Acne drug at centre of ‘first’ IPR ruling of its kind

Pharmaceutical company Supernus and its subsidiary Galderma have had their Oracea (doxycycline) acne treatment drug protected from a generic challenge, in a decision dubbed the “first of its kind”.

The US Patent and Trademark Office (USPTO) rejected arguments by generic company Amneal that three patents covering the drug should be declared invalid.

Amneal had hoped to launch a generic version of the drug, used to treat skin blemishes and bumps, and requested an Inter Partes Review (IPR) at the office after unsuccessful litigation at the US District Court for the District of Delaware.

In its decision, issued on December 9, the office’s Patent Trial and Appeal Board rejected arguments by Amneal that the patents covered obvious variations of earlier research.

Switzerland-based Galderma is the pharmaceutical arm of Nestlé’s skin care company Nestlé Skin Health.

According to Gerald Flattmann, partner at law firm Paul Hastings in New York who represented the patent holders, this was the first time a pharmaceutical patent has been successfully defended through the IPR format.

“More and more of our clients' pharmaceutical and biotech patents have been targeted in IPR proceedings. Therefore, it is increasingly important to navigate this challenging landscape with a winning strategy and a winning team," said Flattmann.

He added: “This win effectively protects Galderma’s product Oracea against generic incursion through to 2027, when the patent in question expires.”

Amneal, which can appeal against the decision, did not immediately respond to a request for comment.