ASTRAZENECA AB v. MYLAN PHARMACEUTICALS INC.
- Dec 8 2021 |
- Category: CAFC Updates
AstraZeneca sued for infringement of all claims of U.S. Patent Nos. 7,759,328; 8,143,239; and 8,575,137, the patents listed in the Orange Book as covering AstraZeneca’s Symbicort® pressurized metered-dose inhaler (pMDI) which was approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Mylan’s Paragraph IV letter argued that the asserted patents are invalid, unenforceable, and/or not infringed. After claim construction, Mylan stipulated to infringement and the district court entered judgment accordingly, and after a bench trial on invalidity determined that Mylan failed to prove that the asserted claims are invalid as obvious. Mylan appeals, challenging 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 question here is whether the concentration of PVP being “0.001%” means 0.001% within one significant figure, i.e., encompassing a concentration of PVP in the range of 0.0005% to 0.0014% (as the district court construed this term), or whether it has a narrower meaning, i.e., precisely 0.001% w/w PVP with only “minor variations”. In light of the testing data in the specification and the amendments and arguments in the prosecution history, the CAFC construes “0.001%” as that precise number, with only minor variations, i.e., 0.00095% to 0.00104%, and therefore vacates the stipulated judgment of infringement and remands for the district court to find whether Mylan’s ANDA Product infringes the asserted claims under the proper claim construction. Mylan also challenges several factual findings underlying the district court’s determination of nonobviousness. Finding no clear error in the district court’s finding that the prior art taught away from the claimed invention, the CAFC affirms the determination of nonobviousness. Judge Taranto, dissents in part with respect to the majority’s construction of the term “0.001%” because in his view that term should be construed to have its significant-figure meaning, and because a finding of infringement is compelled regardless.