TRIPS and Pharmaceutical Patents #251106

Upon successful completion of this course, participants will be able to:

• Analyze the core provisions of the TRIPS Agreement relevant to pharmaceuticals, including patentability criteria, minimum patent term, and exclusive rights conferred.

• Evaluate the public health flexibilities explicitly recognized under the TRIPS Agreement (e.g., compulsory licensing, Bolar exception, government use) and the Doha Declaration on TRIPS and Public Health.

• Assess the impact of pharmaceutical patent protection on innovation, drug prices, and access to medicines in both developed and developing countries.

• Compare how different national legal systems have implemented TRIPS flexibilities to address public health needs.

• Understand the debate around “TRIPS-Plus” provisions in bilateral trade agreements and their implications for access to medicines.

• Formulate informed perspectives on current debates, including the COVID-19 IP waiver and the development of new business models for drug R&D.

This course is designed for professionals involved in the legal, policy, public health, and commercial aspects of pharmaceuticals:

• Intellectual Property Lawyers and Patent Attorneys

• Policy Makers and Government Officials from health, trade, and industry ministries

• Public Health Advocates and NGO Professionals

• Executives and Managerial Staff in pharmaceutical and generic drug companies

• Researchers and Academics in law, public health, and international development

• Representatives from international organizations (WHO, WTO, WIPO, UNITAID, The Global Fund)

• Journalists covering health, trade, and intellectual property

• Pre-assessment
• Live group instruction
• Use of real-world examples, case studies and exercises
• Interactive participation and discussion
• Power point presentation, LCD and flip chart
• Group activities and tests
• Each participant receives a binder containing a copy of the presentation
• slides and handouts
• Post-assessment

Day 1: The Foundation: TRIPS Agreement and Patent Basics

• Morning Session: Introduction to the International IP System

  • The History and Rationale of Patents: Incentivizing Innovation vs. Granting Monopolies.

  • The Creation of the WTO and the TRIPS Agreement: Why IP became a trade issue.

  • Core TRIPS Principles: National Treatment, Most-Favoured-Nation Treatment.

• Afternoon Session: Key TRIPS Provisions for Pharmaceuticals

  • Patentability Criteria: Novelty, Inventive Step, Industrial Application.

  • Minimum Standards: 20-Year Patent Term, Scope of Patent Rights, Rights Conferred.

  • Case Study: Examine the patent claims for a well-known drug to understand the scope of protection.

Day 2: TRIPS Flexibilities and the Doha Declaration

• Morning Session: The Public Health Crisis and the Push for Flexibilities

  • The HIV/AIDS Pandemic and the Access to Medicines Crisis.

  • The Legal Arsenal: An Overview of TRIPS Flexibilities (Articles 30, 31, 6, 8, etc.).

• Afternoon Session: The Doha Declaration and Its Aftermath

  • The Meaning and Legal Status of the 2001 Doha Declaration on TRIPS and Public Health.

  • The 2003 Waiver and 2005 Amendment: The mechanism for exporting under compulsory license.

  • Workshop: Analyze the text of the Doha Declaration and debate its interpretation.

Day 3: Implementing Flexibilities: Compulsory Licensing in Practice

• Morning Session: The Law and Procedure of Compulsory Licensing

  • Grounds for Granting a Compulsory License (e.g., national emergency, anti-competitive practices, refusal to deal).

  • Procedural Requirements and Adequate Remuneration.

• Afternoon Session: Country Case Studies

  • Thailand & Brazil: Using CLs for HIV/AIDS drugs.

  • Malaysia: Government use for importation.

  • Canada & Rwanda: Using the Export Mechanism.

  • Case Study: Draft the key arguments for and against issuing a compulsory license for a cancer drug in a hypothetical country.

Day 4: Beyond Compulsory Licensing: Other Strategies and “TRIPS-Plus”

• Morning Session: Additional Flexibilities and Strategies

  • Patentability Criteria: Using strict examination to prevent “evergreening.”

  • Bolar/Regulatory Review Exception: Allowing generic preparation before patent expiry.

  • Exhaustion of Rights and Parallel Importation.

• Afternoon Session: The “TRIPS-Plus” Agenda

  • Data Exclusivity and Patent Linkage.

  • Extended Patent Terms.

  • How Bilateral Trade Agreements (e.g., USMCA) undermine TRIPS flexibilities.

  • Debate: Is the “TRIPS-Plus” agenda a legitimate protection of innovation or an unfair barrier to access?

Day 5: Current Challenges and The Future of Pharma Innovation

• Morning Session: Contemporary Issues

  • The COVID-19 Pandemic: The TRIPS Waiver Debate and the C-TAP Initiative.

  • The Role of Voluntary Licenses and The Medicines Patent Pool.

  • Antimicrobial Resistance (AMR): Does the current patent model incentivize new antibiotic development?

• Afternoon Session: Capstone and Synthesis

  • Capstone Exercise: In groups, represent a country’s ministry of health. Develop a national strategy to improve access to a specific high-cost drug, utilizing TRIPS-compliant legal tools and negotiating with the patent holder.

  • Alternative Innovation Models: Prize Funds, PDPs (Product Development Partnerships).

  • Course Recap: The Unresolved Tension and Paths Forward.

  • Final Q&A and Certification.