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Biolyse Paclitaxel Gets Green Light
Biolyse Pharma Corporation v. Bristol-Myers Squibb Company, et al. 2005 SCC 26
The Supreme Court of Canada decided that Biolyse Pharma Corporation ("Biolyse") may market its paclitaxel without first serving a Notice of Allegation ("NOA") on Bristol-Myers Squibb Company ("BMS"). The case involved Biolyse's new drug submission. In the big picture, this case should not have any impact on the requirement for generic companies filing an abbreviated new drug submission to serve a Notice of Allegation ("NOA") on brand name companies. The Supreme Court commented on the correct (purposive) interpretation of the Patented Medicines (NOC) Regulations which will be of importance for future NOC Proceedings. The Court also spoke approvingly of earlier lower court cases on a different issue involving limiting the extent to which patents may be added to the Health Canada Patent Register via a supplemental new drug submission.
Sections 5(1) and 5(1.1) of the Regulations delineate circumstances where an NOA must be served on a brand name company. The Court, in its 6-3 decision, stated that section 5(1.1) of the Regulations does not apply to innovative drugs. Rather, it should be confined to generic copies of patented drugs in the uncommon circumstances when a generic manufacturer purports to copy from another generic but in fact copies from the innovator company listed on the Patent Register. Abbreviated new drug submissions that rely on establishing bioequivalence will continue to be caught by s. 5(1). In this case, the Minister was therefore entitled to issue the NOC to Biolyse for paclitaxcel on the basis of its NDS without subjecting Biolyse to the NOA procedure and the statutory stay of its NOC.
Click here for a more detailed summary of the case. The full text of the Supreme Court decision is available at: http://www.lexum.umontreal.ca/csc-scc/en/rec/html/2005scc026.wpd.html
Bereskin & Parr notes that proposed amendments to the Regulations are intended to ensure a similar result in future cases involving a new drug submission by repealing s. (5.1.1) (note that s. (5.1), which is the main section that catches generic abbreviated new drug submissions and triggers the Regulations, will not be repealed). A link to a Bereskin & Parr article about the proposed amendments to the NOC Regulations is available at:
http://www.bereskinparr.com/publications/update/update-dec-04-2004.html
The government recently informed us that it has not yet determined if any of the proposed amendments will be revised in response to comments from the public. The timeline for implementation of the amended Regulations is also unknown.
Background of the Biolyse v. BMS Case
Biolyse filed a new drug submission for paclitaxel which was approved by Health Canada. The submission was for paclitaxel produced by a novel method from a novel plant source. Bristol-Myers Squibb obtained a court order quashing Biolyse's marketing approval because Biolyse did not serve a NOA on BMS alleging that it would not infringe any relevant claims of BMS' paclitaxel patents on the Health Canada Patent Register (similar to the U.S. Orange Book). Serving an NOA would have given BMS the opportunity to bring an application in the Federal Court. Such an application automatically creates up to a 24 month legislative stay during which the Minister of Health would be precluded from granting Biolyse marketing approval for paclitaxel, while issues of patent infringement and validity were considered by the Federal Court.
The case was unique in that it involved a new drug submission. Biolyse did not refer to BMS' TAXOL (paclitaxel) as a reference product to obtain its approval. Instead, Biolyse referred to its own clinical trial data and published data, including BMS data, in its new drug submission. Most NOC Proceedings involve a generic company filing an abbreviated new drug submission that relies on a brand name company's approved drug as a reference product for establishing bioequivalence. Therefore, this decision has no impact on the requirement for generic companies to serve an NOA on a brand name company when filing an abbreviated new drug submission. BMS claimed that even though Biolyse filed an NDS, it was still required to serve an NOA because BMS had listed three patents for paclitaxel on the register and there was a legitimate issue that BMS may infringe one or more of those patents.
A B&P summary of the Federal Court of Appeal's reasons is at: http://www.bereskinparr.com/publications/update/update-may-19-2005.html
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