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US court protects Shire's Vyvanse patents from generics
25-06-2014 07:07
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Shire received a boost from the US courts on Wednesday, which blocked competitors from selling generic versions of its Vyvanse branded drug for attention-deficit hyperactivity disorder (ADHD).
The five genetic drugmakers - Actavis, Amneal, Mylan, Roxane and Novartis's Sandoz - which had applied to market generic versions will now not be able to launch them until either the patents expire in 2023 or until they make a successful legal appeal that overturns the 18 patent claims ruled on.
After Judge Stanley Chesler of the US District Court for the District of New Jersey ruled in favour of Shire against the five defendants, Shire Chief Executive Flemming Ornskov said the ruling affirmed the company's belief that it has strong patents protecting Vyvanse.
The judge did not dispose of the litigation entirely, however, as in addition to Shire's motion, the court also ruled on five summary judgment motions filed by the defendants.
The court denied a motion from Johnson Matthey, the manufacturer of the active pharmaceutical ingredient (API) in Vyvanse, to dismiss certain indirect infringement claims, dismissed Shire's willful infringement claims, granted defendants' motion concerning non-infringement of certain method of use claims, and denied defendants' two invalidity motions.
Shire, which is trying to shrug off a $46bn takeover approach from US group AbbVie, said this left the court in a position where it must decide whether to conduct a trial on the remaining patent claims, or allow the defendants to immediately appeal this ruling to the Federal Circuit.
It said: "Shire maintains its belief that it has strong infringement claims against each of the six defendants for the patent claims that were not included in Shire's motion, and strongly believes that the asserted patent claims are valid."
-- More to follow --
The five genetic drugmakers - Actavis, Amneal, Mylan, Roxane and Novartis's Sandoz - which had applied to market generic versions will now not be able to launch them until either the patents expire in 2023 or until they make a successful legal appeal that overturns the 18 patent claims ruled on.
After Judge Stanley Chesler of the US District Court for the District of New Jersey ruled in favour of Shire against the five defendants, Shire Chief Executive Flemming Ornskov said the ruling affirmed the company's belief that it has strong patents protecting Vyvanse.
The judge did not dispose of the litigation entirely, however, as in addition to Shire's motion, the court also ruled on five summary judgment motions filed by the defendants.
The court denied a motion from Johnson Matthey, the manufacturer of the active pharmaceutical ingredient (API) in Vyvanse, to dismiss certain indirect infringement claims, dismissed Shire's willful infringement claims, granted defendants' motion concerning non-infringement of certain method of use claims, and denied defendants' two invalidity motions.
Shire, which is trying to shrug off a $46bn takeover approach from US group AbbVie, said this left the court in a position where it must decide whether to conduct a trial on the remaining patent claims, or allow the defendants to immediately appeal this ruling to the Federal Circuit.
It said: "Shire maintains its belief that it has strong infringement claims against each of the six defendants for the patent claims that were not included in Shire's motion, and strongly believes that the asserted patent claims are valid."
-- More to follow --
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