Judge Stearns construed claims in two patents owned by Fresenius Medical Care Holdings, Patent Nos. 6,576,665 and 6,875,445, directed to a calcium acetate drug product for containing hyperphosphatemia in patients suffering from chronic renal failure. The claim construction applies to two consolidated ANDA cases brought by Fresenius against generic drug manufacturers.
The most noteworthy of the claim construction disputes centers around the term “capsule” and whether “capsule” should necessarily mean a capsule of a certain numerical size category.
The plaintiff argued that the independent claims place no restrictions on a capsule’s size and supported its argument through claim differentiation between the independent claim and size category limiting dependent claims. The defendant argued that the language in the specification touting the size benefits of the invention (allowing smaller pills swallowable by renal failure patients) ought to be included in the claim construction.
The court declined to assign a numerical size range to the term “capsule,” noting no clear disavowal of claim scope (and relying on the generic “other variations and modifications may be made” language ubiquitous in patent applications). The court did, however, note that the plaintiff argued size benefits to the Examiner, which appeared to affect the Examiner’s decision to allow the claims. Thus the court ruled that “capsule” was limited to having “a size range consistent with what a human patient with chronic renal failure can manipulate and swallow.” The court left the application of that construction to the jury based on medical evidence presented at trial.
Fresenius Medical Care Holdings, Inc. v. Paddock Labs, Inc., 09-11130-RGS (D. Mass. Oct. 6, 2010)Fresenius Medical Care Holdings, Inc. v. Amneal Pharmaceuticals, LLC., 10-11429-RGS
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