Apotex Inc v. Shire LLC, 2018 FC 637 (Lisdexamfetamine*)
Justice Fothergill - 2018-06-29
Read full decision. Automatically generated summary:
The issues raised in these proceedings are whether the specified claims of the 646 Patent are valid; if so, whether they are infringed by the Plaintiff’s/Respondent’s generic product; and whether the Minister of Health should be prohibited from issuing a Notice of Compliance [NOC] to the Plaintiff/Respondent for its generic product under the Patented Medicines (Notice of Compliance) Regulations. For the reasons that follow, I conclude that the specified claims of the 646 Patent are not invalid on any of the asserted grounds of anticipation, obviousness, overbreadth, or insufficiency of specification. However, the 646 Patent has not been infringed by the Plaintiff’s/Respondent’s manufacture and retention of its generic product for experimental or regulatory use. Finally, the Minister of Health should be prohibited from issuing a NOC to the Plaintiff/Respondent for its generic product.
Decision relates to:
- T-1056-16 - APOTEX INC. v. SHIRE LLC ET AL
- A-283-18(2021 FCA 52) - which is an appeal from this decision
- T-998-16 - SHIRE PHARMA CANADA ULC v. APOTEX INC. ET AL.
- A-282-18(2021 FCA 52) - which is an appeal from this decision