Tay & Partners: Exclusivity of Pharmaceutical Data

Although there is no explicit mention of data exclusivity (DE), Article 39.3 is commonly perceived to be the source of protection extended to pre-existing data generated from big-budget clinical trials and research by innovator companies. DE protects against any commercial use by a third party, usually a company seeking to establish bioequivalence of generic drugs or biosimilars by referencing clinical data of medicinal products to obtain marketing approvals for generics or biosimilars. Under the DE mechanism, these companies may only submit their application which relies on the clinical data generated by innovator companies after the DE period expires.

The DE mechanism is intended and thought to serve as an incentive that encourages development of new drug therapies in a heavily invested research-based industry. It delays generic and biosimilar entries into the market. This allows innovator companies to recoup their often blockbuster investment in drug research and development.

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