A small family-owned biotech company based in St. Catharines, Ont., has won a five-year court battle against U.S. pharmaceutical giant Bristol-Myers Squibb Co. over the rights to sell its inexpensive anti-cancer drug–Paclitaxel for Injection–to Canadian hospitals.
The drug, developed by Biolyse Pharma Corp. in the late 1980s, is made from the needles of the Canadian yew bush and is used to fight the most aggressive forms of ovarian, lung and breast cancer.
Bristol-Myers sells a similar version of the drug under the name Taxol. It accused Biolyse of infringing its Canadian patents, and made use of a provision of the law that ultimately allows patent innovators to block sales by generic competitors for 24 months or more–even if the “infringement” does not exist.
Biolyse's appeal, which made it all the way to the Supreme Court of Canada, has helped shed light on the controversial practice of “evergreening.” A tactic employed by many big pharmas to prevent generic competitors or copycats from selling the same medicines at cheaper prices, the practice involves slapping patents on different additives, doses or delivery methods of a drug.
In a 6-3 decision, the court ruled the U.S. pharmaceutical company's patents did not cover the paclitaxel ingredient in Bristol-Myers' drug–and that preventing Biolyse from selling its version of the cancer-fighting drug would “stifle competition and innovation in the pharmaceutical industry.”
Andrew Roman, the Toronto-based lawyer with Miller Thomson LLP who argued the appeal on behalf of Biolyse, says the decision has “precedential value” because it weighs the public good (of cheaper, more widely available generic drugs) versus “the literal language of the law.” Roamn says it will help to establish clearer boundaries between competition and monopoly in the lucrative drug industry. “It's a victory for the little guy–and for cancer patients,” he says.
Company president Brigitte Kiecken, who founded Biolyse with her husband, Claude Mercure, in 1984, says the court's decision paves the way for future research and development, while giving Biolyse greater access to what Kiecken describes as a $30-million Canadian market, shared with Bristol-Myers and generic competitor Apotex Inc.
“I hope this inspires others not to let the shadow of the dragon scare them away before they even start fighting,” she says.
