News | July 13, 1998

Canadian Court Rules in Favor of Generic Drug Companies

Two drug companies, Apotex, Inc. (Winnipeg, Manitoba) and Novopharm Limited (Scarborough, Ontario), won major victories in two decisions released July 9 by the Supreme Court of Canada. The cases were about generic versions of two drugs, an antibiotic, norfloxacin, and an ulcer drug, nizatidine.

By utilizing regulations under the Patent Act known as the Patented Medicines (Notice of Compliance) Regulations, brand name drug companies Eli Lilly and Merck Frosst have kept these low-cost, generic versions off the market through years of litigation.

There are now almost 150 court cases under the Regulations.

Eli Lilly and Merck have argued that a 1992 supply agreement between Apotex and Novopharm invalidated certain compulsory licenses, under which Novopharm was entitled to sell the drugs without infringing patent rights. The court, however, found that the agreement did not in any way invalidate Novopharm's compulsory license and held that both Apotex and Novopharm were correct in claiming that they were entitled to sell the drugs.

For more information: Stephanie Brooks, Novopharm Limited, 30 Novopharm Court Scarborough, Ontario. Tel: 416-291-8888 xt. 5404.