LEGAL UPDATES
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New MOH guidelines to expedite approval of biosimilars and generics
Two recent MOH Guidelines which just entered into force provide for an expedited approval process of biosimilars and generic products and are intended to prioritize and significantly accelerate launch of biosimilars and generic products. The ‘Prioritized Approval Process’ Guidelines provide that if the marketing of a biosimilar/generic product is expected to generate significant cost savings,…
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TM Update: ILTMO reevaluates and expands the tests for determining likelihood of confusion
In a recent decision, the ILTMO reevaluated and expanded the tests for determining likelihood of confusion under Israeli law de facto aligning Israeli standards with US case law. The ILTMO granted an opposition by The International Olympic Committee against a stylized trademark application for OLIMP Sport Nutrition in class 5. The recently appointed Trademarks Commissioner…
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How many SPCs are required to satisfy the IL PTE eligibility requirement?
PTE grant and duration in Israel are subject to a series of linkages to PTE/SPCs granted in the US and in the five Recognized European Countries (UK, Germany, France, Italy, Spain). The key eligibility prerequisite is the Two-State rule. It provides that if a marketing approval was granted in the US, a prerequisite for IL…
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IL PTE Update: Revocation of a single SPC in the European Recognized Countries invalidates the IL PTE
In a recent decision, the ILPTO clarified the scope of the IL PTE ‘linkage principle’ and held that the revocation of an SPC for a reference patent in any of the European Recognized Countries automatically invalidates the corresponding PTE order in Israel, even if SPCs for reference patents in other European Recognized Countries remain in…
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The 2025 International Comparative Legal Guide for Copyright in Israel by Liad Whatstein & Co.
Our firm recently published the Israel chapter of the 2025 International Comparative Legal Guide for Copyright. The guide can be consulted on the ICLG website, or directly on our website.
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The 2024 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 2024 in the Legal 500 Patent Litigation Comparative Guide. The chapter provides up-to-date information on patent litigation in Israel and covers recent developments. The guide can be consulted on Legal 500’s website, or directly on our website.
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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…
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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…