{"id":99799,"date":"2025-08-21T23:14:39","date_gmt":"2025-08-21T22:14:39","guid":{"rendered":"https:\/\/www.ictrechtswijzer.be\/?p=99799"},"modified":"2025-10-26T18:21:06","modified_gmt":"2025-10-26T17:21:06","slug":"personalized-medicine-what-exactly-is-patentable-in-europe","status":"publish","type":"post","link":"https:\/\/www.ictrechtswijzer.be\/en\/gepersonaliseerde-geneeskunde-wat-is-precies-octrooieerbaar-in-europa\/","title":{"rendered":"Personalized medicine: what exactly is patentable in Europe?"},"content":{"rendered":"

Personalized medicine, in which treatments are tailored to an individual's unique genetic and molecular characteristics, is transforming health care. But can a company monopolize an invention so closely linked to the human body, such as a gene or tailored treatment? Yes, European patent law <\/a>allows this under strict conditions, although it is not the medical act itself that is patented, but rather the underlying technology, such as the isolated gene or the specific use of a drug.<\/p>\n\n\n\n

The legal context: the tension between innovation and access<\/h2>\n\n\n\n

Personalized medicine, also called precision medicine, moves away from the traditional \"one-size-fits-all\" approach. <\/sup><\/sup><\/sup><\/sup>By using biomarkers - such as genes, cells or proteins - doctors can predict how a patient will respond to treatment and offer tailored therapies. <\/sup><\/sup><\/sup><\/sup>This leads to more effective treatments and fewer side effects. <\/sup><\/p>\n\n\n\n

However, the development of these technologies requires huge investments from pharmaceutical companies, technology companies and research institutions. <\/sup><\/sup><\/sup>These parties seek patent protection to recoup their investments and fund further innovation. <\/sup>A patent gives them a temporary exclusive right to prevent others from using their invention commercially. <\/sup><\/p>\n\n\n\n

A fundamental tension arises here. Patients and physicians have an interest in affordable and accessible care. <\/sup>Patents can drive up the price of diagnostic tests and drugs and limit doctors' freedom to choose the best treatment. <\/sup><\/sup><\/sup><\/sup>Thus, the legal framework must strike a delicate balance between encouraging innovation and ensuring access to health care. <\/sup><\/p>\n\n\n\n

The regulatory environment: the fine-grained patent rules in Europe<\/h2>\n\n\n\n

European patent law, primarily enshrined in the European Patent Convention (EPC)<\/a>, is basically broad: any invention in any field of technology can be patented. However, the law provides crucial exceptions that are highly relevant to personalized medicine.<\/p>\n\n\n\n

A discovery versus an invention<\/h3>\n\n\n\n

A mere discovery cannot be patented. A gene as it occurs in the human body is a discovery and thus not patentable. However, the law makes an essential distinction. According to the EU Biotechnology Directive (98\/44\/EC)<\/a>, which serves as an interpretation aid for the EPC, biological material isolated from its natural environment by a technical process does constitute a patentable invention. <\/p>\n\n\n\n

Specifically, a company can patent a human gene if:<\/p>\n\n\n\n

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  1. The gene has been isolated<\/strong> or synthetically<\/strong> reproduced using a technical procedure. <\/li>\n\n\n\n
  2. The industrial application<\/strong> (the function) of the gene is described in the patent application. A DNA sequence without a known function is not an invention. <\/li>\n<\/ol>\n\n\n\n

    The exclusion of medical treatment methods<\/h3>\n\n\n\n

    Article 53(c) of the EPC is the cornerstone of medical practice protection. This article excludes from patenting \"methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body. \" <\/p>\n\n\n\n

    The rationale behind this rule is clear: a physician should have the freedom to choose the best possible treatment without the risk of violating a patent. <\/sup>Thus, the act of the physician himself - making the diagnosis or administering the therapy - can never be the subject of a patent. <\/sup><\/p>\n\n\n\n

    The exception to the exception: products and \"second medical use\"<\/h3>\n\n\n\n

    However, the Section 53(c) exclusion is strictly limited to the method<\/em>. The provision explicitly states that the exclusion does not<\/strong> apply to \"products, in particular substances or compositions, for use in any of these methods.\" This opens the door for two crucial patent opportunities in personalized medicine:<\/p>\n\n\n\n

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    1. Diagnostic kits and devices:<\/strong> A product, such as a medical device or kit that detects a specific biomarker, is perfectly patentable, even if it is used in a diagnostic method. <\/li>\n\n\n\n
    2. Medicines for a specific application:<\/strong> An already known substance can be re-patented for a new medical application. This is called a \"second medical use\"<\/em> . This is of enormous importance for personalized medicine.<\/li>\n<\/ol>\n\n\n\n

      Legal analysis and interpretation<\/h2>\n\n\n\n

      The practice of the European Patent Office (EPO) shows a clear tendency to reward innovation, particularly through \"second medical use\" claims. A company can obtain a patent for the use of a known drug to treat a new, specifically defined patient group<\/strong>. <\/p>\n\n\n\n

      This is the heart of patenting in personalized medicine. For example, a pharmaceutical company may discover that an existing cancer drug is particularly effective in patients with a specific genetic mutation. The company can then apply for a new patent to use that drug specifically to treat patients who carry that mutation.<\/p>\n\n\n\n

      EPO case law, as in the landmark decision T 694\/16<\/a>, sets clear conditions:<\/p>\n\n\n\n