How do we determine the patentability of surgery? Photo credit: National Cancer Institute via Unsplash
Previously, we explored key cases brought before the Supreme Court of the United States (SCOTUS), each involving disputes between two opposing companies or organisations. In this article, we shift our focus to the European Patent Office (EPO), where legal clarity is sometimes needed to determine the fate of a patent application. Specifically, we will examine the decision of G01/07, which addresses a critical question: Can a method of treatment by surgery be considered patentable?
Background: the patent
In 1996, the U.S. company, Medi-Physics, Inc. filed a patent for a new method of imaging moving organs and body parts within the human or animal body using Magnetic Resonance Imaging (MRI) apparatus. Organs such as the heart and lungs move during the imaging process due to breathing and blood circulation, resulting in blurry images, which reduces diagnosis accuracy. Medi-Physics sought to overcome this using a contrast agent, which enhanced the visibility of the organs being imaged. This contrast agent could be administered either through inhalation or through invasive injection into the bloodstream.
…which enhanced the visibility of the organs being imaged.
Background: the legal question
The main legal concern in G01/07 is related to article 53 of the European Patent Convention (EPC), which states, ‘European patents shall not be granted in respect of: [] methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body’. Since the method in question involved an invasive procedure, it had to be determined whether it qualified as ‘treatment by surgery’ or a ‘diagnostic method’ as defined by the EPC.
The division initially rejected the application, ruling that the method fell under the exclusion for surgical treatments.
After the patent application was filed with the EPO, the Examining Division assessed whether it met the criteria for patentability. The division initially rejected the application, ruling that the method fell under the exclusion for surgical treatments. The applicant, Medi-Physics, disagreed and appealed to the Technical Board of Appeal (TBA), which reviews decisions made by the Examining Division.
The TBA found that there was insufficient clarity in existing case law regarding the definition of ‘treatment by surgery’. Consequently, the TBA referred specific legal questions to the Enlarged Board of Appeal (EBA), the highest authority within the EPO, responsible for interpreting the EPC. The EBA was tasked with clarifying the scope of the exclusion, particularly, what constitutes ‘treatment by surgery’ under Article 53.
For a method to be classified as diagnostic, it must include four essential steps…
Legal reasoning
The first issue was to clarify whether the imaging method fell under the category of a ‘diagnostic method’ or ‘treatment by surgery’. The possibility of it being a diagnostic method was quickly ruled out. For a method to be classified as diagnostic, it must include four essential steps: an examination step, a comparison of data, identifying a deviation, and reaching a specific medical conclusion. In this case, the imaging method only prepared the body for diagnostic purposes and did not itself result in any specific diagnosis. The remaining legal debate focused on the definition of ‘treatment by surgery’.
When legal provisions in the European Patent Convention (EPC) require clarification, the Vienna Convention on the Law of Treaties (VCLT) is often referenced. The Enlarged Board of Appeal (EBA) used the VCLT in this case as a framework to approach the issue. The key provision cited was Article 31, which states, ‘[a] treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose’ [original italics]. This legal standard guided the EBA’s interpretation, first through the ordinary meaning of the terms in question and then through an analysis of the object and purpose behind the exclusion.
The EBA began by interpreting the terms in Article 53 using their ordinary meaning. Two interpretations of ‘treatment by surgery or therapy’ emerged. The first was a purpose-based approach, which confined the exclusion to procedures aimed at improving the health of humans or animals. This argument drew parallels between “surgery” and “therapy,” since “therapy” implies a health benefit, suggesting surgery should do the same. Additionally, the term “treatment” was seen as inherently linked to improving health. This view would permit cosmetic surgery, as it is not traditionally aimed at health improvement. The alternative, adopted by the EBA, was a nature-based approach. Here, “surgery” was interpreted broadly, referring to any physical intervention in a medical context, regardless of the procedure’s objective—whether therapeutic, diagnostic, or otherwise.
The next task of the EBA was to define the scope of the exclusion under Article 53 of the EPC, which hinged on the object and purpose behind the provision. The primary aim of this exclusion is to ensure that medical professionals can perform surgical procedures freely, without the risk of patent infringement. This is crucial to maintaining accessibility to medical practices and preventing monopolisation through patents. The EBA clarified that for a procedure to fall under the exclusion of a “surgery,” three key requirements must be met: the procedure must involve an invasive intervention, carry an inherent risk, and require medical expertise to be performed. Based on this interpretation, routine techniques and minor interventions that do not meet these criteria remain patent-eligible.
Based on this interpretation, routine techniques and minor interventions that do not meet these criteria remain patent-eligible.
The EBA also further analysed the boundaries of this exclusion, noting that methods used during surgery that are not inherently surgical remain patentable. In theory, this opens the door to amending claims to avoid exclusion by focusing on non-surgical aspects of the method. For instance, a method could include comprehensive guidance for surgeons, while focusing on the imaging technique or preparatory steps rather than the invasive surgical action itself. As such, while the surgical method would be excluded, the imaging method could remain eligible for patent protection.
Conclusion
Overall, the impact of G01/07 (Treatment by Surgery) was to clarify Article 53. It defined the three requirements to be considered a “surgery” and created guidance for future applications in the medical field. They also emphasised the importance of maintaining public access to medical practices by preventing monopolisation.
In the last article in our series, we will explore something important to all scientists: Inventorship. We will look at a key landmark case that took place in the UK that clarified who the inventor truly is.
