On August 20, the three-judge panel affirmed the May 2007 decision of US District Court Judge Barbara S Jones and ruled that Apotex and Impax had infringed two of AstraZeneca's patents (4,786,505 and 4,853,230).
AstraZeneca has said that it will take Apotex and Impax back to the District Court to seek damages for the infringing sales.
“AstraZeneca will seek a ruling that Apotex's and Impax’s infringing activity was wilful and deliberate, that their conduct was exceptional, and that AstraZeneca is entitled to increased damages and attorneys’ fees,” the company said in a statement.
On December 31 1999, Impax sought approval from the Food and Drug Administration (FDA) to sell 10 and 20-mg generic versions of Prilosec. AstraZeneca filed for infringement and filed a second action against Impax after Impax amended its application to include a 40-mg product.
On appeal, Impax argued that the district court erred in denying its demand for a jury trial and in denying its motion to dismiss Astra’s claims as moot. Impax also challenged the sufficiency of the evidence that its formulation infringes the claims of the ’505 and ’230 patents. Both the arguments were rejected by the Court. Apotex used the defences of anticipation and obviousness.
After the decision AstraZeneca stated: “AstraZeneca is pleased with the decision, affirming that Apotex and Impax infringed our patents, and upholding the validity and enforceability of our patents. The Federal Circuit's decision once again reaffirms the strength of AstraZeneca's intellectual property.”
This victory comes as a relief for AstraZeneca which lost a ruling in May this year, when a Federal Court ruled that US pharmaceutical company Mylan’s generic version of Prilosec did not infringe AstraZeneca’s patents.
Prilosec was the world's largest selling prescription drug in 2000 with sales of over $6 billion. After the patent expired in 2001, AstraZeneca launched Nexium which also treats stomach ulcers, limiting competition from other generic versions of Prilosec. Prilosec is used to treat heartburn, acid indigestion and intestinal ulcers.
Milbank Tweed Hadley & McCloy were the layers for AstraZeneca. Apotex was represented by Katten Muchin Rosenman while Sutherland Asbill & Brennan acted for Impax Laboratories.
