IL PTE Update: Revocation of Foreign PTE/SPC Can Terminate Israeli PTE Before It Enters into Force
In a recent judgment, the Tel Aviv District Court affirmed that an Israeli Patent Term Extension (PTE) expires upon revocation of a PTE/SPC for a reference patent in a Recognized Country, even if the Israeli PTE order has not yet entered into force. Under the Israeli PTE regime, eligibility for a PTE is subject to […]
In a recent decision, the ILPTO reaffirmed its practice with respect to the filing of multiple PTE applications based on the same drug product. Multiple applications are admissible, but they will be examined concurrently and following examination, a single PTE application must be elected. A notice of intention to grant in respect of the elected […]
In a recent judgment, the Jerusalem District Court affirmed the decision of the Deputy Commissioner of Patents that the revocation of an SPC for a reference patent in any Recognized European Country automatically invalidates the corresponding PTE order in Israel, even if SPCs for reference patents in other Recognized European Countries remain in force. Under […]
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 […]