Canada: Patent Claiming One Medicinal Ingredient Not Found To Have Sufficient Product Specificity To Be Listed Against A Drug Containing Two Medicinal Ingredients (Intellectual Property Weekly Abstracts Bulletin: Week Of April 27, 2015)

Last Updated: April 29 2015

Edited by Chantal Saunders , Beverley Moore and Adrian Howard


Patent claiming one medicinal ingredient not found to have sufficient product specificity to be listed against a drug containing two medicinal ingredients

Viiv Healthcare ULC et al. v. Teva Canada Limited et al., 2015 FCA 93

The Court of Appeal has dismissed Viiv Healthcare's appeal of a Prothonotary's decision (2014 FC 328; upheld by the Federal Court: 2014 FC 893) finding that Canadian Patent No. 2,289,753 is not eligible for listing against the combination drug KIVEXA.

The drug contains two medicinal ingredients. The '753 Patent relates to a novel salt of a single medicinal ingredient. Although the patent was added to the Patent Register in 2007, both Teva and Apotex brought motions under paragraph 6(5)(a) of the PM(NOC) Regulations arguing that the '753 Patent was not eligible for listing against KIVEXA.

Even though the Minister agreed that the patent should be listed, it was found that a patent to one medicinal ingredient does not have the degree of product specificity required to be listed against a drug containing two medicinal ingredients.

Respondent's evidence in PM(NOC) case not struck – found to be responsive and did not raise new allegations or facts

Shire Canada Inc. v. Cobalt Pharmaceuticals Company, 2015 FC 458

Shire has lost its appeal regarding the dismissal of its motion to strike certain affidavit evidence submitted by the respondent Cobalt in an application pursuant to the PM(NOC) Regulations. The Court found that Cobalt's evidence was responsive to Shire's evidence, and therefore it did not raise new allegations or new facts not found in Cobalt's NOA.

Supreme Court dismisses leave application relating to utility and sound prediction

Apotex Inc. v. Pfizer Canada Inc. et al., Supreme Court Docket 36227

The Supreme Court has dismissed Apotex's leave to appeal a PM(NOC) decision (2014 FCA 250) that related to utility and sound prediction.

The Supreme Court had summarized the issues in the leave application as follows: 1) How is the utility promised by the patent to be determined? 2) How does promise construction relate to general principles of patent construction? 3) In a subsequent proceeding dealing with an earlier-litigated patent, what circumstances justify a departure by a patentee or a court from a concession or judicial determination made in a prior proceeding on the same patent construction issue?


Pfizer's blue diamond shaped pill not found to be distinctive

Pfizer Products Inc. v. Canadian Generic Pharmaceutical Association, 2015 FC 493

Pfizer's application for the Viagra Tablet Design has been found to not be distinctive under s. 38(2)(d) of the Trade-marks Act, and therefore not registrable, on appeal to the Federal Court. The application related to a three dimensional blue diamond shaped tablet used in association with a pharmaceutical product used for the treatment of sexual dysfunction.

In order to find distinctiveness in the appearance of a pharmaceutical tablet, the Court found it must look at whether the evidence establishes recognition, to "any significant degree", among any group or groups of "ordinary consumers" of the proposed Mark. That is, it does not need to be distinctive to all of the relevant groups: physicians, pharmacists and patients. However, it was found that due to the nature of pharmaceutical products, the reality is that physicians will only have the opportunity to associate the tablet when prescribing (perhaps in describing the tablet to patients or in providing samples or educational materials); that pharmacists will only have the opportunity to associate the tablet when dispensing; and that patients will only have the opportunity to associate the tablet when requesting or purchasing.

In the end, the Court was not convinced that any of the groups would associate the blue, diamond-shaped unmarked Viagra pill with a single source.


Canada has tabled its 2015 Federal Budget and it says amendments are coming to "the Patent Act, Trade-marks Act and Industrial Design Act to provide intellectual property agents with a statutory privilege for confidential communications with clients, enhancing Canada as a place in which to invent and market inventions. This measure will bring Canada's framework in line with other common law countries such as Australia, New Zealand and the United Kingdom. Amendments will also be proposed to modernize administrative practices and increase clarity and legal certainty for businesses. For example, proposed amendments would provide the Canadian Intellectual Property Office with the ability to extend key deadlines in cases of force majeure events such as floods or ice storms."

Amendments to the Copyright Act are also forthcoming, including extending the term of protection of sound recordings and performances from 50 to 70 years. Also, Canada will implement and accede to the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled.

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