February 8, 2024

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 […]

January 28, 2024

ILPTO update: Salt Patents may still be obtained – despite another restrictive ILPTO decision

In a recent decision relating to the tosylate salt of lumateperone, the ILPTO again expressed a highly restrictive view in connection with salt patents. However, salt patents may still be obtained if proper evidence is submitted to establish that the patent is not merely a reflection of routine salt screening. The ILPTO rejected the Patent […]

January 3, 2024

IL Patent Update: Sanctions for misleading representations can target Patentee’s profits

The Supreme Court of Israel held by a majority opinion of an expanded panel that a patentee who willfully provided misleading information to the ILPTO or concealed pertinent information may be liable for restitution of profits derived from delayed generic entry. The judgment results from complex litigation which started more than fifteen years ago and […]

November 7, 2023

The 2023 Legal 500 Israel Patent Litigation Comparative Guide by Liad Whatstein & Co.

Our firm recently published on the Legal 500 platform an updated Israel chapter for 2023 in the Legal 500 Patent Litigation Comparative Guide. The guide can be consulted on Legal 500’s website, or directly on our website.

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 […]

Protein

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 […]

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