Patents in Health-Related Technologies: Professor McMahon’s New Research Published

Patents in health-related technologies have long been a cornerstone of innovation, granting inventors exclusive rights over their creations for a limited period. In August 2025, Professor Aisling McMahon published a significant health law study in the Medical Law Review. The study in the Medical Law Review entitled “Patents over ‘technologies’ related to how we treat, use, and modify the human body: An urgent need for greater bioethics scrutiny.” The peer-reviewed article forms part of the European Research Council-funded PatentsInHumans project. Professor McMahon leads this project as the Principal Investigator. It examines how patents, and the ways they are used, affect technologies connected to the human body. The research places a strong focus on bioethical implications.

The study notes that European law prohibits patents on the human body itself. However, it allows patents on technologies that treat, use, or modify it. Examples include medicines, isolated human genes, and neuro-technologies. Professor McMahon proposes a five-category framework to understand these technologies. She argues that patenting and licensing decisions can greatly affect autonomy, dignity, and bodily integrity. The article calls for more legal and ethical scrutiny in granting and licensing such patents. It suggests that specific licensing conditions could address concerns in certain contexts.

For Stevens Law Group, this work provides valuable insight. It connects patents, bioethics, and healthcare policy in ways that matter for advising clients.

Understanding Patent Rights in Healthcare

A patent grants its holder the legal authority to stop others from using, selling, or making an invention without permission. This exclusive right typically lasts 20 years. In healthcare, patents can apply to pharmaceutical compounds, diagnostic tools, genetic sequences, and medical devices.

Rightsholders control how these technologies are distributed and under what conditions. They decide who gains access and on what terms. Licensing agreements serve as the primary means of granting usage rights. These contracts often include restrictions that can influence the availability of essential medical products.

Patents incentivize innovation by offering exclusivity and the potential for significant profit. However, they also give rightsholders a governance role over certain health technologies. This gatekeeping power has direct implications for treatment access, pricing, and the speed of technological progress. Balancing these interests remains one of the central challenges in health-related patent law.

Categories of Health-Related Patents

Health-related patents cover a wide spectrum of technologies. One practical way to understand them is to divide them into categories:

Technologies derived from the body – such as isolated genes or hormones.
Tools or methods acting on the body – including surgical instruments and diagnostic procedures.
Substances external to the body that treat it – such as medicines.
Integrated medical devices – like implantable pacemakers or neurotechnology systems.
Technologies affecting human enhancement or reproduction – such as certain advanced reproductive techniques.

Each category raises distinct legal and ethical issues. For instance, patents on isolated genes may restrict access to genetic testing. Meanwhile, patents on medical devices can limit hospitals’ ability to repair or modify equipment without infringing rights. Understanding these distinctions is essential for lawyers advising clients in the healthcare technology sector.

Patents on Genetic Material

The patenting of genetic material is one of the most debated areas in intellectual property law. European law forbids patents on the human body itself. However, it allows patents on isolated genetic sequences if identified through technical processes and tied to a disclosed function.

Critics argue that such patents commodify human biology and restrict access to vital diagnostic tests. The well-known BRCA1 and BRCA2 gene patent dispute in the United States brought these concerns into public view. The patent holder’s enforcement strategy limited access to breast and ovarian cancer testing. It also raised prices and prevented patients from seeking second opinions.

Although the U.S. ultimately barred patents on naturally occurring genes, Europe still allows them under certain legal criteria. This keeps the debate alive, especially as personalized medicine expands. Lawyers, policymakers, and bioethicists continue to scrutinize the impact of these protections on patient access and public health.

Patents on Diagnostic and Surgical Tools

European patent law excludes certain treatment and diagnostic methods performed directly on the body. However, it does not exclude the tools, devices, or laboratory processes used in those methods. As a result, medical imaging equipment, robotic surgical systems, and in-vitro diagnostic kits can all be patented.

Such patents can shape the availability of medical procedures. Hospitals and clinics must either pay licensing fees or avoid using patented technologies. In the case of non-invasive prenatal testing (NIPT), enforcement of certain patents has led some providers to discontinue specific tests. This reduction in options has affected patient choice.

These scenarios raise critical legal and ethical questions. Policymakers must weigh intellectual property rights against the need for accessible healthcare services. Lawyers advising healthcare providers need to anticipate these conflicts when assessing the risks of adopting patented medical technologies.

Patents on Medicines and Therapeutic Substances

Medicines represent one of the largest and most economically significant categories of health-related patents. A pharmaceutical patent can protect a novel active ingredient, a new formulation of an existing drug, or even a new use for a known compound. These protections reward investment in research and development by granting exclusivity. At the same time, they directly influence the price and availability of treatments.

In many cases, pharmaceutical companies employ a strategy called evergreening. This involves obtaining new patents for minor modifications, such as changes in dosage form or delivery methods. The goal is to extend market exclusivity beyond the original 20-year term. While legal, this practice can delay the entry of lower-cost generic alternatives. The result is often higher prices for patients and health systems.

From a legal standpoint, advising clients in this sector requires careful navigation of both national and international regulations. The TRIPS Agreement mandates patent protection across all fields of technology, including pharmaceuticals. Compliance with these obligations is essential for securing and enforcing rights. For law firms like Stevens Law Group, structuring licensing agreements that meet these requirements while considering public health priorities is a crucial task. Such agreements must balance profit motives with the ethical responsibility to make life-saving treatments accessible.

Integrated Medical Devices and Bodily Integrity

Ethical and Legal Tensions

The intersection of patents, healthcare, and ethics creates persistent tensions. Patents reward innovation by providing exclusive rights. However, those same rights can lead to monopolistic practices, limit competition, and restrict patient access to essential treatments.

European patent law includes a “morality clause” under Article 53(a) of the European Patent Convention. This provision excludes inventions from patentability if their exploitation would be contrary to public order or morality. In practice, the European Patent Office interprets this clause narrowly. In the Relaxin gene case, for instance, it rejected arguments based on human dignity, focusing solely on technical criteria.

For practitioners, ethical considerations often lie outside the scope of patent examination and enforcement. Policymakers and courts must address such concerns through broader regulation or legislation. This leaves lawyers in a challenging position—balancing legal compliance with ethical awareness when advising clients on patent strategy in healthcare.

Legal Pathways for Access

Patent law does offer mechanisms designed to improve access to health technologies. One example is compulsory licensing. This allows a government to authorize a third party to produce a patented product without the patent holder’s consent. Such licenses are typically granted in exchange for a royalty. Although potentially valuable in public health emergencies, compulsory licensing is rare in Europe and often involves complex political and economic negotiations.

Another pathway is voluntary licensing, where the patent holder agrees to share rights under negotiated terms. Programs like the Medicines Patent Pool have expanded treatment access for diseases such as HIV/AIDS. However, similar frameworks for advanced medical devices or diagnostic tools remain limited.

For legal advisors, drafting these agreements requires balancing commercial objectives with public health needs. This involves addressing regulatory requirements, ensuring fair compensation for innovation, and supporting broader access goals. Law firms must craft solutions that meet both business and societal expectations.

Future Challenges

Emerging technologies promise to intensify debates around patents in healthcare. Gene editing tools like CRISPR, advanced neurotechnologies, and next-generation reproductive techniques often blur the line between treatment, enhancement, and human modification. These developments raise fundamental questions about how far patent protection should extend.

As innovation accelerates, so too will the ethical stakes. The decisions made by patent holders, regulators, and lawmakers will influence not only who can access these technologies but also how they shape human health and society at large. For law firms, staying ahead of these developments is critical to providing informed, strategic advice to clients in the health technology sector.

Conclusion

Patents in health-related technologies sit at the intersection of law, ethics, and public policy. They provide powerful incentives for innovation but also create structures of control that can influence who benefits from medical advances. The European legal framework allows for broad patentability, including in areas closely tied to the human body, but ethical considerations often receive limited attention in formal decision-making processes.

For stakeholders—whether they are innovators, healthcare providers, or patients—the challenge lies in finding a balance between rewarding invention and ensuring equitable access. Stevens Law Group is well-positioned to assist clients in navigating these issues, from securing patent protection to structuring licensing agreements that align with both legal requirements and societal values.

References:

Medlaw – Medical Law Review

maynoothuniversity.ie – Professor Aisling McMahon publishes article examining the bioethical implications of patents on health-related technologies in Medical Law Review