Abstract
AbstractLinking patent protection to generics’ regulatory approvals is a heated topic of discussions and a friction point among countries proposing higher protection for patented drugs. Patent linkage has been pushed through bilateral and regional agreements outside of the WTO system. It is widely understood that patent linkage is implemented to delay the market entry of generic medicines. It is argued here that developing countries are not obliged to take up TRIPs plus patent-linkage obligations.A list of approved drugs and their therapeutic equivalence can be published by every country. The patent information can also be published to be made known to everybody. Regulatory mechanisms and patent protection should be kept in separate parallel tracks. Any attempt to link the two streams to prevent the registration of generics based solely on alleged patent infringement would negatively affect access to medicines worldwide.Patent linkage provisions are TRIPS-plus commitments, as there is no such obligation under the WTO TRIPS Agreement. The analysis of 16 countries which provide for patent linkage shows that it is, in most cases, a resulting commitment from regional trade agreements or bilateral agreements. Patent linkage provisions are not acceptable to the developing world, and any attempt to introduce these will affect the accessibility and affordability of generic medicines in the developing world.
Highlights
Access to essential medicines is a developmental challenge to developing countries under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs).1 Accessibility, affordability, and availability of medicines are the prime objectives of any developing country’s public health policy.2 Access to drugs is vital in the background that, after food, the second-largest household expenditure is on medication, and this is paid out of pocket in these countries due to a lack of sufficient public health programs
This paper argues that linking a generic drug’s market approval to its branded equivalent’s patent status is detrimental to access to medicines in developing countries and least developed countries
Applications for generic drugs will be accepted 12 months before the expiry of United Arab Emirates (UAE) patent protection provided that the application does not contain any information relating to the patentee, which is protected under Article 36 of the TRIPS agreement
Summary
Access to essential medicines is a developmental challenge to developing countries under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). Accessibility, affordability, and availability of medicines (medicines and drugs are interchangeably used in this paper hereinafter) are the prime objectives of any developing country’s public health policy. Access to drugs is vital in the background that, after food, the second-largest household expenditure is on medication, and this is paid out of pocket in these countries due to a lack of sufficient public health programs. Generic companies to provide cheap drugs in developing countries without delay.16 This early working limited exception under Article 30 of the TRIPs Agreement does not infringe patented drug owners’ rights. It is argued that India and other developing countries should not statutorily link patent protection with marketing approvals of generic drugs, which is well beyond the TRIPs obligations. Studies have revealed that generic drug approval applications were late by 30 months due to patent linkage provisions and the infringement litigation.22 These infringement cases increase the cost of drugs, and the generics lost the right to enter the market during the stay period. EU believes that any tinkering with the bolar provision through patent linkage will delay the entry of generic drugs into the European market.. Commission made it clear that patent linkage delays the entry of generic medicines and a clear abuse of the EU regulatory system. Patent linkage is considered illegal in the EU under Regulation (EC) No 726/2004 and Directive (EC) No 2001/83).
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