AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 21-1729 (Fed. Cir. 2021)
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AstraZeneca’s asserted patents are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book), as covering AstraZeneca’s Symbicort® pressurized metered-dose inhaler (pMDI). The Symbicort® pMDI is approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD). AstraZeneca has marketed a dry powder inhaler version of Symbicort® (Symbicort® Turbuhaler) since the early 1990s. Both the Symbicort® pMDI and the Symbicort® Turbuhaler administer two active ingredients to the lungs—formoterol, a bronchodilator that opens the airway, and budesonide, a steroid that reduces inflammation in the lungs. Mylar's predecessor submitted an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to manufacture and sell a generic version of Symbicort® pMDI.
AstraZeneca sued Mylan for infringement. After claim construction, Mylan stipulated to infringement. The district court entered judgment accordingly, then held a bench trial and determined that Mylan failed to prove that the asserted claims are invalid as obvious. The Federal Circuit vacated the judgment of infringement, disagreeing with the district court’s claim construction of “0.001%,” the claimed amount of the excipient PVP, on which the stipulated judgment of infringement was based. The court affirmed the determination of nonobviousness, finding no clear error in the district court’s finding that the prior art taught away from the claimed invention.
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