Use Patents Can Be Useful: The Case of Rescued Drugs

Arti, K.; Rice, Grant

doi:10.1126/scitranslmed.3009120

Cited by 6 publications

(3 citation statements)

References 9 publications

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“…The commercialization process for repurposed drugs has also presented challenges as patent protection and market exclusivity are not as robust as drugs with a strong "composition-of-matter" patent. In the case of repurposed drugs, "use" patents serve as the primary means of protecting the intellectual property (IP) and market exclusivity once the drug becomes commercialized [142]. The best example is the multiple sclerosis drug BG-12 (dimethyl fumarate).…”

Section: Intellectual Property Considerationsmentioning

confidence: 99%

Drug Repositioning Approaches for the Discovery of New Therapeutics for Alzheimer's Disease

Kim

2015

Neurotherapeutics

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Summary Alzheimer's disease (AD) is the most common cause of dementia and represents one of the highest unmet needs in medicine today. Drug development efforts for AD have been encumbered by largely unsuccessful clinical trials in the last decade. Drug repositioning, a process of discovering a new therapeutic use for existing drugs or drug candidates, is an attractive and timely drug development strategy especially for AD. Compared with traditional de novo drug development, time and cost are reduced as the safety and pharmacokinetic properties of most repositioning candidates have already been determined. A majority of drug repositioning efforts for AD have been based on positive clinical or epidemiological observations or in vivo efficacy found in mouse models of AD. More systematic, multidisciplinary approaches will further facilitate drug repositioning for AD. Some experimental approaches include unbiased phenotypic screening using the library of available drug collections in physiologically relevant model systems (e.g. stem cell-derived neurons or glial cells), computational prediction and selection approaches that leverage the accumulating data resulting from RNA expression profiles, and genome-wide association studies. This review will summarize several notable strategies and representative examples of drug repositioning for AD.

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Section: Intellectual Property Considerationsmentioning

confidence: 99%

Drug Repositioning Approaches for the Discovery of New Therapeutics for Alzheimer's Disease

Kim

2015

Neurotherapeutics

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“…New use may be found for drugs that have been approved by the U.S. Food and Drug Administration (FDA), as well as ‘failed’ drugs that passed phase I clinical trials to evaluate safety, but were not effective in phase II or III clinical trials. In this latter group, patent protection can provide financial incentives for additional clinical trials to examine a new use 4 . FDA-approved drugs with expired patents may be viable as well and new use can be evaluated in population studies, before initiating additional clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Novel use of FDA-approved drugs identified by cluster analysis of behavioral profiles

Edmister

Hernández

Ibrahim

et al. 2022

Sci Rep

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Repurposing FDA-approved drugs is an efficient and cost-effective approach in the development of therapeutics for a broad range of diseases. However, prediction of function can be challenging, especially in the brain. We screened a small-molecule library with FDA-approved drugs for effects on behavior. The studies were carried out using zebrafish larvae, imaged in a 384-well format. We found that various drugs affect activity, habituation, startle responses, excitability, and optomotor responses. The changes in behavior were organized in behavioral profiles, which were examined by hierarchical cluster analysis. One of the identified clusters includes the calcineurin inhibitors cyclosporine (CsA) and tacrolimus (FK506), which are immunosuppressants and potential therapeutics in the prevention of Alzheimer’s disease. The calcineurin inhibitors form a functional cluster with seemingly unrelated drugs, including bromocriptine, tetrabenazine, rosiglitazone, nebivolol, sorafenib, cabozantinib, tamoxifen, meclizine, and salmeterol. We propose that drugs with ‘CsA-type’ behavioral profiles are promising candidates for the prevention and treatment of Alzheimer’s disease.

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“…In addition to regulatory exclusivity, we also have orphan drug exclusivity (7-year product exclusivity) and paediatric exclusivity for additional 6 months (Murteira et al 2014). Strategic combination of new composition of matter and use patent together with a formulation and/or new use protected from generics provides strongest market exclusivity and thereby maximises the returns from the repurposed drug product (Smith 2011;Rai and Rice 2014).…”

Section: Regulatory Exclusivitymentioning

confidence: 99%

Repurposing – second life for drugs

Ayyar¹,

Subramanian²

2022

PHAR

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Drug repurposing refers to finding new indications for existing drugs. The paradigm shift from traditional drug discovery to drug repurposing is driven by the fact that new drug pipelines are getting dried up because of mounting Research & Development (R&D) costs, long timeline for new drug development, low success rate for new molecular entities, regulatory hurdles coupled with revenue loss from patent expiry and competition from generics. Anaemic drug pipelines along with increasing demand for newer effective, cheaper, safer drugs and unmet medical needs call for new strategies of drug discovery and, drug repurposing seems to be a promising avenue for such endeavours. Drug repurposing strategies have progressed over years from simple serendipitous observations to more complex computational methods in parallel with our ever-growing knowledge on drugs, diseases, protein targets and signalling pathways but still the knowledge is far from complete. Repurposed drugs too have to face many obstacles, although lesser than new drugs, before being successful.

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Use Patents Can Be Useful: The Case of Rescued Drugs

Abstract: Contrary to conventional wisdom, use patents can have both commercial and therapeutic value.

Cited by 6 publications

References 9 publications

Drug Repositioning Approaches for the Discovery of New Therapeutics for Alzheimer's Disease

Drug Repositioning Approaches for the Discovery of New Therapeutics for Alzheimer's Disease

Novel use of FDA-approved drugs identified by cluster analysis of behavioral profiles

Repurposing – second life for drugs

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Use Patents Can Be Useful: The Case of Rescued Drugs

Abstract: Contrary to conventional wisdom, use patents can have both commercial and therapeutic value.

Cited by 6 publications

References 9 publications

Drug Repositioning Approaches for the Discovery of New Therapeutics for Alzheimer's Disease

Drug Repositioning Approaches for the Discovery of New Therapeutics for Alzheimer's Disease

Novel use of FDA-approved drugs identified by cluster analysis of behavioral profiles

﻿Repurposing – second life for drugs

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Repurposing – second life for drugs