shutterstock_1289877622_sergiy_palamarchuk
Sergiy Palamarchuk / Shutterstock.com
15 August 2019AmericasSarah Morgan

Sanofi victorious at Fed Circ in prostate cancer drug dispute

Sanofi secured a win at the US Court of Appeals for the Federal Circuit yesterday, August 14, after the appeals court concluded a lower court lacked authority to invalidate claims of a patent covering a prostate cancer drug.

In a precedential decision, the Federal Circuit concluded that a district court was wrong to find certain claims invalid in a Sanofi patent, while affirming the lower court’s finding that generic drugmakers had failed to prove a second patent on the drug was invalid.

Sanofi’s two patents, US numbers 8,927,592 and 5,847,170, respectively claim the compound cabazitaxel and methods of using it. The drugmaker markets cabazitaxel under the trade name Jevtana to treat certain drug-resistant prostate cancers.

Fresenius and the other defendants (collectively known as Fresenius) filed Abbreviated New Drug Applications to market generic versions of Jevtana, prompting Sanofi to sue the parties for patent infringement at the US District Court for the District of New Jersey.

Defendants counterclaimed for a declaratory judgment of invalidity of the ‘592 patent but the case proceeded to a bench trial concerning both patents.

However, while the case was pending, the Patent Trial and Appeal Board (PTAB) instituted inter partes review of the ‘592 patent. Soon after the district court trial began, the PTAB held claims 1–5 and 7–30 unpatentable as obvious and denied Sanofi’s motion to amend its claims.

Sanofi appealed against the board’s denial of its motion to amend, but didn’t appeal against the board’s decision of unpatentability with respect to claims 7, 11, 14–16, and 26.

In December 2017, Sanofi disclaimed the above-mentioned claims and informed the district court.

But the district court concluded that a case or controversy still existed with respect to the claims, despite the disclaimer, and held they were invalid as obvious. The New Jersey court also held that Fresenius had failed to prove that claims 1 and 2 of the ‘170 were obvious over the prior art.

Both parties appealed against the district court’s decision.

Sanofi argued that after it disclaimed the particular claims, there was no longer a case or controversy regarding those claims, so the district court lacked authority to invalidate them.

In agreement with Sanofi, the Federal Circuit concluded that the drugmaker’s disclaimer “mooted any controversy” over the claims.

“The court thus lacked authority to disinter the already disclaimed claims and declare them invalid. Accordingly, we vacate the court’s judgment concerning the disclaimed claims,” said Circuit Judge Alan Lourie, on behalf of the court.

On Fresenius’ appeal, the Federal Circuit affirmed the lower court.

Fresenius had argued that cabazitaxel, claimed in claims 1 and 2 of the ‘170 patent, would have been obvious over docetaxel and that the district court committed a “cascading series of factual and legal errors”.

In affirming the judgment, Lourie said: “We agree with Sanofi and conclude that Fresenius’s convoluted obviousness theory lacks merit.”

After vacating the district court’s judgment of obviousness concerning the disclaimed claims, and affirming its finding of nonobviousness concerning claims 1 and 2 of the ‘170 patent, the Federal Circuit awarded costs to Sanofi.

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Big Pharma
5 June 2019   A German court has rejected a bid from French pharmaceutical company Sanofi to have a patent infringement case dismissed.
Americas
15 April 2019   Fresenius Kabi has submitted a petition for inter partes review of US patent number 9,856,287, a patent owned by Amgen.

More on this story

Big Pharma
5 June 2019   A German court has rejected a bid from French pharmaceutical company Sanofi to have a patent infringement case dismissed.
Americas
15 April 2019   Fresenius Kabi has submitted a petition for inter partes review of US patent number 9,856,287, a patent owned by Amgen.

More on this story

Big Pharma
5 June 2019   A German court has rejected a bid from French pharmaceutical company Sanofi to have a patent infringement case dismissed.
Americas
15 April 2019   Fresenius Kabi has submitted a petition for inter partes review of US patent number 9,856,287, a patent owned by Amgen.