Federal Circuit Patent Watch: IPR petitioner must show reasonable expectation of success for specific claimed dosage

Federal Circuit Patent Watch: IPR petitioner must show reasonable expectation of success for specific claimed dosage

Client Alert

Authors

Precedential Federal Circuit Opinions

  1. TEVA PHARMACEUTICALS USA v. CORCEPT THERAPEUTICS, INC. [OPINION] (2021-1360, 12/07/2021) (MOORE, NEWMAN, and REYNA)           

    Moore, C.J. The Court affirmed the PTAB’s IPR decision that claims directed to a specific dosage of mifepristone were not invalid as obvious. The Court held that the PTAB did not err by requiring Teva to show a reasonable expectation of success for the specific claimed dosage. The Court explained that the PTAB “applied the correct standard, requiring only a reasonable expectation of success and tying its analysis to the scope of the claimed invention.” In addition, the Court concluded that “substantial evidence supports the [PTAB’s] finding that the general working conditions disclosed in the prior art did not encompass the claimed invention, i.e., there was no overlap in ranges” of the claimed invention and the prior art.

  2. ASTRAZENECA AB v. MYLAN PHARMACEUTICALS INC. [OPINION] (2021-1729, 12/08/2021) (TARANTO, HUGHES, and STOLL)      

    Stoll, J.  The Court vacated a district court judgment of infringement, affirmed the district court’s determination of nonobviousness, and remanded. This is a patent infringement case involving three asserted patents identified by AstraZeneca as covering its “Symbicort® pressurized metered-dose inhaler (pMDI).” The issue of infringement turned on claim construction. The Court explained that the claim construction issue is “whether the concentration of PVP being ‘0.001%’ means 0.001% within one significant figure—encompassing a concentration of PVP in the range of 0.0005% to 0.0014%, as AstraZeneca contends and as the district court construed this term—or it has a narrower meaning in view of the specification and the prosecution history—precisely 0.001% w/w PVP with only ‘minor variations,’ as Mylan contends.” The Court concluded that “Mylan’s proposed construction, albeit articulated differently, is correct because it ‘most naturally aligns with the patent’s description of the invention,’ as further informed by the prosecution history.… We therefore construe ‘0.001%’ as that precise number, with only minor variations, i.e., 0.00095% to 0.00104%.” With respect to the validity issue, the Court concluded that the district court did not clearly err in finding that the prior art taught away from the claimed invention, and that this alone was “sufficient to sustain the nonobviousness determination.”

    Judge Taranto dissented in part with respect to the claim construction issue.

Authors

More From This Series

Notice

Unless you are an existing client, before communicating with WilmerHale by e-mail (or otherwise), please read the Disclaimer referenced by this link.(The Disclaimer is also accessible from the opening of this website). As noted therein, until you have received from us a written statement that we represent you in a particular manner (an "engagement letter") you should not send to us any confidential information about any such matter. After we have undertaken representation of you concerning a matter, you will be our client, and we may thereafter exchange confidential information freely.

Thank you for your interest in WilmerHale.