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

Docket No. 2013-1409

June 3, 2015

Brief Summary: DC claim construction decision based on intrinsic evidence reviewed de novo (after SCOTUS remand) and reversed as inconsistent with that evidence (e.g., “logical reading of the claim”, no unambiguous disavowels).

Summary: This case was remanded from SCOTUS (135 S. Ct. 1174 (2015)) following the 2015 Teva decision (135 S. Ct. 831) (original 2014 FC decision: 746 F.3d 1326). The FC determined that the case “does not involve factual findings to which [it] owe[s] deference under Teva” and “again reverse[d]” the DC claim construction findings regarding US 6,773,720 (LIALDA®, high percentage (80-95%) controlled release composition 5-amino-salicylic acid, “mesalamine”, for treating inflammatory bowel diseases). The DC construed several terms, including “inner lipophilic matrix” and “outer hydrophilic matrix”, Watson’s product infringed the claims 1 and 3 of the ‘720 patent which were not invalid under § 112 (written description or enablement). The opinion explained the SCOTUS Teva decision clarified that the FC review of a DC decision based on intrinsic evidence (claims, specification, prosecution history) is de novo but a decision based on extrinsic evidence is reviewed for clear error. Here, the FC wrote, the decision was based on intrinsic evidence and the decision was reviewed de novo, considering the claim terms (ordinary and customary meaning (Dow, FC 2001; Phillips, FC 2005), specification (“‘may shed contextual light’…on the ordinary and customary meaning” (Aventis, FC 2013), and the prosecution history (e.g., “where the patentee has unequivocally disavowed a certain meaning to obtain his patent” (Omega Eng’g, FC 2003); “doctrine of prosecution disclaimer only applied to unambiguous disavowels” (Grober, FC 2012)). And “a court may look to extrinsic evidence, such as dictionaries and expert testimony, to ‘shed useful light on the relevant art’ and for a variety of other purposes” (Phillips, FC 2005) but “should discount any expert testimony ‘that is clearly at odds with the claim construction mandated by the…written record of the patent” (Key Pharm., FC 1998). The FC panel concluded the DC constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” was inconsistent with the intrinsic evidence (“logical reading of the claim…one matrix [cannot] be both hydrophilic and lipophilic”, specification (e.g., the “Background of the Invention”; “the matrix that is deemed the ‘lipophlic’ matrix cannot have hydrophilic properties”), and prosecution history (no unambiguous disavowels)). And “[a] court must identify ‘[t]he construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention’” (Phillips, FC 2005). Thus, the DC decision was reversed and remanded.

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