Use Patents Can Be Useful : The Case of Rescued Drugs

Pharmaceutical firms may forego development of small molecules for which they cannot secure strong “product” or “composition-of-matter” patents. During the time these composition-of-matter patents remain in force, they not only block third parties from marketing the drug for the patentee's use but also block the marketing of new uses discovered by third parties. In contrast, so-called “use” patents, which protect a selected therapeutic use, can often be evaded through "skinny labeling" at the U.S. Food and Drug Administration. Still, despite the apparently limited commercial power of use patents, pharmaceutical firms do seek them, even on relatively small improvements. Consequently, use patents as a category are frequently viewed as covering innovation of only “secondary” therapeutic value. Here, we discuss an important context, very relevant to the movement towards "rescue" of small-molecule drugs that failed in initial clinical trials, in which use patents can have substantial commercial and therapeutic value. However, careful protection of the ability to secure use patents will be important