Executive summary

With the increasing modern advances in genetic technology and innovation, ethical issues regarding intellectual property of genetic inventions have emerged. Concerns over accessibility to healthcare, debates over the privatization of genetic material, and concerns over the hindrance of medical research and innovation lay the basis for raising the question of if gene patenting is an ethical practice. Patents create restrictions on the accessibility of modified genes, considering the prohibition of naturally occurring gene sequences to be patented. In medical practice, genetic patents have been criticized for limiting access to affordable diagnostic tests for patients, and creating challenges for medical research of diseases in which certain gene patterns are patented.

Overview

The history and impact of gene patenting is complex, and addresses a multitude of policy interactions. These issues are rooted in the overarching issue of healthcare accessibility, and facilitation of biomedical advancement.

Pointed Summary

• Gene patents have negative effects accessible healthcare
• Gene patents raise prices of diagnostic services offered by hospitals 
• Monopolies on gene sequences and treatments

Relevance 

Gene patents have been criticized for their restriction of accessible and affordable healthcare due to their involvement of genetic sequences relating to critical diseases like breast cancer, as well as for their hindrance of medical research. Although processes for laboratories to gain licensure to study certain patented material such as cDNA exist, licensure comes at a cost which creates obstacles for researchers in funding. In 2010, when a gene sequence for hereditary hemochromatosis was patented, there was a 26% decrease in the number of laboratories testing for hereditary hemochromatosis (Huang, 2014). This decrease not only has implications on obstructing innovation and advancement, but also creates obstacles for patients seeking diagnostic tests to access laboratories. Furthermore, medical diagnostic screenings often utilize an analysis of an individual’s genes to assess their susceptibility to a certain disease and aid the creation of a preemptive  treatment plan. Gene patents, however, massively increase the cost of these gene tests by requiring licensure, which creates economic restrictions for hospitals to offer the highest quality of care to patients. For example, screening for the BRCA1/2 mutation is often used to create preemptive treatment plans due to its association with a 40-80% increase in an individual’s susceptibility to  breast cancer, and 16-40% increase to ovarian cancer; however, due to a patent on the gene by the company Myriad, cost for licensure alone was quoted to be $395 to $2400 (Huang 2014). The patent additionally causes Myriad to have a monopoly over the licensure due to the resulting lack of competition, which causes a stagnation of these prices since the company has no incentive to prioritize market demand over profit. The price of licensure alone results in hospitals not being able to offer complete and quality services to patients, thus causing patients to not have access to quality healthcare.

History

The first gene patents were filed in the 1980s, exercising the ruling in the supreme court case, Diamond v. Chakrabarty. In Diamond v. Chakrabarty, it was ruled that living organisms were permissible to be patented if they were a result of human innovation (Justia Law, 2020). This laid the groundwork of genetic innovation by opening the doors to recognize the legitimacy of genetic innovation. In 1990, the Human Genome Project was founded to pioneer biological research and discovery around human DNA (National Genome Research Institute, 2020). The Human Genome Project marked a breakthrough in DNA research and advancement, facilitating innovation in the realm of genetics. Furthermore, heated debates about the ethicality of genes began to emerge in 2013 with the supreme court case, Association for Molecular Pathology v. Myriad Genetics (Cartwright-Smith, 2014). This case ruled that patents on naturally occurring DNA sequences were impermissible. This ruling triggered ethical challenges in bioethics regarding gene patenting that are still contested and relevant in the present-day, such as the classification of ‘synthetic’ genes, and the environmental impact and disruption of the dissemination of synthetic genes to natural organisms. 

Current Stances

The Institute for Cancer Research (ICR) (2013) outlines ethical practices on patenting genetic information, such as that DNA sequence research should be published to be accessible publicly to protect the benefit of patients. Additionally, the ICR’s stance on gene patenting opposes the validity of cDNA patents, offering that cDNA has the same genetic information as naturally-occurring DNA; believes that gene patents prohibit treatment of cancer; restricts the freedom of operation in the medical field; and opposes the validity of isolated DNA to be patented (Institute of Cancer Research, 2013). Defenses of the practice of gene patenting are also prominent, providing that gene patents facilitate quality research of companies by reducing the pressure of competition, encourages innovation in genetic engineering by providing the lure of patent-holding, and open the doors to investment (Genetics Generation, 2015).

Tried Policy

 Historically, many policies have been tried to both defend and oppose the practice of gene patenting. The Hatch-Waxman act of 1984 laid the framework for a window of exclusivity to protect patent-holders from generic versions of their innovation to be introduced into markets (FDA, 2019), protecting the rights of patent-holders such as those of gene patents to have their innovations generalized. Additionally, the ruling made in the 2013 case Association for Molecular Pathology (AMP) v. Myriad Genetics outlined oppositions to gene patenting, forbidding the patenting of naturally occurring DNA sequences (Cartwright-Smith, 2014). However, the Patent Eligibility Restoration Act of 2023 attempts to reverse the rulings of AMP v. Myriad Genetics. 

Policy Problem

A. Stakeholders

The contested ethicality of gene patents affects stakeholders in gene patenting, such as biotechnology or pharmaceutical companies who benefit from gene patenting. Stakeholders include companies such as Myriad Genetics, 23andMe, Illumina, Amgen, etc. who currently hold gene patents and are heavily prominent in genetic engineering. 

‍

B. Risks of Indifference

The risks of not addressing the bioethical issues of gene patents has implications on the future of healthcare accessibility and costs The practice of gene patenting can cause the cost of offering certain diagnostic services to increase, having the effect of causing hospitals to decrease their diagnostic testing services, as well as raising prices to accommodate for licensure. For example, licensure to access certain genes patented by Myriad Genetics ranges from $395 to $2400 (Huang 2014). This cost for licensure alone vastly increases the price that hospitals must pay to offer services that involve genetic material, making quality healthcare less accessible as these tests are often crucial to the creation of preemptive treatment plans.

‍

C. Nonpartisan Reasoning

The current ongoing attempts surrounding gene patenting involve the debated Patent Eligibility Restoration Act of 2013. Supporters of the act argue that the act can maintain the United States’ competitiveness in the realm of bioengineering by facilitating patents that encourage research and innovation domestically (Saul, 2024). Additionally, supporters outline that the act reduces the ambiguity in the classification of synthetic vs naturally-occurring DNA (Saul, 2024). Opposition to the act argue that the act would only facilitate the restriction of the expansion of genetic research and medical use, and also would discourage institutions having collaborative research with the increased competition that the act implicates (Saul, 2024).

Policy Options

Other options to the future of gene patenting have included broad licenses and patent pooling. With the issue of licensure to access patent genetics being expensive and hindering genetic testing, research, and diagnosis, the solution of patent pooling has offered an alternative where patent holders allow open-access within communities of patent holders for licensure to patent genetics (Rodrigues & Stasi, 2019). While this solution offers a facilitation of acquiring license for patent genes, this solution still disregards the issue of medical access, as hospitals would still run into the financial obstacle of licenses to run diagnostics tests and services for preemptive care plans. Additionally, broad licensing has been offered as a way to mitigate the exclusivity that is implicated with gene patenting (Caulfield, Gold, & Cho, 2008). With broad licensing this also offers the solution of making licensure for gene patents cheaper and more accessible to mass parties. However, broad patenting then poses an increased risk to patent infringements and legal complexities with allowing mass parties access to the patent. Additionally, broad licensing of patents still maintains a financial burden and can also increase the ease of a company to have monopolies, by allowing patent holders control over a more vast portion of the market. 

Conclusions

At the nexus of ethics, law, and healthcare gene patenting is still a controversial topic. Despite encouraging domestic innovation and investment in genetic technologies,- gene patents present serious obstacles to affordability and accessibility, especially in the medical sector. Both patients looking for inexpensive diagnostic tests and researchers trying to further medical science now face difficulties due to the monopolization of genetic sequences and the exorbitant costs of patent licensing. Despite providing viable alternatives to address these problems, policy solutions like broad licensing and patent pooling have their own disadvantages such as the potential for increasing monopolization and legal complications. Policies must strike a balance between safeguarding intellectual property rights and making sure that genetic discoveries benefit society as a whole as the debate over gene patenting continues. More thorough and creative legislative frameworks are required going forward, to guarantee that genetic discoveries are available reasonably priced and beneficial to society.

Acknowledgment

The Institute for Youth in Policy wishes to acknowledge Gwen Singer, Mason Carlisle, Lilly Kurtz, Paul Kramer. and other contributors for developing and maintaining the Fellowship Program within the Institute.

References

1. Cartwright-Smith L. Patenting genes: what does Association for Molecular Pathology v. Myriad Genetics mean for genetic testing and research? Public Health Rep. 2014 May;129(3):289-92. doi: 10.1177/003335491412900311. PMID: 24790252; PMCID: PMC3982540.
2. Caulfield T, Gold ER, Cho MK. Patenting human genetic material: refocusing the debate. Nat Rev Genet. 2000 Dec;1(3):227-31. doi: 10.1038/35042087. PMID: 11252752; PMCID: PMC2220019.
3. Contreras, J. (2022, August 4). Another Legislative Attempt to Revive Gene Patenting. Bill of Health. https://blog.petrieflom.law.harvard.edu/2022/08/04/another-legislative-attempt-to-revive-gene-patenting/
4. Diamond v. Chakrabarty, 447 U.S. 303 (1980). (2020). Justia Law. https://supreme.justia.com/cases/federal/us/447/303/
5. FDA. (2019). Hatch-Waxman Letters. FDA. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters
6. Genetics Generation. (2015). Genetics Generation. Genetics Generation. https://knowgenetics.org/patenting-genes-pros-and-cons/
7. Huang YH. Gene patents: a broken incentives system. J Relig Health. 2013 Dec;52(4):1079-84. doi: 10.1007/s10943-013-9758-2. PMID: 23877132; PMCID: PMC3819421.
8. Merz JF, Cho MK. What are gene patents and why are people worried about them? Community Genet. 2005;8(4):203-8. doi: 10.1159/000087956. PMID: 16244473; PMCID: PMC2220018.
9. National Human Genome Research Institute. (2020). The Human Genome Project. National Human Genome Research Institute. https://www.genome.gov/human-genome-project
10. NIBusinessInfo. (n.d.). Advantages and disadvantages of getting a patent. Nibusinessinfo.co.uk. https://www.nibusinessinfo.co.uk/content/advantages-and-disadvantages-getting-patent

11. Stasi A, Rodrigues IP. Dealing with Patent Fragmentation in Genetics: Can Patent Pools Facilitate the Development of CRISPR Gene-Editing Technology? J Law Med. 2019 Jul;26(4):866-873. PMID: 31682364.
12. Sual, J. (2024, May 1). Gene Patents: Striking the Right Balance Between Incentive and Innovation [Review of Gene Patents: Striking the Right Balance Between Incentive and Innovation]. Fordham Law Review. https://fordhamlawreview.org/issues/gene-patents-striking-the-right-balance-between-incentive-and-innovation/

‍