Canada: Order Of Prohibition Granted For One Patent Due To Insufficiency Of NOA (Intellectual Property Weekly Abstracts - Week Of October 15, 2012)

Last Updated: October 18 2012
Most Read Contributor in Canada, September 2016

Edited by Chantal Saunders and Beverley Moore

NOC Proceedings

Order of Prohibition Granted for One Patent due to Insufficiency of NOA

Bristol-Myers Squibb Canada Co. v. Mylan Pharmaceuticals ULC

Drug: SUSTIVA efavirenz

This is a proceeding commenced under the Patented Medicines (Notice of Compliance) Regulations, seeking an order to prohibit the Minister of Health from issuing a notice of compliance to Mylan for efavirenz, an anti-retroviral drug used to treat HIV infection. An Order of prohibition was granted in respect of one patent, but the application was dismissed in respect of the second patent.

Mylan made an allegation of inutility in respect of the first patent. The Court found that BMS met its burden on the issue of inutility on the basis that the Notice of Allegation was insufficient, and granted the Order of prohibition. The Court also addressed Mylan's inutility allegation on the merits. In particular, the Court first discussed the principles of claim construction and noted that resort to the disclosure is permissible but elements cannot be imported from the disclosure to the claims. The Court noted that "it is also not appropriate to ascribe meaning to words in the claims by reference to "stray phrases" found in the disclosure". The Court held that Mylan read a promise into the claims to found its allegation of inutility. Accordingly, on the merits, the Court found that Mylan's allegation was not justified.

In respect of the second patent, which claimed a particular polymorph characterized by x-ray powder diffraction, the Court noted that Mylan improperly attempted to read purity into the claims, and accepted BMS' construction of the claims. The Court found that the polymorph claimed in the patent was not anticipated and was not obvious. In respect of the allegation by Mylan that it would not infringe the patent, the Court noted that Mylan provided no information about its product and refused to provide samples. BMS argued that an adverse inference should be drawn. The Court held that BMS's expert could have conducted experiments to respond to Mylan's allegation of non-infringement, but did not. Accordingly, the Court found that BMS failed to demonstrate that Mylan's allegation of non-infringement is not justified.

Other Cases of Interest

Listing of Patent on Patent Register against Combination Drug Refused

Gilead Sciences Canada Inc. v. Canada (Health).


This is a decision of the Court of Appeal in respect of a decision of the Court determining that the patent at issue is not eligible for listing on the Patent Register. Our summary of the case is found here.

COMPLERA contains three medicinal ingredients. The Patent claims two of those three medicinal ingredients, together with a third unnamed anti-viral agent. The third medicinal ingredient found in COMPLERA is not mentioned in the claims.

The Court of Appeal found, contrary to the Court's finding, that the claims do not claim a formulation because a formulation must contain both medicinal and non-medicinal ingredients. Thus, the Court of Appeal found that the patent falls under paragraph 4(2)(a) as the relevant claims consist of chemically stable combinations of medicinal ingredients. Gilead noted that the Guidance Document relating to the NOC Regulations states that a claim to one medicinal ingredient is eligible for listing in respect of a product which contains the medicinal ingredient in combination with other medicinal ingredients. The Court of Appeal found that the wording of the Regulations themselves suggest that the product specificity requirement is a high threshold and, therefore, the three medicinal ingredients in the product must be set out in the patent claims for the patent to be eligible for listing on the Register.

The Court of Appeal therefore upheld the Court's conclusion that the patent claims fail the requirement for product specificity and therefore cannot be listed. The Court of Appeal that success was divided and therefore both parties bore their own costs in the present appeal.

Other Industry News

CIPO started consultations with respect to Chapter 21: Final Action and Post-Rejection Practice in MOPOP. The draft was released for public consultation October 9, until November 23, 2012.

CIPO's proposed Practice Notice "Correction of errors introduced in the naming of an applicant at the time of filing or national entry" will go into effect as of October 12, 2012.

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