July 11, 2024

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 […]

April 4, 2024

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 […]

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 […]

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 […]

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