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 […]
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 […]
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.
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 […]
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?
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
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
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.
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.
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 […]