In Re Bendamustine Consolidated CasesC.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:

  1. "solid form of bendamustine hydrochloride, designated as bendamustine hydrochloride Form 1”
  2. "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"
  3. ''tertiary-butyl alcohol"
  4. "pharmaceutical composition"
  5. "containing not more than about 0.5% bendamustine ethyl ester"
  6. "trace amount of tertiary-butyl alcohol"
  7. "stable lyophilized preparation"
  8. "amount of HPlmeasured at time zero after reconstitution"
  9. "bendamustine degradants"
  10. "containing less than or equal to 4.0% (area percent of bendamustine) of bendamustine degradants"
  11. "pharmaceutical composition"
  12. "lyophilized preparation" and "lyophilized composition"
  13. "an X-ray powder diffraction pattern comprising the following reflections:  7.9, 15.5, and 26.1±0.2 degrees 28"