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Enzo Biochem, Inc. v. Applera Corp.

United States District Court, D. Connecticut

February 22, 2016

ENZO BIOCHEM, INC., ENZO LIFE SCIENCES, INC. and YALE UNIVERSITY, Plaintiffs,
v.
APPLERA CORP. and TROPIX, INC., Defendants.

RULING ON PLAINTIFFS’ MOTION FOR ENTRY OF JUDGMENT AND DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Janet Bond Arterton, U.S.D.J.

This twelve-year old case is before this Court after a second remand from the Federal Circuit which vacated this Court’s finding of infringement and directed the Court to “determine, consistent with” the Federal Circuit’s analysis, “whether the accused product infringes.” Plaintiffs Enzo Biochem, Inc., Enzo Life Sciences, Inc. and Yale University (“Enzo”) now move [Doc. # 566] for entry of judgment on the current jury verdict, and Defendants Applera Corp. and Tropix, Inc. (“Applera”) move [Doc. # 568] for summary judgment. For the following reasons, Plaintiffs’ motion is denied and Defendants’ motion is granted.

I. Background

The parties’ familiarity with the background of this case is presumed. Briefly, Plaintiffs initiated this patent infringement suit in 2004, accusing Defendants of infringement of six patents, including United States Patent Nos. 5, 476, 928 (“‘928 patent”), 5, 449, 767 (“‘767 patent”), and 5, 328, 824 (“‘824 patent”), which cover various techniques and processes for detecting the presence of a particular strand of nucleic acids (i.e., DNA or RNA) in a sample. (See Compl. [Doc. # 1].) Relevant here, the ‘824, ‘928, and ‘767 patents disclose the invention of non-radioactive labeling and specify formation of a complex of hybridized[1] nucleotides and a detectable polypeptide.

Specifically, the ‘767 and ‘824 patents claim in part: “A method of detecting the presence or absence of a nucleic acid in a sample which comprises the steps of (a) contacting under hybridizable conditions said sample with at least one compound comprising the structure [DIAGRAM] wherein A comprises at least three carbon atoms and represents at least one component of a signaling moiety capable of producing a detectable signal . . . .” (Claim Construction Ruling [Doc. # 137] at 5 (quoting ‘824 Pat. 30:49-31:29).) The parties disputed whether this language should be read to encompass both direct and indirect identification systems or only indirect systems.[2] On October 13, 2006, following a Markman hearing, this Court issued its Claim Construction Ruling [Doc. # 137], finding in Plaintiffs’ favor that the patents cover both direct and indirect detection.

Thereafter, on September 6, 2007, the Court entered summary judgment [Doc. # 261] in favor of Defendants. Plaintiffs appealed, and in a March 26, 2010 decision, the Federal Circuit reversed this Court’s judgment that the ‘767, ‘824, and ‘928 patents are invalid for indefiniteness and that the ‘767 and ‘824 patents are invalid as anticipated, and affirmed the Court’s judgment that the ‘928 patent is invalid as anticipated. Enzo Biochem Inc. v. Applera Corp. (Enzo II), 599 F.3d 1325 (Fed. Cir. 2010). On remand, this Court denied [Doc. # 418] Applera’s motion for summary judgment on infringement and equitable defenses. Plaintiffs waived their claims for infringement of the ‘824 patent and limited their assertion of the ‘767 patent to claims 1, [3] 8, [4] 67, [5] 68, [6] and 70, [7] and the case proceeded to trial.

Following seven days of evidence, the jury returned a verdict finding that Defendants’ accused BigDye and dRhodamine dye-terminator products directly infringed, and induced customers to infringe, claims 1, 8, 67, 68, and 70 by Defendants’ manufacture, use, or sale of their reagent products and sales of DNA sequencing instruments. (See Jury Verdict [Doc. # 476].) The jury rejected Defendants’ invalidity defenses of lack of written description, lack of enablement, and anticipation, and issued two advisory findings that (1) Enzo had not unreasonably delayed in filing suit, and (2) ABI was not materially prejudiced by the delay in filing this lawsuit. (Id.) The jury awarded Enzo $48, 587, 500.00 in reasonable royalty damages. (Id.) Judgment [Doc. # 544] entered in Plaintiffs’ favor on January 7, 2014. Defendants appealed.

On appeal, Defendants raised three issues: (1) “[w]hether the finding of infringement should be reversed because, contrary to the district court’s claim construction, the ‘767 patent does not cover the directly detectable terminator nucleotides of the accused products”; (2) “[w]hether, assuming the ‘767 patent covers direct detection, the patent is invalid for lack of written description because nothing in the specification describes possession of directly detectable nucleotides, and the only disclosure of such nucleotides is prior art which presented problems overcome by the described indirectly detected nucleotides”; and (3) “[w]hether, assuming the ‘767 patent covers directly detectable nucleotides, the patent is invalid for lack of enablement because nothing in the specification explains how to make or use a directly detectable nucleotide other than certain prior art detection systems, which presented problems overcome by the enabled indirect detection methods.” (Defs.’ Opening Br., Ex. 1 to Stone Decl. at 16.[8])

The Federal Circuit began by reciting the language of claim 1, which it stated was “representative.” Enzo II, 599 F.3d at1152. The entirety of the court’s discussion then focused on construing the language of claim 1, at the end of which the court concluded that “as claim 1 is limited to indirect detection by its own plain meaning, it would be inappropriate to use the doctrine of claim differentiation to broaden claim 1 to include a limitation imported from a dependent claim, such as direct detection.” Id. at 1157. The court therefore held that this Court “erred in construing the disputed claims of the patent-in-suit to cover both direct and indirect detection, ” and reversed this Court’s “claim construction, vacate[d]” the Court’s “finding of infringement, ” and “remand[ed]” to the Court “with instruction to determine, consistent with the analysis in this opinion, whether the accused product infringes.” Id.

II. Discussion

The parties’ motions raise several distinct issues pertaining to claims 67, 68, and 70 on the one hand, and claims 1 and 8 on the other. These arguments are discussed in turn below.

A. Claims 67, 68, and 70

With respect to claims 67, 68, and 70, the parties’ briefs attempt to reason through the Federal Circuit’s somewhat cryptic mandate and its effect on claims 67, 68, and 70. The confusion arises because while Defendants raised the issue on appeal of whether any of the claims of the ‘767 patent cover direct detection (in Defendants’ words, whether the “‘767 patent . . . cover[s] the directly detectable terminator nucleotides of the accused products” (Defs.’ Opening Br. at 16)), the Federal Circuit’s opinion analyzes only the language of claim 1, before concluding that “[t]he district court erred in construing the disputed claims of the patent-in-suit to cover both direct and indirect detection, ” Enzo II, 599 F.3d at 1157 (emphasis added).

Plaintiffs contend that the Court should enter judgment in its favor on claims 67, 68, and 70 because the jury already found that the accused products infringed those claims, and that finding is not affected by the Federal Circuit’s decision. (See Pls.’ Mem. Supp. Mot. for Entry of J. [Doc. # 567] at 13.) According to Plaintiffs, the Federal Circuit construed only claim 1, leaving the scope of claims 67, 68, and 70 unchanged. (See id.) Although Plaintiffs acknowledge that under this theory, claims 67, 68, and 70 are broader than claim 1, [9] from which they depend, in violation of 32 U.S.C. § 112 ¶ 4, [10] they argue that Defendants have waived this defense by not raising it earlier, and that if the Federal Circuit thought otherwise, it would have remanded for a determination of invalidity rather than of infringement. (See Id. at 14-16.) Indeed, Plaintiffs assert, in light ...


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