Patent Law and Global Public Health

Part I of this course examines patent law in general. Each of the 7 modules contains (a) a recorded lecture (roughly 90 minutes in length) that describes a major dimension of the patent system and (b) a set of readings that juxtapose the ways in which an important issue within that dimension is currently addressed in several jurisdictions.

Part II considers how patent law (and other aspects of the legal system) might be leveraged or modified in order to mitigate the ongoing global health crisis. The first of its five modules considers the causes and roots of that crisis. The remaining four modules examine a variety of ways in which we might mitigate it — and reduce the probability of future crises.

Part I: Patent Law

Module 101: An Overview of the Patent System

• Lecture: Patent Fundamentals (Fisher) 
  • Part A: Obtaining a Patent (35 minutes) (vimeo version) (mp4 version) 
  • Part B: Exploiting a Patent (17 minutes) (vimeo version) (mp4 version) 
  • Part C: Challenging a Patent (29 minutes) (vimeo version) (mp4 version)
• Discussion: Employee Inventions
  • USA: Stanford University v. Roche Molecular Sys., 563 U.S. 776 (2011)
  • Europe: “Patent Assignments and The German Act On Employee Inventions” (2021)
  • China: Jennifer Che & Sally Yu, “How Far Can an Employer Reach to Own Employee-made “Service Inventions”?” (China Patent Strategy 2020)
  • India: Kartikeya Prakash, “The Dilemma of Employer-Employee Patent Ownership in India” (2021)
  • Brazil: Industrial Property Law, Articles 88-93; Ownership of patents arising from employee’s inventions

Module 102: Eligibility

• Lecture: Patentable Subject Matter (Fisher) 
  • Part A: Expansion (48 minutes) (vimeo version) (mp4 version)
  • Part B: Harmonization (25 minutes) (vimeo version) (mp4 version)
  • Part C: Contraction (39 minutes) (vimeo version) (mp4 version)
• Discussion: 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: Sufficiency
  • USA: Oulette, “Do Patents Disclose Useful Information” (2012), pages 550-565
  • Europe: Regeneron Pharmaceuticals v. Kymab Ltd., 2020 UKSC 27
  • China: Zhizhen v. Apple (Supreme People’s Court 2020)
  • India: Aparna Kareer and Sneha Agarwal, “Too much information or not quite enough? Experimental data in Indian patent applications” (2021)

Module 104: Newness

• Lecture: Newness (Fisher)
  • Part A: Novelty & Statutory Bars (49 minutes) (Vimeo version) (mp4 version) 
  • Part B: The Inventive Step (38 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 (46 minutes) (vimeo version) (mp4 version)
  • Part B: Patent Duration (29 minutes) (vimeo version) (mp4 version) 
• Discussion: Claim Construction
  • South Africa: Melody Musoni, “The Doctrine of Equivalents in Patent Claim Interpretation” (2017)
  • Singapore & United Kingdom: Joel Sherard, Divergent Paths: The Doctrine on Equivalents in Singapore and the United Kingdom, 2019 Sing. COMP. L. REV. 80 (2019).
  • Bagley, Okediji & Erstling, “Around the World with Claim Construction: The Improver Cases” (forthcoming 2021)
  • Protocol on the Interpretation of Article 69 EPC

Module 106: Infringement

• Lecture:  Infringement (Fisher) 
  • Part A: Forbidden Conduct (40 minutes) (vimeo version) (mp4 version) 
  • Part B: Defenses and Limitations (58 minutes) (vimeo version) (mp4 version) 
• Discussion: Exhaustion and Differential Pricing
  • Policy: Fisher, “When Should We Permit Differential Pricing of Information?” (2007)
  • 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
  • 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)
  • Argentina: Landmark decision issued on pharmaceutical patent enforcement (2010)

Part II: Responding to the Global Health Crisis

Module 201: The Global Health Crisis

• Lecture: The Global Health Crisis (Fisher) (vimeo version) (mp4 version)
• Readings:
  • United Nations High-Level Panel on Access to Medicines, Final Report, pages 13-20
  • Fisher & Syed, A War Not Easily Won (draft 2022), Introduction and chapters 1-2

Module 202: Improving Pharmaceutical Markets

• Lectures
  • Potential Ways of Increasing Access to Medicines: Technology Transfer, Local Production, and Differential Pricing (Fisher) (40 minutes)
  • Voluntary Licensing (20 minutes)
    • Clifford Samuel, former Senior Vice President, Gilead Sciences
    • Claudio Lilienfeld, former Senior Director, International Government Affairs, Gilead Sciences
  • The Southern Africa Quality Assurance Network (20 minutes)
    • Nelson Mandela, Mission for Essential Drugs and Supplies, Kenya
• Readings:
  • 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)
  • Peter Lee, “Tacit Knowledge Transfer and the Patent Bargain“ (2022)

Module 203: Improving Intellectual Property

• Lectures:
  • Adjusting Patent Law: the TRIPS Flexibilities (Okediji)
  • Curbing COVID in Bolivia
    • [representative of Unidad de Medicamentos y Tecnologia en Salud]
• Readings:
  • Bagley & Okediji, “The Political Economy of Patents”
  • Fisher & Rigamonti, “The South Africa AIDS Controversy: A Case Study in Patent Law and Policy” (2005)
  • Okediji, Case Study on Compulsory Licensing, Bolivia, and COVID Vaccines (2022)
  • 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) (80 minutes)
• Readings:
  • Dean Baker, “Drugs are Cheap” (2017)
  • Philip Stevens & Stephen Ezell, “Delinkage Debunked” (2020)
  • Fisher & Syed, A War Not Easily Won (draft 2022), chapter 6

Module 205: Looking Forward

• Three Views:
  • Coronavirus: The Big Questions (Bill Gates) (interview with Financial Times, 2019) (22 minutes)
  • Preparation for the Next Pandemic (Ashish Jha) (20 minutes)
  • A Feasible Combination of Legal Reforms (Fisher) (30 minutes)
• Reading:
  • 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)