Pfizer Fails to Maintain Patent on Norvasc in Canada

From Bloomberg:
Pfizer Inc., the world’s biggest drugmaker, failed to maintain its patent on the hypertension drug Norvasc in Canada after a federal judge granted Ratiopharm GmbH permission to sell a generic version of the medicine.

More than 7.8 million prescriptions of amlodipine besylate, marketed by Pfizer as Norvasc, are sold annually in Canada, Ulm, Germany-based Ratiopharm said today. A generic version probably will save Canadian patients about C$180 million ($155 million) a year, the closely held company said. Pfizer said it will appeal.

“We are extremely pleased at the decision by the Federal Court,” Jean-Guy Goulet, chief executive officer of Ratiopharm Canada, said in a statement. “This decision opens the amlodipine patent to generic manufacturers in Canada, the last major jurisdiction where the patent was held.”

Ratiopharm challenged the Canadian patent in 2004 and won in 2006. Pfizer successfully reversed the ruling on appeal. Ratiopharm then sued to invalidate Pfizer’s patent, with Judge Roger Hughes ruling in favor of Ratiopharm yesterday. ...more

Generic drug maker suit against federal government reaches trial stage

From the Canadian Press:
Federal regulations that bar Canada's generic drug makers from copying brand-name products for eight years after patents expire will come under the judicial microscope Tuesday as a two-year-old lawsuit reaches Federal Court.

The generic drug makers want the court to set aside rules that they argue cost consumers $115 million in extra drug costs every year.

The regulations, implemented in 2006 under the Food and Drugs Act, were designed to protect the extensive and expensive data that manufacturers need to seek approval for a drug. The data include the results of studies and clinical trials.

The rules prohibit Health Canada from licensing a generic version - generally cheaper than the brand-name equivalent - until after the eight-year period for those drugs where patent protections have lapsed. ...more

Patent system seen stifling medical breakthroughs

From the Globe and Mail:
An outdated intellectual property system is preventing lifesaving medicines and cutting-edge technologies from reaching those who need them the most, a leading expert on patents asserted yesterday.

"If things don't change, we're going to all have fewer medicines to treat whatever the next diseases are," warned E. Richard Gold, director of the Centre for Intellectual Property Policy at McGill University. "Not only will we not develop those drugs for cancer and heart ... but we won't get the innovative breakthrough drugs unless we change."

From communities in Brazil to corporate boardrooms, Dr. Gold and his team found an endemic mistrust among those involved in the patent system that is stifling innovation and preventing technology from entering the market and helping those in both developed and developing nations.

He and his colleagues presented their report, which was seven years in the making, to civil servants and industry observers in Ottawa yesterday.

The report found that the heavy-handed control on patents resulted in much controversy - and that change is needed. ...more

Proposed drug changes could cost N.B. millions

From the Fredericton (NB) Daily Gleaner:
Regulatory changes proposed by the federal government that would delay the introduction of generic versions of brand-name drugs could mean millions of dollars in extra costs for New Brunswick's drug plan.

The Conservative government introduced changes to Canada's drug patent rules in April that critics claim would allow pharmaceutical companies to extend exclusive rights on some drugs beyond the current 20-year term.

New Brunswick Health Minister Mike Murphy said Thursday the proposed changes may delay the introduction of generic versions of popular drugs such as cholesterol-lowering medication Lipitor, blood-pressure drug Norvasc, and Celebrex.

He said the province spent more than $14 million on the trio of medications last year, adding generic versions would slash prices by up to 50 per cent.

Medication for seniors and nursing-home residents, among others, costs the drug plan more than $160 million annually. ...more

Trade gambit doubles cost of cancer medicine

From the Globe and Mail:
A chemotherapy medicine that sells for $500 a vial is about to be marketed for double that amount due to changes in Canada's intellectual property rules that, unwittingly, will leave one pharmaceutical company with a monopoly on a long-established cancer drug.

The regulation changes will give Sanofi-aventis Canada eight years of market exclusivity over the colorectal cancer drug oxaliplatin as soon as the firm receives its licence from Health Canada to sell it - expected as early as next month.

That means that three other companies will have to stop selling versions of oxaliplatin to cancer centres, hospitals and patients at deep discounts. ...more