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4 January 2022AmericasAlex Baldwin

Fed Circ rejects Sanofi’s bid to resurrect Lantus patents

The US Court of Appeals for the Federal Circuit has rejected several bids from French pharma giant Sanofi to revive claims in its Lantus SoloStar insulin pen patents.

The Federal Circuit handed down three rulings against Sanofi  moving Mylan closer to being able to make its own generic insulin pens.

Sanofi had sued Mylan for infringing its  Lantus patents with its own generic insulin pen devices, prompting Mylan to challenge the patents at 10 separate proceedings at the Patent Trial and Appeal Board (PTAB).

In these IPR proceedings, the PTAB invalidated claims in five of Sanofi’s Lantus SoloStar patents covering the pen-type injectors.

Sanofi challenged prior rulings from the PTAB which invalidated parts of its US Patents 8,992,486 and 9,526,844, 9,604,008, 8,679,069 and 8,603,044.

The Federal Circuit rulings published on December 29, 2021, were consolidated from the 10 separate inter partes review petitions submitted by Mylan in 2020. These rulings confirmed PTAB’s decisions in all cases.

Sanofi argued that the PTAB had committed numerous errors in its analysis, primarily that it had inappropriately relied on common knowledge to supply limitations missing in prior art in its invalidation of the ‘486 and ‘844 patent.

But the Federal Circuit affirmed the board’s decision that claims 21-30 of the ‘844 patent were unpatentable and denied Sanofi’s motion to amend with substitute claims 31-38 of the same patent was moot. It also denied Sanofi the chance to substitute claims of the ‘486 patent.

In two of the three Federal Circuit decisions, Sanofi argued that the board erred in finding that there was a motivation to combine two references in its decision to invalidate the ‘008, ‘069 and ‘044 patents.

Again, the Federal Circuit found that the board did not err in the decision to combine the two references.

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29 April 2021   GlaxoSmithKline has submitted an amicus brief to the Court of Appeals for the Federal Circuit claiming that the ruling on Amgen v Sanofi could “threaten incentives to invest in future discoveries.”

More on this story

Americas
29 April 2021   GlaxoSmithKline has submitted an amicus brief to the Court of Appeals for the Federal Circuit claiming that the ruling on Amgen v Sanofi could “threaten incentives to invest in future discoveries.”
Big Pharma
13 April 2021   UK company C4X Discovery has agreed an exclusive licensing deal with Sanofi worth a potential €414 million, which will see the French pharmaceutical company develop anti-inflammatory therapies.

More on this story

Americas
29 April 2021   GlaxoSmithKline has submitted an amicus brief to the Court of Appeals for the Federal Circuit claiming that the ruling on Amgen v Sanofi could “threaten incentives to invest in future discoveries.”
Big Pharma
13 April 2021   UK company C4X Discovery has agreed an exclusive licensing deal with Sanofi worth a potential €414 million, which will see the French pharmaceutical company develop anti-inflammatory therapies.