Claim Construction Opinion Issues In ANDA Case

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Unimed Pharmaceuticals, LLC, et al. v. Perrigo Company, et al., C.A. No. 13 – 236 – RGA, March 11, 2015.

Andrews, J.  Court issues a claim construction opinion in ANDA case regarding  terms from nine patents.

The disputed technology relates to the administration of testosterone.  The following terms were construed:

  1. “consisting essentially of”
  2. “gelling agent”
  3. “Ethanol”
  4. “hydroalcoholic gel consisting of”
  5. “1.0% to 10.0% (w/w) of 0.1 N sodium hydroxide”
  6. “7.0% (w/w) 0.1 N sodium hydroxide”; “The amount of the .01 N sodium hydroxide is 7.0% (w/w)”; “The 0.1 N sodium hydroxide is in an amount of7.0% (w/w)”
  7. “0.1 N sodium hydroxide”
  8. “composition consisting of”
  9. “gel pharmaceutical composition [ … ] obtained by combining the following ingredients which consist of”
  10. “[T)he amount of sodium hydroxide is in the range of 1.0% to 10% (w/w) of 0.l N sodium hydroxide”
  11. “0.1 N sodium hydroxide”
  12. “gelling agent”
  13. “dehydrated ethanol”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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