LEGAL UPDATES
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IL Ministry of Health Update: New “VIP Super Fast-Track Registration” for generic/biosimilar drugs
The IL Ministry of Health launched a new “VIP Super Fast-Track Registration” which will allow for marketing of imported generic and biosimilar drugs within 45 days from the date of filing the fast-track application. The new fast-track option is open for up to 10 products per year which will be selected by the HMOs (Sick…
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ILPTO update: Differences in glycosylation profiles may be sufficient to support PTE eligibility of proteins
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…
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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…
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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…
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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…
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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.
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The 2024 International Comparative Legal Guide for Copyright in Israel by Liad Whatstein & Co.
Our firm recently published the Israel chapter of the 2024 International Comparative Legal Guide for Copyright. The guide can be consulted on the ICLG website, or directly on our website.
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IL TM Update: Court holds that smell-a-likes are not infringing
In a recent judgment, the Tel Aviv District Court held that the marketing of smell alike perfumes does not amount to trademark infringement and does not violate other goodwill-related causes of action. The defendant’s products were marketed under the defendant’s name “Oil de L’amor” below which appeared the word “compatible” in small font and then…
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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…