The Center for Innovation Policy at Duke Law
The Center for Innovation Policy at Duke Law is a forum for independent
analysis and balanced discussion of policies for promoting technological
innovation that enhances long-term social welfare.
Upcoming Events
Constitutional Principals: Administrative Adjudication and Arthrex
February 12 | 12:00 p.m. - 1:30 pm
On March 1, 2021, the Supreme Court will hear argument in United States v. Arthrex, Inc. The issue before the Supreme Court is the application of the Appointments Clause to judges of the Patent Trial and Appeals Board (PTAB), a tribunal established by Congress in 2012 within the U.S. Patent and Trademark Office. In the decision, the Court of Appeals for the Federal Circuit held that the administrative patent judges of the PTAB, currently appointed by the Commerce Secretary, were principal officers who had to be appointed by the President and confirmed by the Senate. The Federal Circuit then determined that it could cure the Appointments Clause defect by prospectively severing the application of statutory removal protections to the judges. The Supreme Court will hear argument on both the principal officer question and the issue of proper remedy. Arthrex is the sixth Supreme Court case on the PTAB, and the second constitutional challenge. Persistent controversies surrounding the tribunal raise important questions for patents and innovation policy. And as a matter of administrative and constitutional law, the Arthrex case brings into sharp focus not only the proper construction of the Appointments Clause but more broadly the proper role of administrative adjudication.
The distinguished commentators on this panel include a Federal Circuit judge and renowned academics whose scholarship has focused on the key patent, administrative, and constitutional issues.
Recently Published
Accountability, Secrecy, and Innovation in AI-Enabled Clinical Decision Software
Arti K. Rai, Isha Sharma, & Christina Silcox
Journal of Law and the Biosciences, 14 November 2020
https://doi.org/10.1093/jlb/lsaa077
Abstract: This article employs analytical and empirical tools to dissect the complex relationship between secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD). Although secrecy can provide incentives for innovation, it can also diminish the ability of third parties to adjudicate risk and benefit responsibly. Our first aim is descriptive. We address how the interrelated regimes of intellectual property law, Food and Drug Administration (FDA) regulation, and tort liability are currently shaping information flow and innovation incentives. We find that developers regard secrecy over training data and details of the trained model as central to competitive advantage. Meanwhile, neither FDA nor adopters are currently asking for these types of details. In addition, in some cases, it is not clear whether developers are being asked to provide rigorous evidence of performance. FDA, Congress, developers, and adopters could all do more to promote information flow, particularly as ML-CD models move into areas of higher risk. We provide specific suggestions for how FDA regulation, patent law, and tort liability could be tweaked to improve information flow without sacrificing innovation incentives.
Trust, but Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software
Christina Silcox, Arti K. Rai, & Isha Sharma
September 18, 2020
The Center for Innovation Policy at Duke Law and the Duke-Margolis Center for Health Policy white paper, funded by the Greenwall Foundation, discusses ways to incentivize innovation in AI-enabled medical products while effectively communicating how and when to use them.
Latest News
The Future of American Innovation & the Role of the University
A discussion with USPTO Director, Andrei Iancu
Thursday, January 14, 2021
Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (USPTO) spoke to the Duke, UNC, and Triangle communities about building a supportive and inclusive innovation ecosystem. He discussed the new National Council for Expanding American Innovation (NCEAI) launched in 2020, highlighting the need for additional support for under-represented minorities (URM) & women entrepreneurs.
Hosted by Bryant Moore, UNC Office of Technology Commercialization. Q&A moderated by CIP Faculty Director Arti K. Rai.
New Voices in Intellectual Property Scholarship
Saurabh Vishnubhakat, Research Fellow for the Center, moderated a “New Voices in Intellectual Property Scholarship” panel at the AALS 2021 Annual Meeting. The panel provided junior intellectual property scholars an opportunity to receive useful feedback on their work from more senior reviewers before submitting their work for publication. Lidiya Mishchenko, Center Research Fellow, presented her recent work entitled “Thank You for Not Publishing.” The project addresses the heretofore unrecognized cost of publishing unexamined patent applications. The amorphous scope of patent applications injects new levels of uncertainty into patent examination and freedom to operate searching for market participants. The paper considers ways to optimize how and when patent applications are published for improved notice.
Coronavirus Conversations
Restoring Faith in Public Science Agencies
A Fireside Chat with
Dr. Anthony Fauci and Mr. Alan Alda
Friday, December 18, 2020
The Center for Innovation Policy at Duke Law co-hosted this event with Duke Science & Society, the Duke Global Health Institute, the Georgetown Law O’Neill Institute for National and Global Health, the Harvard Petrie-Flom Center for Bioethics, the Stanford Law Center for Law and the Biosciences, and the Yale School of Public Health.
As the numbers of COVID-19 infections, hospitalizations and deaths mount, we nonetheless have reason to be optimistic. Two promising vaccines, developed at record speed using cutting-edge technology, are set to be delivered to our first responders and most vulnerable citizens. A new administration will take office in January, and has promised to elevate science and science-driven policy. But the pandemic is far from over. We must treat the sick, bring infection rates under control, and successfully distribute the vaccine to most of the American public. All of this depends on rebuilding the faith of ordinary Americans in the doctors, scientists and scientific agencies who should rightfully be leading us through this perilous time.
The co-hosts and our honored guests, Dr. Anthony Fauci and Mr. Alan Alda, discussed how to restore the faith of the American people in science and the scientific agencies—what we must do now, and in the months ahead, to rebuild their trust in these essential actors and institutions.
Guests:
Dr. Anthony S. Fauci — Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health; Chief Medical Advisor, President-Elect Joseph Biden
Alan Alda — Six-time Emmy and Golden Globe Award Winning Actor; Inventor of the Alda Method; Founder and Visiting Professor, Alan Alda Center for Communicating Science at Stony Brook University
Moderator: Hank Greely, J.D. — Deane F. and Kate Edelman Johnson Professor, Stanford Law School; Director, Center for Law and the Biosciences; Director, Stanford Program in Neuroscience and Society; Chair, Steering Committee of the Center for Biomedical Ethics
Coronavirus Conversations
Emergency Use Authorization, Public Trust, and Vaccines
Thursday, November 5, 2020
The COVID-19 crisis has spurred tremendous public and private innovation efforts, particularly in the area of vaccines. Although the social benefits of one or more safe and effective vaccines are undeniable, analysts are concerned that a vaccine authorized by the FDA through emergency use authorization (EUA) may not be both safe and effective. Additionally, in the area of vaccines, public trust plays a large role in determining ultimate social benefit. So the effect of EUA on public trust in COVID-19 vaccine innovation, and in the FDA more generally, merit close attention.
The Center for Innovation Policy at Duke Law (CIP), together with Duke Science & Society and other co-sponsors, hosted a discussion of the suitability of the EUA process for COVID vaccine innovation. The discussion featured former FDA Commissioner Robert Califf and Founder and Director of the Scripps Research Translational Institute Eric Topol. It was moderated by CIP Director and Elvin R. Latty Professor Arti Rai.
Coronavirus Conversations
On the Ground: Inside the COVID-19 Vaccine Trials
Thursday, November 5, 2020
The Center for Innovation Policy at Duke Law co-hosted this event with Duke Science & Society, the Duke Global Health Institute, the Georgetown Law O’Neill Institute for National and Global Health, the Harvard Petrie-Flom Center for Bioethics, the Stanford Law Center for Law and the Biosciences, the UNC HIV Cure Center, and the Yale School of Public Health.
Ten months into the pandemic, we are making rapid progress toward developing a safe and effective COVID-19 vaccine, with several vaccines in Phase 3 trials in the US alone. Despite this remarkable speed, concerned citizens and members of the medical and public health communities naturally have questions: What does it mean about overall safety and effectiveness that some projects have been paused to ensure the safety and health of vaccine trial participants? Who has been included in the trial process, and how representative are they of our society? When the first vaccines are found to be safe and effective, how effective can we expect them to be, based on current indications? Join the speakers, who are overseeing COVID-19 vaccine trials for Moderna and Pfizer, in a discussion of how the COVID-19 vaccine trials are progressing in the U.S., what current indications are about their safety and efficacy, and when we can expect initial approvals for early or limited use.
Panelists: Cindy Gay, M.D., M.P.H. — Principal Investigator, University of North Carolina site of the Moderna SARS-COV-2 vaccine trial, Associate Professor of Medicine, Division of Infectious Diseases; Medical Director, UNC HIV Cure Center; Chip Walter, M.D. — Principal Investigator, Duke University site of the Pfizer SARS-COV-2 vaccine trial, Professor of Pediatrics, Affiliate, Duke Global Health Institute, Member in the Duke Clinical Research Institute, Member of the Duke Human Vaccine Institute; Moderator: Nita Farahany, J.D., Ph.D. — Duke University; Director, Duke Initiative for Science & Society; Professor of Law and Philosophy, Duke University
Future-Proofing Spectrum Regulation?
Wednesday, October 21, 2020
The event was moderated by Professor Stuart M. Benjamin, Faculty Co-Director of The Center for Innovation Policy at Duke Law, who is on a team that was awarded a grant to study spectrum policy. The award and seminar are for the the National Science Foundation’s Spectrum Innovation Initiative: National Center for Wireless Spectrum Research. The speakers were Philip Marnick, Group Director, Spectrum, Ofcom, and Dean Brenner, Senior Vice President, Spectrum Strategy & Tech Policy, Qualcomm. The panel discussed questions such as: In which situations is exclusive use preferable to shared use and vice-versa? Which policies might optimally encourage innovation and shared spectrum use? How spectrum policies might allow for successful adaptation to unforeseen future developments?
View the recording of the seminar in the timeline of the Facebook page: https://www.facebook.com/spectrum.seminar.3
Duke researchers conduct study on information flow in health-related machine learning, propose improvements
September 2, 2020
The Center for Innovation Policy at Duke Law and the Robert J. Margolis Center for Health Policy at Duke University have collaborated on a study investigating the intricate interrelationship of trade secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD).
Benjamin and colleagues to study future of wireless technologies
Stuart Benjamin, Douglas B. Maggs Professor of Law and Faculty Co-Director of The Center for Innovation Policy at Duke Law, is part of an interdisciplinary team just awarded a National Science Foundation grant to study spectrum policy. The team will explore future wireless technologies beyond 5G and IoT as part of the NSF's Spectrum Innovation Initiative.
Center welcomes new Fellow
Lidiya Mishchenko has joined The Center for Innovation Policy at Duke Law as a Research Fellow. Professor Mishchenko is also a Visiting Associate Professor at Duke Law School. Prior to arriving at Duke Law, she clerked for The Hon. Timothy K. Dyk of the U.S. Court of Appeals for the Federal Circuit and in a variety of technology-related roles at Jones Day, Fish & Richardson, and WilmerHale.
Symposium on Artificial Intelligence in Federal Agencies
July 9, 2020
Faculty Co-Director, Professor Arti Rai, is a panelist at the second program of the Administrative Conference of the United States’s Symposium on Artificial Intelligence in Federal Agencies, addressing “Artificial Intelligence and Administrative Law Doctrines: Challenges and Opportunities”. Other panel members are Cary Coglianese, University of Pennsylvania Law School, and Deirdre Mulligan, University of California Berkeley School of Information; the program is moderated by David Vladeck, Georgetown University Law Center. View a recording of the program here. More information on the series is available here.
Center for Innovation Policy receives Laura and John Arnold Foundation grant to examine the impact of low quality biopharmaceutical patents on drug pricing
Arti Rai, Elvin R. Latty Professor of Law and Faculty Co-Director of the Center for Innovation Policy, is the principal investigator for a one-year grant from the Laura and John Arnold Foundation to examine how the Patent Trial and Appeals Board (PTAB) affects the biopharmaceutical industry. Specifically, Rai's multi-institutional team of researchers will investigate how challenges to small-molecule drug patents and biologics patents before district courts and the PTAB may affect decision making by biopharmaceutical innovators.
More News
Trust, But Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software
Thursday, January 23, 2020
By 2021, the size of the health AI market is expected to be about 11 times what it was in 2014, growing from $600 million to an estimated $6.6 billion. With this explosion of health AI technology comes an urgent need to better understand how to effectively communicate information about these tools in order to harness benefits and mitigate risks. Clinical decision software enabled by AI represents a particularly important area of focus. Information around appropriate use, benefits, and risks is potentially more complicated to determine and/or disclose for AI-enabled clinical decision software than for traditional medical devices. For example, AI-enabled software that utilizes certain deep learning techniques can make recommendations, but there may be no way for a human to understand how the software came to that recommendation. Additionally, commercial competitiveness concerns may restrict how much information a company may want to release. In the absence of information about “how the software works,” what information do stakeholders want? What information do companies want to share?
To explore these issues and more, the Center for Innovation Policy at Duke Law and the Duke-Margolis Center for Health Policy held a public meeting to better understand how to incentivize innovation in this space while communicating necessary information to stakeholders on how to use these products safely and effectively. Specific topics included:
- Informational needs around AI-enabled clinical software during regulation, adoption, and point-of-use;
- How information needed for this software may differ from that needed for traditional medical products and therefore how to effectively communicate it; and
- The role of innovation incentives, such as patents and trade secrecy, over information flow.
- Funding for this meeting was made possible in part by a grant from the Greenwall Foundation. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Greenwall Foundation nor does mention of trade names, commercial practices, or organizations imply endorsements.
Rai joins panel to discuss pharma patents and pricing practices
December 10, 2019
Faculty Co-Director, Professor Arti Rai, participated in a ‘Stakeholder Panel Discussion’ at the Bipartisan Policy Center in Washington, D.C. The panel was part of the BPC’s Health Week program, “Examining Pharmaceutical Patent Practices & Their Impact on Drug Prices.” The program explored how pharmaceutical patents and market exclusivity can incentivize innovation in the United States, while various patent practices can also impact the affordability of brand drugs and biologics, especially for debilitating conditions such as rheumatoid arthritis, cancer, and diabetes. The ‘Stakeholder’ panel of experts discussed the tactics used to delay competition through the patent system and the possible policy solutions to address this important issue.
Rai calls on Congress to act “surgically” following Federal Circuit ruling on administrative patent judges
November 19, 2019
Faculty Co-Director, Professor Arti Rai, appeared before the Subcommittee on Courts, Intellectual Property, and the Internet of the U.S. House of Representative's Committee on the Judiciary. The hearing examined how the rulings in Arthrex v. Smith & Nephew and other recent court decisions affect proceedings before the Patent Trial and Appeal Board. Duke Law article on Prof. Rai's testimony. | Link to Subcommittee information and video of the hearing.
Duke researchers receive Greenwall Foundation grant to address issues of AI-enabled health care delivery
Faculty Co-Director, Professor Arti Rai, is one of the principal investigators for this one-year grant from The Greenwall Foundation.
Righting the Research Imbalance
Stephen A. Merrill
Research in the physical sciences and engineering yields results important to technological innovation, national security, and economic growth. But since the end of the Cold War, public funding of work in these fields has lagged in relation to the size of the economy, expenditures by governments of other countries, and our own government’s support of the biological and medical sciences. Building on presentations at a CIP conference in Washington, this white paper documents the extent of the deficit, explains how it came about and why attempts to correct it have failed, shows that non-federal government sources of funding (industry, universities, and philanthropy) have not stepped up to compensate, and discusses what steps beyond the FY 2018 Consolidated Omnibus Appropriations Act increases are needed.