HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Friday, October 30, 2020

The Patentability of Gene Related Inventions in Personalized Medicine Under European and US Patent Law

Ayben Işılay Özdoğan, The Patentability of Gene Related Inventions in Personalized Medicine Under European and US Patent Law, MIPLC Master Thesis Series (2018/19)

Personalized medicine defines an individualized healthcare system based on patients’ unique characteristics, such as genetic information. It aims to reduce the predictable risk of disease and improve response to treatment by applying a specific therapy. This particular field brings along the gene related patent applications. In recent years, ethical sides, policy considerations on patent applications in gene sequences, and gene related diagnostic and treatment methods led to many debates among biotech/pharma companies, patent stakeholders, researchers, clinicians, and patients. Although the patent system is an incentive for the dissemination of the innovation by providing recovery to the companies for their investments, it is claimed that gene related patents are violating human rights by removing the information (gene sequences are like large databases) from the public domain. Patent protection for gene related inventions is treated differently, relying on diverse grounds in different countries, and there is no consistency in different patent laws in terms of patentability for these inventions. In Europe, the boundaries are set clearly in EPC and the Biotech Directive, whilst in the US, patent protection for gene related inventions is mostly assessed under eligibility criteria. The subject matter eligibility requirements are defined under 35 U.S.C. § 101 in the US. A draft bill, planned to reform the patent eligibility in the US, was introduced on May 22, 2019, and came along with many debates. The fear is that if enacted, decisions of some prominent cases such as Mayo and Myriad may be opened to discussions again. However, there is uncertainty whether this draft bill will ease the patentability of genetic inventions or not, it will be clear only after several decisions of the CAFC or the Supreme Court. On the other hand, this draft legislation may meet the long-felt need after Mayo and Myriad cases which may contribute to the development of bioeconomy in the US. The bill questions the patent system in the US independent from its enactment. At this stage, it is hard to estimate the possible influence of this bill on Europe. Nevertheless, it is commonly accepted that this proposal will approximate the US patent law to European patent law.

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