Australian court affirms Mylan patent invalidation

The  Federal Court of Australia has upheld a patent victory for Indian generic manufacturer  Sun Pharma over  Mylan in a dispute over cholesterol drug fenofibrate.

In a judgment issued today, July 3, the Federal Court upheld the previous decision of a lower court to dismiss Mylan’s infringement claims, as well as to invalidate the three asserted patents.

The dispute arose after Sun applied to market a generic, film-coated fenofibrate tablet in Australia in 2016.

Mylan sued Sun Pharma for infringement of three patents, while Sun responded with applications for a finding of invalidity in each asserted patent.

The three Mylan patents were found to be obvious in light of prior art which included research projects into the use of fenofibrate, known as the ACCORD Eye Study Protocol and the FIELD study.

In today’s judgment, the Federal Court dismissed Mylan’s appeal of that decision and affirmed that all three patents were invalid.

The Federal Court accepted that the judge hearing the case at the lower court had made some errors in interpreting expert witnesses’ evidence, but ruled that this didn’t affect the conclusions on infringement and validity.

Mylan was ordered to pay Sun Pharma’s costs.

While the Federal Court’s ruling comes as a blow to Mylan, the company won a high-profile victory over Israeli pharmaceutical company Neurim at the  English High Court last month.

The court denied Neurim’s request for an injunction to block Mylan from marketing a generic version of the Israeli company’s insomnia drug.

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