Exploring Evergreening: Insights from Two Medicines

Moir, Hazel V. J.

doi:10.1111/1467-8462.12171

Cited by 5 publications

(12 citation statements)

References 22 publications

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“…Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs now included in the combination. Other countries Moir 2016 [ 109 ] Retrospective empirical case study exploring two types of secondary ‘evergreening’ patents—new formulations and closely related chemical variants. Quantifies the cost of such evergreening patents to the Pharmaceutical Benefits Scheme.…”

Section: Resultsmentioning

confidence: 99%

“…An Australian case study estimated the costs of delayed entry of generics for two medicines due to two types of secondary patents: new formulations and closely related chemical variants. Delayed entry of generics due to such secondary patents cost over $AU1.1 billion over 8 years for one drug and $AU150 million for another drug [ 109 ].…”

Section: Resultsmentioning

confidence: 99%

“…Similarly, all articles examining secondary patents found negative impacts for access to medicines including longer monopoly periods that delayed the market entry of cheaper generics [ 19 , 104 , 106 , 107 ], increased costs to taxpayers [ 109 ] and social welfare losses [ 107 ]. The only article that included a focus on resource poor settings found that measures to restrict secondary patenting had limited effectiveness in Argentina and no measurable impact in India and Brazil [ 110 ].…”

Section: Discussionmentioning

confidence: 99%

“…This systematic review included a small number of papers that were authored by some of this review’s authors [ 35 , 74 , 109 ]. Quality assessment of these articles was delegated to a team member who was not an author.…”

Section: Conflict Of Interestmentioning

confidence: 99%

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What is the impact of intellectual property rules on access to medicines? A systematic review

et al. 2022

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Background It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains ‘flexibilities’ designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions. Methods We searched Proquest, SCOPUS, Web of Science, PubMed, JSTOR, Westlaw and Lexis Nexis. Peer reviewed articles, government reports and other grey literature were included. Articles were eligible for inclusion if they were quantitative, in English, included a measure of cost, price, availability of or access to medicines, were about intellectual property or data exclusivity rules and published between January 1995 and October 2020. Ninety-one studies met our inclusion criteria. We systematically reviewed the studies’ findings and evaluated their quality using a modified quality assessment template. Results and conclusion Five broad overarching themes and 11 subthemes were identified based on the articles’ foci. They were: trade agreements (divided into EU FTAs and those that include the USA); use of TRIPS flexibilities (divided into compulsory licencing and parallel importation); patent expiry/generic entry/generic pathway (divided into comparative studies and single country studies); patent policies (also divided into comparative studies and single country studies) and TRIPS-plus rules (divided into data exclusivity, patent term extensions and secondary patenting). Most studies focused not on specific trade agreements, but on TRIPS-plus provisions, which can also be found within some trade agreements. The main finding of this review is that the stronger pharmaceutical monopolies created by TRIPs-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments. There is evidence that TRIPS flexibilities can facilitate access to medicines although their use is limited to date. There were few studies that included resource poor settings, signalling a need for greater research in such settings where the impact on access to medicines is likely to be more damaging.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Conflict Of Interestmentioning

confidence: 99%

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What is the impact of intellectual property rules on access to medicines? A systematic review

et al. 2022

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“…If one is more sceptical that this lengthy term of protection is justified for such minor discoveries, it follows that the public may not be getting the benefits it should from a truly competitive market in medicines. Studies conducted in the United States (Kapczynski et al , 2012), Australia (Moir 2016) and Switzerland (Vernaz et al , 2013) reveal that secondary patenting leads to higher prices and reduced competition due to negative effects on generic market entry.…”

Section: Beyond Product Process and Use: What Drug Companies Actuallmentioning

confidence: 99%

Healthcare innovation and patent law’s ‘pharmaceutical privilege’: is there a pharmaceutical privilege? And if so, should we remove it?

Dutfield

2017

HEPL

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This article reviews current trends in patent claims regarding personalised, stratified and precision medicine. These trends are not particularly well understood by policymakers, even less by the public, and are quite recent. Consequently, their implications for the public interest have hardly been thought out. Some see personalised and other secondary drug patent claims as promoting better targeted treatment. Others are inclined to see them as manifestations of 'evergreening' whereby companies are, in some cases quite cynically, trying to extend market monopolies in old products or creating new monopolies based on supposedly improved versions of such earlier drugs. The article claims that the relaxation of 'novelty' is a privilege unavailable to inventions in other fields and that on balance the patent system does privilege this industry and that no adequate case has yet been made thus far to prove the public benefits overall.

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Cambodia's Imminent Graduation from Least Developed Country Status: What Will be the Impact of the TRIPS Agreement on Access to HIV and Hepatitis C Medicines in Cambodia?

Tenni,

Lexchin,

Phin

et al. 2024

International Journal of Social Determinants of Health and Heal

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Cambodia has experienced exponential economic growth in recent years and is expected to graduate from least developed country (LDC) status within the next decade. Membership of the World Trade Organization (WTO) will require Cambodia to grant product and process patents for pharmaceuticals upon LDC graduation. This study aims to measure the impact of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on the price of HIV and hepatitis C medicine in Cambodia once it graduates from LDC status and is obliged to make patents available for pharmaceutical products and processes. Using scenarios based on likely outcomes of accession to the TRIPS Agreement, it measures the impact on the price of the HIV treatment program and compares that impact with the hepatitis C treatment program. Graduation from LDC status would be expected to result in a modest increase in the cost of the antiretroviral (ARV) treatment program and very large increases in the cost of the direct acting antivirals (DAA) treatment program. If annual treatment budgets remain constant, patent protection could see 1,515 fewer people living with HIV able to access ARV treatment and 2,577 fewer people able to access DAA treatment (a drop in treatment coverage of 93%).

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Exploring Evergreening: Insights from Two Medicines

Cited by 5 publications

References 22 publications

What is the impact of intellectual property rules on access to medicines? A systematic review

What is the impact of intellectual property rules on access to medicines? A systematic review

Healthcare innovation and patent law’s ‘pharmaceutical privilege’: is there a pharmaceutical privilege? And if so, should we remove it?

Cambodia's Imminent Graduation from Least Developed Country Status: What Will be the Impact of the TRIPS Agreement on Access to HIV and Hepatitis C Medicines in Cambodia?

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