Bio

Lisa Larrimore Ouellette is the Deane F. Johnson Professor of Law at Stanford Law School, as well as a Senior Fellow at the Stanford Institute for Economic Policy Research. Her scholarship addresses empirical and theoretical problems in intellectual property and innovation law. She takes advantage of her training in physics to explore policy issues such as how scientists use the technical information in patents, how scientific expertise might improve patent examination, the patenting of publicly funded research under the Bayh–Dole Act, and the integration of IP with other levers of innovation policy. She has applied these ideas to biomedical innovation challenges including the opioid epidemic, the COVID-19 pandemic, and pharmaceutical prices. She has also written about multiple legal issues in trademark law, about the evidentiary value of online surveys, and about the potential for different standards of review to create what she terms “deference mistakes” in numerous areas of law.

Professor Ouellette is also an acclaimed teacher and nationally recognized intellectual property law expert. She has coauthored a free patent law casebook, Patent Law: Cases, Problems, and Materials. She has written over 350 posts for her blog, Written Description, and her commentary has appeared in publications including the New York Times, Wall Street Journal, TIME Magazine, and Slate. She has been selected to design and lead pedagogy training for other Stanford Law faculty. In 2018, she received the law school’s John Bingham Hurlbut Award for Excellence in Teaching.

Prior to her appointment at Stanford Law School in 2014, Professor Ouellette was a Postdoctoral Fellow at the Information Society Project at Yale Law School. She also clerked for Judge Timothy B. Dyk of the U.S. Court of Appeals for the Federal Circuit and Judge John M. Walker, Jr. of the U.S. Court of Appeals for the Second Circuit. She holds a J.D. from Yale Law School, where she was an Articles Editor of the Yale Law Journal and a Coker Fellow in Contract Law. She earned a Ph.D. in physics from Cornell University as well as a B.A. in physics from Swarthmore College, and she has conducted scientific research at the Max Planck Institute, CERN, and NIST.

Academic Appointments

Professional Education

  • J.D., Yale Law School, Law (2011)
  • Ph.D., Cornell University, Physics (2008)
  • B.A., Swarthmore College, Physics (Major) and Mathematics (Minor) (2002)

Contact

  • Academic
    ouellette@law.stanford.edu
    University - Faculty Department: Law School Position: Professor
    • Stanford Law School
    • 559 Nathan Abbott Way
    • Stanford,  California  94305 

Additional Info

Links

All Publications

  • Using Bayh-Dole Act March-In Rights to Lower US Drug Prices. JAMA health forum Ouellette, L. L., Sampat, B. N. 2024; 5 (11): e243775

    Abstract

    Importance: In December 2023, the Biden-Harris Administration released a proposed framework for exercising government march-in rights (effectively granting compulsory licenses for those patents to generic drug makers) under the Bayh-Dole Act on patents on taxpayer-funded drugs, which has renewed questions about whether march-in rights could promote cost savings through generic competition or harm pharmaceutical innovation.Objectives: To determine the feasibility of using march-in rights to remove patent barriers to generic competition.Design, Setting, and Participants: This cross-sectional study examined government funding information from multiple sources for patents listed in the Food and Drug Administration (FDA) Orange Book from 1985 to 2023. Data analysis was completed in August 2024.Exposures: New drug applications (NDAs) with Orange Book-listed patents, including (1) all new molecular entities (NMEs) approved from 1985 to 2022; (2) all NDAs with an Orange Book patent listed between 1985 and 2023; and (3) NDAs with unexpired patents listed in a recent (October 2023) edition of the Orange Book.Main Outcomes and Measures: The main outcome was whether the drugs had any or all patents that were public-sector patents subject to the Bayh-Dole Act, based on combining different data sources for identifying patents that resulted from federal funding. Public-sector patents resulting from intramural research, which are not subject to march-in rights under the Bayh-Dole Act, were identified separately.Results: Of 883 new molecular entities approved from 1985 to 2022, 68 (8%) had a Bayh-Dole patent, but only 18 (2%) had solely Bayh-Dole patents. Of 2832 drugs with patents listed for 1985 to 2023, 142 (5%) had a Bayh-Dole patent, but only 38 (1%) had solely Bayh-Dole patents. Of 1213 drugs with Orange Book patents listed in October 2023, 41 (3%) had a Bayh-Dole patent, but only 14 (1%) had solely Bayh-Dole patents.Conclusion and Relevance: This cross-sectional study found that, although Bayh-Dole march-in rights could remove patent barriers to generic entry for a few drugs, their overall effect would be limited.

    View details for DOI 10.1001/jamahealthforum.2024.3775

    View details for PubMedID 39485334

  • Real-World Prior Art STANFORD LAW REVIEW Masur, J. S., Ouellette, L. 2024; 76 (4): 703-769

    View details for Web of Science ID 001227603800002

  • The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices: An Update Ouellette, L. L., Sampat, B. N. National Bureau of Economic Research. 2024 ; NBER Working Paper (32217):
  • IP and Access to Publicly Funded Research Results in Health Emergencies: US Policy, Law and Practice Ouellette, L. L. World Intellectual Property Organization. 2024 ; WIPO Discussion Paper
  • Improving equity in patent inventorship. Science (New York, N.Y.) Chien, C. V., Ouellette, L. L. 2023; 382 (6675): 1128-1129

    Abstract

    Expanding who gets credit for invention may boost participation in innovation.

    View details for DOI 10.1126/science.adj2911

    View details for PubMedID 38060641

  • The NBER Orange Book Dataset: A user's guide. Research policy Durvasula, M., Hemphill, C. S., Ouellette, L. L., Sampat, B., Williams, H. L. 2023; 52 (7)

    Abstract

    This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"-a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry. We summarize the Orange Book's coverage and discuss the opportunities and challenges associated with using these data for research. Empirical validations against various administrative datasets suggest that Orange Book records are, largely, complete and accurate. We conclude with a specific use case-calculating legal exclusivity periods for drugs-to highlight the types of choices that researchers must make when using this resource.

    View details for DOI 10.1016/j.respol.2023.104791

    View details for PubMedID 38130474

    View details for PubMedCentralID PMC10731339

  • Valuing Medical Innovation Stanford Law Review Hemel, D. J., Ouellette, L. L. 2023; 75: 517-599

    View details for DOI 10.2139/ssrn.4195858

  • The Generic Drug Trilemma Entrepreneurship and Innovation Policy and the Economy Hemel, D. J., Ouellette, L. L. 2023; 2

    View details for DOI 10.1086/723235

  • Innovation Law and COVID-19: Promoting Incentives and Access for New Health Care Technologies COVID-19 and the Law: Disruption, Impact and Legacy Sachs, R. E., Ouellette, L. L., Price II, W., Sherkow, J. S. Cambridge University Press. 2023: 225-236

    View details for DOI 10.1017/9781009265690.025

  • Patent Law: Cases, Problems, and Materials Masur, J. S., Ouellette, L. L. https://www.patentcasebook.org/. 2023
  • Responding to the opioid crisis in North America and beyond: recommendations of the Stanford-Lancet Commission. Lancet (London, England) Humphreys, K., Shover, C. L., Andrews, C. M., Bohnert, A. S., Brandeau, M. L., Caulkins, J. P., Chen, J. H., Cuellar, M., Hurd, Y. L., Juurlink, D. N., Koh, H. K., Krebs, E. E., Lembke, A., Mackey, S. C., Larrimore Ouellette, L., Suffoletto, B., Timko, C. 2022; 399 (10324): 555-604

    View details for DOI 10.1016/S0140-6736(21)02252-2

    View details for PubMedID 35122753

  • Trademark Law Pluralism UNIVERSITY OF CHICAGO LAW REVIEW Hemel, D. J., Ouellette, L. 2021; 88 (5): 1025-1080

    View details for Web of Science ID 000697565600001

  • Private and Public Investments in Biomedical Research. AEA papers and proceedings. American Economic Association Durvasula, M., Ouellette, L. L., Williams, H. 2021; 111: 341-345

    View details for DOI 10.1257/pandp.20211105

    View details for PubMedID 34386715

    View details for PubMedCentralID PMC8356751

  • Improving Scientific Judgments in Law and Government: A Field Experiment of Patent Peer Review JOURNAL OF EMPIRICAL LEGAL STUDIES Ho, D. E., Ouellette, L. 2020; 17 (2): 190–223

    View details for DOI 10.1111/jels.12249

    View details for Web of Science ID 000534645700001

  • THE MEDICARE INNOVATION SUBSIDY NEW YORK UNIVERSITY LAW REVIEW Lemley, M. A., Ouellette, L., Sachs, R. E. 2020; 95 (1): 75–129

    View details for Web of Science ID 000523565300002

  • How do patent incentives affect university researchers? INTERNATIONAL REVIEW OF LAW AND ECONOMICS Ouellette, L., Tutt, A. 2020; 61

    View details for DOI 10.1016/j.irle.2019.105883

    View details for Web of Science ID 000527941600009

  • Innovation policy and the market for vaccines. Journal of law and the biosciences Xue, Q. C., Ouellette, L. L. 2020; 7 (1): lsaa026

    Abstract

    Vaccines play a crucial role in improving global public health, with the ability to stem the spread of infectious diseases and the potential to eradicate them completely. Compared with pharmaceuticals that treat disease, however, preventative vaccines have received less attention from both biomedical researchers and innovation scholars. This neglect has substantial human and financial costs, as vividly illustrated by the COVID-19 pandemic. In this article, we argue that the large number of ``missing'' vaccines is likely due to more than lack of scientific opportunities. Two key aspects of vaccines help account for their anemic development pipeline: (1) they are preventatives rather than treatments; and (2) they are generally durable goods with long-term effects rather than products purchased repeatedly. We explain how both aspects make vaccines less profitable than repeat-purchase treatments, even given comparable IP protection. We conclude by arguing that innovation policy should address these market distortions by experimenting with larger government-set rewards for vaccine production and use. Most modestly, policymakers should increase direct funding-including no grants and public-private partnerships-and insurance-based market subsidies for vaccine development. We also make the case for a large cash prize for any new vaccine made available at low or zero cost.

    View details for DOI 10.1093/jlb/lsaa026

    View details for PubMedID 32733687

    View details for PubMedCentralID PMC7381976

  • Reforming the Patent System Ouellette, L. L., Williams, H. Brookings Institution. 2020 ; The Hamilton Project (2020-12): 1-23
  • University Patenting: Is Private Law Serving Public Values? Michigan State Law Review Ouellette, L. L., Weires, R. 2020; 2019: 1329-1387
  • Policy Experiments to Address Gender Inequality Among Innovators Houston Law Review Madl, A. C., Ouellette, L. L. 2020; 57: 813-841
  • Innovation institutions and the opioid crisis. Journal of law and the biosciences Hemel, D. J., Ouellette, L. L. 2020; 7 (1): lsaa001

    Abstract

    The US has recently-and belatedly-come to recognize opioid addiction as a public health crisis. What has gone mostly unrecognized is the degree to which this crisis is intertwined with US intellectual property law and related elements of US innovation policy. Innovation institutions-the legal arrangements that structure incentives for production and allocation of knowledge goods-encouraged the development and commercialization of addictive painkillers, restricted access to opioid antidotes, and (perhaps most importantly) failed to facilitate investments in alternative, nonaddictive treatments for chronic pain. Although innovation policy does not bear all the blame for the opioid wave that has washed over communities across the country, innovation institutions are bound up in the ongoing epidemic to a degree that so far has gone underappreciated. This article examines the proliferation of opioid use and abuse through the lens of innovation policy, and it envisions ways in which innovation institutions could help to contain the crisis. Along the way, it seeks to derive broader lessons for innovation policy scholarship as well as recommendations for institutional reform. The opioid crisis challenges the conventional understanding of IP law as a trade-off between allocative efficiency and dynamic efficiency; it highlights the potentially pernicious role of IP protection for addictive and habit-forming products; and it exposes deep flaws in the structure of federal subsidies for and regulation of prescription drugs. It also draws attention to the political and cultural factors that contribute to innovation policy failures. Ultimately, the opioid crisis underscores both the urgency and the limits of institutional change in the innovation policy domain.

    View details for DOI 10.1093/jlb/lsaa001

    View details for PubMedID 34221414

  • Innovation Policy Pluralism YALE LAW JOURNAL Hemel, D. J., Ouellette, L. 2019; 128 (3): 544–614

    View details for Web of Science ID 000457342900001

  • Science fiction: Fictitious experiments in patents. Science (New York, N.Y.) Freilich, J. n., Ouellette, L. L. 2019; 364 (6445): 1036–37

    View details for DOI 10.1126/science.aax0748

    View details for PubMedID 31197002

  • Selling Patents to Indian Tribes to Delay the Market Entry of Generic Drugs JAMA INTERNAL MEDICINE Ablavsky, G., Ouellette, L. 2018; 178 (2): 179–80

    View details for DOI 10.1001/jamainternmed.2017.7463

    View details for Web of Science ID 000424261600003

    View details for PubMedID 29297039

  • PUBLIC PERCEPTIONS OF GOVERNMENT SPEECH SUPREME COURT REVIEW 2017 Hemel, D. J., Ouellette, L., Hutchinson, D. J., Strauss, D. A., Stone, G. R. 2018: 33–92

    View details for Web of Science ID 000437078300002

  • What Causes Polarization on IP Policy? UC Davis Law Review Wittlin, M., Ouellette, L. L., Mandel, G. N. 2018; 52: 1193-1241
  • Adjusting Patent Damages for Nonpatent Incentives Texas Intellectual Property Law Journal Ouellette, L. L. 2018; 26: 187-213
  • Bayh-Dole beyond borders JOURNAL OF LAW AND THE BIOSCIENCES Hemel, D. J., Ouellette, L. 2017; 4 (2): 282–310

    View details for DOI 10.1093/jlb/lsx011

    View details for Web of Science ID 000417361000003

  • Who reads patents? Nature biotechnology Ouellette, L. L. 2017; 35 (5): 421-424

    View details for DOI 10.1038/nbt.3864

    View details for PubMedID 28486445

  • A MARKET TEST FOR BAYH-DOLE PATENTS CORNELL LAW REVIEW Ayres, I., Ouellette, L. L. 2017; 102 (2): 271-334

    View details for Web of Science ID 000393359400001

  • Knowledge Goods and Nation-States MINNESOTA LAW REVIEW Hemel, D. J., Ouellette, L. L. 2017; 101 (1): 167-243

    View details for Web of Science ID 000400083900004

  • Pierson, Peer Review, and Patent Law VANDERBILT LAW REVIEW Ouellette, L. L. 2016; 69 (6): 1825-1848

    View details for Web of Science ID 000393222600012

  • HOW COURTS ADJUDICATE PATENT DEFINITENESS AND DISCLOSURE DUKE LAW JOURNAL Allison, J. R., Ouellette, L. L. 2016; 65 (4): 609-695

    View details for Web of Science ID 000368202700001

  • Trade and Tradeoffs: The Case of International Patent Exhaustion Columbia Law Review Sidebar Hemel, D. J., Ouellette, L. L. 2016; 116: 17-31
  • Deference Mistakes UNIVERSITY OF CHICAGO LAW REVIEW Masur, J. S., Ouellette, L. L. 2015; 82 (2): 643-731

    View details for Web of Science ID 000357841800002

  • PATENT EXPERIMENTALISM VIRGINIA LAW REVIEW Ouellette, L. L. 2015; 101 (1): 65-128

    View details for Web of Science ID 000351116700002

  • Patentable Subject Matter and Nonpatent Innovation Incentives UC Irvine Law Review Ouellette, L. L. 2015; 5: 1115-1145
  • Nanotechnology and Innovation Policy Harvard Journal of Law and Technology Ouellette, L. L. 2015; 29: 33-75
  • The Google Shortcut to Trademark Law California Law Review Ouellette, L. L. 2014; 102: 351-407
  • Cultural Cognition of Patents IP Theory Ouellette, L. L. 2014; 4: 28-36
  • Beyond the Patents–Prizes Debate Texas Law Review Hemel, D. J., Ouellette, L. L. 2013; 92: 303-382
  • The polarizing impact of science literacy and numeracy on perceived climate change risks NATURE CLIMATE CHANGE Kahan, D. M., Peters, E., Wittlin, M., Slovic, P., Ouellette, L., Braman, D., Mandel, G. 2012; 2 (10): 732-735

    View details for DOI 10.1038/NCLIMATE1547

    View details for Web of Science ID 000310104100010

  • Do Patents Disclose Useful Information? Harvard Journal of Law and Technology Ouellette, L. L. 2012; 25: 545-607
  • What Are the Sources of Patent Inflation? An Analysis of Federal Circuit Patentability Rulings Yale Law Journal Online Ouellette, L. L. 2011; 121: 347-373
  • Addressing the Green Patent Global Deadlock Through Bayh-Dole Reform Yale Law Journal Ouellette, L. L. 2010; 119 (7): 1727-1738
  • How Many Patents Does It Take to Make a Drug? Follow-On Pharmaceutical Patents and University Licensing Michigan Telecommunications and Technology Law Review Ouellette, L. L. 2010; 17: 299-336
  • Access to Bio-Knowledge: From Gene Patents to Biomedical Materials Stanford Technology Law Review Ouellette, L. L. 2010; 2010
https://orcid.org/0000-0003-4363-7530