New amendments to the Patented Medicines (Notice of Compliance) Regulations came into effect on October 1, 1999. The amendments were aimed at ensuring that a generic manufacturer who wishes to enter the market, when there are patents listed for an innovative product, must notify the innovator that it is seeking to enter the market. The amendments to the Regulations were inspired by the Minister of Health’s interpretation of the interplay between the Food and Drug Regulations and the NOC Regulations.
The policy underlying the Regulations is that there should be an opportunity for patent issues such as infringement to be decided in a summary manner prior to a generic manufacturer being able to enter the market. However, the decision of the Minister of Health to issue a NOC (marketing approval) to Nu-Pharm Inc., in February of 1999, for its generic version of Merck Frosst’s top-selling heart drug,VASOTEC without Nu-Pharm having to comply with the NOC Regulations called into question the scope of the NOC Regulations.
The amendments to the NOC Regulations set out more fully the circumstances in which a generic manufacturer must notify an innovator that it has applied for regulatory approval. The changes make it clear that where a generic wishes to enter the market, and there is an explicit or implicit reference or comparison with an innovator’s drug for which patents exist on the Patent List, the patentee will be notified, and will have the opportunity to have the patent issues evaluated by the Federal Court prior to the generic product being granted approval to enter the market.
In the matter involving Nu-Pharm Inc., the NOC issued after a Federal Court decision finding that Nu-Pharm could use an identical generic as a "Canadian Reference Product" under the Food and Drug Regulations, and need not use the innovator’s product. On this basis, the Minister found that there was no reference to the Merck Frosst’s VASOTEC product, and that the NOC Regulations did not apply. As a result, Merck had no opportunity to deal with the issue of patent infringement prior to Nu-Pharm Inc. entering the market with its product.
Merck sought judicial review of the decision to issue the NOC. Gowlings acted as counsel, with G. Alexander Macklin and Carina DePellegrin appearing for Merck Frosst. On November 23, 1999, Madame Justice McGillis found that, even though Nu-Pharm had indicated it was comparing itself to another generic, the NOC Regulations applied, in that the Merck product was in effect the product to which a comparison was made. Therefore, the NOC should not have issued.
The latest amendments to the NOC Regulations applied prospectively from the date of their coming into force, i.e. from October 1, 1999, but were not retroactive, and so did not affect the VASOTEC matter. The new amendments should ensure that a similar situation will not occur in future.
Adrienne Blanchard is an Associate in the Ottawa Gowlings office. She can be reached by e-mail at email@example.com.
Jamie Mills is an Associate in the Ottawa Gowlings office. He can be reached by e-mail at firstname.lastname@example.org.
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