Israel Patent Office Updates Examination Guidelines on Sub‑Population

Claims in Personalized Medicine

The Israel Patent Office (ILPO) has recently issued updated Examination Guidelines addressing patent applications directed to sub-populations in the context of personalized medicine. These developments are relevant to patent applicants in the pharmaceutical, biotechnology, diagnostics, and digital‑health fields seeking protection for precision‑medicine technologies in Israel.

The updated Examination Guidelines provide important clarification regarding the examination of novelty (Section 4 of the Patent Law) and inventive step (Section 5 of the Patent Law), particularly where the claimed invention lies in identifying a specific subgroup within a broader known patient population. The revised Examination Guidelines provide important clarification of examination practice regarding the requirement of sub-population claims.

These developments are in line with the growing importance of personalized medicine in modern drug development. In recent years, a significant proportion of newly approved therapies have been tailored to specific patient populations. For example, approximately one-third of new molecular entities approved by the U.S. Food and Drug Administration (FDA) in recent years have been classified as personalized medicines, underscoring the growing importance of precision‑medicine-based patents.

In terms of novelty, the Examination Guidelines clarify that a claim directed to treatment of a specific patient subgroup should not be rejected for lack of novelty solely because that subgroup forms part of a broader known population, provided that the subgroup itself was not explicitly disclosed in the prior art. Accordingly, claims directed to treatment of patient groups defined by characteristics such as genetic mutations or polymorphisms, phenotypic traits, diagnostic biomarkers, predicted responders or non-responders may be considered novel if the prior art does not expressly disclose treatment of that specific subgroup. However, novelty will generally be denied if the exact target population is explicitly described in the prior art, even if only as one option within a list of alternatives.

In terms of inventive step, a claim that differs from the prior art only by defining a target population within a broader known population may be considered obvious, especially where the subgroup could be identified through routine clinical investigation or analysis. Inventive step may nevertheless be supported where, for example, the prior art teaches away from treating the claimed subgroup; or where the characteristic defining the subgroup was not previously known to be associated with the claimed therapeutic effect and the applicant demonstrates an unexpected technical advantage. Evidence of improved clinical outcomes or other unexpected effects can therefore be important in supporting inventive step.

Overall, the updated guidance provides greater clarity and predictability for applicants pursuing applicants pursuing personalized-medicine inventions in Israel.