AstraZeneca Loses Ruling Over 2018 and 2021 Crestor Patents

AstraZeneca Plc lost a U.S. appeals court bid to protect its best-selling drug, Crestor, from generic competition until as late as 2021.

A judge was correct to dismiss AstraZeneca’s lawsuits against Teva Pharmaceutical Industries Ltd. and other generic-drug makers over patents on the cholesterol drug that expire in 2018 and 2021, the U.S. Court of Appeals for the Federal Circuit in Washington said today. The court is still considering the validity of the main patent on Crestor, which expires in 2016.

Crestor generated $6.6 billion in sales last year for London-based AstraZeneca, almost 20 percent of the company’s total revenue. The two patents cover methods of using the active ingredient rosuvastatin calcium for certain types of patients.

The generic-drug companies had sought approval to sell copycat medicine only for treatments not covered by the patents. The appeals court ruled that, based on that pledge, AstraZeneca didn’t have the right to sue to block the competition.

AstraZeneca sued over the 2018 and 2021 patents after winning a ruling that upheld the validity of the 2016 patent, which covers the main compound of the drug. Arguments on the compound patent case were heard in October.

In addition to Petah Tikva, Israel-based Teva, the world’s biggest generic-drug maker, the other companies sued include Apotex Inc., Aurobindo Pharma Ltd., Cobalt Pharmaceuticals Inc., Mylan Inc., Par Pharmaceutical Cos. and Sun Pharmaceutical Industries Ltd.

The case is AstraZeneca Pharmaceuticals LP v. Apotex Corp., 2011-1182, -1183, -1184, 1185, -1186, -1187, -1188, -1189, and -1190, U.S. Court of Appeals for the Federal Circuit (Washington. The lower court case is AstraZeneca Pharmaceuticals LP v. Apotex Corp., 10-338, U.S. District Court for the District of Delaware (Wilmington).

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