Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73

Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73

The Full Court concluded the patent was not invalid for lack of inventive step or lack of fair basis: the skilled addressee would not as a matter of routine have carried out the immediate release tablet bioavailability experiment with an expectation of success and thus would not be led directly to the invention claimed; the claims were not limited by the specification to micronization or spraying, and thus were fairly based. The manufacture of the relevant experimental tablets was part of the experimental proof, r 34.50 was engaged, and there was no error in refusing leave to adduce that evidence. The appeals were dismissed and costs awarded against the applicants.

Parties
Appellant: Generic Health Pty Ltd; Appellant: Lupin Australia Pty Limited; Appellant: Apotex Pty Ltd; Respondent: Bayer Pharma Aktiengesellschaft; Respondent: Bayer Australia Limited
Jurisdiction
Australia
Judgment Date
19 June 2014
Procedural Posture
Appeal / Judgment on Appeal
Outcome
Appeals dismissed
Legal Topics
Inventive Step (obviousness), Fair Basis, Novelty, Practice and Procedure (leave to Appeal, Admissibility of Experimental Evidence)
Intellectual Property Law Patents Inventive Step (obviousness) Fair Basis Novelty Practice and Procedure (leave to Appeal, Admissibility of Experimental Evidence)

Case Brief

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Parties

Generic Health Pty Ltd

Appellant

Lupin Australia Pty Limited

Appellant

Apotex Pty Ltd

Appellant

Bayer Pharma Aktiengesellschaft

Respondent

Bayer Australia Limited

Respondent

Procedural Posture

Appeal / Judgment on Appeal

Legal Issues

  1. 1 Whether the invention claimed in the patent lacked an inventive step (was obvious)
  2. 2 Whether the claims were fairly based on the specification
  3. 3 Admissibility of experimental evidence (manufacture of tablets) under r 34.50 of the Federal Court Rules 2011 (Cth)

Ratio Decidendi

The Full Court concluded the patent was not invalid for lack of inventive step or lack of fair basis: the skilled addressee would not as a matter of routine have carried out the immediate release tablet bioavailability experiment with an expectation of success and thus would not be led directly to the invention claimed; the claims were not limited by the specification to micronization or spraying, and thus were fairly based. The manufacture of the relevant experimental tablets was part of the experimental proof, r 34.50 was engaged, and there was no error in refusing leave to adduce that evidence. The appeals were dismissed and costs awarded against the applicants.

Court Disposition

Appeals dismissed

Orders

  • Leave to appeal granted for some applications
  • Appeal dismissed