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The Ottawa Citizen / By James Baxter

Canadian generic drug manufacturers were handed a setback by the World Trade Organization yesterday after Canada's patent regime was found to violate global trade rules.

The WTO issued a confidential interim report to Canadian trade officials stating that Canada's patent laws do not respect its international obligations under the international agreement on trade-related aspects of intellectual property, known as the TRIPS Agreement. The WTO will issue a formal report in mid-April.

While the ruling affects about 100,000 patents on a variety of products, it is widely considered that it will have its greatest effect on the pharmaceutical businesses. Generic drug manufacturers, which make and sell versions of well-known drugs once the patents have expired, have been eagerly awaiting expiries on a host of drugs patented in the late 1970s and early 1980s. The WTO ruling could delay the availability of rights on some popular drugs by up to three years.

Under TRIPS, which came into effect in January 1995, Canada agreed to an international standard on patents being for 20 years from the date the patent was filed. Prior to 1989, Canada's patent laws granted 17 years of patent protection.

The U.S. protested that by not accepting the international standard on pre-1989 patents, Canada was in a position to claim a patent had expired in Canada when it was still in effect in other countries. Canadian officials had countered that, as patents can take up to five years from the time they are filed to the time they are ultimately awarded, there was not a substantive difference between the old laws and Canada's obligations under TRIPS.

The WTO disagreed and will formally tell Canada to bring its patents into line with international standards when it issues its ruling publicly in April. Canada will then have 60 days to appeal, which trade experts in Ottawa say is likely.

International Trade Minister Pierre Pettigrew refused comment, except to say that Canada is reviewing the interim report and preparing its comments for the panel.: