Author: jia chang Zhang

Introduction

With the development of science and technology, the patentability of biotechnology, especially human genes, has always been in dispute. Proponents argue that human genes should be patented without restriction, and that any possible challenges and concerns can be addressed by patent standards. This article will first analyz patent systems in the United States and Europe to examine the patentability of genes, and the role of patent standards in protecting human genetic development. Then focus on evaluating the legitimate concerns raised by opponents about human gene patents and assesses whether the three criteria for patents can fully solve existing problems. Finally, by introducing the unique licensing system in Canada, a new solution to the problem of human genetic patents is found outside the patent system.

Gene patents and patent criteria

“Gene patent” is a general term which contains several types of inventions. The role of genetic research is huge for the diagnosis and treatment of certain diseases. For example, BRCA1 or BRCA2 genes in the human body can be related to breast or ovarian cancer. Certain changes in these two genes may indicate a higher risk of breast or ovarian cancer. However, for a long time, there have been many differences between the public and scholars on the issue of whether human genes can be patented. The supporting party won to a certain extent, because in the United States and Europe, human genes are considered a patentable subject. On the contrary, the opposing party always believes that for moral and ethical reasons, human genes cannot be patented.

Although, Patents on isolated genes, specifically related to BRCA1 and BRCA2, were successfully invalided in 2013 in the US in Association for Molecular Pathology v Myriad Genetics Inc. However, the invalidity of this patent has little to do with morality and health, but because of patent criteria. By analyzing this case, we can learn the role of patent standards in gene patents. At the same time, we can also feel the indispensable status of morality and health and well-being in gene patents.

In the U.S., Myriad Genetics Inc., which patents the BRCA1 and BRCA2 genes, is the only U.S. test supplier for BRCA1 and BRCA2. Which brings huge profits to Myriad company. However, Justice Thomas rendered the Supreme Court's decision in Myriad cases on 13 June 2013, which ruled:

“naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring”. 

Despite the victory, the reasons for the ruling were different from those of the plaintiff. The court ruled that the invalidity of isolated DNA patents was based on a narrow technical basis. The Court noted that the reason was that 'the law of nature, natural phenomena and abstract ideas could not be granted patents' in USC. section 101, and that patent 'protection' was excluded because of the delicate balance between the creation of 'incentive mechanisms'. Leads to creation, invention and discovery' and 'obstruction may even indeed stimulate the flow of information about invention'. Therefore, the monopoly of natural materials will not help the technological revolution and renewal in a certain field.

In short, BRCA1 and BRCA2 genes cannot be patent due to their nature property. In other words, they did not meet the patent criteria. However, the ethics and health-related concerns raised by the plaintiffs have not been resolved. On the contrary, this decision is only limited to technical judgments, ignoring the moral concerns of the general public and making people feel unsatisfied. Novelty, invention steps and industrial applications can prevent some natural products from being patented, thus avoiding an improper monopoly on natural substances. Nevertheless, it seems that they cannot solve all the problems for gene patents.

Not only in the United States, but also in Europe, Directive 98/44 on the Legal Protection of Biotechnological Inventions, which have been issued on July 6, 1998, to balance the rapid development of biological science and patent law. Unlike the EPC, the Directive provides a brief summary of the factors considered to be key factors in addressing the protection of biotechnology. Under art.53(c) EPC the diagnosis and treatment of human diseases cannot be the subject of patent grants. However, this exclusional treatment is interpreted as applying only to methods carried out in the human body or in the body. It is clear that the study and modification of human genes is carried out in the laboratory and is outside the body, so this clause is not excluded.

In the past, European systems provided that commercial developments could not be patented for inventions that were contrary to morality or ordre public. Opponents have used this article to refute the patentability of genes. However, in the HOWARD FLOREY/Relaxin case, the EPO stated that they were the institutions that granted patents, not the institutions that determined ethical standards. The invention held by the defendant met all the patent conditions, so the defendant's patent was upheld. The European Patent Office declares that 'DNA itself is not life but one of the chemical entities involved in biological processes'. As a result, the claim was rejected by the EPO after a limited substantive review. It can be seen that the European Patent Committee's attitude towards human gene patents is to try to avoid the constraints of the moral clauses in the EPC.

Moreover, in the Directive, it is easy to clearly find the provisions on the patentability of biological products. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature. Whether referring to the verdicts of past cases or regulations tailored to biological products, the EU seems willing to continue to grant patents for biotechnology products such as gene patents. The premise is that these inventions meet the patent criteria set out in the EPC. Otherwise, they may be declared invalid because they do not satisfy novelty, invention steps or industrial applicability.

The cases in Europe and the United States reflect the different treatments of genetic patents in the two regions. In the United States and other regions where there is no patentability of human genes, the confirmation and invalidity of gene patents are determined by case law and judicial interpretation. The EU chose a more direct approach, which is to formulate a separate bill for biotechnology. Although these two regions have some regulations on gene patents. Their regulations are mainly limited to the technical level. 

Undoubtedly, using patent criteria to restrict the patentability of human genes is a relatively objective method. Because in most cases, human genes are regarded as part of the human body and are naturally occurring substances. Although it can be extracted into substances separated from the human body through industrial and technical processing. If it does not change its form and function, it can only be regarded as a natural product.

In EPC Art. 54, novelty means that an invention is considered to be new if it does not form part of the state of the art on the priority date. In other words, an invention should not be a part of anything has made available to the public in any way before the date of applying an EU patent. Inventive step in EPC is shown that ‘an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person who is skilled in the art’. In addition, Art. 57 EPC shows that ‘an invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture’. Industrial applicability is also known as utility in the United States. Although the patent system of each region is different, the above-mentioned patent criteria are reflected in the patent laws of most countries. However, even if human genes are isolated, the functions of specific genes may already be well known to the public. Not only that, but the functions of human genes are also formed naturally, not created by technology. By which I mean, the industrial steps of human genes and the non-significance of technological progress are difficult to examine and judge. Finally, human genes themselves are difficult to put into industrial applications. Even in the case of Myriad, it is the genetic testing technology that is actually being applied instead of the specific gene itself. Therefore, human genes in natural existence cannot meet the standards of novelty, inventive step, and industrial applicability (which called utility in the United States). Regarding patent criteria as a restriction on the patentability of human genes can avoid improper monopoly of natural substances. So as to solve some of the problems raised by opponents, such as how to solve the destruction of genes and patent systems by biological companies.

For some other concerns have been raised by opponents, such as gene patents that will hinder technological innovation in the fields of medicine and health, International treaties also provide some solutions. Article 31 of the TRIPS agreement provides for compulsory licensing. This provision allows the use of patented inventions without the consent of a third-party patent holder authorized by the government or the government. Compulsory licensing becomes particularly important when patent holders conduct economic monopoly in a certain field for improper purposes, especially in the medical and health field. Compulsory license limits the rights of patent holders to a certain extent and provides protection for the patentability of genes.

However, whether from the perspective of patent standards or from the perspective of morality, genes must be subject to certain restrictions if they are to be patented. In addition, although patent standards and compulsory license systems provide the feasibility for obtaining gene patents, patent standards do not seem to be able to solve all the problems that gene patents will bring.

Gene Patent and Morality Concerns

Although patent standards provide protection for the patentability of human genes to a certain extent, people's concerns about human gene patents are not limited to this.

Shortly after the Myriad case was first ruled in the United States in 2010, the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) released their report to the U.S. Secretary of Health and Human Services, studying the effects of gene patents on human health. 

Key findings in the SACGHS report were:

Patents on genetic discovery do not seem to help with the disclosure of basic genetic research, the development of genetic testing or stimulating research findings.

The effects of human gene patents on patients include restrictions on available tests due to market cleanup, restrictions on access to tests due to health insurance issues, and restrictions on access to second opinions and sample sharing to ensure quality.

From the above results, it can be seen that the granting of patents for human genes not only fails to promote scientific research institutions, but it may also make it more difficult for other institutions to make progress because of its monopoly. As a result, gene patents may hinder the improvement of human health by medical treatment.

In addition to these, genetic patents may bring high genetic testing costs. The BRCA1 and BRCA2 tests reportedly cost about $2,200, while competitive BRCA tests cost $995.14 after ruling on rival company DNA Traits. Moreover, once the patent for a specific gene is held by a certain institution, it may result in the only genetic testing provider on the market for this gene. When the sole genetic testing provider receives a large number of test samples, the waiting time for genetic testing will become longer. Also, when the customer is not satisfied with the genetic test, because there is only the only test provider on the market, he or she cannot turn to other institutions for comparison. If genes are not held as patents, but are protected in other ways, thereby freeing up market share, the above problems may be solved.

With the rise of feminist activities in modern times, the connection between gene patents and women's health and well-being has attracted more and more scholars' attention. For example, the BRCA1 and BRCA2 genes, which are most closely related to breast and ovarian cancer, have been granted patents, which may increase the cost of detecting related cancers for women. This will hinder women's health improvement. Sexism and human health and well-being should also be considered in the field of patentability of human genes. Perhaps, promoting genetic and genetic testing into the public domain is a better solution.

However, as a legal monopoly, patents cannot solve their own limitations that conflict with morality. This is not realistic to shake the inherent system of patents in a short period of time. Therefore, in particular in the case of health-related biotechnology, the use of patents to create potential risks to health and life requires solutions other than patent system. In this regard, the Canadian case provides a useful reference.

An approach out of patent system

In March 2016, Children's Hospital of Ontario (CHEO) filed a lawsuit in federal court in Canada challenging a patent for a gene associated with Long QT syndrome, a disease involving irregular heart rhythms. The settlement provides CHEO with a license to test the syndrome. Long QT syndrome is a rare genetic disease that can be fatal. This is mainly manifested in abnormal electrical activity of the heart, which can lead to irregular heartbeats. Because the disease has the potential to cause sudden death in an adult without warning, testing mutations in genes associated with the disease is the most direct and early way to detect the disease. 

CHEO shows the main driver of the challenge is their doctors' desire to secure opportunities for improvement for patients and their families. In particular, there are concerns that gene patents could affect patients and their families. At the time, sample testing was conducted in the United States, not by CHEO itself, for fear of patent infringement. This means that the test takes longer, the cost of testing increases, and the database of samples and results of the test is not available to CHEO. This can seriously affect CHEO's ability to detect and respond to the disease.

The main purpose of the settlement is that CHEO can provide genetic testing, disease diagnosis and medical research for Long QT genes on a non-profit basis for patients and potentially sick people in Canada. Moreover, because the protected area of the agreement is limited to Canada, the desire of other regions to enjoy low-cost medical treatment in Canada cannot be realized. In this way, the license protects the interests of gene patent holders.

In a summery, if we want to support the patentability of genes, we should take the problems that may arise seriously and design the relevant solutions appropriately. To address the potential health effects of gene patents. Therefore, from a practical point of view, a tailor-made licensing method in Canada can be considered an effective solution in the short term. It is not without its drawbacks, but its feasibility is worth exploring. This approach could be used in other technical environments and other jurisdictions pending the improvement of the patent system.

Conclusion

This essay analyzes the relationship between human gene patents and genetic standards through different treatments in the United States and Europe. It can be seen that for human gene patents, genetic standards can indeed solve a number of problems to some extent. For example, if a gene holder maliciously monopolizes genetic testing and destroys the market, compulsory licensing would limit his rights. In addition, restrictions on genetic standards can prevent natural products from being unfairly monopolized. At the same time, it can also be seen that human genes cannot be granted unlimited patents, because human genetic patenting has a huge impact on human health.

However, for some practical ethical problems, due to the limitations of the patent system, patent standards alone cannot be completely resolved. Canada's licensing system, based on existing problems, provides appropriate licensing to protect the interests of patent holders and promotes the improvement of genetic testing and diagnosis for human health. Therefore, under the existing conditions, in order to promote the development of genetic research and the improvement of human health, it is worth studying to find solutions outside the patent law.

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