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Federal Court of Appeal upholds Federal Court decision finding Shire's VYVANSE patent valid


Introduction
The Federal Court of Appeal (FCA) recently dismissed Apotex s appeal of the Federal Court decision which held that the claims of Canadian Patent 2,527,646 (the 646 patent) were valid and prohibited the minister of health from issuing a notice of compliance to Apotex for its lisdexamfetamine (LDX) product (Shire s VYVANSE) until the expiry of the 646 patent (
The prohibition application under the pre-amended Patented Medicines (Notice of Compliance) Regulations was consolidated with Apotex s action seeking a declaration of invalidity and non-infringement. Apotex appealed both judgments.
Amphetamine was an established treatment for conditions such as attention deficit hyperactivity disorder but as it is an immediate release compound, it requires patients to take doses frequently throughout the day. LDX is a prodrug of amphetamine that provides sustained release and reduces abuse potential. ....

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