International IP Law Explained: Berne, Paris & TRIPS

TRIPS contains mechanisms allowing countries to override patent protections during public health emergencies: Article 31 permits compulsory licensing for generic production, and Article 6 enables parallel imports from cheaper markets. During the 2001 anthrax crisis, the US invoked TRIPS flexibility to approve generic alternatives when Bayer refused to supply Cipro at reduced prices, eventually securing supply at 95 cents per pill. When South Africa sought to use TRIPS flexibilities for HIV/AIDS generic medications, 39 pharmaceutical companies sued the government. Protesters demanded the right to access affordable treatments. Eventually, pharmaceutical companies withdrew lawsuits and paid legal costs. In 2005, India aligned patent laws with TRIPS, introducing Article 3D which blocks patents for drugs lacking substantial innovation—explaining why Novartis' anti-cancer drug failed patent approval.

The TRIPS Agreement contains flexibilities allowing countries to protect public health during emergencies. Article 6 permits parallel imports without patent holder permission for limited periods. Article 31 enables compulsory licensing for generic production without paying patent rights during healthcare emergencies. During the 2001 anthrax crisis, the US invoked these provisions to obtain generic alternatives when Bayer refused to supply Cipro at reduced prices. Similarly, South Africa faced lawsuits from 39 pharmaceutical companies when attempting to use compulsory licensing for HIV/AIDS medications, highlighting tensions between commercial interests and public health rights.

The TRIPS Agreement contains flexibilities for public health protection. Countries can issue compulsory licenses (TRIPS clause 30) allowing domestic production of generic medicines without patent holder permission during health emergencies. Countries can also use parallel imports (TRIPS clause 6) to import medicines from countries with better economic conditions without patent holder consent. Countries like Brazil have used compulsory licensing as negotiation tools, successfully reducing medicine prices. However, when South Africa attempted to use these flexibilities for HIV/AIDS treatment, 39 pharmaceutical companies sued the government. The Doha Declaration confirmed that flexibilities exist and can be used to protect public health, though implementation remains complex.

Compulsory licensing allows governments to authorize third parties to produce patented products without the patent holder's consent under specific circumstances: national emergencies, public health crises, or situations where the patent holder fails to meet public needs. The TRIPS Agreement permits this for public health emergencies, and Brazil implemented this through Law 14.200/2021. The patent holder retains the right to receive 1.5% royalties on sales.

The TRIPS Agreement establishes a three-part framework: principles balancing creativity promotion with public health needs, non-discrimination requirements, and minimum IP protection standards. The Doha Declaration (2001) clarified that TRIPS should be interpreted to accommodate public health obligations, particularly during health emergencies. During the COVID-19 pandemic, India, South Africa, and Kenya proposed a TRIPS waiver for vaccines, leading to a 2022 ministerial decision clarifying compulsory licensing procedures and permitting vaccine exports. However, TRIPS serves dual functions as both enabler and barrier—creating flexibilities while imposing minimum standards that developing countries must implement domestically. Effectiveness depends on national legislation, inter-ministerial coordination, and regional integration mechanisms like the African Continental Free Trade Area.

Post-TRIPS, several agreements have raised IP standards: (1) Regional trade agreements (FTAs, EPA) demand data exclusivity (beyond Article 39), extended patent terms (beyond 20 years), and patent linkage; (2) ACTA and Trans-Pacific Partnership require enhanced enforcement measures; (3) Bilateral investment treaties extend protection through fair and equitable treatment principles; (4) Unilateral domestic measures may raise standards beyond TRIPS. These TRIPS-plus agreements reflect ongoing efforts to harmonize and increase international IP protection beyond minimum TRIPS standards.

USMCA (United States-Mexico-Canada Agreement) and CPTPP (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) represent the highest standards of intellectual property protection in modern trade agreements. USMCA, evolving from NAFTA, includes 12-year data exclusivity for pharmaceuticals, patent term extension for regulatory delays, and enhanced trade secret protection prohibiting government access to proprietary information. CPTPP, despite initial tensions between the US and member states, incorporates IP provisions similar to the Korea-US FTA, including protection for unregistered famous trademarks and expanded geographical indications protection. The agreements demonstrate how trade negotiations increasingly incorporate comprehensive IP frameworks that benefit not just negotiating parties but also third countries through spillover effects, with reforms extending to all domestic actors rather than just foreign companies.

TRIPS Plus clauses in free trade agreements extend intellectual property protections beyond TRIPS minimum standards, creating challenges for developing countries by restricting government flexibilities like compulsory licensing and parallel imports, potentially limiting access to medicines and hindering technology transfer; Argentina argues that IP systems should serve innovation, knowledge diffusion, and socioeconomic development rather than becoming ends in themselves, and that states must balance patent rights with the public domain's role in enabling innovation.

TRIPS Plus clauses are additional intellectual property obligations in free trade agreements that exceed the minimum standards of the TRIPS Agreement, potentially restricting countries' ability to design IP policies aligned with their national needs and realities. These clauses may expand patentable subject matter, limit patent exceptions, and impose additional requirements such as patent term extensions for regulatory delays. Countries negotiating these agreements often face challenges due to limited resources and capacity to fully understand the implications of these obligations, and it is essential for nations to understand the full scope of these provisions to protect public interest, particularly in areas like access to medicines.

Impact assessment studies use scenario analysis to quantify how TRIPS-plus provisions affect medicine prices, public spending, and domestic production. Studies from Argentina and Brazil demonstrate that adopting patent term extensions and data exclusivity provisions would significantly increase medicine costs. For example, Brazil's analysis showed potential 40-73% price increases for HIV and hepatitis C treatments, with corresponding increases in public health expenditure. These studies reveal that while pharmaceutical industries achieved 95% of their goals during TRIPS negotiations, they continue pushing for the remaining 5% through bilateral agreements, progressively reducing policy space for developing countries.

WIPO offers international systems for registering intellectual property in multiple countries simultaneously: (1) PCT system for patents - simplifies international patent filing; (2) Madrid system for trademarks - allows registration in multiple countries through one application; (3) Hague system for industrial designs - enables filing up to 100 designs simultaneously; (4) Lisbon system for geographical indications. These systems reduce costs and complexity compared to filing separately in each country.

The Madrid System is an international treaty administered by WIPO that allows trademark owners to seek protection in multiple countries through a single application process, simplifying the procedure, reducing costs, and enabling centralized management of trademark portfolios across designated member countries.

This comprehensive section establishes the foundational framework for international intellectual property protection. The PCT covers utility inventions (methods, devices, compositions) across 155+ member countries, while the Hague Agreement handles industrial designs protecting visual appearances like GUIs and product aesthetics. Madrid manages trademark international registration. Key distinctions include: most countries use registration systems without substantive examination, unlike the U.S. requirement for human inventorship. The fundamental problem addressed is that practitioners often use overly technical jargon preventing effective client communication. The Paris Convention established earlier timelines (6 months for designs, 12 months for utilities), but PCT and Hague address these limitations through centralized filing systems.

The Patent Cooperation Treaty (PCT) is a treaty among almost all industrial countries allowing a single patent application to be filed in a receiving office, with common search and examination performed. The PCT system does NOT provide for provisional patent applications, which are unique to the United States (and India). For inventors located in the US planning to manufacture in China and sell in EU/UK, the recommended strategy is: (1) File a US provisional patent application first, which provides 12 months of priority; (2) Within that 12-month period, file a PCT application; (3) After PCT examination, file national phase applications in China, EU, and UK within 30-31 months from the original filing date. Alternatively, one could file national applications directly in each country within 12 months of the provisional filing.

The Madrid System (International Trademark Registration) is the most commonly used method for international trademark protection. It allows applicants to file a single application to seek protection in multiple countries through the World Intellectual Property Organization (WIPO). The system requires applicants to have a national trademark registration or application in their home country (called the 'basic mark'). The international application is dependent on this basic mark for 5 years, meaning any issues with the basic mark can affect the international registration. The system currently covers 110 countries, allowing applicants to select multiple countries in a single filing.

IP protection is inherently national, creating enforcement challenges for cross-border AI infringement. Current treaties limit protection to domestic borders. Saudi Arabia has expanded treaty participation from 4 to 14 agreements, targeting the G20 average of 17. New international treaties like the RI Design Treaty aim to establish minimum global requirements. Offices are forming bilateral collaborations to share information and accelerate processing. Regional cooperation is emerging as a trend to handle increased AI-generated applications while maintaining quality standards.

On May 24, 2023, the World Intellectual Property Organization (WIPO) signed a treaty with 138 nations (with more signing since) requiring that if a patent involves genetic information, the source of that genetic information must be named in the patent. This was intended to enable royalty payments to source nations. The video criticizes this treaty as 'shabby' and notes that it could potentially include any genetic sequence, including those created by artificial intelligence, which could be incorporated into products like mRNA vaccines. This treaty was a sticking point in WHO negotiations because it conflicted with the goal of equitable access to pandemic products.

Digital piracy costs $29.2 billion annually with over 215 billion monthly visits to pirate sites. The Protecting Lawful Streaming Act closed loopholes enabling streaming piracy, with the first prosecution announced in May 2024. AI presents both threats and opportunities for IP protection, with industry reporting AI-powered hacking to bypass encryption and steal trade secrets. Five nations including the US, UK, Canada, Australia, and New Zealand have united against Chinese IP theft, yet streaming pirates routinely locate themselves in jurisdictions resistant to US legal process. The Fmovies case demonstrates how cases can stall for years while sites continue operating.

This webinar explains how intellectual property rights intersect with frameworks governing genetic resources, tracing the historical evolution from the Paris Convention (1883) to modern agreements like the Nagoya Protocol (2010), which established three core pillars: the Convention on Biological Diversity, the Bonn Guidelines, and the Nagoya Protocol itself. The presentation covers three types of interfaces between IP and genetic resources: statutory interfaces (national access and benefit-sharing legislation), technical interfaces (prior art databases and sequence data standards like WIPO ST.26), and rights management interfaces (contractual tools for licensing and material transfer). Key challenges include harmonizing disclosure requirements for genetic resources in patent applications, defining the scope of ABS provisions for derivatives and sequence data, and balancing provider country benefits with innovation facilitation. WIP's work includes capacity building, training programs, and a searchable database of ABS contract clauses to help practitioners navigate these complex intersections.

The WIPO Treaty on Genetic Resources and Associated Traditional Knowledge, adopted by consensus on May 24, 2024, represents a historic paradigm shift in international intellectual property law, marking the first time developing countries and indigenous peoples became policy makers rather than takers in IP negotiations; the treaty introduces a landmark disclosure requirement for patent applicants to disclose the source and origin of genetic resources and associated traditional knowledge, addressing biopiracy while maintaining innovation incentives, and explicitly recognizes indigenous peoples as stewards of biodiversity and custodians of traditional knowledge, though its practical effectiveness depends on achieving sufficient ratifications and overcoming resistance from some developed countries and mega-diverse nations.