Round Table on ILPO Examination Guidelines – Biotechnology

I recently participated in a Round Table organized by the Israeli Patent Office (ILPO) to discuss potential updates to the Examination Guidelines on two complex topics: claims directed to treatment of subpopulations (a key issue in personalized medicine) and defining antibodies in claims. Interestingly, without any direction from the organizers, litigators ended up sitting on one side of the (rectangular rather than round) table, while prosecution patent attorneys sat on the other. Although both topics are important and evoked engaging discussions, the first subject resonated more strongly with me, as it relates to current trends in medicine.

What follows is not intended to be a comprehensive review of either the topic or the wide-ranging discussion that took place, but rather a brief overview of some of the main points raised during the meeting.

The Guidelines and Proposed Changes
The discussion centered on a potential revision to Section 6.11 of Appendix Vav of the Guidelines, which deals with novelty. As currently phrased, this section prevents granting a patent for a known treatment of a known disease when the only distinction is in applying the treatment to a new subpopulation that falls within the originally treated population.
The ILPO presented three possible approaches:
1. Considering claims for treating a new subpopulation to be novel if they include a diagnostic step (i.e., to determine whether a subject belongs to the new subpopulation).
2. Leaving the section unchanged.
3. Deleting the section entirely and instead assessing such claims under the criteria for inventive step.

Diverging Perspectives
As might be expected, opinions divided largely along professional lines. Litigators on one side of the table leaned towards maintaining the current approach under novelty (option 2), arguing that treating a subpopulation of an already treated population does not constitute something new. On the other side of the table, prosecution patent attorneys generally favored deleting the section and examining the matter under inventive step criteria (option 3).

The rationale for the latter position stems from how medical understanding evolves. What was once seen as a single disease category (for example, “cancer” or “lung cancer”) is now increasingly recognized as encompassing multiple distinct diseases, often defined by specific genetic mutations. From this perspective, a newly identified subpopulation can be regarded as representing a novel disease, with unique characteristics and potentially optimal treatments. Focusing treatment on such subpopulations could improve efficacy and reduce unnecessary treatment for patients who are unlikely to benefit from them. Research that identifies these subpopulations and the corresponding treatments should be encouraged and supported, potentially through patent protection.

Reflections on Enforcement and Alternative Approaches
It seemed that ILPO representatives were somewhat surprised that neither group selected the first option, which proposed including a diagnostic step in the claim. The idea of incorporating a diagnostic step into the claims appears to be a step in the right direction, but raises other issues, such as a questionable enforceability.

A related idea that emerged, which I find worth exploring, is the possibility of an implicit diagnostic step. This could be framed by adding a “wherein” clause to the claim requiring that the subject has been diagnosed as belonging to the newly identified subpopulation. Whether this approach would overcome the same enforceability concerns remains an open question and would likely require further consideration.

Acknowledgment and Broader Context
As a final note, I would like to acknowledge the ILPO for initiating this dialogue, for taking the time to hear various perspectives, and for demonstrating openness to refining the Guidelines. One of the ongoing challenges for any patent authority is to strike a balance between protecting generic competition and fostering innovation. How that balance is set in this context may ultimately shape the future of personalized medicine in Israel.