Rai receives grant to study the effect of large patent portfolios on competition, pricing, standardization, and innovation
The project focuses on a group of expensive biologics that represent an outsized percentage of U.S. biopharmaceutical spending.
Elvin R. Latty Professor of Law Arti Rai
Arti K. Rai, the Elvin R. Latty Distinguished Professor of Law and faculty co-director of the Center for Innovation Policy at Duke Law, has received a $300,000, one-year grant from Arnold Ventures to study the effect of large patent portfolios held by branded biopharmaceutical firms on competition, pricing, standardization, and innovation. The focus of the project is a particularly expensive group of therapeutic interventions known as large-molecule biologics. These biologics constitute only about 2% of prescriptions in the U.S. but represent almost 50% of U.S. biopharmaceutical spending.
One particularly challenging component of the patent portfolios held by branded biologics firms involves patents on manufacturing processes. For potential competitors, the number of manufacturing process patents is difficult to determine, as is their validity. Patenting can also hamper efforts to foster beneficial standardization. At the same time, drastic moves to cut these portfolios, sometimes known as “thickets,” may be inadvisable. Improvements in manufacturing processes are necessary, and patents can provide such incentives.
The project aims to assess the number of manufacturing process patents held by biologics firms with the largest revenues; determine whether these patents have indicia associated with strategic filing and potential invalidity; assess patent characteristics that can be used to predict assertion in litigation against biosimilars; and formulate policy proposals that ensure timely entry by biosimilars and foster standardization while maintaining appropriate incentives for improvement of manufacturing technologies.
Rai’s research has previously been funded by Arnold Ventures, as well as the National Institutes of Health, the National Science Foundation, the Kauffman Foundation, the Greenwall Foundation, and the Woodrow Wilson Center.
An internationally recognized expert in intellectual property law, innovation policy, administrative law, and health law, Rai served as senior advisor on innovation law and policy issues to the Department of Commerce’s Office of General Counsel in 2021 and regularly advises other federal and state agencies as well as Congress on these issues. From 2009 to 2010, she headed the Office of Policy and International Affairs at the U.S. Patent and Trademark Office.
Rai will be assisted in her work by Dr. Osmat Azzam Jefferson, a new Senior Fellow at the Center for Innovation Policy. Azzam Jefferson holds a Ph.D. from Cornell University in plant virology and biochemistry as well as two master’s degrees in science and international law from the American University of Beirut and the Australian National University, respectively.
In her previous role as a science and technology professor at Queensland University of Technology, Australia, and a director a of product for the Lens project, Azzam Jefferson consulted with over fifty patent offices to better understand changes in the offices’ patentability requirements for genetic information in patents. She also co-founded the Innovation Information Initiative with economists and data scientists from the Massachusetts Institute of Technology, the University of California Berkeley, and Columbia University. She has presented her research findings at numerous international conferences and business forums, and her key research contributions have been published in highly-ranked peer reviewed journals.