Merchant & Gould Scores Significant Patent Litigation Victory for Generic Pharmaceutical Manufacturers over AstraZeneca

February 10, 2012

U.S. Appeals Court Upholds Dismissal of AstraZeneca's Crestor Patent Suits


Merchant & Gould, an intellectual property law firm, today announced it has won a litigation victory on behalf of its client Aurobindo Pharma Ltd and other generic pharmaceutical manufacturers. The United States Court of Appeals for the Federal Circuit upheld a lower court's dismissal of multiple patent lawsuits filed by AstraZeneca against several generic pharmaceutical manufacturers over patents for Crestor® that will expire in 2018 and 2021.

"We are pleased with the Court of Appeals decision to affirm the dismissal of AstraZeneca's infringement claims," said Shane A. Brunner, lead counsel for Merchant & Gould. "The decision confirms the important role that 'Section viii Statement' play in the Hatch-Waxman statutory scheme by permitting generic manufacturers to 'carve out' patented and approved indications from their product label in order to avoid infringing a patent and to expedite generic market entry."

In this case, AstraZeneca sued Aurobindo and other generic manufacturers for infringement of two patents covering uses of the drug rosuvastatin calcium, which goes by the brand name Crestor®. Aurobindo moved to dismiss the case because it was not seeking FDA approval to market rosuvastatin calcium for the uses claimed in the patents, which Merchant & Gould argued was a requirement under the Hatch-Waxman Act. AstraZeneca argued that although Aurobindo was not seeking approval for the patented uses, Aurobindo's generic rosuvastatin calcium would be prescribed by physicians for the patented uses regardless of the indications sought by Aurobindo. The district court granted Aurobindo's motion to dismiss. On appeal, Merchant & Gould briefed and argued on behalf of the defense group. The oral argument before the Federal Circuit took place on November 7, 2011. On February 9, 2012, the Federal Circuit decided in favor of Aurobindo and the other defendants holding that AstraZeneca failed to state a claim for infringement under the Hatch-Waxman Act and that the claims were not ripe for adjudication.

Also involved from Merchant & Gould were Jeffrey S. Ward, Edward J. Pardon, Rachel C. Hughey, Wendy M. Ward, Joel F. Graham, Kathy Bergman, Jody Pizzala, Julie King and Amy Miller.

The case is AstraZeneca Pharmaceuticals LP v. Apotex Corp. et al., case number 11-1182, in the U.S. Court of Appeals for the Federal Circuit.