Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, P.; Muscionico, D.; Salomon, Jean-Luc; Bonnabry, Pascal

doi:10.1371/journal.pmed.1001460

Cited by 39 publications

(46 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Because secondary patents can postpone the entry of low cost-generic competitors and the subsequent reduction in prices, and thus potentially reduce access to medicines, governments have implemented policies to address them (Scherer 2000;Vernaz et al 2013). In the US, for example, evaluation (or, more precisely, re-evaluation) of secondary pharmaceutical patents tends to occur by courts after patents are granted, when questionable patents are litigated.…”

Section: Secondary Patenting and Developing Countriesmentioning

confidence: 99%

TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India

Sampat

Shadlen

2015

St Comp Int Dev

View full text Add to dashboard Cite

This article compares national approaches toward secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures countries have enacted policies to address applications for secondary pharmaceutical patents, how they function, and whether, in practice, these measures limit secondary patents. We analyze the cases of India and Brazil. We assemble data on pharmaceutical patent applications filed in the two countries, code each application to identify which constitute secondary applications, and examine outcomes for each application in both countries. The data indicate that Brazil is less likely to grant applications than India, but in both countries the measures designed to limit secondary patents are having little direct effect. This suggests, on the one hand, that critics of these policies, such as the transnational pharmaceutical sector and foreign governments, may be more worried than they should be. On the other hand, champions of the policies, such as NGOs and international organizations, may have cause for concern that laws on the books are not having the expected impact on patent outcomes in practice. Our findings also suggest that, at the drug level, the effects of countries' approaches toward secondary patents need to be understood in the context of their broader approaches toward TRIPS implementation, including when and how they introduced pharmaceutical patents in the 1990s and 2000s.

show abstract

Section: Secondary Patenting and Developing Countriesmentioning

confidence: 99%

TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India

Sampat

Shadlen

2015

St Comp Int Dev

View full text Add to dashboard Cite

show abstract

“…In the case of small molecule drugs, once the market exclusivity period ends, competitors producing bioequivalent generic drugs can enter the market, and the drug price quickly falls. In this week's PLOS Medicine , Nathalie Vernaz and colleagues study the consequences of this delicate balancing act going awry due to the cumulative effects of so-called life-cycle management (or “evergreening”) strategies employed by the drug's manufacturer [1].…”

mentioning

confidence: 99%

Rising Health Care Costs and Life-Cycle Management in the Pharmaceutical Market

Kesselheim

2013

PLoS Med

View full text Add to dashboard Cite

show abstract

“…When the generic version of the drug becomes available, pharmacists cannot substitute it for the new (branded) version because state laws allow drug substitution only if the dosage strength and other characteristics remain the same. [30][31][32][33][34][35][36][37][38] For instance, over more than a decade, Abbott Laboratories produced several bioequivalent formations of fenofibrate, already in generic form. Through a complex switching approach involving the sequential launch of branded reformulations (not superior to the first-generation product) and patent litigations to delay the approval of the generics, the maneuvers were estimated to cost the US health care system ;$700 million a year.…”

Section: Product Hoppingmentioning

confidence: 99%

Strategies that delay or prevent the timely availability of affordable generic drugs in the United States

Jones

Carrier

Silver

et al. 2016

Blood

View full text Add to dashboard Cite

High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented.

show abstract

Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

Cited by 39 publications

References 27 publications

TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India

TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India

Rising Health Care Costs and Life-Cycle Management in the Pharmaceutical Market

Strategies that delay or prevent the timely availability of affordable generic drugs in the United States

Contact Info

Product

Resources

About