FICPI's CET 5 Study & Work Group on Biotech and Pharmaceuticals conducted an international survey of practitioner organisations directed to the patentability of diagnostic methods for medical conditions, diseases, and disorders. The results from the survey reveal a landscape that is both converging on core principles and diverging in implementation.
The survey results indicate that patent eligibility for diagnostic methods appears to be somewhat constrained1. The survey results reveal a central global dividing line: methods performed directly on the human or animal body are generally excluded from patent eligibility, whereas in vitro methods and patent claims limited to technical steps (e.g. measurement or detection) are more likely to be allowed.
The survey results show that most jurisdictions do not impose categorical bans on related subject matter such as polymorphs or diagnostic kits; approximately 65.52% of respondents reported no prohibition on polymorphs, and 58.06% indicated that diagnostic kits are patent eligible. Moreover, the survey participants indicated that biomarker-based diagnostic claims could be patentable, depending on claim drafting and scope considerations.
Heightened scrutiny of diagnostic methods
The survey further demonstrates that jurisdictions apply heightened scrutiny to diagnostic methods in three distinct ways. First, statutory filters impose explicit substantive thresholds beyond traditional novelty and inventive step.
India provides one example of a statutory filter. Section 3(i) of the Indian Patent Act excludes from patent eligibility diagnostic and treatment methods applied to the human or animal body. Moreover, India permits the patenting of polymorphs and related derivatives of known compounds, but only if it results in enhanced efficacy. Together, these provisions create a materially higher bar for patenting pharmaceutical and diagnostic innovations.
Second, guideline-driven scrutiny operates through patent office examination practices. Brazil exemplifies this approach by requiring detailed physicochemical characterisation of polymorphs and by applying nuanced guidelines that exclude diagnostic methods involving the human body or yielding a clinical conclusion, while permitting in vitro methods and intermediate technical steps. Argentina similarly reflects this model, where PTO guidelines may treat polymorphs as lacking human intervention - even in the absence of an express statutory exclusion - thereby raising barriers to patentability.
Third, several jurisdictions apply doctrinal or analytical frameworks, often influenced by European Patent Office (EPO) practice. For example, Greece expressly notes that it follows EPO approaches when in doubt, and other jurisdictions such as Finland and Singapore reflect similar analytical reasoning. These systems do not necessarily rely on explicit statutory exclusions alone but instead examine whether a claim encompasses the full set of steps leading to a clinical diagnosis (e.g. data collection, comparison, deviation identification, and attribution). Patent claims limited to intermediate technical steps—particularly those performed in vitro—are more likely to survive, whereas claims that culminate in a diagnostic determination are typically excluded.
Areas of agreement
Despite these differences, the survey identifies meaningful areas of global harmonisation. There is near-universal agreement that methods of treatment or prevention tied to diagnostic steps are not patent eligible (93.33% “No”), while methods of measuring biological parameters, distinct from making a diagnostic decision, are generally patentable (86.67% “Yes”). Many jurisdictions also recognise alternative claiming strategies, such as claims directed to kits, compositions, or uses, although the permissibility of these approaches varies and is often closely scrutinised to ensure the claims do not merely recite excluded subject matter in another form.
These commonalities suggest an emerging global consensus: patent systems are willing to protect technical implementations and measurement technologies but remain cautious about granting exclusive rights over clinical decision-making or medical acts.
From a United States perspective, offered here as a comparative observation rather than a direct survey finding, diagnostic methods are not categorically excluded. Instead, eligibility is governed by judicial exceptions under 35 U.S.C. § 101, as articulated in cases such as Mayo and Alice, which focus on whether claims are directed to natural laws or abstract ideas and whether they include an “inventive concept”. In practice, however, U.S. outcomes often parallel the international trend identified in the survey: claims directed to correlations or diagnostic conclusions are frequently found ineligible, while claims emphasising concrete technical steps, such as in vitro assays or measurement techniques, are more likely to withstand scrutiny.
Conclusion
The survey therefore highlights a key strategic takeaway for global patent practice: regardless of doctrinal differences, successful claim drafting increasingly depends on isolating technical, sample-based processes from clinical reasoning, thereby aligning with both international norms and U.S. eligibility jurisprudence.
FICPI's view
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Next steps
If you would like to get involved with the activities of FICPI's Study & Work Group on Biotech and Pharmaceuticals (CET 5), visit: https://ficpi.org/cetcommissions/cet-5-biotechnology-and-pharmaceuticals or contact the Chair, Rowan Joseph: [email protected]
CET Group 5 is dedicated to following, reporting and providing substantive comments and opinions on emerging issues relating to the patenting and regulatory affairs in the Biotechnology and Pharmaceutical fields.
[1] Approximately 30 practitioners from 27 countries participated in the survey.