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District court's grant of a preliminary injunction against defendant from manufacturing generic version of a drug for treating respiratory diseases, and finding plaintiff's kit claims invalid
Astrazeneca LP v. Apotex, Inc., 09-1381, concerned a challenge to the district court's grant of a preliminary injunction barring defendant from launching a generic version of a budesonide drug for treating respiratory diseases, made and distributed under the approval of the United States Food and Drug Administration (FDA) by plaintiff and covered under method and kit claims in plaintiff's patents, and determination that the kit claims are invalid.
In affirming the district court's judgment, the court held that, because defendant has not demonstrated that that any of the district court's findings regarding irreparable harm are clearly erroneous, there is no reason to disturb the district court's determination that plaintiff would suffer irreparable harm. The court also held that the district court correctly determined that the kit claims are invalid as the claimed instructions here are not entitled to patentable weight as the instructions in no way function with the drug to create a new, unobvious product.