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North Carolina Journal of Law & Technology

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data exclusivity, patent, FDA, patents, disclosure


Intellectual Property Law | Law


There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right is included in most international trade agreements.

The patent and data exclusivity regimes are different. The patent regime is one-size-fits-all; it protects new, useful and nonobvious inventions subject to sufficiency of disclosure. In contrast, the data exclusivity regime has both a different target (only pharmaceuticals) and purpose (efficacy & safety). The two systems are administered independently. Yet they apply to the same products and the two rights belong to the same entities.

This Article proposes to prioritize data protection over patents by offering an extension of data exclusivity periods in exchange for not applying for a patent, or letting the patent lapse. As the Article explains, this would create stronger incentives to perform clinical research on molecules that may have positive outcomes in clinical trials including naturally occurring substances and other subpatentable inventions.

The Article conditions the proposed extension on fuller disclosure of clinical data, which would benefit both the public and scientists. Although public disclosure of an invention is a key function of patent law, it is often of poor quality due to excessive use of “patentese.” In the specific case of pharmaceuticals, it is further weakened by the fact that patents are normally applied for well before human clinical trials have been concluded. Under current rules, clinical trial data submitted to governments are often not made public.

Finally, the Article proposes text to be used in future trade agreements—with specific modalities for developing and least-developed countries.



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