Battle Over Patents: The Impact of Oil States on the Generic Drug Industry
Jonathan J. Darrow, Ameet Sarpatwari & Gregory Curfman
ABSTRACT. In the 2018 case of Oil States Energy Services v. Greene's Energy Group, the U.S. Supreme Court upheld the constitutionality of inter partes review, a non-judicial proceeding for challenging patents that was created by Congress as part of the 2011 Leahy-Smith America Invents Act. By establishing inter partes review, Congress hoped to rebalance patent policy to make it faster and less costly to invalidate erroneously granted patents in all fields of technology. In the pharmaceutical industry, generic drug companies have embraced inter partes review, filing hundreds of challenges in the first five years after its creation, with moderate success. Biologics, which make up a growing class of pharmaceutical products, are sometimes covered by dozens or scores of patents. As more of these complex therapeutics are developed and approved, inter partes review is expected to play an increasingly important role.
AUTHOR. Jonathan J. Darrow, S.J.D., LL.M., J.D., M.B.A., Assistant Professor, Harvard Medical School. 1620 Tremont St., Suite 3030, Boston, MA 02120 Phone: 347-792-2246, Fax: 617-232-8602, Email: jjdarrow@bwh.harvard.edu. Ameet Sarpatwari, Ph.D., J.D., Assistant Professor, Harvard Medical School. Gregory Curfman, M.D., Deputy Editor, Journal of the American Medical Association. From the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital. LL.M. "waived" upon admission to the S.J.D. program. This research was supported by Arnold Ventures, with additional support from the Harvard-MIT Center for Regulatory Science and the Engelberg Foundation.
RECOMMENDED CITATION. Jonathan J. Darrow, Ameet Sarpatwari & Gregory Curfman, Battle Over Patents: The Impact of Oil States on the Generic Drug Industry, 19 Yale J. Health Pol'y L. & Ethics (2019). Available at: https://digitalcommons.law.yale.edu/yjhple/vol19/iss1/3.