will introduce a balanced IP formula which requires the organic interplay between IP rights and IP responsibilities (IPR2).
Medical applications of 3D printing
Throughout history and across the globe, human beings have been constantly trapped in the restless pursuit of a better, longer, or even perpetual life. In this digital age, while healthcare can now be delivered by digitisation, the possibility of scanning and reproducing oneself is not so remote. Recently, scientists reproduced human tissues, skins, bones, and even organs in the laboratory via 3-Dimensional printing technology (3D printing). 3D printed organs (such as a bladder derived from autologous cells) have been implanted into patients’ bodies. Although the technology to print off a fully-functional complex organ, such as the heart or kidney, would need at least 15-20 years to mature, scientists are now able to print liver cells on-chip for use in drug toxicity tests. By significantly reducing the cost of clinical trials, new drug innovation would be more efficiently accelerated compared to traditional clinical trials which involve human subject research. It is anticipated that once the printing technologies are ready to replicate and to implant a fully-functional organ into the human body, patients would not have to be put on a long waiting list for organ implantation. This could relieve the Government’s health burden by resolving the shortage of transplantable human organs on the market.
Barriers and access to technology
Yet there is no free lunch on the market. Scientists have already been securing monopolies over these technologies by attracting royalties that must be paid by those who want to use these patented 3D printing technologies as a medical device to print an organ. In the end the price would not necessarily be as affordable as we would like. Looking back at the access to medicines (ATM) campaign and the BRCA 1 and BRCA 2 genetic diagnosis technology in recent patent history, the conflicts between intellectual property rights (IPRs) and the human right to health have been repeatedly threatening the justification for individual private ownership over intangible intellectual property. For those fortunate or rich enough to afford the patented drugs, or patented diagnostic technologies, like Angelina Jolie, a bad medical report does not necessarily mean the end of the world. But for those less fortunate or deprived, receiving a negative medical report would be tantamount to hearing a death sentence. This is why legitimacy of patent exclusivity is being mooted. Is it legitimate to grant monopolies over key technologies which could save lives? Is it okay to block the way to recovery when scientists are given the key to cure? To what extent is the commercialisation or instrumentalisation of such technologies justifiable? Should monopolies be absolute? What are the associated social responsibilities accompanying individual ownership once granted? While patent monopolies are indeed a critical tool for innovation, over-protection will surely stifle creativity and have a detrimental effect on competition and access to information. In the EU, there is a morality clause in determining patentability, though the lack of clarity in defining morality often leads to a superficial application of the test. In the Harvard/Onco-mouse case it was held that, from a utilitarian perspective, a patent could be granted as long as the benefits to human kind outweigh the sufferings of the animal and that an ‘abhorrent’ threshold was introduced to the suffering/benefit test. The ‘abhorrent’ test is obviously based on the perspective of a reasonable European citizen, perhaps from a middle-class background, but not specifically the view of a reasonable man from a deprived community in other jurisdictions, let alone the abhorrent feelings mice would experience when injected with cancer cells for the purpose of being used as an experimental tool. In a globalised market, it would be intriguing to find out what a universal ‘abhorrent’ threshold is like, if any such thing exists. Recent cases WARF/Stem Cells, Brustle v Greenpeace, International Stem Cell Corporation v. Comptroller General of Patents, Designs and Trade Marks, further examined the interpretation of morality through the lens of the definition of a human embryo – whether human embryonic stem cells (HESCs) were involved in the development of technology. The European Patent Convention (EPC) also provides another limitation to patentability: the medical treatment exemption. Yet the interpretation of medical treatment, again, leads to a rather restrictive approach in filtering patentability.
A balanced IP formula: IPR2 = IP rights + IP responsibilities
The unique social and bioethical implications of medical 3D printing technologies demand more holistic reflections on the role of patents. IP rights are not absolute but, rather, form a social contract comprising ‘gives and takes’. These should dance with IP responsibilities constantly carving and fine-tuning each other for the optimal balance of IPRs. IP responsibilities are expected to be discharged in tandem with the granting of monopolistic IP rights. Upon receiving exclusivity rights, right holders are obliged to fulfill their social responsibilities of benefit sharing, diffusion of technology and technology transfer embedded in the WTO Agreement on Trade Related-Aspects of Intellectual Property Rights (TRIPS Agreement). In the same vein, the UK Nuffield Council on Bioethics has proposed a ‘Public ethics’ approach as opposed to the traditional piecemeal ‘individual interests’ approach, in relation to biotechnology innovation and regulation. Economists including Joseph Stiglitz and Keith Maskus also reflect on the inefficiency of over-reliance on the patent system for innovation. A portfolio approach, or a comprehension approach, is proposed to complement the downsides of patent monopoly. Patents are not the sole solution for research and development of science and technology. Instead, alternative types of incentive such as prizes and government funding are desirable in order to foster an efficient market. From the history of extending the terms of IP protection as well as the new extended terms of IP protection in bilateral and regional trade agreements, there are ongoing initiatives to consolidating market exclusivity. There seem to be increasing hurdles to taking advantage of the full flexibilities of IP, yet a sustainable IPR system would require mutual underpinning of IP rights and IP responsibilities in order to strike a balance between IP rights and human rights to health.
Phoebe Li is a Lecturer in Law at Sussex Law School. She is currently working on intellectual property for digital health and 3D printing. Her papers may be downloaded at: http://ssrn.com/author=2009958.