Abstract
BackgroundIn order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations. These regulations were meant to achieve a balance between the timely entry of generic medicines and the rights of patent holders. The regulations tied the regulatory approval of generic medicines to the patent status of the original brand-name product.DiscussionSince their introduction the regulations have been a source of contention between the generic and the brand-name industry. While the regulations have generated a considerable amount of work for the Federal Court of Canada both sides dispute the interpretation of the "win rate" in the court cases. Similarly, there is no agreement on whether multiple patents on single drugs represent a legitimate activity by the brand-name industry or an "evergreening" tactic. The generic industry's position is that the regulations are being abused leading to the delay in the introduction of lower cost generic products by as much as 8 years. The brand-name companies counter that the regulations are necessary because injunctions against the introduction of generic products are frequently unavailable to them. The regulations were amended in 2006 and again in 2008 but both sides continue to claim that the regulations favour the other party. The battle around the regulations also has an international dimension with interventions by PhRMA, the trade association representing the United States based multinational companies, arguing that the regulations are not stringent enough and that Canada needs to be placed on the U.S. Priority Watch List of countries. Finally, there are multiple costs to Canadian society as a result of the NOC regulations.SummaryDespite the rhetoric there has been almost no empiric academic research done into the effect of the regulations. In order to develop rational policy in this area a number of key research questions have been formulated.
Highlights
In order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations
Linkage regulations are not just a domestic concern, the Pharmaceutical Research and Manufacturers of America (PhRMA), the body representing brand-name companies in the United States, has been an active participant in the debate about them and the following section addresses its arguments
At the time when Rx&D presented its statistics, there were 125 cases where there was no hearing; the 20 cases where the Notice of Allegation (NOA) was withdrawn were counted as a win for the patentee but the 100 cases where the innovator either accepted the NOA or the case was otherwise settled were not counted as wins for the generic [8]
Summary
Judicial hearings The Canadian Generic Pharmaceutical Association (CGPA) claims that between 1998 and 2003, the generic companies won 80% of the court cases [7]. The Federal Court ruling was seen as undermining that protection and as a consequence there was a concern that many patents submitted in full compliance with the listing requirements, as they were interpreted and applied prior to June 17, 2006, could be deleted from, or not added to, the Patent Register This could result in earlier than anticipated loss of market exclusivity for a number of brand-name drugs. Pharmaceutical Research and Manufacturers of America (PhRMA) PhRMA regards the 2008 regulation changes as a positive step but at the same time maintains that “serious and systematic deficiencies remain with the PM [Patented Medicines] NOC Regulations.” [18] PhRMA bases its position on three points: brand-name companies have no effective right of appeal; there are limitations on the listing of valid patents; patent infringement proceedings need strengthening. Do the regulations affect investment decisions by either generic or brand-name companies?
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