Sanofi and Regeneron, seeking to shield Dupixent, lose first IPR try against Amgen

Dupixent package
Sanofi and Regeneron's Dupixent racked up $30.5 million in Q2 sales.

To defend against Amgen’s claim that Sanofi and Regeneron had infringed one of its patents with new atopic dermatitis rollout Dupixent, the development partners went the inter partes review route to try to invalidate the patent in question. And so far, that effort has come up empty.

The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) has declined to institute the first of three reviews Sanofi and Regeneron had sought, Jefferies analyst Biren Amin wrote in a Thursday note to clients.

The reason? In their challenge, the drugmakers couldn’t convince the PTAB that there was substantial evidence to invalidate any of the patent’s claims, Amin wrote, adding that “according to the PTAB, an institution of the IPR is granted if there is reasonable likelihood of the petitioner prevailing with any one of the claims challenged in the petition.”

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It’s a win for Amgen, which is relying on the patent in questiondubbed ‘487—for a patent infringement suit it filed in California in April.

But Regeneron and Sanofi still have two more shots on goal. They’ve got two additional IPRs that the PTAB could take up for review, and the body could make decisions on those in the first half of next year, Amin notes.

The tussle over Dupixent, which analysts have tapped as a future blockbuster, began back in March before the product was even approved. The med’s makers learned that Amgen had hired counsel to prosecute infringement of the '487 patent, so they sued preemptively, seeking a declaration that their prospect didn’t cross the line. Amgen sued back the following month.

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For Sanofi and Regeneron, Amgen is a familiar foe. They’re currently squaring off against the California company in a high-profile patent battle over PCSK9 contender Praluentthe archrival of Amgen’s Repatha.

Meanwhile, Dupixent is steamrolling; it raked in $30.5 million in Q2 after launching in March, Sanofi said.