ARTICLE
28 December 2021

Federal Circuit Patent Watch: IPR Petitioner Must Show Reasonable Expectation Of Success For Specific Claimed Dosage

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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.
United States Intellectual Property
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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.

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ARTICLE
28 December 2021

Federal Circuit Patent Watch: IPR Petitioner Must Show Reasonable Expectation Of Success For Specific Claimed Dosage

United States Intellectual Property
Contributor
WilmerHale provides legal representation across a comprehensive range of practice areas critical to the success of its clients. With a staunch commitment to public service, the firm is a leader in pro bono representation. WilmerHale is 1,000 lawyers strong with 12 offices in the United States, Europe and Asia.
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