Amendments to the Patented Medicines (Notice of Compliance) Regulations and the Data Protection Provisions of the Food and Drug Regulations in Force

© 2006, Deeth Williams Wall LLP. All Rights Reserved. By: Nicholas J. Wong (October 25, 2006)

On October 18, 2006, the Government of Canada published the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (PM (NOC) Regulations) and the Regulations Amending the Food and Drug Regulations (Date Protection) (Data Protection Regulations). They came into force on October 5, 2006. According to the Government, the amendments are intended to provide certainty, predictability and balance to the intellectual property framework for pharmaceuticals and bio-pharmaceuticals in Canada.

Data Protection Regulations
The Data Protection Regulations clarify and implement Canada's obligations under the North American Free Trade Agreement and the Trade-Related Aspects of International Property Rights to protect research data submitted to regulatory authorities by innovative companies. The amendments provide new and innovative drugs with a guaranteed minimum market exclusivity of eight years. An additional six months of data protection is available for innovative drugs that are the subject of pediatric studies.

In addition, Canada will now provide a six-year, no-filing period within which a generic manufacturer, seeking to make a direct or indirect comparison to an innovative drug, will not be permitted to file a new drug or abbreviated new drug submission with the Minister.

PM (NOC) Regulations
The amendments to these Regulations are intended to strike a balance between effective patent enforcement for new and innovative drugs with the timely market entry of lower priced generics, by setting out the rules for listing patents on Canada's Patent Register (Register) and clarifying when listed patents must be addressed by a generic manufacturer. In addition, a number of ancillary amendments were made in order to reduce unnecessary litigation and to improve the overall effectiveness of the regime.

i) Changes to Patent Listing Requirements
In order for a patent to be listed on the Register to qualify for protection under the PM (NOC) Regulations, the patent must be relevant to the product that the innovator is approved to sell. Section 4 of the PM (NOC) Regulations now provides more precise language regarding the intended link between the subject matter of a patent on a patent list and the content for the underlying submission for a notice of compliance (NOC) in relation to which it is submitted.

More specifically, a patent is eligible for listing on the Register in respect of a new drug submission if the patent contains: (1) a claim for the approved medicinal ingredient, (2) a claim for the approved formulation containing that medicinal ingredient, (3) a claim for the approved dosage form, or (4) a claim for an approved use of the medicinal ingredient.

The amended section 4 also confirms the right to list new patents on the basis of a supplemental new drug submission (SNDS) and sets out listing requirements. Under these requirements, a patent is eligible for listing if the SNDS is for a change in formulation, a change in dosage form, or a change in the use of the medicinal ingredient, and the patent contains a claim for the changed formulation, the changed dosage form, or the changed use of the medicinal ingredient and an NOC has used in respect of the SNDS.

The amended section 4 also contains new language necessary to support the listing of dosage form patents. A new definition for "a claim for the dosage form" has also been added to section 2 to provide protection for novel delivery systems.

These amendments include a grandfathering provision which provides that patents submitted for listing prior to July 17, 2006, the publication date in Part I of the Canada Gazette, remain subject to listing requirements prior to the amendments.

ii) Changes to Requirements Governing When Listed Patents Must be Addressed
Under the amendments to section 5, the Register will now be "frozen" so that a generic manufacturer is not required to address patents that are added to the Register after the filing date of its regulatory submission for an NOC. For generic manufacturers that have filed a submission or a supplement for an NOC in respect of a generic version of an innovative drug with patents on the Register before October 5, 2006, the "freezing" date is deemed to be October 5, 2006.

iii) Other Amendments
The amendments to section 3 address the situation in which an innovator withdraws an original form of a drug from the market in order to prevent generic manufacturers of a Canadian Reference Product in order to delay generic entry into the market. The Minister is now required to delete any patents on the Register for a drug for which the drug identification number (DIN) has been cancelled, 90 days after the date of cancellation (section 3(3)), unless the DIN was cancelled because of a change in manufacturer of a drug (section 3(4)). However, the Minister must re-list the deleted patents if a DIN is reassigned for the same drug and marketing is resumed (section 3(5)).

The amendments to section 5 now prevent a generic manufacturer from serving a Notice of Allegation (NOA) before a submission or supplement for an NOC is filed. Prior to the amendments, an NOA alleging only invalidity could be served before the generic manufacturer filed its regulatory submission.

The amendments also repeal subsection 5(1.1). This is consistent with the decision in Bristol-Myers Squibb Co v Canada (Attorney General), 2005 SCC 26, in which the Supreme Court of Canada confirmed that the PM (NOC) Regulations do not apply to a subsequent entry submission where the Minister requires the sponsor of the submission to conduct independent clinical trials to establish safety and efficacy of its drug.

Section 6(5) now permits summary dismissal, in whole or in part, of an application to prohibit the Minister from issuing an NOC until after the expiration of a patent that is the subject of an NOA.

The section 8 damages provision, which sets out the remedies available to a generic manufacturer seeking compensation for any loss arising from the delay for which an innovator is liable, has been amended to remove reference to "profits" from section 8(4). This change prevents generic manufacturers from claiming the innovator's profits as a remedy for the delay, and limits the remedy only to the generic manufacturer's damages. Finally, the addition of section 3(6) confirms that the Minister is not liable for damages for any delay under section 8.

For a copy of the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, visit: http://canadagazette.gc.ca/partII/2006/20061018/html/sor242-e.html.

For a copy of the Regulations Amending the Food and Drug Regulations (Data Protection), visit: http://canadagazette.gc.ca/partII/2006/20061018/html/sor241-e.html

For more information, visit:
Industry Canada

Contact Nicholas J. Wong for more information on Amendments to the Patented Medicines Regulations.