Canadian Supreme Court to hear high-profile patent dispute

Canada’s highest court is set to hear a hotly anticipated dispute pitting generic company Apotex against drug companies Sanofi and Bristol-Myers Squibb (BMS).

The latest part of the dispute, an appeal by Apotex against an earlier decision, will decide whether the generic maker infringed a patent covering Plavix (clopidogrel bisulfate), a drug used to prevent blood clots after a heart attack.

Plavix is developed and marketed by Sanofi and BMS.

The Supreme Court of Canada will hear the start of the appeal tomorrow (November 4).

The outcome could provide guidance surrounding the “utility” requirement in Canadian patent law.

Apotex was initially victorious in the case after the Federal Court of Canada ruled that Sanofi and BMS’s patent was invalid, paving the way for it to market a generic version. The decision was later overturned by the Federal Court of Appeal.

According to Gunars Gaikis, partner at Smart & Biggar/Fetherstonhaugh in Toronto, the case is being “closely watched” by both the generic and pharmaceutical industries.

Gaikis said the utility requirement had, in recent years, led to valuable patents on “several top-selling drugs being found invalid”.

The dispute between the drug makers has been running since 2011.

The Federal Court’s initial decision found the BMS and Sanofi patent invalid for a lack of utility, as it “promised” the drug would be useful in humans.

But, according to the same court, that claim had neither been demonstrated nor soundly predicted as of the filing date.

Last year, the Federal Court of Appeal overturned the decision after it found there was no “explicit promise” in the patent application.

Gaikis added: “The problem for patentees in Canada is that the current law requires any utility found to be promised by a patentee to be demonstrated or soundly predicted by the Canadian filing date.

“The Supreme Court is expected to consider whether this current high threshold for the utility requirement should be lowered or otherwise varied,” he added.