Pharmaceutical Patent Challenges: Company Strategies and Litigation Outcomes

Grabowski, Henry G.; Brain, Carlos; Taub, Anna Levine; Guha, Rahul

doi:10.1162/ajhe_a_00066

Cited by 20 publications

(20 citation statements)

References 19 publications

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“…Specifically, there were 1,477 patent challenges for new medicines approved between 2007 and 2011 in Korea. Interestingly, we detected similar trends in the United States, 4,27,28 indicating a race to patent challenges, which occurred sooner following the marketing of new molecular medicines.…”

Section: Discussionsupporting

confidence: 56%

“…3 In addition, the Hatch-Waxman Act provides an incentive for generic applicants to challenge the patents of the original medicine on the grounds of noninfringement and invalidity. 4 The first generic applicant to file a paragraph IV challenge resulting in marketing prior to patent expiration is granted 180-day exclusivity (first generic exclusivity). 5 It should be noted that the Hatch-Waxman Act does not apply to biologics; therefore, biologics are not subject to the same patent linkage system afforded to chemical entities.…”

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confidence: 99%

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Does the Patent Linkage System Prolong Effective Market Exclusivity? Recent Evidence From the Korea-U.S. Free Trade Agreement in Korea

2019

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This study evaluated the effect of the patent linkage system, fully introduced by the Korea-U.S. Free Trade Agreement in 2015, on patent challenges and the effective market exclusivity of new medicines in Korea. We used pharmaceutical approval data and pharmaceutical litigation data to detect new medicines and their counterparts, to collect patent challenges against new medicines, and to calculate effective market exclusivity for new medicines. Then, a nonparametric event history model was applied to statistically explain the duration of the market exclusivity of new medicines. Between 2007 and 2011, a total of 94 new medicines, consisting of 82 new chemical entities and 12 new biologics, were approved. The patent linkage system encouraged patent litigations to occur sooner, with a race to challenge the patents by various generic applicants. However, it was difficult to conclude that patent challenges had a significant impact on the prolongation of effective market exclusivity. The patent linkage system had a neutral effect on the effective market exclusivity of new medicines and encouraged patent challenges without abbreviating effective market exclusivity. In addition, this study highlights an important issue regarding biologics that has not been the subject of market competition, even for patent challenges.

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Section: Discussionsupporting

confidence: 56%

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confidence: 99%

Does the Patent Linkage System Prolong Effective Market Exclusivity? Recent Evidence From the Korea-U.S. Free Trade Agreement in Korea

2019

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“…An analysis by one of the co-authors of observed and expected future generic entry dates (incorporating information from litigation outcomes and settlements) finds a statistically significant downward effect on MEPs from patent challenges, all else equal. In addition, top-quintile sales drugs experience a statistically significant downward trend in projected MEPs over time 11 . These find-…”

Section: Discussionmentioning

confidence: 99%

Updated trends in US brand-name and generic drug competition

Grabowski

Long

Mortimer

et al. 2016

Journal of Medical Economics

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“…As an incentive to patent challenges, and to promote the timely availability of generics, the first to file a successful paragraph (iv) certification receives 180 days of marketing exclusivity –during which time the FDA may not approve another generic version of the same product [2, 25]. The 180-days starts from the earlier of the date of first commercial marketing or the date of the court decision finding that the patent is either invalid or not infringed by the generic 16…”

Section: Resultsmentioning

confidence: 99%

Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States

et al. 2018

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BackgroundThe inclusion of patent linkage mechanisms in bilateral and plurilateral trade and investment agreements has emerged as a key element in the United States’ TRIPS-Plus intellectual property (IP) negotiating agenda. However, the provisions establishing patent linkage mechanisms in several agreements appear to reflect a degree of ambiguity, potentially enabling some flexibility in their implementation. In this study, we reviewed the features of the prototypic patent linkage mechanism established by the Hatch-Waxman Act in the United States, and compared these with the implementation of systems in three countries whose agreements with the US include patent linkage obligations. From these analyses, we draw lessons for moderating the impact of these mechanisms on access to generic medicines.MethodsWe reviewed the features of the patent linkage mechanism in the US, and undertook a detailed analysis of relevant treaty provisions and the manner of implementation in Canada, Australia, and South Korea.ResultsA key difference between the US implementation of patent linkage and that of its trading partners is the disparate treatment afforded to biologics. Because of the significant differences in the regulatory frameworks applying to small molecule and biologic medicines in the US, the Hatch- Waxman provisions do not apply to biologics and they are not subject to patent linkage. By contrast, the regulatory frameworks in Canada, Australia and South Korea do not reflect similar distinctions and thus patent linkage mechanisms also capture biologics. Additional variations in implementation, mainly the result of constructive ambiguities in the respective treaty texts, offer potential opportunity for mitigating the adverse impact of patent linkage provisions on market entry of generic medicines. Practical measures include ensuring the availability of an accessible, transparent and easily searchable database of patent information; avoiding automatic stays of generic marketing approval where possible; and requiring certification by rights holders to prevent abuse of the system.ConclusionsWhere countries accept treaty obligations to establish patent linkage mechanisms, the impact on access to generic medicines may be moderated to a degree by retaining and exploiting constructive ambiguities in the treaty text and addressing practical aspects of implementation.

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Pharmaceutical Patent Challenges: Company Strategies and Litigation Outcomes

Cited by 20 publications

References 19 publications

Does the Patent Linkage System Prolong Effective Market Exclusivity? Recent Evidence From the Korea-U.S. Free Trade Agreement in Korea

Does the Patent Linkage System Prolong Effective Market Exclusivity? Recent Evidence From the Korea-U.S. Free Trade Agreement in Korea

Updated trends in US brand-name and generic drug competition

Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States

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