Canada forced to honour Bayer’s patent on ciprofloxacin (Cipro)

David Spurgeon Quebec British Medical Journal 27oct01

In an embarrassing mix-up, Canada’s federal government will pay twice for a supply of the antibiotic ciprofloxacin (marketed as Cipro) that it ordered to protect Canadians in case they are faced with an outbreak of anthrax, as has happened in the United States.

The federal health department broke its own drug patent rules when it ordered the drug from a generic drug manufacturer, Apotex. The patent, held by Bayer AG, does not expire until 2004.

After a meeting of officials from the health department and both companies on Monday, the government announced it will still pay the generic firm the amount of its contract— $C1.3m (£580 000; $824 000)—and will buy another 900 000 tablets from Bayer. Bayer’s price is said to be $C2.50 a tablet, compared with Apotex’s $C1.50.

Health department officials said the generic drugs were ordered after Bayer was unable to supply the amount demanded, but Bayer officials deny this.

Federal health minister Allan Rock said that there were different versions of the events but maintained his primary responsibility was to protect Canadians by ordering the drug.

Under the patent act, the government could have obtained authorisation to have a non-patented version of Cipro on a non-commercial basis, but it failed to ask for this.

Joe Clark, who heads the Progressive Conservative party, charged in a parliamentary debate that Rock had lost control of his department, while Canadian Alliance leader Stockwell Day said Canadians didn’t know who was telling the truth.

Speculation arose as to whether Apotex would sue if its contract was broken or Bayer would demand compensation for a breach of its patent.

The issue reflects the Canadian government’s long standing problem of trying to encourage pharmaceutical companies to produce new drugs by means of a strong patent law, while simultaneously trying to ensure that Canadians can obtain the drugs they need at a reasonable cost.

In 1993, legislation extended the patent protection of new pharmaceuticals to 20 years. This has been criticised by some groups, including Canadian Pensioners Concerned, which last May in a submission to parliamentary and senate committees, called 20 years "far too generous."