Directory

Bibliography

Forthcoming

Intellectual Property Sandboxes, Boston University Law Review (forthcoming) (with Jonathan S. Masur) |(with Christopher Buccafusco)

Works in Progress

Invigorating Judicial Review of Agency Head Discretion: Lessons from Patent Adjudication (with S. Sean Tu)
Limited Objection of Intellectual Property, Health Law and Bioethics Scholars to Debtors' Proposed Asset Sale in the Bankruptcy of 23andMe Holding Co. (with Jorge L. Contreras) |(with Daniel Aaron) |(with Kimberly A. Kaphingst) |(with Holly Fernandez Lynch) |(with Christopher Morten) |(with Ana Santos Rutschman)

Books

Intellectual Property and Biotechnology (Edward Elgar, 2011) (editor)
Law and the Mental Health System: Civil and Criminal Aspects (Thomson/West 3d ed. 1999, 4th ed. 2004, 5th ed. 2009) (with Christopher Slobogin & Ralph Reisner)

Articles & Essays

Patents on AI-Derived Drugs: Empirical Evidence and Legal Challenges, 44 Nature Biotechnology 362-364 (2026) (with Janet Freilich)
Molecular Diagnostic Patenting After Mayo v. Prometheus: An Empirical Analysis, 22 Journal of Empirical Legal Studies 144-162 (2025) (with Colleen V. Chien) |(with Jenna Clark)
Recent Changes in Discretionary Denials of Drug Patent Challenges, 3 Health Affairs Scholar: qxaf215, 1-3 (2025) (with S. Sean Tu) |(with Aaron S. Kesselheim)
The Future of AI Regulation in Drug Development: A Comparative Analysis, 12 Journal of Law and the Biosciences: lsaf028, 1-14 (2025) (with Gabriela Lenarczyk) |(with Timo Minssen) |(with Nicholson Price)
The Puzzle of Biologics Manufacturing Platform Patents, 43 Nature Biotechnology 295-299 (2025) (with Osmat Azzam Jefferson) |(with W. Nicholson Price II) |(with S. Sean Tu) |(with Saurabh Vishnubhakat)
The Reliability Response to Patent Law's AI Challenges, 59 UC Davis Law Review 97-145 (2025)
What Patents on AI-Derived Drugs Reveal, 388 Science 924-926 (2025) (with Janet Freilich)
Four Decades of Orphan Drugs and Priorities for the Future, 391 New England Journal of Medicine 100-102 (2024) (with Michael S. Sinha) |(with Ariel D. Stern)
Introducing Biosimilar Competition for Cell and Gene Therapy Products, 11 Journal of Law and the Biosciences: lsae015, 1-37 (2024) (with Nitzan Arad) |(with Brian Canter) |(with Steven Colvill) |(with Elizabeth Staton) |(with Sabine Sussman)
Access to Biomedical Innovation — Inside the Legal Labyrinth, 388 New England Journal of Medicine 1537-1540 (2023)
Brief of Intellectual Property Law Professors and Scholars as Amici Curiae in Support of the Respondents, Amgen, Inc., et al., v. Sanofi, et al., No. 21-757 (U.S. Feb. 10, 2023) (with others)
Cryptic Patent Reform Through the Inflation Reduction Act, 37 Harvard Journal of Law & Technology 57-104 (2023) (with Rachel E. Sachs) |(with W. Nicholson Price II)
Bioinformatics at the Patent Office, in Bioinformatics, Medical Informatics and the Law 120-132 (Jorge L. Contreras, A. J. Cuticchia & Gregory J. Kirsch eds., 2022) (with Saurabh Vishnubhakat)
Post-Grant Adjudication of Drug Patents: Agency and/or Court?, 37 Berkeley Technology Law Journal 139-169 (2022) (with Saurabh Vishnubhakat) |(with Jorge Lemus) |(with Erik Hovenkamp)
An Administrative Fix for Manufacturing Process Patent Thicket, 39 Nature Biotechnology 20-22 (2021) (with W. Nicholson Price)
Clearing Opacity Through Machine Learning, 106 Iowa Law Review 775-812 (2021) (with W. Nicholson Price II)
Whether and How the U.S. Government Should Exercise Its Compulsory Licensing Authority Under 28 U.S.C. § 1498 and the Bayh-Dole Act, 11 NYU Journal of Intellectual Property & Entertainment Law 38-59 (2021) (with Rebecca S. Eisenberg) |(with Tahir Amin) |(with Henry Hadad) |(with Rachel Sachs)
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)(with Christina Silcox) |(with Isha Sharma)
Accountability, Secrecy, and Innovation in AI-Enabled Clinical Decision Software, 7 Journal of Law and the Biosciences 1-26 (2020) (with Isha Sharma) |(with Christina Silcox)
Expanding Access and Reducing Prices for Drugs to Prevent HIV: Should Government Enforce Its Patent Rights Against the Pharmaceutical Industry?, 323 JAMA 821-822 (2020) (with Lawrence O. Gostin)
Knowledge Transfer for Large-Scale Vaccine Manufacturing, 369 Science 912-914 (2020) (with W. Nicholson Price II) |(with Timo Minssen)
How Logically Impossible Patents Block Biosimilars, 37 Nature Biotechnology 862-863 (2019) (with W. Nicholson Price II)
Importance of Participant-Centricity and Trust for a Sustainable Medical Information Commons, 47 The Journal of Law, Medicine & Ethics 12-20 (2019) (with Amy L. McGuire) |(with Mary A. Majumder) |(with Angela G. Villanueva) |(with Jessica Bardill) |(with Juli M. Bollinger)
Machine Learning at the Patent Office: Lessons for Patents and Administrative Law, 104 Iowa Law Review 2617-2641 (2019)
Patent Institutions: Shifting Interactions Between Legal Actors, in Research Handbook on the Economics of Intellectual Property Law 473-488 (Ben Depoorter, Peter Menell & David Schwartz eds., 2019)
The USPTO’s Patent Trial and Appeal Board, in Research Handbook on the Economics of Intellectual Property Law 92-103 (Ben Depoorter, Peter Menell & David Schwartz eds., 2019) (with Saurabh Vishnubhakat)
Brief for 72 Professors of Intellectual Property Law as Amici Curiae in Support of Respondents, Oil States Energy Services, LLC v. Greene's Energy Group LLC, No. 16-712 (U.S. 2016) (with others)
Creating a Data Resource: What Will It Take to Build a Medical Information Commons?, 9 Genome Medicine: 84, 1- 5 (2017) (with Patricia A. Deverka) |(with Mary A. Majumder) |(with Angela G. Villanueva) |(with Margaret Anderson) |(with Annette C. Bakker)
Legal Issues in Genomic and Precision Medicine: Intellectual Property and Beyond, in Genomic and Precision Medicine: Foundations, Translation, and Implementation 357-366 (Geoffrey S. Ginsburg & Huntington F. Willard eds., 2017)
Overcoming the Legal and Regulatory Hurdles to Value-Based Payment Arrangements for Medical Products (Duke-Margolis Center for Health Policy, 2017)(with Gregory W. Daniel) |(with Thomas Barker) |(with Christian Springer) |(with Marianne Hamilton Lopez) |(with Jane Kalinina) |(with Katie Greene) |(with Jingyuan Qian) |(with Mark B. McClellan)
Racing for Academic Glory and Patents: Lessons from CRISPR, 358 Science 874-876 (2017) (with Robert Cook-Deegan)
Risk Regulation and Innovation: The Case of Rights-Encumbered Biomedical Data Silos, 92 Notre Dame Law Review 1641-1667 (2017)
Brief of Amici Curiae 56 Professors of Law and Economics in Support of Petition of Writ of Certiorari, TC Heartland LLC v. Kraft Foods Brands Group LLC, No. 16341, (U.S. Oct. 17, 2016) (with others)
Comment to the SEC in Support of the Enhanced Disclosure of Patent Technology License Information, 2016(with Colleen V. Chien) |(with Jorge L. Contreras) |(with Carol A. Corrado) |(with Stuart J.H. Graham) |(with Deepak Hegde) |(with Saurabh Vishnubhakat)
Open Letter on Ethical Norms in Intellectual Property Scholarship, 29 Harvard Journal of Law & Technology 1-13 (Spring 2016) (with Robin Feldman) |(with Mark A. Lemley) |(with Jonathan S. Masur)
Administrative Power in the Era of Patent Stare Decisis, 65 Duke Law Journal 1561-1597 (2016) (with Stuart Benjamin)
Manufacturing Barriers to Biologics Competition and Innovation, 101 Iowa Law Review 1023-1063 (2016) (with W. Nicholson Price II)
Strategic Decision Making in Dual PTAB and District Court Proceedings, 31 Berkeley Technology Law Journal 45-124 (2016) (with Saurabh Vishnubhakat) |(with Jay P. Kesan)
The Changing Life Science Patent Landscape, 34 Nature Biotechnology 292-294 (2016) (with Jacob S. Sherkow)
Brief of Professors Peter S. Menell et al. as Amici Curie in Support of Neither Party Teva v. Sandoz, No. 13-854, slip op. (U.S. Jan. 20, 2015)
Accountability, Government Rights, and the Public Interest: A Thirty-Year Retrospective, in The Chicago Handbook of University Technology Transfer and Academic Entrepreneurship 75-96 (Albert N. Link, Donald S. Siegel & Mike Wright eds., 2015) (with Bhaven Sampat)
Are Trade Secrets Delaying Biosimilars?, 348 Science 188-189 (2015)
Intellectual Property Issues and Synthetic Biology Standards, 33 Nature Biotechnology 24-25 (2015) (with Jorge L. Contreras) |(with Andrew W. Torrance)
The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances, in FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies 402-413 (Holly Fernandez Lynch & Gleen I. Cohen eds., 2015)
When Biopharma Meets Software: Bioinformatics at the Patent Office, 29 Harvard Journal of Law & Technology 206-241 (2015) (with Saurabh Vishnubhakat)
Use Patents Can Be Useful: The Case of Rescued Drugs, 6 Science Translational Medicine 1-3 (2014) (with Grant Rice)
A New Market Access Path for Repurposed Drugs (Ewing Marion Kauffman Foundation, 2014)(with Dominique Pahud) |(with Lesa Mitchell) |(with John Wilbanks) |(with Melissa Stevens) |(with Scott Weir) |(with John McBride) |(with Lili Portilla) |(with Ed Pezalla) |(with Mike Nameth) |(with Bernadette O'Donoghue) |(with Debra Lappin) |(with Mary Ogle) |(with Scott Howell)
Intellectual Property and Alternatives: Strategies for Green Innovation, in Intellectual Property Rights: Legal and Economic Challenges for Development 356-391 (Mario Cimoli et al. eds., 2014) (with Jerome H. Reichman) |(with Jonathan B. Wiener) |(with Richard G. Newell)
Competing with the "Patent Court": A Newly Robust Ecosystem, 13 Chicago-Kent Journal of Intellectual Property 386-393 (2014)
Diagnostic Patents at the Supreme Court, 18 Marquette Intellectual Property Law Review 1-9 (2014)
Intellectual Property and Alternatives: Strategies for Green Innovation, in Intellectual Property Rights: Legal and Economic Challenges for Development 356-391 (Mario Cimoli et al. eds., 2014) (with Jerome H. Reichman) |(with Richard G. Newell) |(with Jonathan B. Wiener)
US Executive Branch Patent Policy, Global and Domestic, in Patent Law in Global Perspective 85-96 (Ruth L. Okediji & Margo A. Bagley eds., 2014)
Use Patents Can Be Useful: The Case of Rescued Drugs, 6 Science Translational Medicine 248fs30-1-248fs30-3 (August 2014) (with Grant Rice)
Biomedical Patents at the Supreme Court: A Path Forward, 66 Stanford Law Review Online 111-117 (2013)
Improving (Software) Patent Quality Through the Administrative Process, 51 Houston Law Review 503-543 (2013)
Moving Beyond "Isolated" Gene Patents, 341 Science 137-138 (2013) (with Robert Cook-Deegan)
The Nagoya Protocol and Synthetic Biology Research: A Look at the Potential Impacts (2013) (with Margo A. Bagley)
Accountability in Patenting of Federally Funded Research, 30 Nature Biotechnology 953-956 (2012) (with Bhaven N. Sampat)
Patent Validity Across the Executive Branch: Ex Ante Foundations for Policy Development, 61 Duke Law Journal 1237-1281 (2012)
Rand Patents and Exclusion Orders: Submission of 19 Economics and Law Professors to the International Trade Commission, 2012(with Colleen Chien) |(with Richard J. Gilbert) |(with Carl Shapiro) |(with Thomas F. Cotter) |(with Stefania Ghosh) |(with Eric Goldman) |(with Dan L. Burk) |(with Daniel R. Cahoy) |(with Michael A. Carrier) |(with Jorge L. Contreras) |(with Joseph Scott Miller) |(with Michael Risch) |(with Jason Schultz) |(with Ted M. Sichelman) |(with Katherine J. Strandburg) |(with Esther Van Zimmerman) |(with Christal Sheppard)
Use Patents, Carve-Outs, and Incentives--A Battle in the Drug-Patent Wars, 367 New England Journal of Medicine 491-493 (2012)
Valuing Health Care: Improving Productivity and Quality (2012) (as part of the Kauffman Task Force on Cost Effective Health Care Innovation)
Who's Afraid of the Federal Circuit?, 121 Yale Law Journal Online 335-345 (2011)
Intellectual Property, 2010 Developments in Administrative Law and Regulatory Practice x, 1-15 (2010)
Unstandard Standardization: The Case of Biology, 53 Communications of the ACM 37-39 (2010)
Proprietary Science, Open Science and the Role of Patent Disclosure: The Case of Zinc Finger Proteins, 27 Nature Biotechnology 140-144 (2009) (with Subhashini Chandrasekharan) |(with Sapna Kumar) |(with Cory M. Valley)
A Kernel for Open Source Drug Discovery in Tropical Diseases, 3 PLoS Neglected Tropical Diseases: e418, 1-10 (2009) (with Leticia Ortı) |(with Rodrigo J. Carbajo) |(with Ursula Pieper) |(with Narayanan Eswar) |(with Stephen M. Maurer) |(with Ginger Taylor) |(with Matthew H. Todd) |(with Antonio Pineda-Lucena) |(with Andrej Sali) |(with Marc A. Marti-Renom)
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 213-218 (Geertrui Van Overwalle ed., 2009)
Growing Pains in the Administrative State: The Patent Office's Troubled Quest For Managerial Control, 157 University of Pennsylvania Law Review 2051-2081 (2009)
Structuring U.S. Innovation Policy: Creating a White House Office of Innovation Policy (2009) (with Stuart Minor Benjamin)
University Software Ownership and Litigation: A First Examination, 87 Perspectives: Teaching Legal Research and Writing 1519-1570 (2009) (republished and revised in Perspectives on Commercializing Innovation 395 (Scott Kieff & Troy A. Paredes eds., 2012)) (with John R. Allison) |(with Bhaven Sampat) |(with Colin Crossman)
Is Bayh-Dole Good for Developing Countries? Lessons from the U.S. Experience, 6 PLoS Biology 2078-2084 (2008) republished in, Intellectual Property Rights: Legal and Economic Challenges for Development 201-215 (MarioCimoli et al. eds., 2014) (with Jerome H. Reichman) |(with Anthony D. So) |(with Bhaven N. Sampat) |(with Robert Cook-Deegan) |(with Robert Weissman) |(with Amy Kapczynski)
Building a Better Innovation System: Combining Facially Neutral Patent Standards with Therapeutics Regulation, 45 Houston Law Review 1037-1057 (2008)
Fixing Innovation Policy: A Structural Perspective, 77 George Washington Law Review 1-88 (2008) (with Stuart M. Benjamin)
Intellectual Property and Alternatives: Strategies for Green Innovation (Chatham House, Programme paper: EEDP 08/03 (reprinted in Intellectual Property Rights: Legal and Economic Challenges for Development (Mario Cimoli et al. eds., 2014)) , 2008)(with Richard Newell) |(with Jerome Reichman) |(with Jonathan B. Wiener)
Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery, 8 Yale Journal of Health Policy, Law & Ethics 1-36 (2008) (reprinted in, Gene Patents and Collaborative Licensing Models: Patent Pools, Clearinghouses, Open Source Models and Liability Regimes 247-287 (Geertrui Van Overwalle ed., 2009)) (with Jerome H. Reichman) |(with Paul F. Uhlir) |(with Colin Crossman)
Knowledge Commons: The Case of the Biopharmaceutical Industry, 12 First Monday 4 (2007)
Open Source and Private Ordering: A Commentary on Dusollier, 82 Chicago-Kent Law Review 1439-1442 (2007)
Synthetic Biology: Caught Between Property Rights, the Public Domain, and the Commons, 5 PLoS Biology 389-393 (2007) (with James Boyle)
Synthetic Biology: The Intellectual Property Puzzle, 85 Texas Law Review 1745-1768 (2007) (with Sapna Kumar)
The Ends of Intellectual Property: Health as a Case Study, 70 Law and Contemporary Problems 125-130 (Spring 2007)
Who's Afraid of the APA? What the Patent System Can Learn from Administrative Law, 95 Georgetown Law Journal 269-336 (2007) (with Stuart M. Benjamin)
"Open and Collaborative" Biomedical Research: Theory and Evidence, in Advancing Knowledge and the Knowledge Economy 391-413 (Brian Kahin & Dominique Foray eds., 2006)
Harnessing and Sharing the Benefits of State Sponsored Research, 21 Berkeley Technology Law Journal 1187-1213 (2006) (with Rebecca S. Eisenberg)
A Brief History of BioPerl (2005) (with Colin Crossman)
Open and Collaborative Research: A New Model for Biomedicine, in Intellectual Property Rights in Frontier Industries 131-158 (Robert W. Hahn ed., 2005)
Proprietary Rights and Collective Action: The Case of Biotechnology Research with Low Commercial Value, in International Public Goods and Transfer of Technology Under a Globalized Intellectual Property Regime 288-306 (Keith E. Maskus & Jerome H. Reichman eds., 2005)
Finding Cures for Tropical Diseases: Is Open Source an Answer?, 1 PLoS Medicine: e56, 180-183 (2004) (with Stephen M. Maurer) |(with Andrej Sali)
Finding Cures for Tropical Diseases: Is Open Source an Answer?, 6 Minnesota Journal of Law, Science & Technology 169-175 (2004) (This article is based on S.M. Maurer, et al., Finding Cures for Tropical Diseases: Is Open Source an Answer?, 1 PLoS Medicine (2004)). (with Stephen M. Maurer) |(with Andrej Sali)
Allocating Power over Fact-Finding in the Patent System, 19 Berkeley Technology Law Journal 907-922 (2004)
Patenting Organisms and Basic Research, in 4 Encyclopedia of Bioethics 1981 (Stephen G. Post ed., 2004) (with Rebecca S. Eisenberg)
Private Ownership of Inventions, in 4 Encyclopedia of Bioethics 2130 (Stephen G. Post ed., 2004)
Proprietary Considerations, in Handbook of Stem Cells 793-798 (Robert P. Lanza ed., 2004) (with Rebecca Eisenberg)
The Increasingly Proprietary Nature of Publicly Funded Biomedical Research: Benefits and Threats, in Buying in or Selling Out?: The Commercialization of the American Research University 117-126 (Donald G. Stein ed., 2004)
Bayh-Dole Reform and the Progress of Biomedicine, 66 Law & Contemporary Problems 289-315 (Winter/Spring 2003) (with Rebecca Eisenberg)
Engaging Facts and Policy: A Multi-Institutional Approach to Patent System Reform, 103 Columbia Law Review 1035-1135 (2003)
Genome Patents: A Case Study in Patenting Research Tools, 77 Academic Medicine 1368-1372 (2002)
Genes and the Just Society: Preface, 39 San Diego Law Review 649-650 (2002)
Genetic Interventions: (Yet) Another Challenge to Allocating Health Care, 39 San Diego Law Review 657-67 (2002) (reviewing Allen Buchanan et al., From Chance to Choice: Genetics and Justice (2000))
Locating Gene Patents Within the Patent System, 2 American Journal of Bioethics 18-19 (Summer 2002)
Pharmacogenetic Interventions, Orphan Groups, and Distributive Justice: The Role of Cost-Benefit Analysis, 19 Social Philosophy & Policy 246 (2002)
Specialized Trial Courts: Concentrating Expertise on Fact, 17 Berkeley Technology Law Journal 877-898 (2002)
Evolving Scientific Norms and Intellectual Property Rights: A Reply to Professor Kieff, 95 Northwestern University Law Review 707-13 (2001)
Fostering Cumulative Innovation in the Biopharmaceutical Industry: The Role of Patents and Antitrust, 16 Berkeley Technology Law Journal 813 (2001)
Health Care Fraud and Abuse: A Tale of Behavior Induced by Payment Structure, 30 Journal of Legal Studies 579-87 (2001)
The Information Revolution Reaches Pharmaceuticals: Balancing Innovation Incentives, Cost, and Access in the Post-Genomics Era, 2001 University of Illinois Law Review 173-210 (2001)
Addressing the Patent Gold Rush: The Role of Deference to PTO Patent Denials, 2 Washington University Journal of Law & Policy 199-227 (2000)
The Physician as a Health Care Proxy, 29 Hastings Center Report 14-19 (1999) (with Mark Siegler) |(with John Lantos)
Intellectual Property Rights in Biotechnology: Addressing New Technology, 34 Wake Forest Law Review 827-47 (1999)
Reflective Choice in Health Care: Using Information Technology to Present Allocation Options, 25 American Journal of Law & Medicine 387 (Summer/Fall 1999)
Regulating Scientific Research: Intellectual Property Rights and the Norms of Science, 94 Northwestern University Law Review 77-152 (1999)
Rationing Through Choice: A New Approach to Cost-Effectiveness Analysis in Health Care, 72 Indiana Law Journal 1015-97 (1997)
Cost-Effectiveness and Cost-Benefit Analyses in the Medical Literature: Are the Methods Being Used Correctly?, 116 Annals of Internal Medicine 238-244 (1992) (with I. Steven Udvarhelyi) |(with Graham A. Colditz) |(with Arnold M. Epstein)

Newspaper Articles and Commentary

Congress Must Repair USPTO's Inter Partes Review Process, Law360 Expert Analysis (May 1, 2026) (with Sean Tu) |(with Aaron Kesselheim)
The Future of Scientific Innovation, The Regulatory Review (May 4, 2025) (with Tasneem Mohammad)
Patent Puzzles After the Supreme Court’s 2024 Administrative Law Cases: Stare Decisis, Rulemaking, and Discretion, PatentlyO (July 24, 2024)
Orange Book Over-Declaration Of Pharmaceutical Patents: The Advantages Of Ex Ante Over Ex Post Review, Health Affairs Forefront (December 13, 2023) (with Jorge L. Contreras)
What Does ‘Bona Fide Competition’ Actually Mean in the Biologics Market?, STAT (September 6, 2023)
Rebooting America: Innovation Policy, 40 Duke Law Magazine (January 1, 2021)
Acknowledging the Public Role in Private Drug Development: Lessons From Remdesivir, STAT (May 13, 2020) (with Justin Hughes)
The Need for Speed: Process and Product Quality in Track 1, Law 360 (December 6, 2016) (with Elliot Chen)
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 (June 18, 2015)
Taming the Mongrel: Aligning Appellate Review of Claim Construction with its Evidentiary Character in Teva v. Sandoz, Patentlyo (June 30, 2014) (with Peter S. Menell) |(with J. Jonas Anderson)
Patentable Subject Matter at the Supreme Court: An Exceptional Case?, SCOTUSblog (February 4, 2013)

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Directory

Bibliography

Forthcoming

Works in Progress

Books

Articles & Essays

Newspaper Articles and Commentary

Arti K. Rai