Diagnostic methods are generally characterized by a physical stage of detection or quantification of one or more analytes (markers) and a stage of correlation with a pathology or predisposition. The COVID-19 pandemic has underlined the importance of these technologies, with a global market estimated to exceed $100 billion by 2025. However, patent protection for these methods varies considerably from country to country.
Thirty years after the ADPICS (Trade-Related Aspects of Intellectual Property Rights) agreements, Art.27(3) of which provided that its members could exclude diagnostic methods from patentability, what is the situation? What is meant by 'diagnostic methods' being excluded in different countries? Which countries are in favor of patent protection for diagnostic methods, which exclude them, and which others have an evolving practice in line with innovations and case law?
This article examines the current situation in several regions of the world (North America, Europe, South Africa, Asia and Oceania), and gives you some advice on how to adapt your IP strategy if you're developing innovations in medical diagnostics.
In the USA, claims to diagnostic methods are generally considered ineligible for patent protection under 35 USC §101, as they are often seen as seeking to protect a natural phenomenon ('natural law'). However, there are exceptions and strategies for securing protection for diagnostic methods in the US:
- Include at least one concrete/physical step (e.g. sample collection, measurement of analyte levels, use of specific equipment);
- Add at least one unconventional element (e.g. new measurement technique); and/or
- Couple diagnostic features with a treatment step (e.g. a method comprising diagnosis of a patient followed by treatment of the patient in a specific way based on the diagnosis).
Furthermore, the devices or products used in diagnostic methods are patentable, provided they are not products of nature. Thus, a natural antibody or nucleic acid is not patentable, even when isolated from its environment, but an antibody or nucleic acid coupled to a detectable marker such as a fluorophore is patentable.
In Canada, and as indicated in our previous article (link), since 2020, it has been possible to protect diagnostic methods provided they include physical steps. For example, a method that includes a step for detecting or quantifying an analyte in a biological sample is patentable, but a method in which the diagnosis is simply based on the analysis of previously obtained data is not.
In Europe, the situation is equally complex, but the rules are different from those in the USA . Diagnostic methods practised on the human or animal body are excluded from patentability under Article 53c) of the European Patent Convention (EPC). Decision G1/04 of the Enlarged Board of Appeal and the Examination Guidelines specify that only diagnostic methods which include all the following steps are excluded from patentability:
- The collection of results (examination phase),
- Comparison of these results with reference values,
- Detection of a significant difference in the comparison, and
- Attribution of this difference to a particular clinical profile (decision phase),
Steps of a technical nature being performed on the human or animal body.
Deleting one of steps 1) to 4) in order to escape exclusion may sometimes be impossible if this step constitutes a technical feature essential to the implementation of the invention.
However, when deleting one of steps 1) to 4) is possible, the method is then protectable. Furthermore, if the technical steps are not performed on the human or animal body, then the method does not fall within the scope of the exclusion and is therefore patentable.
It is therefore possible to:
- Protect in vitro and ex-vivo diagnostic methods, i.e. those applied to samples previously taken from the human or animal body (e.g. T1920/21: method for measuring carbon isotope content in a respiratory sample collected in a bag);
- Protect data acquisition methods, including the collection and analysis of data without leading to a clinical diagnosis;
- To protect diagnostic products, compositions and kits used in diagnostic methods (these are explicitly excluded from the exclusion); and/or
- To explore the possibility of reformulating diagnostic method claims to secure protection (e.g. T505/19: an antibody for use in an in vivo diagnostic method for an inflammatory disease of the central nervous system).
In New Zealand, diagnostic methods on the human body are excluded from patentability, but in vitro or ex-vivo methods are eligible, as in Europe, as are diagnostic methods applied to the bodies of non-human animals.
In South Africa, diagnostic methods performed on humans or animals are generally considered ineligible for patent protection, but substances and compositions intended for use in a diagnostic method are eligible. However, we do not have sufficient experience of the acceptability of in vitro and ex-vivo diagnostic methods: in fact, the South African Patent Office does not carry out a thorough examination of patent applications to determine whether the claimed inventions meet the requirements for patentability. This substantive examination is carried out by a court during infringement or revocation proceedings, and to our knowledge there are no case-law decisions on the specific subject of the patentability of diagnostic methods, and in particular in vitro and ex-vivo diagnostic methods. Consequently, and waiting for future decisions, our local agents recommend securing these aspects by adapting the claims to what would be patentable in other jurisdictions, notably Europe (see above).
In Australia, as indicated in our previous article (link), diagnostic methods are patentable. A method for diagnosing (disease Y) comprising measuring/detecting (marker X) in (body/tissue/sample). This is therefore the least restrictive of the countries studied in this article, and should be considered as part of your IP protection strategy.
In Asia, diagnostic methods are excluded from patentability in most jurisdictions, but what this exclusion covers varies from one jurisdiction to another.
In Japan, diagnostic methods practiced on the human body are excluded from patentability (the exclusion does not apply to veterinary diagnostic methods). However, it is possible to protect the products used in the diagnostic method, data analysis methods, as well as processes for treating a sample that has been extracted from the human body (cells, tissues), provided that the process does not include the diagnostic phase stricto sensu and that said treated samples are not returned to the same body (otherwise, they would be treatment methods, also excluded from patentability).
In China, diagnostic methods cannot be protected by patent. There, a diagnostic method is understood to be performed on a living human or animal body, and its immediate purpose is to obtain a diagnosis of a disease or pathological condition. If the method is applied to in vitro samples, but its purpose is the same as above, the method is also excluded, contrary to the situation in Europe. Also included in the category of diagnostic methods are methods for assessing the risk of suffering from a disease (not yet present) and methods for predicting the therapeutic efficacy of a drug.
Here again, and despite this more restrictive context than in the other countries studied, there is a strategy for escaping exclusion: reformulate diagnostic method claims as the use of compound X for the preparation of a kit used in the diagnosis of a disease.
In India, diagnostic methods are excluded. A diagnostic method is defined as a method for identifying the existence or non-existence of a disease or condition for the treatment of human subjects. The exclusion therefore does not apply to veterinary diagnostic methods.
In humans, the exclusion is not limited to in-vivo diagnostics. However, the Indian Office is said to have granted patents on in-vitro procedures (so, there are inconsistencies in the Indian Office's determination of what does and does not fall within the scope of diagnostic methods, potentially in favor of the applicants).
In Vietnam, diagnostic methods are not eligible for patent protection. These are methods which (i) are carried out on living organisms (human or animal) or in vitro on human or animal samples, and (ii) whose primary objective is to diagnose a disease or pathological condition. The context is therefore quite restrictive, as in China. We therefore recommend protecting products and kits used in diagnostic methods, as well as methods for obtaining intermediate results that do not allow direct diagnosis. Thus, to maximize the chances of obtaining patent protection in these countries, we recommend that, where the invention lends itself to protection under local law, devices or products used in diagnostic methods, as well as methods for obtaining intermediate results that do not allow diagnosis to be made, should be protected in parallel with the diagnostic methods themselves. These may nevertheless be protected in a number of countries, sometimes subject to reformulation of the claims.
Protection of diagnostic methods therefore varies widely from one jurisdiction to another. Of the countries analyzed,Australia is the most favorable to patent protection for diagnostic methods. Europe, Canada, South Africa, New Zealand and Japan are in favor of protecting data analysis methods, products used in diagnostic methods, as well as in vitro and ex-vivo diagnostic methods (except in Japan; to be followed in South Africa). In the USA, diagnostic methods must include technical and non-conventional steps to be eligible. Finally, China, India and Vietnam are the least favorable (although a few cases of in vitro diagnostic methods have been granted); it is recommended that priority be given to protecting the products used in the methods.
The growth of the self-testing market and MedTech technologies underlines the importance of IP protection for innovative companies in medical diagnostic. Our Regimbeau teams are at your disposal to help you navigate this complex landscape and best protect your innovations in this field.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
