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Timing of patent filing and market exclusivity

Nature Reviews Drug Discovery volume 10, pages 487–488 (2011)Cite this article

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Market exclusivity — the period during which a new drug is protected from direct competition from generic versions of the drug — is a key element of commercial success in the drug industry. Regulatory agencies such as the US Food and Drug Administration (FDA) provide a limited period of market exclusivity for each newly approved drug or formulation; for example, the FDA provides 5 years for a new chemical entity (NCE), 3 years for a new formulation of an existing drug and 7 years for an orphan drug. Patents may also create a barrier to the entry of generic drugs if the generic drug infringes on a claimed invention in a granted patent. Because the patent term for an NCE often extends beyond the exclusivity period provided by the regulatory agencies, patents generally define the duration of market exclusivity for an NCE.

For patent applications that were filed after June 1995, statutory patent expiry in the United States and Europe occurs 20 years after the date of filing the non-provisional patent application (for example, a PCT (Patent Cooperation Treaty) application). A provisional patent application is often filed 1 year earlier; in this case, patent expiry would occur 21 years after the provisional application was filed. However, because the patent holder does not receive commercial benefit until the product has been approved by regulatory agencies, authorities in the United States and Europe both provide exclusivity extensions for patented drugs, which are intended to compensate for patent life that is lost during the lengthy drug development and regulatory process. Such extensions can prolong the effective patent expiry date beyond 21 years after the filing of the provisional application.

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Figure 1: Model of the relationship between patent filing date, market authorization date and expected duration of market exclusivity in the United States.
Figure 2: Real-world examples.
Figure 3: Importance of timing of initiation of clinical trials.

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  1. Michael K. Dunn is at Ferring Research Institute, Inc, 4245 Sorrento Valley Boulevard, San Diego, California 92121, USA. michael.dunn@ferring.com,

    Michael K. Dunn

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  1. Michael K. Dunn
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Dunn, M. Timing of patent filing and market exclusivity. Nat Rev Drug Discov 10, 487–488 (2011). https://doi.org/10.1038/nrd3494

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