ARTICLE · 20 MAY 2014

Pharma In Brief - Court Imposes Cost Sanctions For Repeat Litigation Under NOC Regulations

Norton Rose Fulbright Canada LLP

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The Federal Court dismissed Bayer’s application for an Order prohibiting a Notice of Compliance to Apotex Inc. for its generic YAZ® birth control product.

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Case: Bayer Inc. and Bayer Pharma Aktiengesellschaft v. Apotex Inc. et al. ("Bayer")

Drug: drospirenone + ethinylestradiol (YAZ®)

Nature of case: Prohibition proceeding under Patented Medicines (Notice of Compliance) Regulations ("Regulations")

Date of decision: May 1, 2014

Summary

On May 1, 2014, the Federal Court dismissed Bayer's application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. ("Apotex") for its generic YAZ® birth control product until the expiry of Canadian Patent No. 2,179,728 ("Apotex Proceeding"). This decision reaffirms the Court's approach to avoid repeat s. 6 litigation on the same patent by brand manufacturers against multiple generics under the Regulations.

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