Cephalon, Inc. v. Celgene Corp.

985 F. Supp. 2d 171, 2013 WL 6234582, 2013 U.S. Dist. LEXIS 170676
CourtDistrict Court, D. Massachusetts
DecidedDecember 3, 2013
DocketCivil Action No. 11-12226-RGS
StatusPublished
Cited by1 cases

This text of 985 F. Supp. 2d 171 (Cephalon, Inc. v. Celgene Corp.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Cephalon, Inc. v. Celgene Corp., 985 F. Supp. 2d 171, 2013 WL 6234582, 2013 U.S. Dist. LEXIS 170676 (D. Mass. 2013).

Opinion

[174]*174MEMORANDUM AND ORDER ON CLAIM CONSTRUCTION

STEARNS, District Judge.

Acusphere, Inc., and its exclusive licensee Cephalon, Inc. (collectively, Acusphere), brought this lawsuit against Celgene Corp. and Abraxis BioScience, LLC (collectively, Celgene),1 alleging that Celgene’s antitumor drug Abraxane infringes U.S. Patent RE40, 493, “Porous Paclitaxel Matrices and Methods of Manufacture Thereof’ (the '493 patent). To resolve the dispute over the reach of the '493 patent, the parties ask the court to construe the meaning of eleven of the patent’s asserted claims. A hearing on the joint request was held on August 28, 2013.

BACKGROUND

The '493 patent teaches a pharmaceutical composition of paclitaxel that dissolves more than a thousand times faster than non-formulated paclitaxel. Paclitaxel is a taxane compound extracted from the bark of the Pacific yew tree. Taxanes are chemotherapeutic agents that slow the spread of tumor cells in the body by inhibiting cell division. Taxanes, however, are nearly indissoluble in water, making dosages difficult to administer without causing extreme discomfort. The prior formulation of paclitaxel required several hours to infuse and contained Cremophor — a solubizing agent that can cause severe allergic reactions. The '493 patent teaches a remedy for insolubility by integrating paclitaxel (or another taxane) into a dry, porous matrix containing pharmaceutical excipients. Immersed in water, the matrix releases nanoparticles and microparticles of paclitaxel. These particles, in turn, exhibit increased aqueous solubility and dissolve rapidly when diluted in a parenteral fluid medium prior to intravenous injection.

CLAIM CONSTRUCTION

Legal Standards

Claim construction is a question of law for the court’s determination. Markman v. Westview Instruments, Inc., 52 F.3d 967, 970-971 (Fed.Cir.1995) (en banc). In performing the required analysis, the court first looks to the language of the claims themselves. “It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005) (internal quotation marks and citation omitted). A claim term is to be construed in accordance with its “ordinary and customary meaning,” which is the “meaning that the term would have to a person of ordinary skill in the art [PHOSITA] in question at the time of the invention, i.e. as of the effective filing date of the patent application.” Id. at 1312. The ordinary and customary meaning of a claim term is determined “in the context of the entire patent, including the specification.” Id. at 1313.

Because the purpose of the specification is to teach one skilled in the art the process for replicating the invention, the specification will, in most cases, be “ ‘dispositive; it is the single best guide to the meaning of a disputed term.’ ” Id. at 1315, quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996). “[T]he specification may reveal a special definition given to a claim term by a patentee that differs from the meaning it [175]*175would otherwise possess.” Id. at 1316. However, “the written description in such a case must clearly redefine a claim term so as to put a reasonable competitor or one reasonably skilled in the art on notice that the patentee intended to so redefine that claim term.” Elekta Instrument S.A. v. O.U.R. Scientific Int’l, Inc., 214 F.3d 1302, 1307 (Fed.Cir.2000) (internal quotations and citation omitted). “Absent an express intent to impart a novel meaning, claim terms take on their ordinary meaning.” Id.

The final element of intrinsic evidence to which a court may turn for guidance is the prosecution history of the patent. While it may not be as reliable as the specification, the prosecution history “can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be.” Phillips, 415 F.3d at 1317. “Where an applicant argues that a claim possesses a feature that the prior art does not possess in order to overcome a prior art rejection, the argument may serve to narrow the scope of otherwise broad claim language.” Seachange Int’l, Inc. v. C-COR Inc., 413 F.3d 1361, 1372-1373 (Fed.Cir.2005).

Disputed Terms

The disputed terms are part of all asserted claims. Independent Claim 1 of the '493 patent is representative.

A pharmaceutical composition comprising a porous matrix formed of a hydrophilic excipient, a wetting agent and nanoparticles and microparticles of a taxane, wherein the nanoparticles and microparticles have a mean diameter between about 0.01 and 5|jim and a total surface area greater than about 0.5m 2 /mL, wherein the porous matrix is in a dry powder form, and wherein upon exposure to an aqueous medium, the matrix dissolves to leave the taxane nanoparticles and microparticles, wherein the dissolution rate of the taxane nanoparticles and microparticles in an aqueous solution is increased relative to unprocessed taxane.

A. “Nanoparticles” and “Microparticles”

All of the asserted claims require a matrix formed of, inter alia, “nanoparticles and microparticles of taxane ... havfing] a mean diameter between about 0.01 and 5m....” Acusphere argues that because there are no universally accepted size ranges distinguishing nanoparticles from microparticles, it acted as its own lexicographer for purposes of the '493 patent in assigning the particles an undifferentiated diameteric range. Celgene responds that for a PHOSITA, the terms refer to two distinct types of particles, differentiated from one another by size, with nanopartieles being the smaller of the two. Celgene argues that in ordinary usage, nanoparticles are understood to have a diameter between 1 and 1,000 nanometers (nm), while microparticles have a diameter between 1 to 1,000 microns (|rm). Moreover, according to Celgene, Acusphere’s lexicographic argument conflates the diameters of particles in a composition with the mean diameter of the population, which renders any distinction between nanoparticles and microparticles in the claims meaningless. As Celgene sees it, “a mean diameter value does not inform a PHOSITA about the size of any particle in a composition, and therefore cannot define whether a composition contains nanoparticles, microparticles, or both.” Def.’s Reply Br. at 1-2. Stated another way, if “nanoparticles and microparticles” are de[176]*176fined indistinguishably by their mean diameter, the population could theoretically be comprised entirely of nanoparticles or microparticles, contrary to the conjunctive language of the claim.

Finally, Celgene argues that the prosecution history contradicts Acusphere’s proposed construction.

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Related

Cephalon, Inc. v. Abraxis Bioscience, LLC
618 F. App'x 663 (Federal Circuit, 2015)

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Bluebook (online)
985 F. Supp. 2d 171, 2013 WL 6234582, 2013 U.S. Dist. LEXIS 170676, Counsel Stack Legal Research, https://law.counselstack.com/opinion/cephalon-inc-v-celgene-corp-mad-2013.