LEGAL UPDATES
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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…
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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…
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IL TM Update: New Legislation To Encourage Parallel Importation
As part of government policy to encourage parallel importation, Amendment 23 of the Economic Competition Act, 2023 was enacted for the purpose of limiting activities by authorized importers to prevent parallel importation. Despite this recent legislative initiative, some exceptions to parallel trade still remain. One of the key provisions of the new legislation bans the…
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Israel Life Sciences Commercialization and Life Sciences Regulation Q&As by Liad Whatstein & Co.
Our firm recently published on the Thomson Reuters Practical Law platform two new Q&A guides for the Israeli judicial landscape regarding Life Sciences Regulation and Commercialization. The guides can be consulted on Thomson Reuters Practical Law:• Life Sciences Regulation in Israel: Overview• Life Sciences Commercialisation in Israel: Overview Or directly on our website:• Life Sciences…
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ILTMO Update: Bad Faith Use Of A Mark Can Lead To Its Revocation
In a recent precedential decision, the ILTMO held that bad faith use of a trademark registration can lead to its revocation. The decision involved a petition to revoke a trademark registration for a stylized logo design of the mark BMX for bicycles. When the trademark application was examined, the trademark owner conceded that BMX per…
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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…
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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…
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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…
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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…
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IL TM Update: Parallel Imports Not Permitted in Cases of Split TM Ownership
In a recent precedential judgment (CA 7934/20 Jafora v. Ben Shlush), the Israel Supreme Court held that in cases of split ownership of the same trademark in Israel and another country, trademark rights are not exhausted and parallel imports are not permitted. Jafora, Israel’s second largest manufacturer of soft drinks, is the registered owner of…