Federal Circuit upholds two patent decisions over Copaxone
The US Court of Appeals for the Federal Circuit has upheld two decisions that said patents relating to the dosage of Teva’s Copaxone (glatiramer acetate) 40mg/mL treatment are invalid.
The court announced both decisions on Friday, October 12.
Copaxone is a treatment for relapsing-remitting multiple sclerosis.
Both of the disputes relate to US patent numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are all called “Low frequency glatiramer acetate therapy” and cover Copaxone.
The patents are owned by Israel-based Yeda Research & Development and licensed to Teva.
Before Copaxone 40mg/mL was available, the US Food and Drug Administration (FDA) approved Copaxone 20mg/mL.
In 1996, the FDA approved Teva’s New Drug Application for Copaxone 20mg injected daily.
In 2015, Teva sued a selection of generic companies including Mylan, Sandoz and Amneal Pharmaceuticals at the US District Court for the District of Delaware after they submitted Abbreviated New Drug Applications to manufacture and sell generic versions of Copaxone 40mg.
Teva alleged that the applications infringed the ‘413, ‘250, ‘302 and ‘776 patents.
However, the district court said that all of the asserted claims of the Copaxone patents were invalid as obvious.
According to the district court, a dosage of 40mg glatiramer acetate three times a week would be obvious to try. The court also said that there were only two tested dosage amounts—20mg and 40mg. In addition, the district court noted that researchers were pursuing less frequent dosage regimes.
Teva appealed against the decision.
The company argued that the district court’s judgment that the dosing regime of Copaxone would have been obvious to a person of skill in the art was incorrect.
“Specifically, Teva argues that the district court impermissibly relied on hindsight and an improper ‘obvious to try’ analysis, and analysed the obviousness of individual claim elements, rather than the invention as a whole,” explained the Federal Circuit.
The Federal Circuit said last week that the district court did not err in reaching the conclusion that the patents were obvious.
According to the Federal Circuit, the 40mg, three times a week regimen was obvious in light of the prior art.
In addition, the Federal Circuit said that the district court did not make an error in concluding that a person of ordinary skill in the art would be motivated to administer the 40mg glatiramer acetate three times a week.
The Federal Circuit added that this frequency was desirable “because the prior art indicated that less frequent administration increased patient adherence while maintaining efficacy”.
The district court’s previous judgment was upheld and no costs were awarded.
Also on Friday, the Federal Circuit upheld the US District Court for the District of Delaware’s decision that all the claims of the Copaxone patents are unpatentable as obvious, following an appeal by Yeda.
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