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Biolyse Pharma Corporation v. Bristol-Myers Squibb Company, et al. 2005 SCC 26

Detailed case summary

The Court considered the grammatical and ordinary sense of the words and noted that the word “submission” would appear to be all inclusive. The Court also noted that the general context of the Regulations was to help generic drug companies and at the same time curb potential patent abuse by them. After reviewing the scheme of the Patent Act and the NOC the Court noted that BMS did not invent or discover paclitaxel. Secondly, it is not every use of the patented invention that will trigger the NOC Regulations. Thirdly, the limiting words of s. 55.2(4) are not affected by the so-called “paramountcy clause” set out in s. 55.2(5) which states that the section is paramount over inconsistent or conflicting Acts or regulations. The court considered the wording of s. 4(1) because it provides the template on which s. 5(1.1) is modelled. The Court approved earlier Federal Court cases on s. 4(1) that stated that the word “submission" does not include all submissions. It does not include a supplementary NDS. Applying a purposive interpretation, the Federal Court in these cases held that to read “submission” in s. 4(1) to include all NDSs would allow innovator companies to sidestep the time limits applicable to patent lists by the simple expedient of submitting a supplementary New Drug Submission (SNDS) making corporate or technical changes to their filing (Bristol-Myers, at para. 19). Such a result would not be consistent with the scheme of the NOC Regulations as a whole. In the Supreme Court's view, this purposive approach is correct. Section 5(1.1) should therefore receive a similarly purposive interpretation. The word “submission” should also be construed so as to fulfill the purposes laid out in s. 55.2(4) of the Patent Act.

The Court also noted that s. 5(1.1) was intended to prevent a generic company from relying on another generic company's drug submission where the reality was that the supporting data for both generic manufacturers had been filed by the innovator drug company. This was not the situation in the present appeal.

In its conclusion on the issue of interpretation, the court held that the interpretation offered by BMS of s. 5(1.1) pushes the provision well beyond its stated purpose of preventing generic manufacturers from hiding their reliance on innovator drugs by putting forward as their reference drug another generic manufacturer's product, in circumstances where both generics are simply copies of the innovator drug. If the approval of the generic drug is related to the work of another drug manufacturer in respect of which a patent list has been filed (as in the Nu-Pharm type situations), it will be caught by s. 5(1.1). However in this case, as stated, the motions judge found that the Minister did not rely on the BMS work. He relied on work performed by Biolyse itself and “on what was known to scientists in the public realm about paclitaxel” (para. 40).

The broad interpretation urged by BMS would lead to an absurd result. The “medicine” in the drug to which the patent list relates need not itself be patented, or indeed owe anything to the ingenuity of the “first” person. It could be a “medicine” whose usefulness was discovered by somebody else (as in the case of paclitaxel) or something in the public domain as common as penicillin. So long as such “medicine” shows up as a component, however minor, in the chemical composition of the drug to which the patent list relates, the “second person” (including an innovator who is seeking to manufacture a new and useful drug) is barred from proceeding to market by the automatic statutory freeze, and this “bar” will continue for so long as the patent list holder can evergreen its product by resort to patentable improvements to other components or additions, be they ever so minor. This would stifle competition and innovation in the pharmaceutical industry and produce a result at odds with what the regulator was trying to achieve.

In its conclusion, the Court held that s. 5(1.1) does not apply to innovative drugs. It should be confined to applications for generic copies of patented drugs in the circumstances contemplated by the regulator, i.e. where a manufacturer makes a submission for a NOC for a drug which contains a medicine that it purports to copy from another generic but in fact copies from the innovator company that has filed the patent list. That is not this case. Where the applicant relies on bioequivalence, it will be caught by s. 5(1). On the facts here, neither s. 5(1) nor s. 5(1.1) applies. Accordingly, I conclude that the Minister was entitled to issue the NOC to the appellant Biolyse on the basis of its NDS without subjecting Biolyse to the statutory freeze.

If BMS believes that the Biolyse product infringes its patent(s), it has recourse to the usual remedies under the Patent Act. The NOC ought not to have been quashed, and the appeal should be allowed with costs throughout.

Prepared by Laurence MacPhie

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