June 22, 2023

ILPTO update: PTE Eligibility of Proteins

In a recent decision, the ILPTO Deputy Chief Examiner held that different glycosylation is insufficient to confer PTE eligibility if a protein with the same amino acid sequence was previously approved. The decision is inconsistent with previous ILPTO case law and we expect further clarification of the ILPTO position in the coming months. The ILPTO […]

March 15, 2023

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 […]

December 15, 2022

ILPTO Update: Second medical use SPCs are irrelevant in determining the term of IL PTEs

In a recent judgment, the IL Supreme Court clarified that supplementary protection certificates (SPCs) granted in the EU5 countries, which are not based on the first marketing authorization for an active ingredient, should not be considered in determining the term of IL PTE orders. Boehringer Ingelheim filed a petition for PTE in Israel with respect […]

July 11, 2022

ILPTO Update: Impact of cancellation of first product registration on validity of the IL PTE 

According to a recent controversial District Court judgment (Wyeth v. The Manufacturers’ Association of Israel), even when switching to a new generation product comprising the active ingredient, it is still necessary to maintain in force the original product registration on which the IL PTE was based (the first registration permitting the use of the active […]

March 21, 2022

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 […]

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