A more favourable approach to patient population claims by the ILPTO
The ILPTO has signalled a significant shift in how patient population claims will be examined – making such claims easier to obtain and defend.
The new draft examination guidelines lower the novelty threshold of patient population claims and focuses instead on the inventive step of such claims. According to the draft guidelines, novelty of patient population claims will be denied only if the target population was explicitly described in the prior art. In contrast, the definition of the same target population merely utilizing different parameters will not confer novelty. Importantly, when the target population was not explicitly described in the prior art, the claim will be regarded as novel even if the claimed population is part of the previously treated patient population.
When examining the inventive step of patient population claims, key considerations supporting inventiveness would be whether the parameter defining the patient population (e.g., a genetic mutation) was not known to be associated with the claimed treatment; whether the treatment of the claimed patient population results in unexpected clinical advantages; and whether there are additional technical differences involved in the treatment of the claimed patient population such as different dosing regimens. On the other hand, absent some degree of teaching away or an unexpected advantage or some other technical difference associated with the new patient population, a claim merely targeting a sub-group of previously treated patients will be regarded as prima facie obvious.
Assuming the new proposed guidelines are accepted (a likely scenario), there will be significantly more maneuvering room for patentees to obtain claims targeting new patient populations. We will advise once the new guidelines are formally adopted.
This update article is provided for general information only and is not in lieu of legal advice. Please contact us directly for any required advice on specific matters.