ILPTO Update: Non-Extendable IL PTE Deadlines

The ILPTO recently reconfirmed that missing the 90-day deadline for reporting the grant of a US PTE, which fulfils the ‘Two-State Requirement’, results in loss of PTE eligibility.

The IL PTE system is based on the ‘Two-State Requirement’ linking eligibility of IL PTE to the grant of PTE/SPC in the US and in at least one of the EU-5 countries (UK, Germany, France, Italy, Spain). As part of its reporting obligations, the patentee must notify the ILPTO of the grant of any new PTE/SPC for a Reference Patent in the US and the EU-5 countries within 90 days from the date of grant.

The 90-day deadline for reporting the grant of the specific PTE/SPC which fulfils the ‘Two-State Requirement’ is non-extendable. In practice, as the US PTE is almost always granted after the earliest SPC in the EU-5 countries, it is the 90-day term for notifying the grant of the US PTE which is non-extendable.

In a recent decision, the ILPTO rejected a PTE petition because the patentee (Newron Pharmaceuticals) was 10 days late in notifying the ILPTO of the grant of the US PTE. The Patents Commissioner rejected the patentee’s assertions that the statutory text can be construed in a manner permitting a deviation from the 90-day term, that the particular circumstances of the case leading to the late reporting could somehow support an extension, or that loss of PTE grant as a result of late reporting is unconstitutional.

Patentees should accordingly be aware that the strict IL PTE system provides the two following non-extendable deadlines:

• Filing the PTE petition within 90 days from the date of registration of the medical preparation (the deadline applies also when the patent is still pending);

• Reporting the grant of the PTE/SPC (almost always the US PTE) which fulfils the ‘Two-State Requirement’.

In order to prevent inadvertent loss of IL PTE, it is therefore important for patentees to establish appropriate internal monitoring systems to ascertain compliance with the reporting deadlines. As an additional layer of protection to prevent possible communication breakdown resulting in loss of PTE, we also proactively review the online IL Drug Registry to identify new product registrations of our clients, monitor the grant of PTEs/SPCs in the US and the EU-5 countries and send periodic reminders to patentees.

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.