Commentary on Judgment No. 18372 of 2024: The Bolar Clause and Patent Rights

Judgment No. 18372 of July 5, 2024, issued by the Court of Cassation, represents a significant development in jurisprudence concerning patent rights and access to the generic drug market. In particular, the Court addressed the issue of the so-called "Bolar clause" and its applicability to manufacturers of active ingredients intended for third-party generic companies. This article aims to analyze the main aspects of the judgment and clarify the legal meaning of the Bolar clause within the Italian and European context.

The Bolar Clause: A Regulatory Overview

The Bolar clause, or Bolar exemption, permits experimentation activities on patented drugs for the purpose of obtaining marketing authorization (MA) after the patent expires. The primary objective of this legal provision is to ensure timely access to generic drugs, preventing the duration of the exclusive right from being artificially extended. The judgment under review confirms that this exemption can also be invoked by those who produce the active ingredient for the registration purposes of third-party generic companies.

Patent - Drugs - Bolar Exemption - Nature - Applicability to the manufacturer of the active ingredient intended for transfer to third-party generic companies - Conditions. Regarding limitations on patent rights, the so-called "Bolar clause" or "Bolar exemption," which permits experimentation activities on a drug covered by another's patent aimed at obtaining an administrative marketing authorization for the drug after the expiry of the other's patent, pursues the goal of facilitating the timely entry of generic drugs into the market so as not to de facto extend the duration of the exclusive right. It allows generic manufacturers to commence administrative and experimental activities preparatory to obtaining an MA (marketing authorization), even while the reference patent is in force. Consequently, this exemption can also be invoked by a third party who produces the active ingredient of a patented drug for registration purposes not their own, but for third-party generic companies not equipped to produce it themselves but intending to enter the market upon the expiry of the patent's exclusivity. This is conditional upon – in addition to a prior request by the generic company – such registration purpose being contractually indicated as a limit of use, as a provision for the commitment to use the active ingredient according to Bolar purposes.

Conditions for Applicability of the Bolar Clause

The Court has established that for the Bolar clause to be applicable, it is necessary that:

• The manufacturer of the active ingredient must have a prior request from the generic company.
• The registration purpose must be clearly indicated contractually.
• The active ingredient must be used exclusively for registration purposes and not for the direct production of the drug.

These requirements are fundamental to ensure that the exemption is not abused and that the rights of patent holders are respected.

Conclusions

Judgment No. 18372 of 2024 represents a significant step in balancing the rights of patent holders and access to generic drugs. The approval of the Bolar clause in specific contexts offers an opportunity for generic drug manufacturers to prepare for market entry without infringing intellectual property rights. This decision not only clarifies the conditions for the applicability of the Bolar clause but also reiterates the importance of a legal system that fosters innovation and competition in the pharmaceutical sector. With the continuous evolution of European and national regulations, it will be crucial to closely follow future interpretations and applications of these provisions.