IL PTE Update: Revocation of a single SPC in the European Recognized Countries invalidates the IL PTE

In a recent decision, the ILPTO clarified the scope of the IL PTE ‘linkage principle’ and held that the revocation of an SPC for a reference patent in any of the European Recognized Countries automatically invalidates the corresponding PTE order in Israel, even if SPCs for reference patents in other European Recognized Countries remain in force.

Under the Israeli PTE provisions, eligibility for PTE is subject to the ‘Two-State Requirement’, i.e., grant of a PTE in the US and grant of an SPC in at least one of the European Recognized Countries (UK, DE, FR, ES, IT). The IL PTE provisions also provide for a ‘linkage principle’ whereby the IL PTE order expires upon the expiry or revocation of any PTE/SPC for a reference patent in the US/European Recognized Countries.

Following the revocation of the UK patent for apixaban and its corresponding SPC, the Manufacturers’ Association, representing the local generic industry, and additional generic companies, petitioned to revoke the PTE for the corresponding IL compound patent asserting it automatically expired in accordance with the ‘linkage principle’.

Patentee argued that the revocation of the UK SPC had no impact on the IL PTE, which continued to remain in force, because except for the UK SPC, the SPCs for apixaban in all other European Recognized Countries remained in force. Patentee’s position was that the ‘linkage principle’ must be aligned with the Two-State eligibility requirement which is satisfied as long as at least one SPC remains in force in the European Recognized Countries. Patentee also argued that in view of the ex-tunc effect of the revocation of the UK SPC, the present situation should be assessed as if a UK SPC had never been granted which would not have prevented the grant of the IL PTE in accordance with the ‘Two-State Requirement’.

The Deputy Commissioner acknowledged that the asymmetry between the Two-State eligibility requirement and the ‘linkage principle’ is anomalous. The Deputy Commissioner however held that she is constrained by the statutory language (“revocation of any SPC” is an invalidating event) and by the case law requiring strict literal interpretation of the PTE provisions. This is another decision in a long line of decisions in which the ILPTO and IL courts somewhat unenthusiastically pursue a simplistic formal approach to the interpretation of the complex IL PTE provisions.

[Decision dated November 28, 2024 in Petition to revoke the PTE order for IL Patent No. 160693]

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.