Patent Law and Global Public Health

Course Introduction

Introductory lecture (Fisher) (12 minutes) (vimeo version) (mp4 version)

Part I: Patent Law

Module 101: An Overview of the Patent System

• Lecture: Patent Fundamentals (Fisher)
  • Part A: Obtaining Patents (29 minutes) (vimeo version) (mp4 version) 
    • Matt Bryan, The Patent Cooperation Treaty (24 minutes) (vimeo version) (mp4 version)
  • Part B: Exploiting Patents (17 minutes) (vimeo version) (mp4 version) 
  • Part C: Enforcing and Challenging Patents (29 minutes) (vimeo version) (mp4 version)
• Discussion Option A: Employee Inventions
  • PatentX Case Study 057
• Discussion Option B: Lessons from the History of Apple
  • Apple, Inc. (PatentX Case Study 001)

Module 102: Eligibility

• Lecture: Patentable Subject Matter (Fisher)
  • Part A: Expansion [Required] (48 minutes) (vimeo version) (mp4 version)
  • Part B: Harmonization [Required] (25 minutes) (vimeo version) (mp4 version)
  • Part C: Contraction [Optional] (39 minutes) (vimeo version) (mp4 version)
• Discussion Option A: The TRIPS Agreement
  • TRIPS Articles 27-34
  • World Trade Organization, The TRIPS Provisions pertaining to Patents
  • Interview with Jayashree Watal (vimeo version) (mp4 version)
• Discussion Option B: Software Patents
  • USA: Alice Corp. v. CLS Bank (SCOTUS 2014)
  • Europe: European Patent Office, “Hardware and Software”
  • China: “China’s new guidelines – Good news for software patents” (Deacons 2021)
  • India: Barooah, “The Ping-Ponging Paradigm of Patenting Computer Programmes in India” (2020)
  • South Africa: Jwambi and Kutumane v. Nedbank (ongoing)
  • Kenya: Mwaura v. Kenya Industrial Property Institute (2018)

Module 103: Utility and Disclosure

• Lecture:  Utility and Disclosure (Fisher)
  • Part A: Utility (35 Minutes) (Vimeo version) (mp4 version) 
  • Part B: Disclosure (21 Minutes) (Vimeo version) (mp4 version) 
• Discussion Option A: Theories of Intellectual Property
  • William Fisher, “Theories of Intellectual Property,” in Stephen Munzer, ed., New Essays in the Legal and Political Theory of Property (Cambridge University Press, 2001)
  • IP Theory AI Chatbot
• Discussion Option B: Sufficiency
  • United States: Amgen v. Sanofi, Supreme Court of the United States, 2023
  • Europe: Regeneron Pharmaceuticals v. Kymab Ltd., 2020 UKSC 27
  • China: Zhizhen Intelligent v. Apple (2020)
  • India: Aparna Kareer and Sneha Agarwal, “Too much information or not quite enough? Experimental data in Indian patent applications” (2021)
  • Lessons from COVID-19: Peter Lee, “New and Heightened Public-Private Quid Pro Quos: Leveraging Public Support to Enhance Private Technical Disclosure” (2022)

Module 104: Newness

• Lecture: Newness (Fisher)
  • Part A: Novelty
    • A Comparative Overview (21 minutes) (Vimeo version) (mp4 version)
    • [Optional] The Idiosyncratic US System (49 minutes) (Vimeo version) (mp4 version) 
  • Part B: The Inventive Step (40 Minutes) (Vimeo version) (mp4 version) 
• Discussion: The Inventive Step Requirement
  • USA:
    • Toyota v. Reactive Surfaces (CAFC 2020)
    • Chemours Company v. Daikin Industries (CAFC 2021)
  • Europe: Actavis Group v. ICOS Corp. (UK Supreme Court 2019)
  • China: Shuo Liu, “The Inventive Step in Chinese Patent Law Compared With the U.S. Non-Obviousness Standard” (IP Watchdog 2021)
  • India: Patralekha Chatterjee, “Five Years After The Indian Supreme Court’s Novartis Verdict” (2018)
  • Thailand: Thailand Supreme Court Decision No. 7119/2552

Module 105: Claims

• Lecture:  Patent Scope (Fisher)
  • Part A: Claim Construction (51 minutes) (vimeo version) (mp4 version)
  • Part B: Patent Duration (29 minutes) (vimeo version) (mp4 version) 
• Discussion: Claim Drafting
  • BeachBub (PatentX Case Study 005)
• Resources:
  • WIPO Patent Drafting Manual, 2d ed. (2023)

Module 106: Infringement

• Lecture:  Infringement (Fisher)
  • Part A: Forbidden Conduct (40 minutes) (vimeo version) (mp4 version) 
  • Part B: Defenses and Limitations (32 minutes) (vimeo version) (mp4 version) 
• Discussion: Exhaustion and Differential Pricing
  • Select one of the following jurisdictions and be prepared to discuss during the seminar its approach to Exhaustion:
    • USA: Impression Products v. Lexmark (SCOTUS 2017) [abridged]
    • Europe: Katharine Stephens, “Brexit: Exhaustion of Intellectual Property rights” (2021)
    • China: Hui Zhang, Richard Li, and Hanmei Wang, “Patent Exhaustion, Implied License and Contributory Infringement” (2017)
    • India: Astha Sharma & Krishnaja Saseendran, “Parallel Importation under the Indian Patent Act” (2022)
    • Nigeria: Okojie, “The Effects of Parallel Importation on the Nigerian Healthcare Industry” (2016)

Module 107: Remedies

• Lecture:  Remedies for Patent Infringement (Fisher)
  • Part A: Damages and Penalties (38 minutes) (vimeo version) (mp4 version) 
  • Part B: Equitable Relief (42 minutes) (vimeo version) (mp4 version) 
• Discussion: Patent Injunctions
  • Select one of the following jurisdictions and be prepared to discuss during the seminar its approach to Injunctions:
    • USA: Jonathan Barnett, “Has the Academy Led Patent Law Astray?,” 32 Berkeley Technology Law Review 1313 (2017), pp. 1316-1320, 1361-1379
    • Europe: “Recent Developments Regarding Patent Injunctions In Germany” (Morrison Foerster, June 23, 2021)
    • China: Luo Rui, “The power of administrative injunctions in patent infringement,” China Business Law Journal, November 2, 2021
    • India: Natco Pharma Ltd vs Bristol Myers Squibb Holdings (Delhi High Court 2019)

Part II: Responding to the Global Health Crisis

Module 201: The Global Health Crisis

• Lecture: The Global Health Crisis (Fisher)
  • Part A: The Contours of the Crisis (33 minutes) (vimeo version) (mp4 version)
  • Part B: The Roles of Pharmaceutical Products (40 minutes) (vimeo version) (mp4 version)
• Resources:
  • United Nations High-Level Panel on Access to Medicines, Final Report, pages 13-20
  • Owen Jarus, “The Worst Epidemics and Pandemics in History” (2022)

Module 202: Improving Pharmaceutical Markets

• Lectures
  • Improving Pharmaceutical Markets (Fisher) (58 minutes) (vimeo version) (mp4 version)
  • Voluntary Licensing (37 minutes) (Vimeo version) (mp4 version)
    • Clifford Samuel, former Senior Vice President, Gilead Sciences
    • Claudio Lilienfeld, former Senior Director, International Government Affairs, Gilead Sciences
• Resources:
  • Vincent Ahonkhai et al., “Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization,” PLoS ONE 11, no. 11 (2016).
  • Fisher, Okediji & Gehl Sampath, “Fostering Production of Pharmaceutical Products in Developing Countries” (forthcoming 2022)

Module 203: Improving Intellectual Property

• Lecture: Adjusting Intellectual Property Law (Fisher)
  • Part A: Developing Countries (52 minutes) (vimeo version) (mp4 version)
  • Part B: Developed Countries (25 minutes) (vimeo version) (mp4 version)
• Interview with Martin Friede, Coordinator, Initiative for Vaccine Research, World Health Organization (45 minutes) (vimeo version) (mp4 version)
• Resources:
  • Council for TRIPS, “Paragraph 8 of the Ministerial Decision on the TRIPS Agreement, Thematic Session,” October 23, 2023
  • IFPMA, “Boosting Innovation and Access”
  • Fisher & Rigamonti, “The South Africa AIDS Controversy: A Case Study in Patent Law and Policy” (2005)
  • United Nations High-Level Panel on Access to Medicines, Final Report, pages 21-32

Module 204: Alternative Incentive Systems

• Lecture: Potential Alternatives to Intellectual Property: Grants, Prizes, and Regulations (Fisher)
  • Part A: Carrots (27 minutes) (vimeo version) (mp4 version)
  • Part B: Sticks (25 minutes) (vimeo version) (mp4 version)
• Resources:
  • Dean Baker, “Drugs are Cheap” (2017)
  • Philip Stevens & Stephen Ezell, “Delinkage Debunked” (2020)

Module 205: Looking Forward

• Lectures:
  • Coronavirus: The Big Questions (Bill Gates) (interview with Financial Times, 2019) (22 minutes)
  • Preparation for the Next Pandemic (Ashish Jha) (20 minutes) (Vimeo version) (mp4 version)
• Resources:
  • Haochen Sun & Madhavi Sunder, “Intellectual Property, COVID-19, and the Next Pandemic: Diagnosing Problems, Developing Cures” (2022)
  • Matthew Kavanagh,  “Legal Paradigms and the Politics of Global COVID-19 Vaccine Access” (2022)
  • Sapna Kumar & Ana Santos Rutschman,  “New Licensing Avenues to Promote Public Health” (2022)

Final Examination

The final examination for the sixth edition of the course was administered on January 15-19, 2026. The results will be posted here on March 2, 2026. (Apologies to participants for the delay.)

• Prior examinations:
  • The final examination in the first edition of this course is available HERE.
  • The final examination in the second edition of this course is available HERE.
  • The final examination in the third edition of this course is available HERE.
  • The final examination in the fourth edition of this course is available HERE.
  • The final examination in the fifth edition of this course is available HERE.
  • The final examination in the sixth edition of this course is available HERE.

Graduates

A list of the students in the First Edition of the WIPO/Harvard course who both satisfied the participation requirement and passed the final examination is available HERE.

A list of the students in the Second Edition of the WIPO/Harvard course who both satisfied the participation requirement and passed the final examination is available HERE.

A list of the students in the Third Edition of the WIPO/Harvard course who both satisfied the participation requirement and passed the final examination is available HERE.