Please use this identifier to cite or link to this item: https://hdl.handle.net/10419/232253 
Year of Publication: 
2020
Series/Report no.: 
Research Paper No. 127
Publisher: 
South Centre, Geneva
Abstract: 
The European Union (EU) has instituted internal and external measures aimed at protecting and enforcing intellectual property rights. In the area of pharmaceutical patents, the Union has also sought to protect its industries through patent term extension and data exclusivity. Recent EU free trade agreements (FTAs) with developing countries contain chapters on intellectual property that extend patent terms and data exclusivity for pharmaceutical products. Such acts further prolong the lifespan of protection given to existing products and limit generic market entry. I identify the issue as one of “cross-pollination” of laws and argue that since similar laws exist in the internal regime of the EU, incorporating them into the EU would not be too technically difficult. However, to the extent that this regime is simulated in developing countries, implementation would damage the health sectors and economies of these countries. I therefore propose that developing countries should not be forced to adopt such laws through FTAs. If they are forced to adopt the laws after all, there should be a compulsory inclusion of (1) a clause on transitional arrangements for developing countries specific to intellectual property; (2) a clause that clearly links the objectives for intellectual property protection and enforcement (in this context, patent term extension and data exclusivity) to balance the promotion of technological innovation with access to medicines; and (3) a clause on Bolar exemption and a manufacturing waiver.
Subjects: 
Access to Medicines
Biologics
Bolar
Data Exclusivity
European Union (EU)
Flexibilities
Free Trade Agreements (FTAs)
Generic Medicines
Health
India
Innovation
Intellectual Property
Intellectual Property (IP) Enforcement
Patent
Patent Term
Pharmaceuticals
TRIPS
Document Type: 
Research Report
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