AstraZeneca wins patent infringement case over Farxiga generic

AstraZeneca has convinced a federal court to uphold challenged claims of a patent related to its diabetes drug Farxiga (dapagliflozin).

The challenge was bought by generic drugmaker Zydus Pharmaceuticals, which had filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration to create a variant of the drug prior to the expiration of key patents.

District court judge Richard Andrews wrote that, during a four-day bench trial, the parties had narrowed the dispute from all claims in the US patent 6,515,117 and US patent 6,414,126 to claims 1-3. 14 and 16 of the ‘117 patent.

In a memorandum opinion handed down on Friday, 15 October, the US District Court for the District of Delaware ruled that Zydus had failed to prove that any asserted claims of the ‘117 were invalid. It also ruled that Zydus’ proposed generic infringed the patent.

The ‘117 patent covers compounds and methods relating to the inhibition of glucose transporters and was first issued in 2002.

Zydus argued that the claims were invalid as a person with ordinary skill in the art could have expected Dapagliflozin to offer better glucose-reducing effects than a method detailed in the closest prior art—referred to as WO ‘128.

However, Andrews held that WO ‘128 teaches away from key methods detailed in claims 1-3 of the ‘117 patent and that a person of ordinary skill would not have been motivated to arrive at the molecule claimed in the patent.

As claims 14 and 16 relied on the same chemical compound as claims 1-3, Andrews ruled that the Zydus had not managed to prove the obviousness of the ‘117 patent.

Each party will have to submit a final judgment consistent with the memorandum opinion within one week.

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