ILPTO Update: Another IL PTE Revoked For Late Reporting Of Foreign PTE/SPCs

In a recent decision, the ILPTO reiterated that late reporting of the grant of PTE/SPCs in the Recognized Countries (US and the EU-5 Countries) may result in loss of PTE eligibility and revoked Amgen’s PTE for OTELZA.

In accordance with the ‘Two-State Requirement’, when marketing authorizations for a new medical preparation have been granted in the US and the EU-5 Countries (UK, DE, ES, IT, FR), eligibility for IL PTE is subject to the grant of a PTE in the US and the grant of an SPC in at least one of the EU-5 countries. The patentee must notify the ILPTO of the grant of the PTE/SPC within 90 days from the date of grant.

The ILPTO position is that when the grant of a specific PTE/SPC leads to the fulfillment of the ‘Two-State Requirement’ (i.e., the US PTE, if it was granted after an SPC in at least one of the EU-5 Countries, or the first SPC granted in the EU-5 Countries after the US PTE), the deadline for notifying the ILPTO of the grant of this PTE/SPC is non-extendable. Consequently, in such circumstances, late reporting will result in loss of eligibility for IL PTE.

The ILPTO recent decision involves Amgen’s IL PTE for apremilast (the active ingredient in the drug OTELZA). Teva filed a petition to revoke Amgen’s PTE, among others on the grounds that Amgen was late in reporting the grant of the SPC in Italy which led to the fulfillment of the “Two-State Requirement”. Amgen was indeed 3-months late in reporting the Italian SPC and also failed to notify the ILPTO of the late filing beyond the deadline. The ILPTO reiterated that late notification of the grant of the PTE/SPC in such circumstances results in loss of eligibility for PTE and criticized Amgen for concealing from the examiner that it was late in reporting the SPC grant.

This decision again illustrates that it is imperative to set an internal monitoring system to ascertain timely reporting of SPC/PTE grant in any of the Recognized Countries. As a further precaution, we also recommend that the local agent proactively monitor the status of PTE/SPCs in the Recognized Countries to preempt late reporting by the patentee.

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.