Cephalon, Inc., Acusphere, Inc. v. Abraxis Bioscience, LLC, Celgene Corp. et al.

Docket No. 2014-1422, -1442

June 17, 2015


Brief Summary: DC claim construction based on “widely accepted definition”, a textbook and expert testimony affirmed (patentees did not act as their own lexicographers).

Summary: Acusphere appealed DC construction of “nanoparticles”, “microparticles”, “nanoparticles and microparticles of a taxane”, and “wherein upon exposure to an aqueous medium, the matrix dissolves to leave the taxane nanoparticles and microparticles” of US RE40,493 (encompassing a fast-dissolving form of paclitaxel, a “porous matrix form which forms nanoparticles and microparticles of paclitaxel when the matrix is contacted with an aqueous medium”). It is explained that DC claim constructions are reviewed de novo but the underlying factual findings are reviewed for clear error (Teva, US 2015). The FC agreed with the DC construction of “nanoparticles” and “microparticles” based on the “widely accepted definition”, a textbook and expert testimony (“how the art underst[ands] [a] term…[is] plainly a question of fact”, Teva US 2015). Acusphere unsuccessfully argued “there is no universally agreed definition of the size of a nanoparticle”, the opinion noting that the DC’s finding was that the definition was “widely accepted” and not “universal” (Claim construction may “involve[] little more thant the application of the widely accepted meaning of commonly understood words.” Phillips, FC 2005). Acusphere argued that the claims provided a range (“nanoparticles and microparticles of a taxane, wherein the nanoparticles and microparticles have a mean diameter between about 0.01 to 5 μm”) different from the DC definition (i.e., they acted as their own lexicographers (Phillips)) but the FC concluded the claim “provid[es] only a single range (0.01 to 5 μm)” and “could, at most, define the size of either nanoparticles or microparticles, unless the two tersm are construed to have no difference in meaning.” Acusphere’s proposal that “the two terms should be construed as meaning ‘particles of taxane having a mean diameter between about 0.01 to 5 μm” was rejected, the FC noting that “construing the two terms to have no difference in meaning would render one of the terms superfluous, which is disfavored in claim construction” (Merck, FC 2005). In addition, claim 1 originally recited only microparticles and was amended to include nanoparticles to address a prior art rejection and Acusphere could not sufficiently explain that away. Acusphere also argued the DC definition is inconsistent with claim 6 (“wherein the mean diameter of the taxane microparticles is between about 0.50 and 5 μm”) but the FC agreed with the DC’s statement that “[a]ny inconsistency…is a product of Acusphere’s at times seemingly random omission of the term ‘nanoparticles’ in the patent” (“In any event, the lexicography exception requires the patent drafter to ‘clearly set forth a definition of the disputed claim term.” Aventis, FC 2012) (“inconsistent definitions” do not meet the requirement). Acusphere stipulated that infringement cannot be shown under this DC definition and this opinion therefore did not reach construction of the other terms.

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