Arti K. Rai | Scholars@Duke

Arti K. Rai
Elvin R. Latty Distinguished Professor of Law

Arti Rai, Elvin R. Latty Professor of Law and Faculty Director, The Center for Innovation Policy at Duke Law, is an internationally recognized expert in intellectual property (IP) law, innovation policy, administrative law, and health law.

Rai's extensive research on these subjects has been funded by NIH, NSF, Arnold Ventures, the Kauffman Foundation, the Greenwall Foundation, and the Woodrow Wilson Center. Her numerous publications have appeared in both peer-reviewed journals and law reviews. Peer-reviewed journals include Science, the New England Journal of Medicine, JAMA, the Journal of Legal Studies, Nature Biotechnology, and the Journal of Law and the Biosciences.

Rai currently serves as a Senior Advisor on innovation-related law and policy issues to the Department of Commerce’s Office of General Counsel. She also regularly advises other federal and state agencies as well as Congress on these issues. She is a member of multiple distinguished councils, including the National Academies’ Forum on Drug Discovery, Development, and Translation, the Polaris Advisory Council to the Government Accountability Office, and the American Law Institute. She has also served as a member of the National Advisory Council for Human Genome Research, as a public member of the Administrative Conference of the United States, and on numerous National Academies committees.

From 2009-2010, Rai headed the Office of Policy and International Affairs at the U.S. Patent and Trademark Office (USPTO). In that capacity, she led policy analysis of the patent reform legislation that ultimately became the America Invents Act and worked to establish the USPTO’s Office of the Chief Economist. Prior to entering academia, Rai clerked in the Northern District of California and was a litigator at Jenner & Block and the Department of Justice.

Rai graduated from Harvard College, magna cum laude, with a degree in biochemistry and history (history and science), attended Harvard Medical School for the 1987-1988 academic year, and received her J.D., cum laude, from Harvard Law School in 1991.

Current Appointments & Affiliations

Elvin R. Latty Distinguished Professor of Law, Duke Law School, Duke University 2008
Professor of Law, Duke Law School, Duke University 2003
Faculty Network Member of The Energy Initiative, Duke University Energy Initiative, Initiatives 2015
Associate of the Duke Initiative for Science & Society, Duke Science & Society, Initiatives 2017
Core Faculty in Innovation & Entrepreneurship, Duke Innovation & Entrepreneurship, Initiatives 2018
Core Faculty Member, Duke-Margolis Center for Health Policy, Duke - Margolis Center For Health Policy, Initiatives 2019

Contact Information

Duke Law School 210 Science Dr, Duke Box 90362, Durham, NC 27708
Duke Law School Room 3022, Duke Box 90362, Durham, NC 27708
rai@law.duke.edu (919) 613-7276
See the Duke Law profile page
View this faculty member's publications on the Duke Law web site

Background
Education, Training, & Certifications
- J.D., Harvard University 1991
Recognition
In the News
- APR 26, 2021 School of Law
  
  Law's Arti Rai Appointed Senior Advisor in US Department of Commerce
- NOV 6, 2020 School of Law
  
  New Paper Recommends How to Promote Accountability in the Growing Use of AI-Enabled Medical Software
- AUG 19, 2020 School of Law
  
  Law Professor Urges Removal of Legal Obstacles to Vaccine Production
- MAR 28, 2016
  
  Infectious Disease Symposium Convenes at Duke April 1
- FEB 4, 2016 BuzzFeed
  
  Arti Rai comments on patent fight over gene-editing technology
- NOV 16, 2015 The New York Times
  
  Arti Rai proposes method for decreasing prices of expensive class of drugs
- MAY 21, 2015 Nature
  
  Arti Rai comments on likelihood of enacting patent-troll legislation
- MAY 12, 2015 BuzzFeed
  
  Arti Rai discusses partnerships between universities and big pharma
- APR 30, 2015 The New York Times
  
  Arti Rai quoted: With patent litigation surging, creators turn to Washington for help
- APR 15, 2015 Science
  
  Arti Rai discusses wrangling between universities, electronics companies over ‘patent troll’ bill
- APR 30, 2014 The New York Times
  
  Arti Rai comments: Europe's antitrust chief censures Google's Motorola Mobility over key patents
- NOV 13, 2013
  
  Laws New Center for Innovation Policy Promotes Long-Term Economic Growth
- JUL 5, 2013 Boston Herald
  
  Colleges get tough on patent infringement
Expertise
Global Scholarship
- Expertise
  - United States of America (Country)
Research
Selected Grants
- Low-Quality Biopharmaceutical Patents and the PTAB awarded by Arnold Ventures 2020 - 2021
- Explainability and Trade Secrecy in AI-Enabled Clinical Decision Support, Diagnostic, and Predictive Software awarded by Greenwall Foundation 2019 - 2020
- Intellectual Property and Access to Noninvasive Prenatal Genetic Testing awarded by National Institutes of Health 2013 - 2017
- Conference on New Approaches and Incentives in Drug Development awarded by Ewing Marion Kauffman Foundation 2013 - 2014
- Intellectual Property Challenges for the Development of Genomic Diagnostics awarded by National Institutes of Health 2009 - 2012
Publications & Artistic Works
Selected Publications
- Books
  - Rai, A. Intellectual Property and Biotechnology. Edward Elgar, 2011.
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  - Rai, A., C. Slobogin, and R. Reisner. Law and the Mental Health System: Civil and Criminal Aspects, 2009.
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- Academic Articles
  - Rai, A., and W. II. “Clearing Opacity Through Machine Learning.” Iowa Law Review 106, no. 2 (2021): 775–812.
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  - Rai, A., I. Sharma, and C. Silcox. “Accountability, Secrecy, and Innovation in AI-Enabled Clinical Decision Software.” Journal of Law and the Biosciences 7 (2020).
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  - Rai, A., W. II, and T. Minssen. “Knowledge Transfer for Large-Scale Vaccine Manufacturing.” Science 369, no. 6506 (2020): 912–14.
  - Rai, A., and L. Gostin. “Expanding Access and Reducing Prices for Drugs to Prevent HIV: Should Government Enforce Its Patent Rights Against the Pharmaceutical Industry?” Jama 323, no. 9 (2020): 821–22.
  - Rai, A., and W. II. “Clearing Opacity through Machine Learning (In preparation),” 2020.
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  - Rai, A. “Machine Learning at the Patent Office: Lessons for Patents and Administrative Law.” Iowa Law Review 104, no. 5 (2019): 2617–41.
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  - Rai, A., A. McGuire, M. Majumder, A. Villanueva, J. Bardill, and J. Bollinger. “Importance of Participant-Centricity and Trust for a Sustainable Medical Information Commons.” The Journal of Law, Medicine & Ethics 47, no. 1 (2019): 12–20.
  - Rai, A., and W. II. “How Logically Impossible Patents Block Biosimilars.” Nature Biotechnology 37, no. 8 (2019): 862–63.
  - Rai, A., C. Cotropia, D. Crouch, S. Graham, M. Janis, J. Kesan, M. Lemley, A. Mossoff, T. Sichelman, and S. Vishnubhakat. “Response to the Proposed Changes to the Claim Construction Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board (In preparation),” 2018.
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  - Rai, A. “Intellectual Property Issues in Genomics (Accepted).” Annual Review of Genomics & Human Genetics 18 (2017).
  - Rai, A. “Risk Regulation and Innovation: The Case of Rights-Encumbered Biomedical Data Silos.” Notre Dame Law Review 92 (2017): 1641–67.
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  - Rai, A., P. Deverka, M. Majumder, A. Villanueva, M. Anderson, and A. Bakker. “Creating a Data Resource: What Will It Take to Build a Medical Information Commons?” Genome Medicine 9, 84 (2017): 1–5.
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  - Rai, A., and R. Cook-Deegan. “Racing for Academic Glory and Patents: Lessons from CRISPR.” Science 358, no. 6365 (2017): 874–76.
  - Rai, A., R. Feldman, M. Lemley, and J. Masur. “Open Letter on Ethical Norms in Intellectual Property Scholarship.” Harvard Journal of Law & Technology 29, no. 2 (2016): 1–13.
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  - Rai, A., S. Vishnubhakat, and J. Kesan. “Strategic Decision Making in Dual PTAB and District Court Proceedings.” Berkeley Technology Law Journal 31, no. 1 (2016): 45–124.
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  - Rai, A., and J. Sherkow. “The Changing Life Science Patent Landscape.” Nature Biotechnology 34 (2016): 292–93.
  - Rai, A., and S. Benjamin. “Administrative Power in the Era of Patent Stare Decisis.” Duke Law Journal 65 (2016): 1561–97.
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  - Rai, A., and W. II. “Manufacturing Barriers to Biologics Competition and Innovation.” Iowa Law Review 101 (2016): 1023–63.
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  - Price, W Nicholson, and Arti K. Rai. “Drug Development. Are trade secrets delaying biosimilars?” Science (New York, N.Y.) 348, no. 6231 (April 9, 2015): 188–89. https://doi.org/10.1126/science.aab1684.
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  - Rai, A. “Are Trade Secrets Delaying Biosimilars?” Science 348, no. 6231 (2015): 188–89.
  - Rai, A., and S. Vishnubhakat. “When Biopharma Meets Software: Bioinformatics at the Patent Office.” Harvard Journal of Law & Technology 29, no. 1 (2015): 206–41.
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  - Rai, A. “Diagnostic Patents at the Supreme Court.” Marquette Intellectual Property Law Review 18 (2014): 1–9.
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  - Rai, A. “Competing with the "Patent Court": A Newly Robust Ecosystem.” Chicago Kent Journal of Intellectual Property 13, no. 2 (2014): 386–93.
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  - Rai, A., and G. Rice. “Use Patents Can Be Useful: The Case of Rescued Drugs.” Science Translational Medicine 6 (2014): 248fs30.
  - Rai, A. “Biomedical Patents at the Supreme Court: A Path Forward.” Stanford Law Review Online 66 (2013): 111–17.
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  - Rai, A. “Improving (Software) Patent Quality Through the Administrative Process.” Houston Law Review 51 (2013): 503–43.
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  - Rai, A., and M. Bagley. “The Nagoya Protocol and Synthetic Biology Research: A Look at the Potential Impacts,” 2013.
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  - Rai, A., and R. Cook-Deegan. “Moving Beyond "Isolated" Gene Patents.” Science 341 (2013).
  - Rai, A. “Valuing Health Care: Improving Productivity and Quality,” 2012.
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  - Rai, A. “Use Patents, Carve-Outs, and Incentives--A Battle in the Drug-Patent Wars.” New England Journal of Medicine 367 (2012): 491–93.
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  - Rai, A. “Patent Validity Across the Executive Branch: Ex Ante Foundations for Policy Development.” Duke Law Journal 61 (2012): 1237–81.
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  - Rai, A., and B. Sampat. “Accountability in Patenting of Federally Funded Research.” Nature Biotechnology 30 (2012): 953–56.
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  - Rai, A. “Who's Afraid of the Federal Circuit?” Yale Law Journal Online 121 (2011): 335–45.
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  - Rai, A. “Unstandard Standardization: The Case of Biology.” Communications of the Acm 53 (2010): 37–39.
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  - Rai, A. “Intellectual Property.” Developments in Administrative Law and Regulatory Practice 2010 (2010): x,1-15.
  - Kieff, F. S., D. Martens, A. K. Rai, and R. R. Rader. “Panel discussion: Specialized courts: Lessons from the federal circuit.” Journal of Intellectual Property 8, no. 2 (June 3, 2009): 317–42.
  - Ortí, Leticia, Rodrigo J. Carbajo, Ursula Pieper, Narayanan Eswar, Stephen M. Maurer, Arti K. Rai, Ginger Taylor, et al. “A kernel for the Tropical Disease Initiative.” Nature Biotechnology 27, no. 4 (April 2009): 320–21. https://doi.org/10.1038/nbt0409-320.
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  - Cook-Deegan, Robert, and Arti K. Rai. “DNA sequence patents are not in the grave yet.” Nature Biotechnology 27, no. 2 (February 2009): 122. https://doi.org/10.1038/nbt0209-122.
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  - Ortí, Leticia, Rodrigo J. Carbajo, Ursula Pieper, Narayanan Eswar, Stephen M. Maurer, Arti K. Rai, Ginger Taylor, et al. “A kernel for open source drug discovery in tropical diseases.” Plos Neglected Tropical Diseases 3, no. 4 (January 2009): e418. https://doi.org/10.1371/journal.pntd.0000418.
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  - Rai, A. “Growing Pains in the Administrative State: The Patent Office's Troubled Quest For Managerial Control.” University of Pennsylvania Law Review 157 (2009): 2051–81.
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  - Rai, A., J. Allison, B. Sampat, and C. Crossman. “University Software Ownership and Litigation: A First Examination.” Perspectives: Teaching Legal Research and Writing 87 (2009): 1519–70.
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  - Rai, A., S. Chandrasekharan, S. Kumar, and C. Valley. “Proprietary Science, Open Science and the Role of Patent Disclosure: The Case of Zinc Finger Proteins.” Nature Biotechnology 27 (2009): 140–44.
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  - Rai, A., and S. Benjamin. “Structuring U.S. Innovation Policy: Creating a White House Office of Innovation Policy,” 2009.
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  - Benjamin, S., and A. Rai. “Fixing Innovation Policy: A Structural Perspective.” George Washington Law Review 77 (2008): 1–88.
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  - Rai, A. “Building a Better Innovation System: Combining Facially Neutral Patent Standards with Therapeutics Regulation.” Houston Law Review 45 (2008): 1037–57.
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  - Rai, A., and S. Benjamin. “Fixing Innovation Policy: A Structural Perspective.” George Washington Law Review 77 (2008): 1–88.
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  - Reichman, J., A. So, B. Sampat, R. Cook-Deegan, R. Weissman, and A. Kapczynski. “Is Bayh-Dole Good for Developing Countries? Lessons from the U.S. Experience.” Plos Biology 6 (2008): 2078–84.
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  - Reichman, J., P. Uhlir, and C. Crossman. “Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery.” Yale Journal of Health Policy, Law & Ethics 8 (2008): 53–89.
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  - Rai, A. “Knowledge Commons: The Case of the Biopharmaceutical Industry.” First Monday 12 (2007): 4.
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  - Rai, A. “Open Source and Private Ordering: A Commentary on Dusollier.” Chicago Kent Law Review 82, no. 3 (2007): 1439–42.
  - Rai, A. “The Ends of Intellectual Property: Health as a Case Study.” Law and Contemporary Problems 70 (2007): 125–30.
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  - Rai, A., and J. Boyle. “Synthetic Biology: Caught Between Property Rights, the Public Domain, and the Commons.” Plos Biology 5 (2007): 389–93.
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  - Rai, A., and S. Benjamin. “Who's Afraid of the APA? What the Patent System Can Learn from Administrative Law.” Georgetown Law Journal 95 (2007): 269–336.
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  - Rai, A., and S. Kumar. “Synthetic Biology: The Intellectual Property Puzzle.” Texas Law Review 85 (2007): 1745–68.
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  - Kepler, T. B., M. A. Marti-Renom, S. M. Maurer, A. K. Rai, G. Taylor, and M. H. Todd. “Open source research - The power of us.” Australian Journal of Chemistry 59, no. 5 (June 19, 2006): 291–94. https://doi.org/10.1071/CH06095.
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  - Rai, A., and R. Eisenberg. “Harnessing and Sharing the Benefits of State Sponsored Research.” Berkeley Technology Law Journal 21 (2006): 1187–1213.
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  - Rai, A., and C. Crossman. “A Brief History of BioPerl,” 2005.
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  - Rai, A. “Finding Cures for Tropical Diseases: Is Open Source an Answer?” Plos Medicine 1 (2004): 180–83.
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  - Rai, A. “'Patenting Organisms and 'Basic Research,' and 'Private Ownership of Inventions',” 2004, 1980–83.
  - Rai, A. “Engaging Facts and Policy: A Multi-Institutional Approach to Patent System Reform.” Columbia Law Review 103 (2003): 1035–1135.
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  - Rai, A., and R. Eisenberg. “Bayh-Dole Reform and the Progress of Biomedicine.” Law & Contemporary Problems 66 (2003): 289–315.
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  - Rai, A. “Genome Patents: A Case Study in Patenting Research Tools.” Academic Medicine 77 (2002): 1368–72.
  - Rai, A. “Genetic Interventions: (Yet) Another Challenge to Allocating Health Care.” San Diego Law Review 39 (2002): 657–67.
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  - Rai, A. “Locating Gene Patents Within the Patent System.” American Journal of Bioethics 2 (2002): 18.
  - Rai, A. “Pharmacogenetic Interventions, Orphan Groups, and Distributive Justice: The Role of Cost-Benefit Analysis.” Social Philosophy & Policy 19 (2002): 246.
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  - Rai, A. “Specialized Trial Courts: Concentrating Expertise on Fact.” Berkeley Technology Law Journal 17 (2002): 877–98.
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  - Rai, A. “Genes and the Just Society: Preface.” San Diego Law Review 39, no. 3 (2002): 649–50.
  - Rai, A. “Health Care Fraud and Abuse: A Tale of Behavior Induced by Payment Structure.” Journal of Legal Studies 30 (2001): 579–87.
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  - Rai, A. “Evolving Scientific Norms and Intellectual Property Rights: A Reply to Professor Kieff.” Northwestern University Law Review 95 (2001): 707–13.
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  - Rai, A. “Fostering Cumulative Innovation in the Biopharmaceutical Industry: The Role of Patents and Antitrust.” Berkeley Technology Law Journal 16 (2001): 813.
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  - Rai, A. “The Information Revolution Reaches Pharmaceuticals: Balancing Innovation Incentives, Cost, and Access in the Post-Genomics Era.” University of Illinois Law Review 2001 (2001): 173–210.
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  - Rai, A. “Addressing the Patent Gold Rush: The Role of Deference to PTO Patent Denials.” Washington University Journal of Law & Policy 2 (2000): 199–227.
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  - Rai, A. “Intellectual Property Rights in Biotechnology: Addressing New Technology.” Wake Forest Law Review 34 (1999): 827–47.
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  - Rai, A. “Regulating Scientific Research: Intellectual Property Rights and the Norms of Science.” Northwestern University Law Review 94 (1999): 77–152.
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  - Rai, A. “Reflective Choice in Health Care: Using Information Technology to Present Allocation Options.” American Journal of Law & Medicine 25 (1999): 387.
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  - Rai, A., M. Siegler, and J. Lantos. “The Physician as a Health Care Proxy.” Hastings Center Report 29 (1999): 14.
  - Rai, A. “Rationing Through Choice: A New Approach to Cost-Effectiveness Analysis in Health Care.” Indiana Law Journal 72 (1997): 1015–97.
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  - Rai, A. “Cost-Effectiveness and Cost-Benefit Analyses in the Medical Literature.” Annals of Internal Medicine 116 (1992): 338.
  - Rai, Arti, and James Boyle. “Synthetic Biology: Caught between Property Rights, the Public Domain, and the Commons.” Plos Biology 5, no. 3 (n.d.): e58–e58. https://doi.org/10.1371/journal.pbio.0050058.
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- Book Sections
  - Rai, A. “Patent Institutions: Shifting Interactions Between Legal Actors.” In Research Handbook on the Economics of Intellectual Property Law, 473–88. Edward Elgar Publishing, 2019.
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  - Rai, A., and S. Vishnubhakat. “The USPTO’s Patent Trial and Appeal Board.” In Research Handbook on the Economics of Intellectual Property Law, 92–103. Edward Elgar Publishing, 2019.
  - Rai, A. “Legal Issues in Genomic and Precision Medicine: Intellectual Property and Beyond.” In Genomic and Precision Medicine: Foundations, Translation, and Implementation, 357–66. Academic Press, 2017.
  - Rai, A. “The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances.” In FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, 403–12, 2015.
  - Rai, A., and B. Sampat. “Accountability, Government Rights, and the Public Interest: A Thirty-Year Retrospective.” In The Chicago Handbook of University Technology Transfer and Academic Entrepreneurship, 75–96, 2015.
  - Rai, A. “U.S. Executive Branch Patent Policy, Global and Domestic.” In Patent Law in Global Perspective, 85–96. Oxford University Press, 2014.
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  - Rai, A., J. Reichman, R. Newell, and J. Wiener. “Intellectual Property and Alternatives: Strategies for Green Innovation.” In Intellectual Property Rights: Legal and Economic Challenges for Development, 356–91, 2014.
  - Rai, A. “Critical Commentary on 'Open Source' in the Life Sciences.” In Gene Patents and Collaborative Licensing Models: Patent Pools, Clearinghouses, Open Source Models and Liability Regimes, 213–18, 2009.
  - Rai, A. “"Open and Collaborative" Biomedical Research: Theory and Evidence.” In Advancing Knowledge and the Knowledge Economy, 391–414, 2006.
  - Rai, A. “Open and Collaborative Research: A New Model for Biomedicine.” In Intellectual Property Rights in Frontier Industries, 131–58. AEI-Brookings Press, 2005.
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  - Rai, A. “Proprietary Rights and Collective Action: The Case of Biotechnology Research With Low Commercial Value.” In International Public Goods and Technology Transfer in a Globalized Intellectual Property Regime, 288–306, 2005.
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  - Rai, A. “Allocating Power over Fact-Finding in the Patent System,” 19:907–22, 2004.
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  - Rai, A. “The Increasingly Proprietary Nature of Publicly Funded Biomedical Research: Benefits and Threats.” In Buying in or Selling Out?: The Commercialization of the American University, 117–26, 2004.
  - Rai, A., and R. Eisenberg. “Proprietary Considerations.” In 2 Handbook of Stem Cells: Embryonic Stem Cells, 793–98, 2004.
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- Other Articles
  - Rai, A. “Rebooting America: Innovation Policy.” Duke Law Magazine, 2021.
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  - Rai, A., and J. Hughes. “Acknowledging the Public Role in Private Drug Development: Lessons From Remdesivir.” Stat, 2020.
  - Rai, A., and E. Chen. “The Need for Speed: Process and Product Quality in Track 1.” Law 360, 2016.
  - Rai, A. “Letter to U.S. Senate Committee on the Judiciary Concerning Inter Partes Review and Orange Book-Listed Patents.” Letter to the U.S. Senate Committee on the Judiciary, 2015.
  - Rai, A., and G. Rice. “Use Patents Can Be Useful: The Case of Rescued Drugs.” Science Translational Medicine, 2014.
  - Rai, A. “Patentable Subject Matter at the Supreme Court: An Exceptional Case?” Scotusblog, 2013.
- Reports
  - Rai, A., C. Silcox, and I. Sharma. “Trust, But Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software.” Duke-Margolis Center for Health Policy & The Center for Innovation Policy at Duke Law, 2020.
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  - Rai, A., G. Daniel, T. Barker, C. Springer, M. Lopez, J. Kalinina, K. Greene, J. Qian, and M. McClellan. “Overcoming the Legal and Regulatory Hurdles to Value-Based Payment Arrangements for Medical Products.” Duke-Margolis Center for Health Policy, 2017.
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  - Rai, A., C. Chien, J. Contreras, C. Corrado, S. Graham, D. Hegde, and S. Vishnubhakat. “Comment to the SEC in Support of the Enhanced Disclosure of Patent Technology License Information,” 2016.
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  - Rai, A., C. Chien, R. Gilbert, C. Shapiro, T. Cotter, S. Ghosh, E. Goldman, et al. “Rand Patents and Exclusion Orders: Submission of 19 Economics and Law Professors to the International Trade Commission,” 2012.
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  - Rai, A., R. Newell, J. Reichman, and J. Wiener. “Intellectual Property and Alternatives: Strategies for Green Innovation,” 2008.
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Teaching & Mentoring
Recent Courses
Scholarly, Clinical, & Service Activities
Outreach & Engaged Scholarship
- Bass Connections Faculty Team Member . Innovation and Technology Policy Lab . August 2015 - May 2016 2015 - 2016

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Education, Training, & Certifications

In the News

Global Scholarship

Expertise

Selected Grants

Selected Publications

Books

Academic Articles

Book Sections

Other Articles

Reports

Recent Courses

Outreach & Engaged Scholarship