How many SPCs are required to satisfy the IL PTE eligibility requirement?
PTE grant and duration in Israel are subject to a series of linkages to PTE/SPCs granted in the US and in the five Recognized European Countries (UK, Germany, France, Italy, Spain). The key eligibility prerequisite is the Two-State rule. It provides that if a marketing approval was granted in the US, a prerequisite for IL […]
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 […]
In a recent ILPTO PTE update, we reported that the ILPTO rejected a PTE petition for the drug Nexviazyme (avalglucosidase alpha) on the grounds that its registration is not the first regulatory approval permitting the use of the API in view of the previously registered drug Myozime (alglucosidase alfa). These APIs contain the same amino […]
When is a novel protein “new” for PTE purposes?
A recent decision of the ILPTO illustrates its restrictive approach with respect to eligibility of modified versions of previously approved proteins for PTE but the final word has not yet been said. The ILPTO rejected a petition to extend the term of a patent claiming the recombinant antihemophilic factor VIII tuoctocog alfa pegol (Esperoct®). The […]
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 […]
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 […]
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 […]
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 […]
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 […]