Ipr In Trips-Compliant Licensing Of Healthcare Ip.
I. INTRODUCTION: TRIPS AND HEALTHCARE IP
The TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights, 1995) sets minimum standards for IP protection among WTO members. In healthcare:
Patents protect pharmaceuticals, biologics, diagnostics, and medical devices.
Trade secrets protect proprietary formulations, manufacturing processes, and clinical trial data.
Licensing is crucial to make life-saving medicines accessible while respecting IP.
TRIPS compliance requires balancing:
Exclusive rights for patent holders
Public health needs and access to medicines
Flexibilities like compulsory licensing and parallel imports
Key TRIPS provisions affecting licensing:
Article 31 – permits compulsory licensing in public health emergencies.
Article 39 – protects undisclosed information (trade secrets, clinical data).
Article 66 – technical assistance to least-developed countries.
II. STRATEGIES FOR TRIPS-COMPLIANT LICENSING IN HEALTHCARE
Voluntary Licensing
Patent holders voluntarily license generic manufacturers.
Often used in low- and middle-income countries for HIV, TB, or COVID-19 medicines.
Compulsory Licensing
Governments authorize use without consent in emergencies.
Must comply with TRIPS Article 31 conditions (adequate remuneration, prior negotiations, non-commercial use for exports, etc.).
Patent Pools
Multiple IP holders pool patents for collective licensing.
Example: Medicines Patent Pool (MPP) for HIV, TB, hepatitis C.
Technology Transfer
Licenses may include manufacturing know-how.
Must comply with TRIPS disclosure rules without violating trade secrets.
Tiered Pricing and Territorial Licensing
Allows different pricing or license terms based on income levels of countries.
III. CASE LAWS ON TRIPS-COMPLIANT HEALTHCARE LICENSING
Here are six key cases illustrating practical and legal applications:
1. Novartis AG v. Union of India (2013) – “Glivec Case”
Jurisdiction: Supreme Court of India
Facts:
Novartis sought patent protection in India for its cancer drug Glivec. Indian law refused because it was considered a minor modification (Section 3(d) of the Indian Patents Act).
Legal Issues:
Patentability of incremental pharmaceutical innovations.
TRIPS compliance of India’s stricter patentability criteria.
Court Reasoning:
Indian law allows stricter criteria than TRIPS, as long as it complies with Article 27 (patentable inventions must be new, inventive, and industrially applicable).
Novartis’ modified form lacked enhanced therapeutic efficacy → patent rejected.
Licensing Implication:
Voluntary licenses must recognize national differences in patentability.
Encouraged generic production and affordable access in India.
2. Bayer Corporation v. Cipla Ltd. (India, 2012)
Facts:
Bayer sued Cipla for producing a generic version of its patented anti-cancer drug Nexavar, citing patent infringement.
Court Reasoning:
Compulsory license granted in 2012 for public health reasons (making drugs affordable).
Cipla could produce the generic under license with royalty payment to Bayer.
TRIPS Implication:
Article 31 allows compulsory licensing when public health demands.
License terms must ensure adequate remuneration to the patent holder.
Lesson:
Licensing strategies must include flexible royalty agreements for developing countries.
3. Thailand Compulsory Licensing of Efavirenz (2007)
Facts:
Thailand issued a compulsory license for Merck’s HIV drug Efavirenz due to unaffordability for public health programs.
Legal Issues:
Compliance with TRIPS Article 31.
Negotiation with patent holder and royalty determination.
Outcome:
License issued for domestic production and import.
Merck received royalties in line with TRIPS.
Lesson for Licensing:
Countries can legally override patent exclusivity for public health emergencies if remuneration and notification conditions are met.
4. Roche v. Cipla – Tamiflu (India, 2008)
Facts:
During H1N1 pandemic, Roche held patent on Oseltamivir (Tamiflu). Cipla sought to produce a generic for emergency use.
Court Reasoning:
Emphasized public health exception under TRIPS and Indian law.
Emergency licensing allows temporary production to meet urgent needs.
Lesson:
Emergency TRIPS-compliant licensing ensures pandemic preparedness.
Licenses must be time-limited and remunerative.
5. Medicines Patent Pool (MPP) Voluntary Licensing Case – HIV Drugs
Facts:
Multiple pharma companies (Gilead, ViiV) voluntarily licensed patents to MPP for HIV drugs in low-income countries.
Key Points:
Licenses included royalty-free or low-royalty provisions.
Allowed local manufacturers to produce generics for Sub-Saharan Africa.
TRIPS Implications:
Fully compliant voluntary licenses under TRIPS.
Encourages tiered pricing and technology transfer without violating IP.
Lesson:
Structured voluntary licenses can maximize access while protecting patent rights.
6. South Africa – GlaxoSmithKline & Boehringer Ingelheim Voluntary Licensing
Facts:
South Africa negotiated voluntary licenses for ARVs (antiretroviral drugs) during the HIV/AIDS crisis.
Court/Policy Outcome:
Allowed generic production under negotiated royalty payments.
Government ensured compliance with TRIPS flexibilities and Article 31.
Lesson:
Government-facilitated licensing ensures public health goals while respecting IP rights.
IV. STRATEGIC TAKEAWAYS FOR TRIPS-COMPLIANT HEALTHCARE LICENSING
Voluntary vs. Compulsory Licensing
Voluntary: negotiated, flexible royalties, technology transfer.
Compulsory: requires adherence to TRIPS Article 31 and adequate remuneration.
National Law vs. TRIPS
Countries can adopt stricter patentability criteria (India Section 3(d)) while remaining TRIPS-compliant.
Technology Transfer
Licenses must clearly define know-how sharing without violating trade secrets (Article 39).
Emergency Preparedness
Licensing frameworks should allow rapid response in pandemics or epidemics.
Portfolio Management
Track patents, licensing terms, territories, royalty obligations, and compliance with public health exceptions.
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