Novartis AG v Pharmacor Pty Limited (No 3) [2024] FCA 1307

Novartis AG v Pharmacor Pty Limited (No 3) [2024] FCA 1307

Claim 1 of the patent does not cover pharmaceutical compositions where the active pharmaceutical ingredients are present as a complex in which the ions are associated by non-covalent bonds; rather, it is limited to compositions in which the two relevant active ingredients (or their pharmaceutically acceptable salts) are present as separate entities. Valtresto is a single amorphous complex and does not meet this requirement; thus, there is no threatened infringement. Further, the extension of the patent term was not validly granted because the registered product (Entresto) contains a complex that is not disclosed or claimed as such in the specification or claims. Pharmacor's other grounds...

Parties
First Applicant: Novartis AG; Second Applicant: Novartis Pharmaceuticals Australia Pty Limited; Respondent: Pharmacor Pty Limited
Jurisdiction
Australia
Judgment Date
13 November 2024
Procedural Posture
Patent Infringement and Cross Claim for Revocation/rectification / Final Judgment After Hearing
Outcome
Application dismissed; Cross-claim for rectification allowed in part; Validity challenges dismissed
Legal Topics
Patents, Patent Term Extension, Infringement, Claim Construction, Inventive Step, Pharmaceutical Patents
Intellectual Property Law Patents Patent Term Extension Infringement Claim Construction Inventive Step Pharmaceutical Patents

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Parties

Novartis AG

First Applicant

Novartis Pharmaceuticals Australia Pty Limited

Second Applicant

Pharmacor Pty Limited

Respondent

Procedural Posture

Patent Infringement and Cross Claim for Revocation/rectification / Final Judgment After Hearing

Legal Issues

  1. 1 Whether claim 1 of the patent covers a pharmaceutical composition in which the active pharmaceutical ingredients are in the form of a complex in which ions are associated by non-covalent bonds
  2. 2 Whether Pharmacor's intended supply of Valtresto threatens to infringe claim 1 of the patent
  3. 3 Whether the patent term was validly extended under s 70 of the Patents Act 1990 (Cth)

Ratio Decidendi

Claim 1 of the patent does not cover pharmaceutical compositions where the active pharmaceutical ingredients are present as a complex in which the ions are associated by non-covalent bonds; rather, it is limited to compositions in which the two relevant active ingredients (or their pharmaceutically acceptable salts) are present as separate entities. Valtresto is a single amorphous complex and does not meet this requirement; thus, there is no threatened infringement. Further, the extension of the patent term was not validly granted because the registered product (Entresto) contains a complex that is not disclosed or claimed as such in the specification or claims. Pharmacor's other grounds...

Court Disposition

Application dismissed; Cross-claim for rectification allowed in part; Validity challenges dismissed

Orders

  • Parties to bring in agreed or, if not agreed, competing draft orders giving effect to the reasons by 4.00pm, 20 November 2024.
  • Rectification of the Register of Patents to remove reference to extension of patent term to 16 January 2028 and record expiry as 16 January 2023.