In Re Bendamustine Consolidated Cases, C.A. No. 13-2046 – GMS, June 3, 2015
Sleet, J. Markman opinion issues. The court construes 13 terms from 6 patents.
The disputed patents relate to Bendamustine. The following terms are considered:
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"solid form of bendamustine hydrochloride, designated as bendamustine hydrochloride Form 1”
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"an X-ray powder diffraction pattern comprising the following reflections: 8.3, 16.8, and 18.5±0.2 degrees 20"; "an X-ray powder diffraction pattern further comprising the following reflections: 14.0, 22.0, 22.9, 25.1, and 28.3±0.2 degrees 20"; and "an X-ray powder diffraction pattern additionally including, but not limited to, a reflection at 14.0±0.2 degrees 20"
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''tertiary-butyl alcohol"
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"pharmaceutical composition"
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"containing not more than about 0.5% bendamustine ethyl ester"
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"trace amount of tertiary-butyl alcohol"
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"stable lyophilized preparation"
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"amount of HPlmeasured at time zero after reconstitution"
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"bendamustine degradants"
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"containing less than or equal to 4.0% (area percent of bendamustine) of bendamustine degradants"
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"pharmaceutical composition"
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"lyophilized preparation" and "lyophilized composition"
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"an X-ray powder diffraction pattern comprising the following reflections: 7.9, 15.5, and 26.1±0.2 degrees 28"