Patents and plausibility

England, Paul

doi:10.1093/jiplp/jpt199

Cited by 4 publications

(3 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…42 Although patients could be liable for Footnote 35 continued sufficiency, and industrial applicability. For a review, see, England (2014). Not all Member States have imported the concept of plausibility, but they do apply similar criteria, see, for example, Ackermann (2021), pp.…”

Section: The Gap: Ip and Financial Incentives For Repositioningmentioning

confidence: 99%

Repositioning Generic Drugs: Empirical Findings and Policy Implications

Liddicoat

Liddell

Darrow

et al. 2022

IIC

View full text Add to dashboard Cite

Commentators claim that drug repositioning (i.e. developing new uses for authorised drugs) significantly slows when generics are authorised and, therefore, law reform is necessary to encourage more R&D. This study empirically examines this claim by analysing records of clinical trials. It finds that once generics are authorised: (i) commercial trials continue at “active” rates for approximately half of the drugs studied, and (ii) the number of hospital and university trials actually increases. These findings cast doubt on whether additional incentives are needed. They also indicate that a more effective way to reposition drugs is for recently established government programmes to embrace IP strategies and leverage the hospital and university trials as an R&D pipeline.

show abstract

Section: The Gap: Ip and Financial Incentives For Repositioningmentioning

confidence: 99%

Repositioning Generic Drugs: Empirical Findings and Policy Implications

Liddicoat

Liddell

Darrow

et al. 2022

IIC

View full text Add to dashboard Cite

show abstract

“…Inventions are patented merely on the recognition that the claimed technical effect is “reasonably predictable,” “fairly assumable,” or “at least plausible.” No drug testing is required as evidence of a drug's characteristics (England, ; Smyth, ). As a result, patents are filed several years before clinical testing on humans is started (Engelberg, , pp.…”

Section: Clinical Experimentation and Data Exclusivity: An Overviewmentioning

confidence: 99%

The 13th Round: Article 39(3) TRIPS and the struggle over “Unfair Commercial Use”

Alì

2018

World Intellectual Property

View full text Add to dashboard Cite

Property Rights (TRIPS) was the first international agreement to provide for some form of protection for regulatory information submitted by companies in order to obtain marketing authorization for a pharmaceutical product.Nevertheless, after more than 20 years from the formation of the agreement, the ultimate meaning of Article 39 (3) thereof remains contentious among scholars and governments. In detail, it is still debated whether the provision mandates for some form of protection against the practice to authorize generic drugs by relying upon the clinical dossier submitted by drug developers or if it tackles otherwise unlawful conducts as data theft and espionage in the pharmaceutical sector. By reassessing the relevant literature on the topic, and by combining old and new arguments, the present paper argues that Article 39(3) does address regulatory reliance practices. However, it also emphasizes that the impact of the provision on developing countries pharmaceutical policies is greatly mitigated by the flexibility left to WTO members to approve generic drugs by referring to prior foreign authorizations. Finally, the paper concludes by reflecting on an issue often overlooked by commentators, that is, the amount of protection necessary to comply with Article 39(3).

show abstract

“…393–394). Likewise, in Europe, an invention is patentable merely on the recognition that the claimed technical effect is “reasonably predictable,” “fairly assumable,” or “at least plausible.” No drug testing is required as evidence of a drug's characteristics (England, ; Smyth, ). Hence, in modern patent laws, the patentability requirements of novelty and inventive step carry little relevance in promoting clinical experimentation.…”

Section: Final Remarks: Ip Innovation and Disclosurementioning

confidence: 99%

TRIPS and disclosure of clinical information: An intellectual property perspective on data sharing

Alì

2017

World Intellectual Property

View full text Add to dashboard Cite

Health scholars, lawyers, and social activists have greatly emphasized the social benefits of disclosure of clinical reports, that is, dossiers of drugs trials submitted to medical agencies in support of pharmaceutical authorizations. On their side, medical authorities are reluctant to divulge regulatory documents because they fear that they might contain commercial trade secrets of drug applicants. In these regards, the Agreement on Trade Related Aspects of Intellectual Property (TRIPS) prohibits trials disclosure except “where necessary to protect the public” or “unless steps are taken to ensure that the data are protected against unfair commercial use.” This paper delves into the complicacies of the TRIPS discipline to clarify the limits imposed by the treaty on medical agencies, and it goes on to suggest meaningful ways of complying with the TRIPS obligations while retaining most of the benefits associated with trials disclosure.

show abstract

Patents and plausibility

Cited by 4 publications

References 0 publications

Repositioning Generic Drugs: Empirical Findings and Policy Implications

Repositioning Generic Drugs: Empirical Findings and Policy Implications

The 13th Round: Article 39(3) TRIPS and the struggle over “Unfair Commercial Use”

TRIPS and disclosure of clinical information: An intellectual property perspective on data sharing

Contact Info

Product

Resources

About