Intellectual Property, Surrogate Licensing, and Precision Medicine

The fruits of the biotechnology revolution are beginning to be harvested. Recent regulatory approvals of a variety of advanced therapies—Keytruda (pembrolizumab), Kymriah (tisagenlecleucel), and patisiran—have ushered in an age of “precision medicine” treatments that target patients’ specific genetic, physiological, and environmental profiles rather than generalized diagnoses of disease. Therapies like these may soon be supplemented by gene editing technologies such as CRISPR, which could enable the targeted eradication of deleterious genetic variants to improve human health. But the intellectual property (IP) surrounding precision therapies and their foundational technology remain controversial. Precision therapies ultimately rely—and are roughly congruent with—basic scientific information developed in the service of academic research. Much of precision medicine’s IP, however, is held by academic research institutions that employ for-profit surrogate companies, companies responsible both for commercially developing university research and sublicensing university IP to others. This creates an uneasy tension between the public missions of universities and the commercial motives of surrogates, particularly universities’ goals of producing and disclosing scientific information, and surrogates’ goals of exploiting that information for commercial gain. This essay examines the challenges that surrogate licensing poses for the future of precision medicine. It begins by providing a brief summary of precision medicine and its recent developments. Next, it provides an overview of university patenting and the shift toward surrogate licensing. It then explores some of the difficulties concerning surrogate licensing in the context of precision medicine and, later, suggests modified licensing approaches and best practices that may better promote scientific discovery, the development of human therapies, and overall social welfare. Lastly, the essay discusses some larger doctrinal and theoretical implications arising from surrogate licensing in informationally intensive fields, like precision medicine