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Chief Judge Stark issues claim construction, finds preamble limiting

Chief Judge Leonard P. Stark recently issued the Court’s claim construction rejecting defendants’ indefiniteness arguments and finding the preamble limiting.  Mayne Pharma Int’l Pty Ltd. v.  Merck & Co., Inc., No. 15-438-LPS (D. Del. Dec. 27, 2016).  The preamble of the asserted claims stated “A pharmaceutical composition, consisting essentially of ….”  Judge Stark found the preamble limiting “because it provides antecedent basis for the term ‘the composition,’ which appears in the wherein clauses of claims 9 and 12.”  Id. at 14.  Judge Stark construed the to mean “any composition suited for pharmaceutical use” in accord with its plain and ordinary meaning.  Id. at 14-15.  In doing so, Judge Stark rejected defendants’ proposed construction, “a medicinal drug preparation for administration to patients,” because defendants’ proposal improperly narrowed the scope of the claims.  Id.  Judge Stark also rejected defendants’ indefiniteness arguments regarding the terms “consisting essentially of,” “wherein in vivo the composition provides a mean Cmax of at least 100 ng/ml, after administration in the fasted state,” “‘wherein in vivo the composition provides a mean AUC of at least 800 ng.h/ml, after administration in the fasted state,” and “polymer having acidic functional groups.”  Id. at 5-13, 16-17.

Mayne Pharma Int’l Pty Ltd. v. Merck & Co., Inc., No. 15-438-LPS (D. Del. Dec. 27, 2016)

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