The lie of the land: extending exclusivity for pharmaceuticals and biotech


Isabella Liu, Mackenzie DeWerff and Haitao Sun

Market exclusivity allows innovator companies to recoup sizable investments in the research, development, clinical testing and bringing to market of new products.

Market exclusivity is a key incentive for pharmaceutical, agrichemical and biologics innovator companies to assume the enormous risks associated with their investments in R&D and marketing: once a new product comes to market, meaningful profits are possible only through at least some period of exclusive rights for the product.

Around the world, innovator companies use various mechanisms to achieve market exclusivity for any new product. The most pervasive mechanism is patent protection, which under the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement ensures patent owners exclusive rights “to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing” the patented product for the duration of the patent.

Other mechanisms are available in countries such as the US and in the EU, including patent term extension, data exclusivity and patent linkage.

Pharmaceutical, biotech, patent, market exclusivity