TORONTO, Oct. 5 /CNW/ - Teva Novopharm, a leading provider of affordable healthcare solutions, is pleased to announce that the Federal Court of Canada today invalidated Eli Lilly's Canadian Patent No. 2,041,113 (the '113 patent) for the compound olanzapine (Zyprexa(R)), used in the treatment of schizophrenia and bipolar I disorder. The Federal Court judgment issued today by The Honourable Mr. Justice O'Reilly sided, for a second time, with Teva Novopharm's arguments in ruling that Eli Lilly's '113 patent is invalid and, therefore, not infringed by Novo-Olanzapine.
As a result, Teva Novopharm will continue to supply Canadians with Novo-Olanzapine, a cost-effective equivalent to Eli Lilly's Zyprexa(R).
By challenging the validity of Eli Lilly's '113 patent, Teva Novopharm succeeded in launching Novo-Olanzapine in June 2007, four years prior to the expiry of the '113 patent in April 2011. This launch was a breakthrough legal success and one of the largest generic launches in Canadian history, ensuring unprecedented savings for patients, provincial drug plans and third party drug plan sponsors. Today, the average number of olanzapine prescriptions in Canada each year is currently 1.92 million(1), of which Novo-Olanzapine is used to fill over 1.27 million(1). This has resulted in a savings to Canadians of over $138 million(2) since the launch of Novo-Olanzapine in 2007. Without Teva Novopharm challenging Eli Lilly's olanzapine compound patent, these savings would not have been realized. Eli Lilly would have gone on to enjoy a second period of market monopoly (one already enjoyed for over 10 years) at the expense of Canadian patients who would have had no cost-effective alternative to Zyprexa(R) (olanzapine) until the '113 patent expired in April 2011.
Teva Novopharm is very pleased that the ruling of the Federal Court of Canada today agreed with its previous decision, rendered by The Honourable Mr. Justice Hughes on June 5, 2007, under the Patented Medicines (Notice of Compliance) Regulations. This earlier judgment opened the way for Teva Novopharm to receive a Notice of Compliance (NOC) from Health Canada in 2007 and to market Novo-Olanzapine tablets in Canada.
"This is the second significant ruling from the Federal Court of Canada in support of our arguments," said Barry Fishman, Teva Novopharm's President and Chief Executive Officer. "We are delighted the courts have ruled consistently on this patent - we have litigated twice on the same patent, the same issue, against the same manufacturer and the Courts have ruled the same. The '113 patent is invalid and our product does not infringe."
The Novo-Olanzapine launch demonstrates the necessity for adequate incentives, such as premium pricing, for generic manufacturers who challenge patents and bring cost-saving products to market earlier than patent expiry. These types of risks and investments benefit all payors and patients, and generic manufacturers should be rewarded for the supplementary savings generated by such actions.
Novo-Olanzapine is available from pharmacies with a doctor's prescription in 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg tablets. The Drug Identification Numbers (DINs) are: 02276712, 02276720, 02276739, 02276747 and 02276755.
About Teva Novopharm
Teva Novopharm is a leader in providing affordable healthcare solutions to Canadians. Specializing in the development, production and marketing of generic pharmaceuticals, Teva Novopharm consistently provides high-quality, affordable and effective pharmaceuticals. For over 40 years, as the first generic pharmaceutical company in Canada, Teva Novopharm has built professional and consumer confidence as one of Canada's leading pharmaceutical companies. Teva Novopharm is proud to be a part of Teva Pharmaceutical Industries Ltd., the world's largest generic pharmaceutical company.
(1) Source: IMS Health Compuscript (MAT MAY/09)
(2) Source: Brogan Pharmastat
SOURCE TEVA NOVOPHARM
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