By refusing to allow Generic Health to adduce experimental evidence in a patent case currently being heard in the Federal Court, Justice Jagot has made it clear that failing to comply with procedure set out in the Federal Court Rules when conducting experiments can have serious consequences.

In this case, Generic Health conducted an experiment without seeking prior orders from the Court as required by rule 34.50(1). Instead, on day 1 of the trial, Generic Health sought leave to adduce evidence relating to those experiments.

As a threshold issue, Generic Health argued that rule 34.50 did not apply because the evidence only related to the manufacture of tablets to be used in subsequent experiments, and so was not itself experimental proof of a fact.  Justice Jagot rejected this argument, finding that the manufacture of the tablets was part of the broader experiments.

Justice Jagot was then required to decide whether she should, in her discretion, nevertheless grant leave to Generic Health to rely on this evidence.  In refusing to grant leave Justice Jagot relied on the following factors:

  • Generic Health had been aware for some time of Bayer’s assertion that rule 34.50 applied, but had not sought to approach the Court before day 1 of the trial;
  • Generic Health carried out the experiments in circumstances where Bayer was prevented from viewing the process;
  • the evidence Generic Health sought to adduce was to be given by an observer and not from the formulation scientist or supervisor conducting the experiments.  Justice Jagot concluded that this amounted to “just a conclusion which cannot be tested in any meaningful way”.

While this issue arose from a forensic decision made by Generic Health in the preparation of one aspect of its case for trial, it is conceivable that this interlocutory decision will impact Generic Health’s prospects in the substantive dispute (Generic Health itself submitted that excluding the evidence would seriously prejudice its case).  We will update you on the ultimate trial decision when it is delivered.

The case is available online here:

Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2013] FCA 226 (11 March 2013)