Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd

Bayer Pharma Aktiengesellschaft, the owner of an Australian patent for a pharmaceutical combination, sought amendments to the patent claims to include specific dissolution tests for the active agents. The respondents, Generic Health Pty Ltd, opposed the amendments. The matter was heard by the Federal Court of Australia, which had to determine whether the discretion under Section 105 of the Patents Act 1990 should be exercised in favour of Bayer Pharma.

The key legal issue was whether Bayer Pharma's application for patent amendments should be allowed, considering the principles of unreasonable delay, covetous claiming, and unfair advantage. The respondents argued that the application was untimely and that granting the amendments would confer an unfair advantage. Bayer Pharma, on the other hand, contended that the amendments were necessary to correct a drafting error and that there was no unreasonable delay.

The Court found that Bayer Pharma had not acted unreasonably in delaying the application for amendments. The Court concluded that the amendments were necessary to correct a drafting error and did not constitute covetous claiming or provide an unfair advantage to Bayer Pharma. The Court also noted that the infringement of the patent by the respondents was ongoing, and the amendments would not change the nature of the infringement claims. Therefore, the discretion under Section 105 of the Act should be exercised in favour of Bayer Pharma.

The Court ordered the patent to be amended as requested by Bayer Pharma, extended the time for appeal against the decision, and stayed the orders pending the publication of the Court's reasons.