Novartis MS drug appeal upheld in Australia

The Federal Court of Australia has backed Novartis’ appeal against a decision revoking its patent covering a multiple sclerosis drug.

Novartis’ Australian patent application, number. 2013204752, bears the title “Pharmaceutical compositions comprising an S1P modulator”. It relates to pharmaceutical compositions that comprise an S1P modulator, including methods of treating or preventing multiple sclerosis.

According to reports, the patent covers a formulation patent on Novartis’ multiple sclerosis drug Gilenya (fingolimod).

Generic maker Arrow Pharmaceuticals opposed the application and, in May last year, the Commissioner of Patents upheld the opposition, finding that the claimed invention lacked an inventive step.

Novartis subsequently appealed against the decision and in response, Arrow filed a submitting notice, indicating that it did not want to contest Novartis’ appeal.

Yesterday, October 12, the court affirmed the appeal, while also dismissing Arrow’s opposition to the patent application.

The fact that when Arrow filed a submitting notice in the appeal, it had not filed any evidence in the proceedings in opposition to the patent application had “important consequences in the present case”, said Justice Stephen Burley.

He added: “Whilst Novartis is styled as the appellant, because it seeks to overturn the decision of the delegate, as the opponent to the grant of the patent application, Arrow is the effective moving party. The onus remains on Arrow to establish that the grounds upon which it seeks to oppose the grant of the patent are made out.”

In September, the Commissioner of Patents also informed the court that she did not intend to exercise any right to appear in the proceedings.

Burley explained that where an opponent has withdrawn from the proceedings, and the Commissioner of Patents has indicated on the hearing of the appeal that she doesn’t wish to take any active part in the proceedings, and “there is no evidence before the court capable of supporting any actual or potential ground of opposition, there is no basis on which the court can uphold any ground of opposition”.

The patent application will now proceed to grant.

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