Pharma Patent Decision Released

Last week (November 3, 2006) the Supreme Court of Canada (SCC) issued a decison in the battle between AstraZeneca and Apotex on the issue of “evergreening” the protection available for pharmaceutical products. The decision cane be found at AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49

The Patented Medicines (Notice Of Compliance) Regulations govern patented pharmaceutical products in Canada and provide brand-name drug companies with some extra tools in their competition against generic drug manufacturers. Here’s how it works in a nutshell:  a generic drug manufacturer cannot enter the market without a Notice of Compliance (NOC) and no NOC will be issued if the proposed product is the subject of a competitor’s patent.  However, a generic can challenge that patent’s validity or applicability to its own product by issuing a notice of allegation.  The brand name drug company (which owns the patent) may respond by issuing its own application for a prohibition of the NOC.  This response results in an automatic 24‑month “statutory freeze” on the issuance of the NOC to the generic drug manufacturer.  Even after a patent expires, by applying for new improvement patents of “marginal significance” to the expired patent, the brand-name drug company can obtain an indefinite series of 24‑month statutory freezes, which can effectively shut the generic out of the market for that product.  There has been much criticism of this tactic.  This decision helps clarify the rules and warns against the use of the “evergreening” tactic by patent holders. 

No comments

No comments yet. Be the first.

Leave a reply

You must be logged in to post a comment.