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Enzo Life Sciences Inc. v. Hologic Inc.

United States District Court, D. Delaware

October 15, 2018


          Brian E. Farnan, Michael J. Faman, FARNAN LLP, Wilmington, DE John M. Desmarais, Michael P. Stadnick, Justin P.D. Wilcox, Jordan Malz, Peter C. Magic, Kerri-Ann Limbeek, DESMARAIS LLP, New York, NY Attorneys for Plaintiff Enzo Life Sciences, Inc.

          Karen L. Pascale, Pilar G. Kraman, YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, DE Matthew M. Wolf, ARNOLD & PORTER KAYE SCHOLER LLP, Washington, DC Jennifer Skelnar, Wallace Wu, ARNOLD & PORTER KAYE SCHOLER LLP, Los Angeles, CA Marty Koresawa, ARNOLD & PORTER KAYE SCHOLER LLP, San Francisco, CA Attorneys for Defendants Hologic Inc., Grifols Diagnostics Solutions, Inc., and Grifols, S.A.



         Plaintiff Enzo Life Sciences, Inc. ("Plaintiff) sued Defendants Hologic, Inc., Grifols Diagnostics Solutions, Inc., and Grifols S.A. (collectively, "Defendants"), alleging that Defendants infringe Plaintiffs U.S. Patent No. 6, 221, 581 ('"581 patent"). (See generally D.I. 28-1) The patent relates to "[n]uclei acid hybridization assays" that are "detection processes in which target polynucleotides can be detected or the presence or absence of genetic mutations or defects in genetic material can be determined" using "[d]ouble hybrid or multihybrid probes." '581 patent, Abstract; 1:26-31.

         Presently before the Court are the parties' disputes over the meaning of certain claim terms in the asserted claims. The parties submitted technology tutorials (D.I. 88, 89), comments on the opposing side's technology tutorial (D.I. 96, 99), and claim construction briefs (D.I. 83, 84, 95, 97). The Court held a claim construction hearing on July 2, 2018. (See D.I. 115 ("Tr.")) Thereafter, on August 17, the parties provided their updated positions on one disputed term. (D.I. 127)



         The ultimate question of the proper construction of a patent is a question of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015) (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "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 omitted).

         "[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324. Instead, the Court is free to attach the appropriate weight to appropriate sources "in light of the statutes and policies that inform patent law." Id.

         "[T]he words of a claim are generally given their ordinary and customary meaning [which is] the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). The patent specification "is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

         While "the claims themselves provide substantial guidance as to the meaning of particular claim terms," the context of the surrounding words of the claim also must be considered. Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment. . . [b]ecause claim terms are normally used consistently throughout the patent." Id. (internal citation omitted).

         It is likewise true that "[differences among claims can also be a useful guide. . . . For example, the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15 (internal citation omitted). This "presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).

         It is also possible that "the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven when the specification describes only a single embodiment, the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).

         In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence," "consists of the complete record of the proceedings before the PTO [Patent and Trademark Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317. "[T]he 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." Id.

         In some cases, "the district court will need to look beyond the patent's intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period." Teva, 135 S.Ct. at 841. Extrinsic evidence "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to collect the accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of skill in the art, or to establish that a particular term in the patent or the prior art has a particular meaning in the pertinent field." Id. Nonetheless, courts must not lose sight of the fact that "expert reports and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90 F.3datl583).

         Finally, "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction." Renishaw PLC v. Marposs Societa'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Osram GmbH v. Int'l Trade Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (quoting Modine Mfg. Co. v. U.S. Int'l Trade Comm'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).


         A patent claim is indefinite if, "viewed in light of the specification and prosecution history, [it fails to] inform those skilled in the art about the scope of the invention with reasonable certainty." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2129 (2014). A claim may be indefinite if the patent does not convey with reasonable certainty how to measure a claimed feature. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1341 (Fed. Cir. 2015). But "[i]f such an understanding of how to measure the claimed [feature] was within the scope of knowledge possessed by one of ordinary skill in the art, there is no requirement for the specification to identify a particular measurement technique." Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d 1312, 1319 (Fed. Cir. 2015).


         The '581 patent is entitled "Processes for Detecting Polynucleotides, Determining Genetic Mutations or Defects in Genetic Material, Separating or Isolating Nucleic Acid of Interest from Samples, and Useful Compositions of Matter and Multi-hybrid Complex Compositions." The claimed invention relates to "methods for the detection of a target genetic material having a desired base sequence or gene" and "methods for the detection of mutations, such as a point mutation or the detection of a gene or base." '581 patent, 1:18-23. It is "based upon techniques which utilize two labeled single stranded polynucleotide segments which are complementary to the same or the opposite strands of the target genetic material." Id. 1:24-27. According to the patent, this process "result[s] in the formation of a double hybrid and/or a multihybrid." Id. 1:27-29.

         A. "A multihybrid complex composition which comprises three or more nucleic acid strands and two or more separate and mutually exclusive hybrids in said complex"[2]/"A process for forming the multihybrid complex composition of claim 123"[3]

Plaintiff the preamble is not limiting

Defendants the preamble is limiting

Court the preamble is limiting

         Plaintiff argues that the preamble is not limiting because "the body of claim 123 provides a structurally complete formulation of the invention" (D.I. 84 at 4) and the preamble "is not necessary to understand[ing] the [claim] limitations" (D.I. 97 at 2). Defendants argue that the preamble is limiting because it provides an antecedent basis for an element recited in the body of the claim and "breathes 'life and meaning' into the claimed invention" (D.I. 83 at 4), as the "purported invention was a particularly defined multihybrid composition, not a generic composition with multiple hybrids" (D.I. 95 at 3).

         "A preamble is generally construed to be limiting if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim." Proveris Sci. Corp. v. Innovasystems, Inc., 739 F.3d 1367, 1372 (Fed. Cir. 2014) (internal quotation marks omitted). A preamble may be construed as limiting "when it recites particular structure or steps that are highlighted as important by the specification" and when "limitations in the body of the claim rely upon and derive antecedent basis from the preamble, [which] then . . . may act as a necessary component of the claimed invention." Id.[4]

         In the patent-in-suit, formation of a "multihybrid complex" is an important characteristic of the invention. It is mentioned in the title ("multihybrid complex compositions") and the abstract ("Double hybrid or multihybrid probes and compositions are usefully combined with capture assay and immobilization to provide for detection processes . . . ."). All three of the patent's figures illustrate the formation of a multihybrid and describe it as essential to the claimed invention. See '581 patent, Fig. 1 (showing "[h]ybridization to form the multihybrid" as final step); id. Fig. 2 (same); id. Fig. 3 (same); see also Id. 2:45-3:18 ("Brief description of the Figures" describing figures depicting various embodiments and noting, "[w]hen the method of the invention is carried out. . . numerous single stranded polynucleotide segments . . . hybridize ... to form the multihybrid").

         Additionally, the specification expressly defines the multihybrid and makes numerous references to it. See Id. 3:38-44 ("double hybrid can be interconnected so as to form a multihybrid (hereinafter referred to as the 'multihybrid')"); see also, e.g., Id. 5:37-43 ("formation of the multihybrid due to the particles bridging the double hybrids . . . [that] forms a precipitate or glob or glob-like structure which itself is much more readily detectable than the double hybrid"); id. 12:26-50 (explaining how invention can be used to detect different types of ...

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