Healthy Skepticism Library item: 13595

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Publication type: news

Blackwell T.
Generics slam proposed drug patent rules
National Post (Toronto) 2008 May 5
http://www.nationalpost.com/news/story.html?id=494149

Full text:

Industry Minister says move restores fairness, stability

New patent rules just proposed by the federal government would delay generic versions of Lipitor, Viagra and several other blockbuster drugs by as much as two years, costing consumers and taxpayers tens of millions of dollars annually, generic companies are warning.

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” — filing new patents on a drug in an attempt to stave off generic competition.

Generic firms, which stand to lose business as a result of the suggested amendments, call the move an unjustified sop to the brand-name manufacturer.

“It completely surprised us. We had no inkling it was coming,” said Jim Keon, president of the Canadian Generic Pharmaceutical Assocition. “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. Generic copies are as much as 50% cheaper than the brands in some provinces, savings usually seized upon by provincial drug programs.

However, Deirdra McCracken, spokeswoman for Jim Prentice, the Industry Minister, said the new regulations 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 said. “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 brought in regulatory changes that cracked down somewhat on evergreening, the new patents filed by brand-name companies when their original ones are about to expire. Although the validity of the patents are frequently disputed in court, the firms are often able to obtain a two-year, court-ordered stay on generic competition while the matter is adjudicated. That delay can mean tens of millions in additional sales for widely used brand-name drugs.

While putting the brakes on evergreening, the 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 regulations. 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 (Rx&D), said Monday. “This will in no way prevent the generic drug makers from entering the market after the expiry of patents.”

Mr. Lefebvre noted that the prices of generic medications in Canada are among the highest in the industrialized world.

Generic companies are now trying to tally up which products would be affected by the amendments, but they seem to include cholesterol-busting Lipitor, the top-selling prescription drug in Canada; Norvasc, a blood-pressure drug that is the third-best selling medication in Canada; and Viagra, the association says.

Mr. Keon said it appeared the changes were a result of lobbying by the brand-name companies.

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.