By Jessica Dye
(Reuters) – A U.S. appeals court on Wednesday reinstated part of a legal fight by AstraZeneca over a patent protecting its Pulmicort Respules asthma drug, months after the court temporarily halted competitors from distributing generic versions.
The ruling from the U.S. Court of Appeals for the Federal Circuit 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 AstraZeneca patent related to the drug was invalid.
AstraZeneca said in a statement Wednesday that it had “full confidence in the strength of its intellectual property rights” concerning the pediatric asthma drug.
The defendants were not immediately available for comment after regular business hours Wednesday.
AstraZeneca had filed suit earlier this year seeking to block the generic drugmakers from introducing versions of Pulmicort Respules. The defendants countersued, saying that the patents were invalid and that they had not infringed them.
The case went to trial, and in April a federal judge in New Jersey found that one AstraZeneca patent had not been infringed, and that another was invalid. AstraZeneca appealed, and in May the Federal Circuit issued a temporary injunction to block generic versions of the drug from being distributed in the United States.
Defendants Apotex, Watson and Breath Limited had received approval from the U.S. Food and Drug Administration for the drug, and Sandoz received approval while the appeal was pending, AstraZeneca said in a statement.
None of the manufacturers have launched a generic product in the United States, although AstraZeneca has an agreement with Teva Pharmaceuticals allowing that company to sell a generic version, the company said.
According to a regulatory filing from AstraZeneca, Pulmicort generated $ 866 million in worldwide revenue for AstraZeneca in 2012.
(Reporting by Jessica Dye in New York; Editing by Leslie Adler)
- Pharmaceuticals & Drug Trials