International Tale on Gene Patents - between Medical and Legal Uncertainties / Cuento internacional sobre patentes genéticas: entre la incertidumbre médica y jurídica

This work is inspired by the international litigation chronicle of Myriad Genetics that remains of topical importance in the judicial and academic discourse regardless of the time that passed since. It discusses approaches of various jurisdictions to the problem of gene patenting as well as patenting of geneticdiagnostic testing. The article takes under scrutiny the judgments rendered in the U.S., Australia as well as the decisions by the European Patent Office and placesthem into interdisciplinary background of genetic science. The issue is significant, both theoretically and practically. Notwithstanding the expiration of patents that constituted the subject matter of the Myriad’s various lawsuits, the problem still remains currently relevant. Firstly, because the judgments in individual cases did not answer all the questions, but – in some way – only prepared a path for future decisions. Secondly, it is on account of new scientific breakthroughs in the area of human genetics. Consequently, the domain of genetic diagnostics is under continuous development and in the future may continue to reveal new scientific discoveries and (possibly) inventions. The lack of uniform and transparent rules in this field, and well-defined boundaries for potential monopolies constantly brings not only uncertainty for medical practitioners and scientists, but also real disadvantagesfor the patients. (AU)

Esta obra se inspira en la crónica del litigio internacional de Myriad Genetics, que sigue siendo de actualidad en el discurso judicial y académico a pesar del tiempotranscurrido desde entonces. En él se examinan los enfoques de diversas jurisdicciones sobre el problema de las patentes de genes, así como de las patentes de pruebas de diagnóstico genético. El artículo examina las sentencias dictadas en Estados Unidos y Australia, así como las decisiones de la Oficina Europea de Patentes, y las sitúa en el contexto interdisciplinario de la ciencia genética. La cuestión es importante, tanto desde el punto de vista teórico como práctico. A pesar de la expiración de las patentes que constituyeron el objeto de los diversos pleitos de Myriad, el problema siguesiendo de actualidad. En primer lugar, porque las sentencias dictadas en los casos individuales no respondieron a todas las preguntas, sino que –en cierto modo– sólo prepararon el camino para futuras decisiones. En segundo lugar, debido a los nuevosavances científicos en el ámbito de la genética humana. En consecuencia, el ámbito del diagnóstico genético está en continuo desarrollo y en el futuro puede seguirrevelando nuevos descubrimientos científicos y (posiblemente) invenciones. La falta de normas uniformes y transparentes en este ámbito y de límites bien definidos para los monopolios potenciales no sólo genera constantemente incertidumbre para losmédicos y científicos, sino también desventajas reales para los pacientes. (AU)

Framing Ethical Concerns and Attitudes towards Human Gene Patents in the Chinese Press.

This study examines the representations of human gene patents in Chinese newspapers. We conducted a qualitative content analysis of news articles published between 2006 and 2017 to identify the major themes in media coverage, ethical considerations, perceptions of risks and benefits, and attitudes towards the patentability of human genes. The results show that two key ethical concerns were expressed by journalists: (1) that it is morally wrong to own or patent human genes and (2) that gene patents could potentially impede patients' access to healthcare services. Nonetheless, the press coverage has tended to be largely favorable (57.8%), rather than opposed (17.8%) to human gene patenting. There were no normative claims that human genes should not be patentable in China, which indicates a generally positive attitude towards patentability in media discourse. Most articles that expressed criticism toward gene patenting discussed challenges in other countries, with significant attention given to the United States Supreme Court's ruling in the Myriad case that invalidated Myriad Genetics' patents on the BRCA1 and BRCA2 genes. Overall, the newspapers were uncritical of the Chinese gene patenting regime. News reporting on the issue was highly suggestive of a strong pro-commercialization stance, although some discussions emphasized potential risks over benefits. Our analysis highlights the need for balanced media reporting on human gene patents in China and a top-down approach to engage the public in substantive discussions on the ethical and societal implications of the existing patent regime.

Patenting human genes: Chinese academic articles' portrayal of gene patents.

BACKGROUND: The patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars' perspectives on patent protection for human genes. METHODS: A content analysis of academic literature was conducted to identify Chinese scholars' concerns regarding gene patents, including benefits and risks of patenting human genes, attitudes that researchers hold towards gene patenting, and any legal and policy recommendations offered for the gene patent regime in China. RESULTS: 57.2% of articles were written by law professors, but scholars from health sciences, liberal arts, and ethics also participated in discussions on gene patent issues. While discussions of benefits and risks were relatively balanced in the articles, 63.5% of the articles favored gene patenting in general and, of the articles (n = 41) that explored gene patents in the Chinese context, 90.2% supported patent protections for human genes in China. The patentability of human genes was discussed in 33 articles, and 75.8% of these articles reached the conclusion that human genes are patentable. CONCLUSION: Chinese scholars view the patent regime as an important legal tool to protect the interests of inventors and inventions as well as the genetic resources of China. As such, many scholars support a gene patent system in China. These attitudes towards gene patents remain unchanged following the court ruling in the Myriad case in 2013, but arguments have been raised about the scope of gene patents, in particular that the increasing numbers of gene patents may negatively impact public health in China.

Future prospects for gene delivery systems.

INTRODUCTION: Gene therapy is the challenging area of biotechnology. Despite its promise for critical diseases, it has serious safety and efficiency issues, particularly with regards to gene transfer systems. Areas covered: We examined the current situation with gene transfer systems and addressed problems this technology. We then searched patent applications about in the area from the Patentscope online system, the international patent database. We analyzed the data obtained to get a general idea about gene delivery systems designed for future use and assessed approaches for more efficient, safer and valid delivery systems. Expert opinion: When quality assurance terms are fulfilled, some of these issues (genetic changes, mutations) could be minimized during the production process. Modification of vectors for improving their efficiency and safety or development of alternative transfer systems could be the solutions for these problems. Gene transfer technologies are important for gene therapy and should demonstrate effective, target-specific and acceptable safety profiles. For this reason, searching for alternatives to current systems is a necessity.

Commercial Opportunities and Ethical Pitfalls in Personalized Medicine: A Myriad of Reasons to Revisit the Myriad Genetics Saga.

In 1996, the US-based biotechnology company Myriad Genetics began offering genetic diagnostic tests for mutations in the genes BRCA1 and BRCA2, which are linked to hereditary breast and ovarian cancer. Since that time, Myriad has been a forerunner in the field of personalized medicine through the use of effective commercialization strategies which have been emulated by other commercial biotechnology companies. Myriad's strategies include patent acquisition and active enforcement, direct-to-consumer advertising, diversification, and trade secrets. These business models have raised substantial ethical controversy and criticism, often related to the company's focus on market dominance and the potential conflict between private sector profitability and the promotion of public health. However, these strategies have enabled Myriad to survive the economic challenges that have affected the biotechnology sector and to become financially successful in the field of personalized medicine. Our critical assessment of the legal, economic and ethical aspects of Myriad's practices over this period allows the identification of the company's more effective business models. It also discusses of the consequences of implementing economically viable models without first carrying out broader reflection on the socio-cultural, ethical and political contexts in which they would apply.

Synthetic biology, patenting, health and global justice.

The legal and moral issues that synthetic biology (SB) and its medical applications are likely to raise with regard to intellectual property (IP) and patenting are best approached through the lens of a theoretical framework highlighting the "co-construction" or "co-evolution" of patent law and technology. The current situation is characterized by a major contest between the so-called IP frame and the access-to-knowledge frame. In SB this contest is found in the contrasting approaches of Craig Venter's chassis school and the BioBricks school. The stakes in this contest are high as issues of global health and global justice are implied. Patents are not simply to be seen as neutral incentives, but must also be judged on their effects for access to essential medicines, a more balanced pattern of innovation and the widest possible social participation in innovative activity. We need moral imagination to design new institutional systems and new ways of practising SB that meet the new demands of global justice.