Examples of using Data exclusivity in English and their translations into Chinese
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Data exclusivity.
Introduce data exclusivity.
TRIPS does not require countries to provide data exclusivity.
The requirement to impose data exclusivity features in several FTAs.
For instance, the USMorocco FTA provides for data exclusivity.
Maintain data exclusivity, thereby delaying the approval of biogeneric drugs;
In Mexico and Canada, however,new biologics receive just five and eight years of data exclusivity, respectively.
Data exclusivity may also block the production of generics after a compulsory licence is issued.
Related rights are also available,including trade secret and know-how, data exclusivity and orphan drug exclusivity. .
Data exclusivity is a form of legal monopoly protection for a drug, over and above the patent protections.
Published"The Significance of the Data Exclusivity and its Impact on Generic Drugs," 1:1 JIPS 131(Oct. 19, 2017).
Data exclusivity deters and considerably delays the entry of generic medicines and can lead to the maintenance of high prices of medicines.
In Chile, Article 91 of Law 19.996, as amended in 2012[35],provides that test data exclusivity shall not be applied as follows:.
Published“Data Exclusivity: A Tool to Sustain Market Monopoly” in the Jindal Law Review(forthcoming, 2017).
Many scholarly articles and blog posts as well as industry-funded sources state that theUnited States allows for 12 years of data exclusivity.
Data Exclusivity: The RCEP seeks inclusion of a data exclusivity provision over and above patent term restoration.
The law actually provides only four years of data exclusivity for biologic drugs, while the remaining eight years function as market exclusivity.”.
Data exclusivity, being independent from patent protection, can allow pharmaceutical companies to secure monopoly rights for off-patent or non-patentable medicines.
Evidence from Jordan indicates thatpharmaceutical companies are choosing to rely on data exclusivity to enforce their monopoly instead of filing for patents.
Data exclusivity extends from the date of product approval, and this protection period runs concurrently with any remaining patent term protection for the biologic.
In the context of developed countries,as evidence from Canada and Australia suggests, data exclusivity leads to higher costs of prescription medicines.
In most free trade agreements, the data exclusivity approach prevails, although some recent ones contain the possibility of some cost sharing.
The TPP would manage trade in pharmaceuticals through a variety of seemingly arcane rulechanges on issues such as“patent linkage,”“data exclusivity,” and“biologics.”.
Data exclusivity is designed to preserve innovation and recognize the long, costly, and risky process involved while the innovator waits to gain FDA approval.
Trade marks, registered and unregistered design rights, utility models,trade secret, data exclusivity are also available and offer useful commercial protection.
Data exclusivity blocks government regulatory authorities from allowing price-lowering generic competitors to enter the market with previously generated clinical data. .
In the United States,the BPCIA already provides for 12 years of data exclusivity for new biologics, exceeding the minimum 10 years under the USMCA.
Pharmaceutical Data Exclusivity Laws Available- Malaysia has implemented DE since 2011 for undisclosed, unpublished and non-public domain pharmaceutical test data. .
One international comparative study found no relationship between the existence of data exclusivity and the amount of pharmaceutical industry investment in a country.
Professor Srividhya Ragavan published“The Significance of the Data Exclusivity and its Impact on Generic Drugs” in Journal of Intellectual Property Studies(Mar. 2017).