LEGAL UPDATES


  • ILPTO Update: Broad functional antibody claims are not permissible

    ILPTO Update: Broad functional antibody claims are not permissible

    In a precedential decision in the PCSK9 litigation between Sanofi and Amgen, the ILPTO granted the opposition against Amgen’s broad claims to PCSK9 antibodies and limited the scope of functional antibody claims. PCSK9 is a key player in plasma cholesterol metabolism. Its inhibition increases the number of the LDL Receptors on cell surface and thus…

  • IL Ministry of Health Update: New “VIP Super Fast-Track Registration” for generic/biosimilar drugs

    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…

  • ILPTO update: Differences in glycosylation profiles may be sufficient to support PTE eligibility of proteins

    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…

  • When is a novel protein “new” for PTE purposes?

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

    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…

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

    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…

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

    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.

  • The 2024 International Comparative Legal Guide for Copyright in Israel by Liad Whatstein & Co.

    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.

  • IL TM Update: Court holds that smell-a-likes are not infringing

    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…

  • IL Biosimilar Update: New MOH Guidelines Facilitate Registration of Biosimilars

    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…

Tags:
Patents (15) PTE (7) Trademarks (6) Proteins (4) Life Sciences Regulation (3) Q&A (3) Biosimilars (3) Parallel Importation (3) Fraud on the PTO (2) Generics (1) Salts (1) Copyright (1)
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