Roxane Laboratories, Inc. v. Camber Pharmaceuticals, Inc. et al.

Docket No. 2016-1028

November 17, 2016


Brief Summary: DC claim construction regarding the claimed capsule size and decision to transfer affirmed.

Summary: Roxane appealed from a stipulated judgment of noninfringement of its US 8,563,032 relating to calcium acetate capsule formulations based on construction of the claim term “size 00 or less” and an earlier decision transferring the case from OH to NJ. Camber uses a “size 00el” capsule which “has the same diameter as a standard size 00 capsule, but has a greater length and larger fill volume.” The DC “examined the intrinsic record of the ‘032 patent and concluded that the meaning of ‘size 00 or less’ is unambiguous,’ that ‘nothing in the patent…suggests that the applicants understood ‘size 00’ to mean a family of capsule sizes’ that included both standard and elongated size 00 capsules, and that the intrinsic record consistently indicated that ‘size 00’ refers to a single capsule size with a specific weight and fill capacity.” Based on this construction, Roxane stipulated to the noninfringement judgment. The FC panel explained that it reviews a DC’s ultimate claim constructions de novo and any underlying factual determinations involving extrinsic evidence for clear error” (Teva, US 2015; no extrinsic evidence here so construction is reviewed de novo (Shire Dev., FC 2015)). The meaning of claim terms in an issued patent “are generally given their ordinary and customary meaning” but, where the “meaning is…not readily apparent”, may be considered in view of the specification and prosecution history (Phillips, FC 2005). Roxane argued that “nowhere in the intrinsic record did the patentee redefine ‘size 00’ as an indicator of anything other than capsule diameter, and that the patentees did not discuss elongated capsules or consider them as constituting a separate size”, that the DC “ignored the ‘pharmaceutically acceptable’ claim language [relating to] capsule diameter”, and “that its proposed construction is supported by extrinsic evidence.” The FC panel was not convinced, however, and agreed with the DC based on the ‘032 patent written description (“refers to ‘size 00’ twice”, both “having the same weight” (the opinion noting the while “an empty size 00e1 capsule [has] the same diameter”, it has a “different length[] and presumably different weight[]”) and prosecution history (PH). Regarding the PH, the FC panel explained that “the Examiner relied only on Torpac as evidence of capsule sizes and referred to the fill volume of non-elongated size 00 capsules, 0.95 mL, in his analysis”, which “the applicants did not dispute”, Roxane submitted declarations regarding “a particular fill capacity”, and its Reply Brief that “emphasized the claim 1 does not cover capsules that are larger and have more fill capacity than ‘size 00’”. The FC panel also concluded the DC did not abuse its discretion in transferring the case because “the relevant factors, including Roxane’s choice of forum, the location of the complained-of activity, the location and ease of access to sources of proof, and the convenience of all parties in the lawsuit” were considered and determined to be balanced in favor of transfer. Thus, the DC decision was affirmed.

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