2018
DOI: 10.5465/ambpp.2018.17812abstract
|View full text |Cite
|
Sign up to set email alerts
|

Patents, Data Exclusivity, and the Development of New Drugs

Abstract: Pharmaceutical firms typically enjoy market exclusivity for new drugs from concurrent protection of the underlying invention (through patents) and the clinical trials data submitted for market approval (through data exclusivity). Patent invalidation during drug development renders data exclusivity the sole source of protection and shifts the period of market exclusivity at the project level. In instrumental variables regressions we quantify the effect of a one-year reduction in expected market exclusivity on t… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
1
1
1

Citation Types

0
2
0

Year Published

2019
2019
2021
2021

Publication Types

Select...
3

Relationship

0
3

Authors

Journals

citations
Cited by 3 publications
(3 citation statements)
references
References 44 publications
0
2
0
Order By: Relevance
“…As in Western pharmaceutical industries, Chinese firms are required to conduct extensive experiments, to prove both the clinical efficacy and the safety of a new drug. Therefore, following Gaessler and Wagner (2018), as a first measure of development time, we adopted the total series of scientific and clinical experiments required by the Chinese SFDA for a new-drug application. To construct the measure, we used information from the Provisions for New Drug Approval (1985Approval ( , 1999) by the Chinese SFDA, which divides new-drug applications into five distinct categories based on how novel a drug is, ranging from an entirely new active compound (Type 1) to an incremental variant of an existing drug, for instance a new application or intake form (Type 5).…”
Section: Independent Variablesmentioning
confidence: 99%
“…As in Western pharmaceutical industries, Chinese firms are required to conduct extensive experiments, to prove both the clinical efficacy and the safety of a new drug. Therefore, following Gaessler and Wagner (2018), as a first measure of development time, we adopted the total series of scientific and clinical experiments required by the Chinese SFDA for a new-drug application. To construct the measure, we used information from the Provisions for New Drug Approval (1985Approval ( , 1999) by the Chinese SFDA, which divides new-drug applications into five distinct categories based on how novel a drug is, ranging from an entirely new active compound (Type 1) to an incremental variant of an existing drug, for instance a new application or intake form (Type 5).…”
Section: Independent Variablesmentioning
confidence: 99%
“…In order to extend patent terms, the companies can apply for new formulations, new routes of administration, new uses of the drug among other strategies. (237,238) This is very important when considering drug repurposing, once those strategies can make it harder to patent a new method of use for the drug, compromising the legal rights of the new repurposed indication. As a consequence, the expected profit associated with repurposing can be severely affected.…”
Section: Patent Protection and Synthesis Of Repositionable Drugsmentioning
confidence: 99%
“…While the literature has -if at all -focused on the introduction of national patent policies, 232 increasing the strength of patents, 233 extending the patent length, e.g. by TRIPS, 234 and other alternative measures to protect pharmaceutical innovation, such as data exclusivity, 235 there are IP and innovation incentives that have not yet captured major academic interest. These policies are aimed at solving innovation incentive problems concerning specific under-invested disease or treatment types, which could be comparable to antimicrobials.…”
Section: Potential Economic Research Contributionsmentioning
confidence: 99%