Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28

Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28

The relevant claims of the three patents were invalid: the 711 Patent's Swiss-style and method of treatment claims lacked novelty in light of prior disclosures such as the ACCORD Eye Study Protocol and the Squibb Patent, and also lacked inventive step given the common general knowledge and available prior art; claims 12 and 13 of the 964 Patent were not fairly based; the asserted claims of the 807 Patent lacked inventive step as the notional skilled team would have arrived at the claimed invention by routine formulation steps. No infringement was established on valid claims. Saccharin doctrine was not applicable to product claims under Australian law.

Jurisdiction
Australia
Judgment Date
22 January 2019
Procedural Posture
Patent Litigation / Judgment at First Instance
Outcome
Claims revoked; application dismissed
Legal Topics
['patents' 'infringement' 'validity' 'pharmaceuticals' 'swiss Style Claims' 'inventive Step' 'novelty' 'fair Basis' 's 117 Patents Act']
['intellectual Property'] ['patents' 'infringement' 'validity' 'pharmaceuticals' 'swiss Style Claims' 'inventive Step' 'novelty' 'fair Basis' 's 117 Patents Act']

Case Brief

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Procedural Posture

Patent Litigation / Judgment at First Instance

Legal Issues

  1. 1 ['Whether Swiss-style claims were infringed' 'Whether method of treatment claims were infringed under s 117 of the Patents Act' 'Whether the relevant patent claims lack novelty' 'Whether the relevant patent claims lack inventive step' 'Whether certain claims lack fair basis' 'Applicability of Saccharin doctrine under Australian law' "Proper construction of claims, including construction of 'composition' and testing methods"]

Ratio Decidendi

The relevant claims of the three patents were invalid: the 711 Patent's Swiss-style and method of treatment claims lacked novelty in light of prior disclosures such as the ACCORD Eye Study Protocol and the Squibb Patent, and also lacked inventive step given the common general knowledge and available prior art; claims 12 and 13 of the 964 Patent were not fairly based; the asserted claims of the 807 Patent lacked inventive step as the notional skilled team would have arrived at the claimed invention by routine formulation steps. No infringement was established on valid claims. Saccharin doctrine was not applicable to product claims under Australian law.

Court Disposition

Claims revoked; application dismissed

Orders

  • ['Claims 1, 5, 6, 7, 10, 11 and 12 of Australian Patent No. 2006313711 revoked;' 'Claims 12 and 13 of Australian Patent No. 731964 revoked;' 'Claims 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 18, 19, 20, 21, 23, 24, 26, 27, 31, 32, 36, 37, 38, 40, 41, 42, 43, 44, 45, 47, 49, 50, 56, 57, 58, 59, 61, 62, 64, 65, 69, 70, 74, 75,...