Identification of US-pharmaceutical patents expiring between 2018 and 2022 and their effect on the Brazilian domestic market
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ABSTRACT:
SUBMITTER: Paes T
PROVIDER: S-EPMC7538125 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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Project description:Brazilian stock markets underwent a period of remarkable exuberance between early 2016 and March 2020, only to crash with the global turmoil related to health worries and oil prices. The Ibovespa index tripled its market value between a low point in January 2016 and its maximum in January 2020—by March 12, half those gains had been erased. Narratives about a bubble in Brazilian stocks before the global crash and its subsequent burst are plentiful in specialized media. In this paper, we explore this narrative from within the framework of strict local martingale financial bubbles. A key result in this literature states some financial asset price displays a bubble only if it follows a strict local martingale under the equivalent risk-neutral measure. A diffusion process is a strict local martingale if its volatility increases faster than linearly as its level grows. We first apply a nonparametric method to estimate the volatility function of Ibovespa daily prices, then fit a stochastic volatility model whose parameter values can discriminate the underlying price process as either a true martingale or a strict local martingale. Our results are negative towards the presence of a strict local martingale bubble in the Ibovespa index. Strict local martingale bubbles are related to a positive relationship between returns and volatility which does not seem present in the data at hand. We also performed a comparative analysis of the patterns found for the Ibovespa with the S&P500 index, spot Brent oil and gold prices. Electronic supplementary material The online version of this article (10.1007/s43546-020-00005-w) contains supplementary material, which is available to authorized users.
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Project description:BackgroundDrug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination.ObjectiveThis study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe.MethodsThe case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses.ResultsA total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were 'change in administration setting to hospital' (374%, p<0.0001), 'addressing unmet needs' (69%, p<0.05), 'reformulations belonging to Group 3'-that is, change in administration route (117%, p<0.001), and being a repurposed product with the 'same brand name' as the original product (65%, p<0.05).ConclusionWe found that the ability of the repurposed product to address unmet needs, a reformulation where the target product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in the USA, in particular. Although a change of administration from ambulatory to hospital setting seemed to be significantly correlated with a price increase for the target product, only one case was retrieved for this parameter; as such, it was not possible to infer a firm correlation between this parameter and a change in price.
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Project description: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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