Ethinyl estradiol & Drospirenone – Australia

Ethinyl estradiol & Drospirenone – Australia

On 16 March 2017, The Federal Court of Australia has handed down its first detailed damages decision in a long time in a patent infringement claim against a generic pharmaceutical company. In doing so, it sets a new benchmark for damages claims by innovator companies whose products have been illegally copied. In Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2017] FCA 250, Bayer was awarded damages of over $25m plus interest, assessed on Bayer’s pre-tax losses. 
Bayer holds a patent which protects an oral contraceptive which it markets as “Yasmin”. In 2012 Generic Health entered the market with a competing oral contraceptive product known as “Isabelle”. Subsequently, Bayer also marketed its own generic product under the name “Petibelle”. Justice Jagot had previously found that Bayer’s patent was infringed as a result of the sale of “Isabelle”. A factual twist in the case was that Bayer sought to amend some of the original claims of the patent after Isabelle entered the market. Patent infringement proceedings were already on foot. The proposed amendments were tailored to focus more directly on the features of the “Isabelle” product, specifically as to dose, dosage form and testing for solubility. These amendments were approved in late 2012 under section 105 of the Patents Act 1990.

Bayer elected to seek damages for patent infringement, rather than an account of profits. In support of its claim, it argued that every sale of Isabelle, and of its own generic Petibelle, was in reality a lost sale for Yasmin. 
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