This law actually did pass in 2008, courtesy of the Conservative government.

A new set of patent rules proposed by the federal government would delay generic versions of Lipitor, Viagra and several other blockbuster drugs by as much as two years, The National Post reports. And generic drugmakers, not surprisingly, are warning the effort will cost consumers and taxpayers tens of millions of dollars annually.

The government says the regulations would simply restore fairness and stability to the brand-name industry after two court rulings put unexpected new curbs on the practice of “evergreening,” which involves filing new patents on a drug in an attempt to stave off generic competition. Generic drugmakers say the move is an unjustified sop to the brand-name industry, the paper writes.

“It completely surprised us. We had no inkling it was coming,” Jim Keon, president of the Canadian Generic Pharmaceutical Association, tells the Post. “The provincial drug plans (which pay for many medications) are really going to feel this in a big way.”


The affected drugs have combined sales of more than a $1 billion a year and generic versions are up to 50 percent cheaper than the brands in some provinces. But Deirdra McCracken, a spokeswoman for Industry Minister Jim Prentice, tells the paper the new regs are just an attempt to uphold government policy as it was before the court rulings, and avoid abrupt changes to the pharmaceutical market.

“Canada currently has a reputation as an internationally competitive location for innovation and investment,” she tells the Post. “To ensure that reputation stays intact, we need predictable and stable intellectual property laws.”

In the tangled world of drug patent law, the suggested new regulations have a complex background. In 2006, the government cracked down somewhat on evergreening. Still, brand-name drugmakers are often able to obtain a two-year, court-ordered stay on generic competition while patent disputes are adjudicated.

In October, 2006, amendments included a grandfather clause that allowed new patents filed before June of that year to stay on the books. A month later, though, the Supreme Court of Canada brought down a decision that said many new evergreen patents were improper. The Federal Court later applied the reasoning in a separate decision.

Such court judgments could result in “sudden and unexpected loss of market exclusivity for a number of innovative drugs,” Industry Canada says in a preamble to the new reg. The changes would override the rulings and allow Industry Canada to keep the grandfathered patents on the books.

While the amendments could result in “delayed savings” to consumers and provincial drug plans, they are needed to maintain the industry’s confidence in Canada as a place to invest and introduce new products, the department’s statement says.

“The government never intended this part of the [2006] regulations to apply retroactively, since this would have been inequitable,” Jacques Lefebvre, spokesman for Canada’s Research-Based Pharmaceutical Companies, tells the Post. “This will in no way prevent the generic drug makers from entering the market after the expiry of patents.”

Lefebvre noted that the prices for generic meds in Canada are among the highest in the industrialized world. Meanwhile, Keon says the changes were likely the result of lobbying by brand-name companies, according to the paper.

Lobbyists for the industry association, according to a federal registry, include two prominent Conservatives. Goldy Hyder is a Tory strategist and was chief of staff to Joe Clark, then opposition leader, in 2001-2002. Geoff Norquay was director of communications in the office of Stephen Harper, the Prime Minister, in 2004 and 2005, the Post writes.