U.S. appeals court revives patent fight over AstraZeneca drug

Reuters

By Jessica Dye

Oct 30 (Reuters) - A U.S. appeals court on Wednesdayreinstated part of a legal fight by AstraZeneca over apatent protecting its Pulmicort Respules asthma drug, monthsafter the court temporarily halted competitors from distributinggeneric versions.

The ruling from the U.S. Court of Appeals for the FederalCircuit reverses an earlier decision that generic drugmakers-including Apotex Inc, Sandoz Inc and Watson Laboratories Inc-had not infringed an AstraZeneca patent relating to the drug.

The court left intact a finding that another AstraZenecapatent related to the drug was invalid.

AstraZeneca said in a statement Wednesday that it had "fullconfidence in the strength of its intellectual property rights"concerning the pediatric asthma drug.

The defendants were not immediately available for commentafter regular business hours Wednesday.

AstraZeneca had filed suit earlier this year seeking toblock the generic drugmakers from introducing versions ofPulmicort Respules. The defendants countersued, saying that thepatents were invalid and that they had not infringed them.

The case went to trial, and in April a federal judge in NewJersey found that one AstraZeneca patent had not been infringed,and that another was invalid. AstraZeneca appealed, and in Maythe Federal Circuit issued a temporary injunction to blockgeneric versions of the drug from being distributed in theUnited States.

Defendants Apotex, Watson and Breath Limited had receivedapproval from the U.S. Food and Drug Administration for thedrug, and Sandoz received approval while the appeal was pending,AstraZeneca said in a statement.

None of the manufacturers have launched a generic product inthe United States, although AstraZeneca has an agreement withTeva Pharmaceuticals allowing that company to sell a genericversion, the company said.

According to a regulatory filing from AstraZeneca, Pulmicortgenerated $866 million in worldwide revenue for AstraZeneca in2012.

View Comments (0)