July 12, 2023

IL Biosimilar Update: New MOH Guidelines Facilitate Registration of Biosimilars

The updated Biosimilar Registration Guidelines of the Israeli Ministry of Health (“Procedure 127”) will enter into force on July 15th, 2023. The updated Guidelines are intended to facilitate registration of biosimilar products and the switching to biosimilar products from the reference product. According to the updated Guidelines, a biosimilar product submitted for approval in Israel […]


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 […]

January 30, 2023

ILPTO Update: Patent Oppositions No Longer Automatically Stayed

According to a series of recent ILPTO decisions, the ILPTO will no longer stay opposition proceedings against the parent application pending the examination of its divisional applications, if the stay is likely to significantly delay the opposition to the parent. Israel is a pre-grant opposition country. The stay of opposition proceedings pending the examination of […]

January 23, 2023

ILPTO update: Intent to deceive is a prerequisite for finding of Fraud on the PTO

In a recent decision the ILPTO reiterated that subjective intent to deceive is a prerequisite for imposing sanctions on patentees who violated the strict disclosure obligations under the Patents Act. A mistake in good faith by the inventor or the agent prosecuting the application does not amount to Fraud on the PTO and will not […]

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 […]

January 10, 2022

ILPTO Update: ILPTO Recognizes Strawman Oppositions

In a precedential decision, the ILPTO recently recognized for the first time the admissibility of strawman oppositions. Under Israeli law, any person can oppose a patent application prior to its grant. There are no limitations on the standing to oppose and the opponent does not need to establish any particular interest in the proceedings. Strawman […]

December 7, 2021

ILPTO Update: The Deadline for Filing Divisional Applications Cannot Be Extended

The ILPTO clarified in a recent decision that divisional applications can be filed only until the allowance of the parent and that this deadline cannot be extended nor circumvented by seeking cancellation of the allowance of the parent application. Under IL law, divisional applications can be filed only until the allowance of the parent application. […]

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