Personalized medicine: what exactly is patentable in Europe?

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 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.

The legal context: the tension between innovation and access

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

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

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

The regulatory environment: the fine-grained patent rules in Europe

European patent law, primarily enshrined in the European Patent Convention (EPC), 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.

A discovery versus an invention

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), 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.

Specifically, a company can patent a human gene if:

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

The exclusion of medical treatment methods

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. "

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. Thus, the act of the physician himself - making the diagnosis or administering the therapy - can never be the subject of a patent.

The exception to the exception: products and "second medical use"

However, the Section 53(c) exclusion is strictly limited to the method. The provision explicitly states that the exclusion does not 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:

1. Diagnostic kits and devices: 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.
2. Medicines for a specific application: An already known substance can be re-patented for a new medical application. This is called a "second medical use" . This is of enormous importance for personalized medicine.

Legal analysis and interpretation

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.

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.

EPO case law, as in the landmark decision T 694/16, sets clear conditions:

• The new patient group must be clearly distinguishable on the basis of a physiological or pathological status (e.g., the presence of a biomarker).
• There must be a functional relationship between this status and the therapeutic effect. The selection should not be arbitrary; the treatment should be more effective or provide some other benefit for this particular subgroup.
• It is irrelevant whether this subgroup was already unknowingly co-treated within a larger population in the past. What matters is that the subgroup has not yet been deliberately and selectively treated.

This approach creates a strong incentive to conduct further research on existing drugs and identify which patients benefit most from them, which is the essence of personalized medicine.

What this specifically means

• For pharmaceutical companies and researchers: You can not patent the medical procedure but you can patent the instruments. A patent is possible on an isolated gene with a distinct function, a diagnostic test that detects a biomarker, or the novel, targeted use of an existing drug for a specific patient group. Careful and strategic drafting of patent claims is essential.
• For doctors and hospitals: Your freedom to choose the best treatment remains guaranteed. You are not violating a patent by using a particular therapy. However, you will have to pay for the use of patented drugs or diagnostic kits to be purchased by the hospital.
• For patients: The patent system encourages the development of innovative, personalized treatments that directly benefit you. The downside is that the exclusivity granted by a patent can lead to higher costs, as illustrated in the controversy surrounding Myriad Genetics' BRCA gene patents, which significantly increased the price of breast cancer tests.

FAQ (frequently asked questions)

Is my DNA now owned by a company if they patent a gene?
No, absolutely not. The patent does not cover the genes in your body. It covers only the isolated or synthetically produced version of that gene obtained by a technical process and used for the specific industrial application (e.g., in a diagnostic test) described in the patent.

Why are personalized medicines often so expensive?
Research and development (R&D) costs are astronomically high, with a high risk of failure. The patent grants a temporary monopoly, allowing companies to recoup these high costs and invest in future innovations.

Can my doctor use any treatment, even if it is based on a patented invention?
Yes, the medical procedure or method itself is free from patent rights in order to guarantee clinical freedom. So the doctor can apply the treatment, but the hospital will have to purchase the patented products (the specific drug or test kit) needed for that treatment.

Conclusion

European patent law walks a thin line. It rewards innovation in personalized medicine by protecting the concrete tools - the isolated genes, diagnostic kits and specific uses of drugs. At the same time, it safeguards the core of medical practice by excluding the treatment method itself from patenting. This approach encourages the development of life-saving technologies in Belgium while creating an ongoing social debate about affordability and access.