Secondary Patenting Of Branded Pharmaceuticals: A Case Study Of How Patents On Two HIV Drugs Could Be Extended For Decades

Amin, Tahir; Kesselheim, Aaron S.

doi:10.1377/hlthaff.2012.0107

Cited by 56 publications

(50 citation statements)

References 19 publications

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“…al. of a cohort of drugs to which the Canadian equivalent of the Hatch-Waxman linkage regime applied found an average of 40 patents granted per drug [27], while Amin and Kesselheim identified 82 granted US patents covering a sample of two drugs – an average of 41 patents per drug [28]. The patent count methods used in those two studies most closely resembles our method, and their findings regarding overall patent frequency by drug are also close to our findings.…”

Section: Discussionsupporting

confidence: 81%

Patents Associated with High-Cost Drugs in Australia

et al. 2013

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Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by “evergreening” blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug's originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators.

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Section: Discussionsupporting

confidence: 81%

Patents Associated with High-Cost Drugs in Australia

et al. 2013

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“…Industry representatives suggest that process patents may play an important role in life-cycle management strategies [7]. A recent analysis of secondary patents on two antiretroviral drugs reports a large number of unlisted patents, including but not limited to process patents [27].…”

Section: Discussionmentioning

confidence: 99%

Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents

2012

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BackgroundWhile there has been much discussion by policymakers and stakeholders about the effects of “secondary patents” on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents.Methodology/Principal FindingsWe read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims (“independent” secondary patents).We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs.Conclusions/SignificancePolicies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active “life cycle management” or “evergreening” of patent portfolios in the industry.

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“…Each of these steps can generate additional patent applications. As a result, for any given medication it is common to see tens of patents covering the base compound as well as diverse molecular forms, formulations, and uses (Howard 2007;Amin and Kesselheim 2012). widely acknowledged to be an important part of product "life cycle management."…”

Section: Secondary Patenting and Developing Countriesmentioning

confidence: 99%

“…Third, in many developing countries the introduction of pharmaceutical patenting, and the ensuing flood of pharmaceutical patents, may simply overwhelm the capacities of local legal systems to properly handle litigation. A final issue is search costs: not knowing how many patents exist on a given drug creates uncertainty, and conducting searches on patent landscapes in developing countries is particularly difficult (Amin and Kesselheim 2012). For all of these reasons, once patents are granted they may be particularly difficult to overturn in developing countries.…”

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

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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.

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Secondary Patenting Of Branded Pharmaceuticals: A Case Study Of How Patents On Two HIV Drugs Could Be Extended For Decades

Cited by 56 publications

References 19 publications

Patents Associated with High-Cost Drugs in Australia

Patents Associated with High-Cost Drugs in Australia

Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents

TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India

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