News

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.

Trust, But Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software

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.[1]  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 on Thursday, January 23, 2020, 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.

Watch the video of the public metting here.

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.

[1] https://www.accenture.com/_acnmedia/pdf-49/accenture-health-artificial-intelligence.pdf

Rai joins panel to discuss pharma patents and pricing practices

Faculty Co-Director, Professor Arti Rai, participated in a ‘Stakeholder Panel Discussion’ at the Bipartisan Policy Center in Washington, D.C., on December 10, 2019. 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. More information at BPC.

Rai calls on Congress to act “surgically” following Federal Circuit ruling on administrative patent judges

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 on November 19, 2019. 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

Arti Rai, Faculty Co-Director of The Center for Innovation Policy at Duke Law, is one of the principal investigators for this one-year grant from The Greenwall Foundation. Read more here.

 
White Paper

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.

 
Recent Events

AI in the Administrative State: Applications, Innovations, Transparency, Adaptivity

Friday, May 4, 2018 | Duke Law School, Durham, NC

Artificial intelligence (AI) is being employed in the private sector to optimize production processes, pricing, and other business functions. But apart from national security and law enforcement, productive uses in the public sector have received less attention, despite recognition that the administrative state's foremost challenges include efficient processing of ever-increasing amounts of data, and adapting to new information over time. The Center for Innovation Policy at Duke Law, the Duke Center on Law & Technology, the Duke Initiative for Science & Society, and the Rethinking Regulation Program at the Kenan Institute of Ethics held a joint conference at Duke University to explore promising uses of AI and the challenges they pose in administering diverse governmental functions involving science, technology, health and intellectual property.

Are Patents Under Attack?

Friday, April 6, 2018 | Duke Law School, Durham, NC

The Center for Innovation Policy at Duke Law and the Federal Circuit Bar Association presented a one-day program focusing on important patent issues affecting the protection of cutting-edge technology. The program provided 7 hours of CLE credit. Sessions: "Women in IP Breakfast"; "The Impact of Recent Section 101 Patent Eligibility Cases on U.S. Innovation"; "Hot Topics in PTAB Proceedings"; "Moderated Discussion with The Honorable Todd M. Hughes, Judge, U.S. Court of Appeals for the Federal Circuit"; "Supreme Court Review of Federal Circuit Decisions"; "A View from the Bench" (judges discuss effective advocacy and brief writing); and, "Diversity in Courts, Agencies, Corporations and Law Firms."

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  Donald Verrilli, Munger, Tolles &
  Olson (former U.S. Solicitor General)
• 

  John Duffy, University of Virginia
  Law School
• 

  James Smith, Ecolab
  (former Chief Judge, PTAB)

Is Administrative Review of Granted Patents Constitutional? 

Friday, September 22, 2017 | Washington, DC

The U.S. Supreme Court granted certiorari in Oil States Energy Services v. Greene’s Energy Group, a case in which the petitioner argues that the most prominent U.S. Patent and Trademark Office process for analyzing the validity of granted patents “violates the Constitution by extinguishing private property rights through a non-Article III forum without a jury.” This half-day conference gathered distinguished practitioners and legal scholars from a variety of perspectives to discuss potential implications of the case for patent law, for the administrative state, and for affected industries.

This conference was funded through support from Google and InterDigital.

More information

• 

  Gary Epstein, former Chair of the
  FCC's Incentive Auction Task Force
• 

  David Quinalty, Senate Commerce,
  Science & Transportation Committee
• 

  Dorothy Robyn, former
  Commissioner at the G.S.A.

The FCC Spectrum Incentive Auction: Lessons for the Future

Friday, May 12, 2017
Duke University's "Duke in DC" offices

The FCC concluded the most complex auction in history, the culmination of a decade-long planning process for moving spectrum from broadcast to mobile broadband uses. On May 12, 2017, The Center for Innovation Policy at Duke Law held a half-day conference that identified lessons from this auction for spectrum policy, government disposition of assets (whether of spectrum or other resources), and the future of innovation policy generally.

Speakers included: Lawrence Ausubel, Univ. of Maryland, Power Auctions; Jonathan Chaplin, New Street Research; Paul de Sa, Quadra Partners; Gary Epstein, former Chair of Incentive Auction Task Force at FCC; Karla Hoffman, George Mason Univ.; Allan Ingraham, Economists Inc.; Edward Lazarus, Tribune Media; Michael Ostrovsky, Stanford Graduate School of Business; Preston Padden, Boulder Thinking; David Quinalty, Senate Commerce, Science, & Transportation Committee; Charla Rath, Verizon; Dorothy Robyn, former Commissioner at GSA; Gregory Rosston, Stanford Univ.; David Salant, Auction Technologies; Steve Sharkey, T-Mobile; and Ilya Segal, Stanford Univ.

More Information

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  Katrine Bosley, Editas Medicine
• 

  Senator Chris Coons (D-DE), Co-chair, Senate Competitiveness Caucus
• 

  Mary 'Missy' Cummings, Duke Pratt School of Engineering

The Decline in Corporate Research: Should We Worry?

Friday, March 31, 2017, and Tuesday, June 6, 2017
Washington, D.C.

Government data and research point to a long decline in US corporate investment in upstream research. How pervasive is this trend across industries, technologies, and firms of different sizes? How does it compare with research spending by the federal government, universities, and companies abroad? Does it reflect less reliance on research, whoever performs it? Is it explained by capital market pressures, global competition, or other factors? Has it contributed to the slowdown in productivity growth? Are there other reasons policymakers should be concerned? If so, what policy levers should they look to—e.g., intellectual property, tax, government R&D spending, or antitrust enforcement?

These issues were first examined at a conference—The Decline in Corporate Research: Should We Worry?—at "Duke in DC," where speakers included Eduardo Porter, New York Times columnist; Katrine Bosley, Editas Medicine CEO; Bill Raduchel, former AOL CTO; Bill Janeway, Warburg Pincus partner; Eric Toder, Tax Policy Center director; Howard Shelanski, former director OMB’s Office of Information and Regulatory Affairs; and scholars from Duke, Harvard, Columbia, Carnegie Mellon, and Berkeley.

The conference was followed by a briefing—The Decline in Research: Should We Worry?—on Capitol Hill hosted by the co-chair of the Senate Competitiveness Caucus. Speakers included Senator Chris Coons (D-DE); Ashish Arora, Duke Fuqua School of Business; Steven Freilich, University of Delaware Energy Initiative; Stephen Merrill, Duke Law School; Arti Rai, Duke Law School; and, Pian Shu, Harvard Business School.

Both programs were sponsored by a grant from the Ewing Marion Kauffman Foundation.

Find out more about the events and view the archived recordings.

Conference

Congressional Briefing