Mylan v. Aurobindo was decided on May 19, 2017 on appeal from the Eastern District of Texas. There, the district court granted co-Plaintiff Mylan’s motion for a preliminary injunction as to the compound and process patents, finding that Defendant Aurobindo likely infringed the patents under the doctrine of equivalents, and that Arubindo didn’t raise a substantial question of validity. The district court found that co-Plaintiff Apicore would be irreparably harmed through lost sales, lost R&D, price erosion, and the fact of direct competition with an infringer. Aurobindo appealed the injunction grant.
The Federal Circuit reversed the grant of injunction as to the process patents, and affirmed as to the compound patent.
The district court erred in granting the preliminary injunction as to the process patents because Aurobindo raised a substantial question of infringement under the doctrine of equivalents.
The district court didn’t err in granting the injunction as to the compound patent. Arubindo didn’t raise a substantial question as to the patent’s validity.
The Federal Circuit affirmed the irreparable harm finding. There was record evidence that Apicore had, and would continue to “suffer from lost sales, lost research and development, price erosion, and having to directly compete with an infringer.” There was a causal nexus because Aurobindo couldn’t achieve the product purity described in its ANDA without infringing the process and compound patents, and thus its generic drug wouldn’t be on the market “if it had not obtained FDA approval for a product that will likely be found to be covered by the patents.”
Because Aurobindo didn’t challenge the balance of the equity or the public interest factors, the preliminary injunction grant was affirmed as to the compound patent.
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