Canada: Pharmacapsules - January 2005

Last Updated: March 18 2005

Edited by Adrienne Blanchard and Jennifer Wilkie

  • Minister Comments On Clinical Trial Results Registry
  • New Heart And Stroke Foundation Guidelines
  • U.S. Supreme Court To Hear Merck V. Integra Lifesciences "Safe Haven" Case
  • Proposed Malpractice Bill Protects Innovators
  • Supreme Court Refuses To Hear Case That Provides Different Rights Of Appeal For Innovators And Generic Manufacturers
  • PMPRB Informally Considers Two-Price System

Minister Comments On Clinical Trial Results Registry

Health Minister Ujjal Dosanjh took time from evaluating the damage afflicted on Sri Lanka by the tsunami to issue a statement re-emphasizing the government's determination to support the initiative taken by the association of Canada's Research-Based Pharmaceutical Companies and the International Federation of Pharmaceutical Manufacturers Association to establish a registry integrating clinical trial research results. He stated that government officials, cognizant of business confidentiality issues and other compelling reasons of privacy, will work with the pharmaceutical industry and other stakeholders to study ways of respecting these issues while achieving the broader objective of full transparency of clinical trial research. "Canadians need to see the results of clinical trials—good and bad—to be empowered to make intelligent choices about the medicine they take."

For more information, please see:

New Heart And Stroke Foundation Guidelines

The Heart and Stroke Foundation issued new guidelines that addresses waiting times for diagnosis and treatment of high blood pressure. The guidelines advocate a reduction of time from months to days for diagnosis and treatment.

Hypertension in young people is also addressed by the guidelines. In particular, the guidelines address the under-diagnosis and earlier development of hypertension in Canadian adolescents and younger teenagers due to obesity.

Further information may be found at:

U.S. Supreme Court To Hear Merck V. Integra Lifesciences "Safe Haven" Case

The U.S. Supreme Court recently announced that a seven-member panel will hear the Merck v. Integra Lifesciences case to determine whether companies can use rivals' patented drugs to conduct their own research and development. In seeking to determine the scope of "safe harbor" under the Hatch-Waxman Act, Merck petitioned the U.S. Supreme Court to review the Court of Appeals decision that ruled that "safe harbor" did not shield pre-clinical use of patented technology to develop and identify new drugs from infringement liability.

The case originated when Integra Lifesciences sued Merck and others, alleging that their research activity between 1994 and 1998 was a commercial project that infringed its patents on an RGD peptide sequence that promotes cell adhesion to substrates in culture and in vivo. Merck's research was aimed at identifying potential drug candidates that might inhibit blood vessel generation and thus halt tumour growth, including tests that assessed the action of the RGD peptides and the proper mode of administering them for optimum therapeutic effect. After a jury found Merck liable for infringing the patents, a U.S. District Court determined that the "safe harbor" exemption did not embrace the infringing activity. The U.S. Court of Appeal affirmed the district court's refusal to apply the exemption, noting that Merck's research did not supply information to the FDA, but instead, identified the best drug candidate to subject to future clinical testing under the FDA process.

For more information, please see: 3337?OpenDocument

Proposed Malpractice Bill Protects Innovators

President Bush has tendered his support for a bill that will prevent consumers from seeking punitive damages from doctors, drug manufacturers or medical device manufactures in medical malpractice lawsuits. The aim of the bill is to prevent frivolous lawsuits. Drug manufacturers will not be liable for punitive damages provided their drugs were approved by the U.S. Food and Drug Administration. However, the bill does not prevent consumers from seeking other forms of damages including damages for pain and suffering.

For more information, please see:

Supreme Court Refuses To Hear Case That Provides Different Rights Of Appeal For Innovators And Generic Manufacturers

The Supreme Court of Canada dismissed a leave application on January 20, 2005, whereby an innovator sought leave to have the Supreme Court reconsider a decision of the Court of Appeal that conflicts with earlier decisions of the Court of Appeal, and effectively denies a right of appeal to a distinct class of persons, namely, owners of pharmaceutical patents, while providing such a right of appeal to generics.

In this case, the innovator manufacturer had received a prohibition order until patent expiry, based on an allegation of infringement raised by the generic manufacturer. An appeal was brought by the generic manufacturer, but early in the appeal process. The patent expired and an NOC issued to the generic manufacturer. The innovator manufacturer then brought a motion to dismiss the appeal as being moot, having regard to the expiry of the patent and the issuance of an NOC. The generic manufacturer fought this motion on the grounds that if it were successful on appeal, it would be entitled to section 8 damages. The Court of Appeal agreed with the generic manufacturer and maintained the appeal. This Court of Appeal decision flies in the face of earlier Court of Appeal decisions denying innovators the right to pursue an appeal where an NOC issuance had rendered the appeal moot.

To view this decision, please see:

To view the Court of Appeal's decision, please see:

PMPRB Informally Considers Two-Price System

In its most recent newsletter bulletin, the PMPRB has indicated that it is considering informal inquiries from patentees and industry consultants regarding the feasibility of implementing a two-price system. Generally, these inquiries have sought the idea of implementing high list prices, while providing discounts or rebates to some customers such that the average transaction price would not exceed the maximum non-excessive price under the PMPRB's guidelines.

No formal proposals have been made or approvals sought from the PMPRB. The Board states that it will be considering this issue, but that it has an initial concern about possible non-compliance, as well as the potential of reducing transparency of drug prices in Canada if these proposals were implemented. The Board will report its progress on this policy review in the coming months.

Further information may be found at the following link:

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