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 an important evolution in the jurisprudence concerning patent rights and access to the market for generic drugs. 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 generics. This article aims to analyze the main aspects of the ruling and clarify the legal significance of the Bolar clause in the Italian and European context.

The Bolar Clause: A Regulatory Overview

The Bolar clause, or Bolar exemption, allows for the experimentation of patented drugs in order to obtain a marketing authorization (MA) after the expiration of the patent. This legal provision aims primarily to ensure timely access to generic drugs, preventing the duration of exclusivity from being artificially extended. The ruling in question confirms that this exemption can also be invoked by those who produce the active ingredient for the registration purposes of third-party generics.

Patent - Drugs - Bolar Exemption - Nature - Applicability to the producer of the active ingredient intended for transfer to third-party generics - Conditions. Regarding limitations on patent rights, the so-called "Bolar clause" or "Bolar exemption," which allows activities of experimentation on a drug covered by another's patent aimed at obtaining an administrative authorization for the marketing of the drug after the expiration of the other’s patent, pursues the goal of facilitating the timely entry of generic drugs into the market to not effectively prolong the duration of exclusivity, allowing generic manufacturers to begin the administrative and experimental activities leading to the obtaining of a MA (marketing authorization), even while the referenced patent is still in effect; consequently, this exemption can also be invoked by a third party producing the active ingredient of the patented drug for registration purposes not their own, but for third-party generics not equipped to produce independently, but intending to enter the market upon the expiration of the patent exclusivity, provided that - in addition to a prior request from the generic manufacturer - this registration purpose is indicated at the contractual level as a limit of use, as a provision of the commitment to use the active ingredient according to Bolar purposes.

Conditions for the Applicability of the Bolar Clause

The Court established that in order 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 manufacturer.
  • The registration purpose must be clearly indicated at the contractual level.
  • 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 on intellectual property rights. This decision not only clarifies the conditions for the applicability of the Bolar clause but also reaffirms the importance of a legal system that promotes innovation and competition in the pharmaceutical sector. With the ongoing evolution of European and national regulations, it will be crucial to closely follow future interpretations and applications of these provisions.

Bianucci Law Firm