Shire Development, LLC et al. v. Watson Pharmaceuticals, Inc. et al.


Docket No. 2013-1409

RADER, PROST, HUGHES
March 28, 2014

Brief Summary: DC construction of the terms “inner lipophilic matrix” and “outer hydrophilic matrix” reversed as inconsistent with “[t]he prosecution history, the structure of the claim itself, the ordinary meaning of the claim terms, including the Markush group limitations, and the patent’s description of the invention”.

Summary: Watson appealed DC finding of infringement of Shire’s US 6,773,720 related to LIALDA® (5-amino-salicylic acid (mesalamine) for treatment of inflammatory bowel diseases). The DC decision was based on its determination of the meaning of the claims terms “inner lipophilic matrix” and “outer hydrophilic matrix” as “a matrix including at least one lipophilic excipient, where the matrix is located within one or more substances” and “a matrix of at least one hydrophlic excipient, where the matrix is located outside the inner lipophlic matrix”, respectively. The FC panel determined, however, that “[t]hese constructions do not reflect the ordinary and customary meaning of the claim terms in lights of the evidence and are impermissibly broad”. Regarding the “inner lipophilic matrix”, it found the DC erroneously focused “on the lipophlic properties of an excipient in the matrix, rather than the properties of the matrix itself” (“[T]he matrix-not just an excipient within the matrix-must exhibit the stipulated-to lipophilic characteristic…This conclusion is bolstered by the specification.”) The DC had also rejected Watson’s arguments that the inner matrix and the outer matrix must be “separate and distinct” because of the applicants’ disclaimers during prosecution (applicants “described their matrices as ‘separate’ to distinguish over the prior art references”), and the FC agreed (noting no clear disavowel since “[d]uring prosecution, Shire carefully characterized the prior art as not having separate matrices but never actually stated that the claimed invention does have separate matrices.”) However, the FC also explained that these statements “do inform the claim construction” and ultimately concluded, based on “[t]he prosecution history, the structure of the claim itself, the ordinary meaning of the claim terms, including the Markush group limitations, and the patent’s description of the invention” (and Shire’s oral arguments: “They’re separate. No question.”), “that the inner lipophlic matrix is separate from the outer hydrophilic matrix.” The FC also found that “under the district court’s construction, a single mixed matrix with both hydrophilic and lipophilic components…could contain both” matrices while “[t]he claims…require two matrices with a defined spatial relationship.” Thus, the DC constructions were reversed the case remanded.

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