Sandoz AG v Bayer Intellectual Property GmbH [2023] FCA 1321

Sandoz AG v Bayer Intellectual Property GmbH [2023] FCA 1321

Both the 226 and 613 Patents are valid. The key term 'in hydrophilized form' refers to a hydrophobic active compound rendered hydrophilic by coating with a hydrophilic excipient via intensive mixing in a small amount of solution; thus, the Sandoz products, not produced by wet granulation, do not infringe the 226 Patent. Sandoz threatened infringement of claims 3 and 4 of the 613 Patent. The typographical error in the 613 Patent did not result in failure to disclose the best method, as the error was readily rectifiable by a skilled person. Neither patent was shown to be obvious in light of the cited prior art; Sandoz's case failed on inventive step. The amendment to the 613 Patent to...

Jurisdiction
Australia
Judgment Date
02 November 2023
Procedural Posture
Federal Court of Australia Proceeding (intellectual Property/patents) / Judgment After Final Hearing
Outcome
Application by Sandoz dismissed; cross-claim by Bayer allowed in-part; injunction granted against Sandoz to restrain infringement of the 613 Patent; amendment to the 613 Patent allowed; specified cost orders made.
Legal Topics
['patent Infringement' 'patent Amendment' 'validity of Patents' 'best Method Requirement' 'inventive Step' 'clarity of Claims']
['intellectual Property' 'patents'] ['patent Infringement' 'patent Amendment' 'validity of Patents' 'best Method Requirement' 'inventive Step' 'clarity of Claims']

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Procedural Posture

Federal Court of Australia Proceeding (intellectual Property/patents) / Judgment After Final Hearing

Legal Issues

  1. 1 ['Infringement of 613 Patent claims 3 and 4 by Sandoz products' "Proper construction of 'in hydrophilized form' in the 226 Patent" 'Validity of the 226 and 613 Patents (including inventive step, clarity, and best method)' 'Whether an amendment to the 613 Patent should be allowed']

Ratio Decidendi

Both the 226 and 613 Patents are valid. The key term 'in hydrophilized form' refers to a hydrophobic active compound rendered hydrophilic by coating with a hydrophilic excipient via intensive mixing in a small amount of solution; thus, the Sandoz products, not produced by wet granulation, do not infringe the 226 Patent. Sandoz threatened infringement of claims 3 and 4 of the 613 Patent. The typographical error in the 613 Patent did not result in failure to disclose the best method, as the error was readily rectifiable by a skilled person. Neither patent was shown to be obvious in light of the cited prior art; Sandoz's case failed on inventive step. The amendment to the 613 Patent to...

Court Disposition

Application by Sandoz dismissed; cross-claim by Bayer allowed in-part; injunction granted against Sandoz to restrain infringement of the 613 Patent; amendment to the 613 Patent allowed; specified cost orders made.

Orders

  • ["First and Second Applicants' application dismissed." "First and Second Cross-Claimants' cross-claim allowed in-part." 'Sandoz Pty Ltd restrained from infringing claims 3 and 4 of the 613 Patent during the term of the patent.' 'Amendment to Australian Patent AU2006208613 as described in the Annexure allowed.'...