4(2)(b) or not 4(2)(b) – Federal Court of Appeal answers the question in COMPLERA patent listing decision

On October 9, 2012, the Federal Court of Appeal released its Reasons for Judgment holding Canadian Patent No. 2,512,475 was not eligible for listing on the Patent Register in respect of Gilead’s tenofovir + emtricitabine + rilpivirine combination product, COMPLERA. The 475 Patent includes claims to a combination of tenofovir,  emtricitabine and a third “anti-viral”,  that may be a non nucleoside reverse transcriptase inhibitor (“NNTRI”).  Rilpivirine, a known NNTRI, is not expressly referenced in any claim of the 475 Patent.

Gilead has sought judicial review of the Minister of Health’s refusal to add the 465 Patent against COMPLERA.   The judicial review of the Minister was dismissed by Justice Mosley, who held that the 475 Patent did not meet the strict product specificity requirements required by section 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations because the medicinal ingredient claimed in the 475 Patent did not precisely match the medicinal ingredients of COMPLERA.

The Court of Appeal characterized the main issue in the appeal as follows:

The main issue in this appeal is whether Canadian Patent No. 2,512,475 (the ‘475 Patent) is eligible for listing on the patent register in respect of new drug submission 140115 (the NDS) where the medicinal ingredients claimed in the ‘475 Patent do not match up with those in the NDS.

The Court of Appeal held that the Applications Judge has failed to give sufficient weight to the requirement that formulations, unlike the claims of the 475 Patent, include non-medicinal excipients.   The overall inventive step of the 475 Patent is directed to stable combinations of medicinal ingredients and the eligibility of the 475 Patent ought to have been assessed against paragraph 4(2)(a) not 4(2)(b).

Product Specificity

The Court of Appeal held, following its earlier decision in Purdue Pharma, that product specificity requires precise and specific matching between the claims and the approved product. Further there was no reason to adopt different legislative requirements for the paragraphs set out in subsection 4(2). The Court of Appeal rejected Gilead’s reliance on a Health Canada Guidance Document suggesting that a claim to one medicinal ingredient is eligible for listing in respect of a product which contains the said medicinal ingredient in combination with other medicinal ingredients, holding:

[44] Finally, the Guidance Document cited by the appellant is useful to clarify the roles of the different actors in the patented medicine system, notably innovators, generic manufacturers, and the Minister. However, it is not a legally binding document. More significantly, where the Guidance Document is inconsistent with, or in conflict with, the PM (NOC) Regulations, the latter takes precedence over the former (Guidance Document, section 1.2, appeal book, volume II, tab 6C). At the hearing, the Minister conceded that only the PM (NOC) Regulations are a binding statement of law.

[45] I note also that the PM (NOC) Regulations provide no support for the interpretation suggested in the Guidance Document. As noted above, the wording of section 4 is consistent across the four subsections and requires a high degree of specificity between the wording of the claim and the NOC. It would be necessary to read an interpretation into paragraph 4(2)(a) to allow the paragraph to support claims which contain only some of the medicinal ingredients. Such an interpretation goes against the ordinary meaning of the words, the purpose and object of the PM (NOC) Regulations, and the government’s position that product specificity is the key consideration in interpreting section 4. As a result, I would not attribute this interpretation to the PM (NOC) Regulations.

Finding that the 475 Patent lacks the required  product specificity requirement, The Court of Appeal dismissed Gilead’s appeal.

A copy of the Court of Appeal’s Reasons for Judgment may be found here.