On June 17, 2006, changes to key regulations of interest to the pharmaceutical industry were published in the Canada Gazette Part I for a 30 day comment period: Amendments to the Patented Medicines (Notice of Compliance) Regulations and changes to the Food and Drug Regulations (Data Protection).
The pre-published regulations follow 18 months of consultations that were initiated by the publication of two sets of regulations relating to the same subject matter on December 11, 2004. Those regulations were not finalized. The current proposals take into account representations made by stakeholders during consultations.
The deadline for written submissions is July 17, 2006.
Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations")
The NOC Regulations (also known as the Linkage Regulations) set out various rules that govern a pharmaceutical patentee's opportunity to test allegations of patent infringement made by a generic manufacturer that is seeking to bring a competing generic product to market. The changes to the rules are purportedly aimed at reaffirming patent listing requirements and clarifying the circumstances in which patents must be addressed. Other ancillary changes are proposed to be made to reduce unnecessary litigation and improve the overall effectiveness of the regime.
The major proposed changes to the NOC Regulations include:
- Clarifying the patents that may be added to the Patent Register;
- Clarifying the "timing and relevance" rules surrounding the listing of patents on the Patent Register;
- Permitting dosage form patents to be added to the Patent Register;
- Limiting the patents that a generic manufacturer would have to address by sending a Notice of Allegation to a patentee;
- Clarifying the provision which allows a generic manufacturer to seek damages for delayed market entry, to provide that a generic manufacturer may seek damages for its loss, and is not entitled to the profits of the innovator; and
- Providing that patents must be deleted from the Patent Register where a Drug Identification Number (DIN) is cancelled by reason that the product has been withdrawn from the market, subject to certain exceptions.
Food and Drug Regulations (Data Protection)
Food and Drug Regulations (Data Protection)
Amendments to the Food and Drug Regulations are being proposed to clarify and effectively implement Canada's international obligations under the North American Free Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property Rights with respect to data protection. The Regulatory Impact Analysis Statement (RIAS) recognizes that in actual practice the current provisions of the Food and Drug Regulations do not provide a period of data protection.
The proposed data protection regulations would provide for a period of eight years of data protection from the date the innovator obtains its Notice of Compliance (NOC). During this period no competitor could obtain an NOC based on a direct or indirect comparison to the innovative drug. Furthermore, the proposed rules provide a period of six years, after the innovator's NOC is filed, during which no competitor can file a submission comparing, directly or indirectly, to the innovative drug.
Only one term of data protection will apply for each "medicinal ingredient." The regulations provide that "variations" of medicinal ingredients will not obtain a separate period of protection. Specifically, the proposed regulation would ensure that a product which includes a salt, ester, enantiomer, solvate or polymorph, considered a "variation" of a previously approved medicinal ingredient, would not get a separate term of data protection.
The proposal would also extend the eight year period by a period of 6 months in cases where pediatric clinical studies are submitted to the Minister of Health. These must be submitted either with the new drug submission or within 5 years of the filing, and the Minister must determine that the trials were "designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would thereby provide a health benefit to members of those populations" in order for this further protection to be granted.
One curious element of the proposal provides that protection would not apply where "the innovative drug is not being marketed in Canada."
The transitional provisions of the proposed rules are noteworthy, in that data protection would not apply to any NOC that had been granted prior to the date the regulations come into force. Protection would, however, apply to those innovative drugs for which a submission is pending as at the date the proposed regulatory amendments come into force.
The text of the proposed NOC Regulations may be found at:
The text of the proposed Data Protection Regulations may be found at:
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.