Eligibility for Data Protection
The determination of what is an innovative drug eligible for data protection in accordance with section C.08.004.1 of the Food and Drug Regulations
“Innovative drug” as a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.
Under the definition of an innovative drug, drugs that contain medicinal ingredients that have been previously approved in Canada, including drugs that have previously received an NOC, a Natural Product Number (NPN) and/or a Drug Identification Number (DIN), will not be afforded protection. An extension of the period is not available for drugs that are issued an NOC for a new indication, dosage form or other changes made through a supplement to a new drug submission (SNDS) with the exception of SNDSs containing pediatric clinical trial data.
Manufacturer of an innovative drug is granted with an internationally competitive, guaranteed minimum period of market exclusivity of eight years. This market exclusivity will provide an adequate incentive for innovators to invest in research, and to develop and market their products in Canada. An additional six month extension will be applied if an innovator includes clinical trials which were designed and conducted with the purpose of increasing knowledge about the use of the drug in pediatric populations.
Subsequent-entry manufacturer is prevented from filing a submission for a copy of that innovative drug for the first six years of the eight-year period.
The introduction of the six-year “no-filing” data protection period requires an exception to allow for the filing of drug submissions within the framework of Canada’s Access to Medicines Regime.
Atinza’s support
Data protection and Patent listing
Data protection is a key factor that we prioritize for our clients. Atinza will assist in ensuring that your “innovative drug” is equally identified by the Office of Patented Medicines and Liaison (OPML) and therefore subject to data protection provisions of the Food and Drug Regulations. We can also support clients in patent listing, from written to personal appearance before the OPML.