Bolar Exemption for Third-Party Manufacturers of Active Pharmaceutical Ingredients

Bolar Exemption for Third-Party Manufacturers of Active Pharmaceutical Ingredients

Journal article

1 electronic resource (page 751–760)

Extract Code of Industrial Property, Art. 68(1)(b) – Spiriva Headnote by the Editorial Office The Bolar exemption can also apply to activities of third-party manufacturers of an active pharmaceutical ingredient in a patented drug, even if they are not seeking regulatory approval themselves. This applies when they produce the ingredient on behalf of generic drug makers which lack the means to manufacture it but intend to enter the market subsequent to patent expiry. To assert that the scope of the Bolar exemption includes the production of the active pharmaceutical ingredient ab origine and ex ante, a broad interpretation of the exemption is required. This interpretation presupposes not only a prior request from the generics manufacturer but also that, at the brokerage stage, the intended use for regulatory submission is explicitly indicated as a limitation, demonstrating a commitment to conform with the purposes of the Bolar exemption. Supreme Court of Cassation (Corte Suprema di Cassazione), judgment of 5 July 2024 – 18372/2024

Crossref

GRUR International ; 74, 8, 2025, 2632-8550.

[Oxford, England] : Oxford University Press (OUP), 2025.

English

https://academic.oup.com/grurint/article/72/3/231/6998505

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