A Leading Canadian IP Case: The Patent System Meets the Pharmaceutical Regulatory Approval Process

Bristol-Myers Squibb Co v Canada (Attorney General), 2005 SCC 26

In Canada, a pharmaceutical product cannot be sold until it receives approval from the Minister of Health, in the form of a Notice of Compliance. There are two aspects to gaining this approval. The first is the public health aspect: drugs cannot be sold without meeting the safety and efficacy requirements set out under the Food and Drugs Act. The second aspect is the patent aspect, which is governed by the Patented Medicines (Notice of Compliance) Regulations (Regulations), enacted under the Patent Act. Being tied to the regulatory approval process of pharmaceutical products, these Regulations apply only to pharmaceutical patents.

The Regulations dictate the procedure generic companies must follow in order to gain approval for a drug product that relies, in order to prove their own safety and efficacy, to the safety and efficacy data submitted for the drug product of an “innovator” or “brand” company.

In Bristol-Myers Squibb Co v Canada (Attorney General), 2005 SCC 26 (Biolyse), the Supreme Court of Canada had the opportunity to consider how the Regulations should be interpreted in light of the legislative intent with which they were enacted.

In Biolyse, the drug at issue was paclitaxel, a cancer-fighting medicine. In 1971, scientists funded by the US government at the National Cancer Institute (NCI) isolated paclitaxel from the Pacific yew, taxus brevifolia. By 1979, scientists at NCI had conducted extensive testing on paclitaxel, and had identified uses for the drug, including for the treatment of refractory ovarian cancer.

Bristol-Myers Squibb (BMS), brought into the picture by NCI, conducted clinical trials on paclitaxel in the 1980s. BMS was granted a number of Canadian patents related to paclitaxel, although none of these covered the paclitaxel drug itself, since the drug was in the public domain. BMS began selling the drug in Canada under the brand name TAXOL.

Among the steps of the procedure under the Regulations is a step that requires generic companies making a “copy” of drug product to “address” the patents on the Patent Register. “Addressing” a patent on the Patent Register means obtaining consent of the patent owner, agreeing that the NOC will not issue until the expiry of the patent, or notifying the brand name drug company that it has no right to claim under the patent, or that the patent is expired, invalid and/or not infringed.

BMS listed three patents on the Patent Register in relation to TAXOL paclitaxel. Thus, any generic manufacturer that wished to make a generic version of the TAXOL product would have been required to address BMS’s three patents.

Meanwhile in the 1980s, a small Canadian company, Biolyse, recognized that there was a potential supply problem for paclitaxel because the compound had to be extracted from the plant’s bark, which killed the slow-growing bush. Biolyse discovered that paclitaxel could be extracted from another species of yew tree, taxus canadensis, without killing the plant, and that paclitaxel could also potentially be used in non-small-cell lung cancer and forms of breast cancer.

Because Biolyse’s paclitaxel was from a different biological source, and Biolyse claimed that it could be used for these other uses, Health Canada required Biolyse to conduct independent clinical studies. As a result, Biolyse did not rely, or did not rely exclusively, on BMS’s clinical study data. Health Canada insisted that, because of this, Biolyse seek approval by means of a New Drug Submission, and not the Abbreviated New Drug Submission normally used for generic products. After Biolyse completed the requested steps, Health Canada issued a NOC to Biolyse for its paclitaxel product.

BMS launched proceedings, asserting that Biolyse was obligated to address BMS’s Patent Register patents before the Minister of Health was permitted to issue the NOC to Biolyse for its paclitaxel product. BMS made this argument based on section 5 (1.1) of the Regulations (since amended), which required that any person that filed a “submission” for a NOC in respect of a drug that contained a medicine found in another drug that has been marketed in Canada must address the patents on the Patent Register for the other drug.

In a 6-3 decision, the majority of the Supreme Court of Canada (SCC) concluded that Biolyse was not required to address BMS’s Patent Register patents. The majority found that under the modern principles of statutory interpretation, the context of the Regulations was important to consider. After comprehensively examining this context, the majority held that “submission” could not include situations where a company did not rely on the data or information of the other drug.

Gordon Jepson writes:

This is an important case because it was the first time that the Supreme Court of Canada opined on whether interpretations of the Regulations could go beyond the purposes set out in the Regulation-making power of the Patent Act. Those provisions allowed the making of regulations to prevent patent infringement; and in the absence of any suggestion of infringement (BMS never alleged that its patents would be infringed by Biolyse, only that they were entitled to the delaying process of the Regulations), any interpretation of the Regulations which would have required Biolyse (and Health Canada) to comply with them in such a situation was incorrect.

Summary by: Cheryl Cheung

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