Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947

Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947

The term of extension of patent under s 77(1) is calculated based on the earliest regulatory approval date for any pharmaceutical substance referred to in s 70(2), not just those satisfying s 70(3); if that date is less than five years from patent date, extension term is zero; thus, the Register wrongly recorded extension to 27 November 2023 and must be rectified to expiry on 5 July 2022.

Jurisdiction
Australia
Judgment Date
12 August 2021
Procedural Posture
Originating Application and Cross Claim / Final Judgment
Outcome
Originating application dismissed; cross-claim allowed.
Legal Topics
['extension of Patent Term' 'threatened Infringement' 'register Rectification' 'therapeutic Goods Listing']
['intellectual Property' 'patents'] ['extension of Patent Term' 'threatened Infringement' 'register Rectification' 'therapeutic Goods Listing']

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Procedural Posture

Originating Application and Cross Claim / Final Judgment

Legal Issues

  1. 1 ['Whether extension of term of patent is valid under ss 71(2)(b) and 77 of Patents Act 1990 (Cth)' 'Whether the Register should be rectified to reflect expiry of patent term' 'Whether the application for extension was made within period allowed by statute']

Ratio Decidendi

The term of extension of patent under s 77(1) is calculated based on the earliest regulatory approval date for any pharmaceutical substance referred to in s 70(2), not just those satisfying s 70(3); if that date is less than five years from patent date, extension term is zero; thus, the Register wrongly recorded extension to 27 November 2023 and must be rectified to expiry on 5 July 2022.

Court Disposition

Originating application dismissed; cross-claim allowed.

Orders

  • ['The originating application be dismissed.' 'The cross-claim be allowed.' 'Pursuant to s 192(2)(b) of the Patents Act 1990 (Cth) the Register of Patents be amended to remove reference to extension to 27 November 2023 and record expiry on 5 July 2022.' "Applicants to pay respondent's costs of and in connection with...