The skinny on skinny labels

21 December 2017

In a recent decision of Federal Court (Bristol-Myers Squibb Canada v Apotex Inc., 2017 FC 1061), Justice Lafrenière dismissed the prohibition proceeding brought by Bristol-Myers Squibb Canada (BMS) against Apotex Inc. (Apotex) for a generic version of ABILIFY®, which is indicated for several uses.

BMS sought to prohibit Apotex from being issued an NOC for the medicinal ingredient aripiprazole, on the basis that Apotex would infringe BMS’s patent for the use of aripiprazole to treat bipolar I disorder.

However, Apotex alleged it was not seeking approval for the treatment of bipolar I disorder as an indication for Apo-aripiprazole. Instead, Apotex had submitted a “skinny label” for Apo-aripiprazole, only seeking approval for other indications.

The skinny label issue is not a new problem in Canadian patent law, and Justice Lafrenière’s decision highlights the difficulties faced by the patentee. While off-label uses (ie. the use of a drug that it is not indicated for) occur in the healthcare community, it is difficult to argue that this off-label use only occurs due to the generic’s marketing, sales or promotional activity as required to prove the generic induced infringement of the patent. This is especially true in prohibition proceedings under the PM(NOC) Regulations, where the generic version is not yet on the market and any off-label use is hypothetical.

After BMS served its evidence, Apotex brought a summary motion for dismissal of the proceeding. Justice Lafrenière held that BMS did not put forward evidence to support the position that Apotex’s allegation of non-infringement was not justified. In particular, the Court held that BMS’s evidence did not go to all of the required points for proving inducement, and the evidence merely speculative. As a result, the proceeding was dismissed before Apotex was required to file any evidence, as it was held to be an abuse of process.

This decision is currently being appealed by BMS. ABILIFY® is under data protection until January 9th, 2018 and therefore an NOC has not yet issued to Apotex.

Patentees should review their patent portfolio for use patents on drugs which have additional, non-patented indications. With changes to the PM(NOC) Regulations prohibiting future actions on listed patents, it may be worth considering de-listing or deciding not to list use patents that would face skinny label challenges. This will allow for the opportunity to gather actual evidence of off-label use and inducement by the generic before bringing an infringement action.

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