New Report: Mitigating Patent Linkage To Promote Medicines Access In LMICs

A new report reviews how patent linkage mechanisms have been implemented in South Korea, Australia, Canada, and the United States, and identifies precedents for how low and middle-income countries (LMICs) can retain and exploit “constructive ambiguities” in trade treaty text to mitigate the impacts of patent linkage mechanisms and promote the timely availability of generic medicines.

The report, Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States, was published on 24 October in the journal Globalization and Health, under an open access licence. The report was written by Kyung-Bok Son, Ruth Lopert, Deborah Gleeson and Tae-Jin Lee.

Patent Linkage Mechanisms

Patent linkage refers to “the application of a conditional relationship between the granting of marketing approval for a generic medicine and the patent status of the originator reference product,” according to the report.

Patent linkage therefore ensures that applications to regulatory entities for market certification of generic drugs are cross-checked with current lists of patents, to prevent those entities from “inadvertently” contributing to patent infringement by granting marketing rights to generic drugs, the report explains.

Patent linkage further serves as an “early resolution of patent disputes before the generic product in question gains marketing approval [to] avoid the need for complex litigation over damages for marketing an infringing product,” the report states.

However, the report explains that “patent linkage has been shown to have a detrimental effect on access to medicines, by delaying generic market entry and allowing the high prices of originator medicines to remain unrestrained by generic competition.”

Patent Linkage Impact on Access to Medicines

In the US, patent linkage empowers patent owners “to obtain a de facto injunction against a potential infringer without any evaluation of the merits of its claim or the nature of the putative infringement,” the report states. “Empirical research has shown that patent linkage in the United States is highly effective in protecting originator products from competition and discouraging or delaying generic entry, and can extend the effective market monopoly well beyond the protection provided by the patent on the original product.”

Once this injunction is made, the US Food and Drug Administration is legally “precluded” from approving the generic application “for up to 30 months, unless non-infringement or invalidity is established earlier either by court judgment or patent expiry during the 30 months,” according to the report.

Patent linkage has been included as a TRIPS-plus intellectual property provision in “bilateral and plurilateral trade and investment agreements [and] has emerged as a key element in the United States’ TRIPS-Plus intellectual property negotiating agenda,” the report states. TRIPS is the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights.

“Constructive Ambiguities” to Mitigate Effects of Patent Linkage

The report explains that “constructive ambiguities” characterize patent linkage language in US trade and investment agreements with South Korea, Canada and Australia, enabling different interpretations and forms of procedural implementation. “Patent linkage mechanisms may therefore evolve very differently where such ambiguities exist,” the report states.

The authors argue that these cases have implications “for developing countries, as they may well face future pressure to introduce this and other TRIPS-Plus provisions as trade-offs for market access in future trade agreements.”

The report found that some countries require the patent holder to justify any injunction on generic market certification, to prevent abuse of patent linkage and any unnecessary delays in the entry of generic drugs. In Australia, the patent owner must certify that “the infringement proceedings are being commenced in good faith; that they have reasonable prospects of success; and that they will be conducted without unreasonable delay. In Korea, a statement that the request is made with respect to a genuine duly registered patent must also be provided,” according to the report.

Additionally, the report explains that “there are penalty provisions applying to the making of a false or misleading request for a stay in Canada, and for false and misleading certification in Australia.”

In these countries, the patent owner may also “be required to provide compensation for any damages caused by delays to generic market entry in these circumstances,” the report explains.

These examples illustrate how “constructive ambiguities” can also be applied by LMICs to mitigate the effects of patent linkage provisions in future bilateral and plurilateral trade and investment agreements, including the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), the report states.

In the case of LMICs in particular, there are ways that patent linkage might also “impede the use of compulsory licensing, despite being a recognised flexibility within TRIPS (and retained within CPTPP).” To avert this risk, the report recommends that “LMICs should ensure that essential exemptions to patent linkage are provided for in domestic legislation.”