Strategic Patenting by Pharmaceutical Companies – Should Competition Law Intervene?

Gurgula, Olga

doi:10.1007/s40319-020-00985-0

Cited by 33 publications

(24 citation statements)

References 19 publications

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“…On the other hand, IP protection of the old drugs prevents them from entering market as repositioned drugs. Moreover, forced closure of some repositioning projects happens due to risk for wastage of time and money [15]. An important principle in drug repurposing process is market exclusivity, which is defined as "method of use" patents valid for a period of 20 years.…”

Section: Challenges In Drug Repurposingmentioning

confidence: 99%

Antituberculosis Drug Repurposing: A New Hope for Tackling Multi-Challenging TB in Timely Manner

Majeed¹,

Mehraj²,

Ahmad³

2022

Drug Repurposing - Molecular Aspects and Therapeutic Applications

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Tuberculosis still stands as the world’s leading infectious disease as 1/4th of the world’s population harbors Latent TB infection (LTBI) > 10 million develops active TB and ~ 1.5 million people die per year. Approximately 4,65,000 people fell ill with multidrug or rifampicin-resistant tuberculosis (MDR/RR-TB)/year. This deadly TB scenario demands new TB drug regimens to tackle global infection reservoir, and worldwide spread of drug resistance and DS TB. Successful entry of single new drug into market is much complicated mission owing to time, cost, efficacy, and safety issues. Therefore, drug repurposing seems one reliable hope to meet the challenges of modern TB drug discovery timely, as it starts with examining market acclaimed drugs against other diseases for their efficacies against tuberculosis avoiding several lengthy and costly steps required for new molecules. Several drugs have been identified, which show potential for TB treatment. There is need for careful consideration of various trial designs to ensure that TB phase III trials are initiated for fruitful development of new TB treatment regimens. TB drug repurposing will not only give fast track novel drugs but will also serve to identify new targets for future development in cost-effective manner.

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Section: Challenges In Drug Repurposingmentioning

confidence: 99%

Antituberculosis Drug Repurposing: A New Hope for Tackling Multi-Challenging TB in Timely Manner

Majeed¹,

Mehraj²,

Ahmad³

2022

Drug Repurposing - Molecular Aspects and Therapeutic Applications

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“…Each mechanism also requires improvement. 164 Patent law, in contrast, was never 164 Lemley and Feldman (2021); Thambisetty (2018); 't Hoen (2002); Liddicoat and Parish (2021); See also Gurgula (2020) who calls for competition authorities to investigate strategic patenting in the pharmaceutical sector and Gurgula (2021) on general changes needed.…”

Section: Patent Law Reformmentioning

confidence: 99%

The Divisional Game: Using Procedural Rights to Impede Generic/Biosimilar Market Entry

Foss-Solbrekk

2022

IIC

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Despite being used frequently by practitioners in a wide array of technical fields, divisional patent applications (“divisionals”) seldom attract scholarly attention. The lack of scholarly attention is an error, particularly in the pharmaceutical field. Recent case law in the UK reveals that after generic/biosimilar manufacturers successfully revoke patents standing in the way of market entry, divisionals claiming protection for similar subject-matter as the patent that has just been revoked can crop up, hindering generic/biosimilar medicines from entering the market. Moreover, right before or after proceedings start, rightsholders de-designate countries to avoid a negative judgment that may affect a court elsewhere, meaning generic/biosimilar manufacturers initiated legal proceedings for nothing. Such practices demonstrate that divisionals deserve our attention. This article thus fills the scholarly gap by showing how divisionals are (mis)used in practice, before arguing that patent reform is necessary to prevent this from occurring.

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“…In 2018, over two-thirds of cancer medicines were approved for use in multiple indications [ 1 ]. Developing an established medicine for use in a new indication carries a number of advantages over de novo development, including reduced R&D costs and regulatory advantages in terms of secondary patents and extension of marketing exclusivity [ 2 , 3 ]. Oncology medicines in particular may be good candidates for follow-on innovation, as similar underlying causes may be present across cancer types.…”

Section: Introductionmentioning

confidence: 99%

Launch sequencing of pharmaceuticals with multiple therapeutic indications: evidence from seven countries

Mills

Michaeli

Miracolo

et al. 2023

BMC Health Serv Res

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Background New medicines are increasingly being identified as efficacious across multiple indications. The impact of current pricing and reimbursement policies on launch decisions across these indications remains unclear. Objective This paper, first, maps marketing authorisation and HTA coverage recommendation sequences of multi-indication medicines across Germany, France, England, Scotland, Canada, Australia, and the USA, and, second, evaluates the clinical characteristics, clinical development time and coverage recommendation time of multi-indication medicines, drawing comparisons between the first and subsequent indications of an approved molecule. Methods Medicine approvals by the Food and Drug Administration between 2009–2019 were screened to identify multi-indication products with approved oncology indications. Data on clinical trial characteristics, clinical performance and HTA outcomes were extracted from publicly available regulatory approval and HTA reports. Results Relative to subsequent indications, first indications were more likely to receive conditional marketing authorisation, have an orphan designation, have a single arm phase II pivotal trial and lower MCBS score. Subsequent indications had faster HTA coverage recommendation times in England and Canada. While the majority of first indications received HTA coverage recommendations across all settings, the proportion of subsequent indications with HTA coverage recommendations was lower and uptake varied considerably across settings. Conclusions Discordance in the value of first versus subsequent indications can pose major challenges in systems that define price based on the initial indication. Current pricing and reimbursement systems generate significant fragmentation in the approval and availability of multi-indication products across settings.

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Strategic Patenting by Pharmaceutical Companies – Should Competition Law Intervene?

Cited by 33 publications

References 19 publications

Antituberculosis Drug Repurposing: A New Hope for Tackling Multi-Challenging TB in Timely Manner

Antituberculosis Drug Repurposing: A New Hope for Tackling Multi-Challenging TB in Timely Manner

The Divisional Game: Using Procedural Rights to Impede Generic/Biosimilar Market Entry

Launch sequencing of pharmaceuticals with multiple therapeutic indications: evidence from seven countries

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