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Cellectis S.A. v. Precision Biosciences, Inc.

United States District Court, D. Delaware

April 9, 2013

CELLECTIS S.A., Plaintiff,
v.
PRECISION BIOSCIENCES, INC. AND PRECISION PLANTSCIENCES, INC., Defendants

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[Copyrighted Material Omitted]

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[Copyrighted Material Omitted]

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Chad M. Shandler, Esquire of Richards, Layton & Finger LLP, Wilmington, Delaware, Counsel for Plaintiff. Of Richard L. DeLucia, Esquire, Paul M. Richter, Jr., Esquire and Anne Elise Herold Li, Esquire of Kenyon & Kenyon LLP.

Richard L. Horwitz, Esquire and David E. Moore, Esquire of Potter Anderson & Corroon LLP, Wilmington, Delaware, Counsel for Defendants. Of David B. Bassett, Esquire, and Vinita Ferrera, Esquire of Wilmer Cutler Pickering Hale and Dorr LLP.

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MEMORANDUM OPINION

SUE L. ROBINSON, District Judge.

I. INTRODUCTION

Plaintiff Cellectis S.A. (" Cellectis" ) filed the present action against defendant Precision Biosciences, Inc. (" Precision" ) on March 1, 2011, alleging infringement of U.S. Patent No. 7,897,372 (" the '372 patent" ), which is assigned to Cellectis. (D.I. 1) Precision answered the complaint on March 23, 2011 and counterclaimed against Cellectis for non-infringement and invalidity of the '372 patent. (D.I. 10) Cellectis answered the counterclaims on April 18, 2011. (D.I. 21) Cellectis amended the complaint the same day, alleging unfair competition and violations of the Lanham Act, 15 U.S.C. § 1125(a), each relating to allegedly false and misleading commercial representations on Precision's website. (D.I. 22) On May 5, 2011, Precision answered the amended complaint, adding a third affirmative defense that Cellectis is barred from relief " in whole or in part by laches, estoppel and/or other equitable doctrines," and asserting counterclaims.

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(D.I. 27) On June 3, 2011, Cellectis answered the counterclaims in the amended answer. (D.I. 28) Precision's motion for leave to amend its answer and counterclaims to add allegations of inequitable conduct in the procurement of the '372 patent was denied. (D.I. 113; D.I. 170) On October 24, 2012, after leave to file an amended complaint adding Precision PlantSciences, Inc. (hereinafter, collectively with Precision Biosciences, Inc., " Precision" ) as a defendant was granted (D.I. 202), Cellectis filed a supplemental amended complaint (D.I. 203), which Precision answered on November 14, 2012 (D.I. 205).

Presently before the court are several motions for summary judgment: Cellectis' motion for summary judgment of infringement (D.I. 222) and Precision's cross-motion for summary judgment of no literal infringement of the '372 patent (D.I. 227); and Cellectis' motion for summary judgment of no invalidity for anticipation (D.I. 233). Cellectis' motion to exclude testimony by Precision's expert is also pending. (D.I. 231) The court has jurisdiction pursuant to 28 U.S.C. § § 1331 and 1338(a).

II. BACKGROUND

A. Parties

Cellectis is a publicly-traded biotechnology company in the field of genetic engineering, particularly in the use of meganucleases as innovative tools to enable targeted modifications to DNA. (D.I. 22 at ¶ ¶ 10-11; D.I. 27 at 7 ¶ 7) Cellectis was founded in 1999 and is incorporated and headquartered in France. (D.I. 22 at ¶ ¶ 1, 10)

Precision is a privately-held biotechnology company that also has as its focus the development and commercialization of engineered endonucleases. (D.I. 27 at 6 ¶ 6) It was founded in 2006 and is a Delaware corporation with its principal place of business in North Carolina. (D.I. 22 at ¶ 2; D.I. 27 at 6 ¶ ¶ 1,6)

B. The '372 Patent

The '372 patent, entitled " I-Crel Meganuclease Variants with Modified Specificity, Method of Preparation and Uses Thereof," is directed to particular mutated I-Crel [1] meganucleases that bind and cleave DNA at specific sites. (D.I. 1 at ¶ 8 & ex.1) The '372 patent issued from U.S. Patent Application Serial No. 11/908,798 (" the '798 application" ), the U.S. phase application under 35 U.S.C. § 271 of PCT No. PCT/IB2006/001203, filed March 15, 2006 (hereinafter, the " Parent PCT" ). The Parent PCT, in turn, claimed priority to two foreign applications: (1) PCT/IB2005/000981 (March 15, 2005); and (2) PCT/IB2005/003083 (September 19, 2005). The '372 patent names two inventors: Philippe Duchateau and Frederic Paques.

For the present motions, Cellectis asserts that Precision infringes claim 40, which depends from claim 37 (D.I. 223 at 4), and that claims 37, 40, 42, 44, 46, 50, and 52 are not anticipated (D.I. 234 at 1).

III. CLAIM CONSTRUCTION

Claim construction is a matter of law. Phillips v. AWH Corp., 415 F.3d 1303, 1330 (Fed. Cir. 2005) (en banc). Claim construction focuses on intrinsic evidence - the claims, specification and prosecution history - because intrinsic evidence is " the most significant source of the legally operative meaning of disputed claim language." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996); Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Claims must be interpreted from the perspective of one of ordinary skill in the relevant art at the time of the invention. Phillips, 415 F.3d at 1313.

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Claim construction starts with the claims, id. at 1312, and remains centered on the words of the claims throughout. Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001). In the absence of an express intent to impart different meaning to claim terms, the terms are presumed to have their ordinary meaning. Id. Claims, however, must be read in view of the specification and prosecution history. Indeed, the specification is often " the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315.

A. " [M]onomer of an I-Crel meganuclease variant comprising at least one mutation in the amino acid sequence of SEQ ID NO: 70, wherein said at least one mutation comprises a substitution at one or more of the amino acids residues at positions 44, 68 and 70 and said monomer further comprises at least one additional mutation of an amino acid residue directly contacting a DNA target sequence wherein said amino acid residue directly contacting a DNA target sequence is selected from the group consisting of positions 26, 28, 30, 32,33 and 38 modified DNA cleavage specificity relative to the I-Crel meganuclease of SEQ ID NO: 70 in at least one nucleotide in the 3 to 5 triplets"

The court declines to construe the first phrase of independent claim 37, " monomer of an I-Crel meganuclease variant," without the context of the remainder of the claim. While the term comprising is open-ended, the Federal Circuit has held that the term " comprising" may not alter the scope of the claim. Spectrum Int'l, Inc. v. Sterilite Corp., 164 F.3d 1372, 1380 (Fed. Cir. 1998) (" 'Comprising' is not a weasel word with which to abrogate claim limitations.'" ). The patent specification teaches that " other mutations that do not alter the cleavage activity of the variant are not indicated and the nomenclature here does not limti the mutations to the only three positions 44, 68, and 70." ('372 patent, 5:51-54; see also 17:4-14 (describing a variant as " contain[ing] mutations that do not alter its activity" ))

In light of the specification, the court finds that the claim does not encompass limitless mutations [2] and, instead, construes this limitation to mean: " A polypeptide of an I-Crel meganuclease variant, which polypeptide has the amino acid sequence of SEQ ID NO: 70 in which from 1-3 of the amino acids corresponding to positions 44, 68, and 70 of wild-type I-Crel and from 1-6 of the amino acids corresponding to positions 26, 28, 30, 32, 33, and 38 of wild-type I-Crel have been substituted with different amino acids. The claimed polypeptide, when in a dimeric form, is able to cleave DNA. Consistent with the word 'comprising,' the scope of the claim may include other mutations that do not alter the cleavage activity of the variant."

The parties have defined " monomer" as " a molecular building block - e.g.

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a polypeptide - that can be associated with another to form a larger molecule." (D.I. 164) Precision's expert now explains that a single-chain meganuclease includes two domains (not monomers) in order to separate the terms " monomer" and " domain." [3] (D.I. 128 at ex.1 ¶ 66 & n.4; D.I. 230 at ¶ ¶ 11-15) The difference in usage of these terms is not clear cut. When describing the heterodimeric form, the patent specification refers to an I-Dmol monomer (I-Dmol is considered a single-chain meganuclease). ('372 patent, 6:61-7:3) The specification also refers to a heterodimer as " a single-chain chimeric molecule consisting of the fusion of two different I-Crel variants . . . [or] two separate monomers chosen from two different I-Crel variants . . . ." ('372 patent, 10:26- 21) Several of the scientific references cited in the record indicate that one of skill in the art would understand the '372 patent to teach a single-chain meganuclease made up of two " monomers" to be the same as one made up of two " domains." [4] ( See e.g., D.I. 178 at exs. E ...


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