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Integra LifeSciences Corp. v. Hyperbranch Medical Technology, Inc.

United States District Court, D. Delaware

February 20, 2018




         In this action filed by Plaintiffs Integra LifeSciences Corp. ("Integra"), Integra LifeSciences Sales LLC ("Integra Sales"), Confluent Surgical, Inc. ("Confluent") and Incept LLC ("Incept, " and collectively with Integra, Integra Sales and Confluent, "Plaintiffs") against Defendant HyperBranch Medical Technology, Inc. ("Defendant" or "HyperBranch"), Plaintiffs allege infringement of United States Patent Nos. 7, 009, 034 (the '"034 patent"), 7, 332, 566 (the '"566 patent"), 7, 592, 418 (the '"418 patent"), 8, 003, 705 (the '"3705 patent") and 8, 535, 705 (the '"5705 patent") (collectively, the "patents-in-suit" or "asserted patents").[1] Presently before the Court is HyperBranch's motion for summary judgment of non-infringement of claims 1, 6, 12 and 17 of the '5705 patent (the "Motion"). (D.I. 393)[2] The Court recommends that HyperBranch's Motion be GRANTED.

         I. BACKGROUND

         A. The Parties

         Integra is involved in the design, development and manufacturing of medical devices for orthopedics, tissue technologies and speciality surgical solutions, with an emphasis on products that help heal and/or regenerate tissue. (D.I. 1 at ¶ 7) Integra Sales sells and distributes Integra's medical technology products, including Integra's dural sealant products. (Id. at ¶¶ 8, 25) Integra and Integra Sales are affiliates of Confluent, which is a medical device company that has developed in-situ polymerized biomaterials with applications as synthetic sealants and hemostats in minimally invasive surgery, adhesion prevention and interventional procedures. (Id. at ¶¶ 5, 9) Incept is a medical technology company that promotes and advances technological innovation and entrepreneur ship. (Id. at ¶ 10) The asserted patents "relate to Integra's and Integra Sales' dural sealant products and technology, particularly those used by neurosurgeons and orthopedic spine surgeons." (Id. at ¶ 25) Integra, Integra Sales and Confluent are the exclusive licensees of the asserted patents, and Incept owns them by assignment. (Id. at ¶¶ 11-16; D.I. 35, ex. 1 at ¶ 5)

         Defendant HyperBranch is a medical device company that is involved in the business of designing, developing, manufacturing and selling surgical sealants. (D.I. 1 at ¶ 19; D.I. 25 at ¶ 2; D.I. 37 at ¶ 19) In this action, Plaintiffs allege that HyperBranch directly and indirectly infringes the asserted patents by, inter alia, the manufacture, use, sale, and offers to sell of HyperBranch's Adherus Dural Sealant, Adherus Spinal Sealant, Adherus AutoSpray Dural Sealant, and Adherus AutoSpray Extended Tip (ET) Dural Sealant (the "Accused Products"). (D.I. 1 at ¶¶ 28, 35, 42, 49, 56; D.I. 402 at vii-viii)

         B. The '5705 Patent

         The '5705 patent, entitled "Biocompatible Polymers and Hydrogels and Methods of Use" was issued on September 17, 2013, with the application having been filed on November 16, 2007. (D.I. 246, ex. F)[3] The patent contains 18 claims directed to methods of making a biocompatible degradable hydrogel. ('5705 patent, cols. 30:34-32:19) Plaintiffs assert claims 1, 6, 12 and 17 of the '5705 patent. (See D.I. 402 at ix)

         Claim 1 of the '5705 patent, the only independent claim, is representative, and it recites:

1. A method of making a biocompatible degradable hydrogel to treat a medical condition of a patient comprising:
identifying a medical condition for treatment by use of a hydrogel formed in situ in a patient and fully degradable in a patient in less than about 180 days; and mixing a first precursor with a second precursor in situ in the patient to form the hydro gel for treatment of the medical condition, with the first biocompatible synthetic hydrophilic polymer precursor having a water solubility of at least 1 gram per 100 milliliters and comprising at least two electrophilic functional groups; and the second biocompatible synthetic hydrophilic polymer precursor comprising at least two nucleophilic amine functional groups; and wherein
(i) the first precursor is selected to have only one or two chemically hydrolytically degradable ester bonds per every electrophilic functional group on the first precursor; and
(ii) the second precursor comprises at least three nucleophilic functional groups; wherein the biodegradable groups of the hydrogel consist of the esters and the hydrogel as placed in situ in the patient is essentially fixlly degradable in a patient in less than about 180 days, and wherein mixing the first and the second synthetic hydrophilic polymer precursors forms crosslinking covalent bonds that are reaction products of the electrophilic and the nucleophilic groups, wherein essentially every ester bond in the hydrogel is separated from other ester bonds in the hydrogel by at least three covalent bonds when the hydrogel is formed.

('5705 patent, col. 30:34-65 (emphasis added))

         C. Procedural History

         Plaintiffs filed the instant case on September 15, 2015. (D.I. 1) On September 25, 2015, Chief Judge Leonard P. Stark referred this case to the Court to hear and resolve all pretrial matters, up to and including the resolution of case-dispositive motions. (D.I. 15)

         Briefing on the instant Motion was completed on December 21, 2017, (D.I. 463), and the Court heard oral argument on the Motion (and various other summary judgment and Daubert motions filed in the case) on January 5, 2018, (D.I. 482 (hereinafter, "Tr.")). A 7-day trial is set to begin on April 16, 2018. (D.I. 173)


         A. Summary Judgment

         A grant of summary judgment is appropriate where "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). The moving party bears the burden of demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-86 n.10 (1986). If the moving party meets this burden, the nonmovant must then "come forward with specific facts showing that there is a genuine issue for trial." Id. at 587 (emphasis in original) (internal quotation marks and citation omitted). If the nonmoving party fails to make a sufficient showing on an essential element of its case with respect to which it has the burden of proof, the moving party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). During this process, the Court will "draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150 (2000).

         However, in order to defeat a motion for summary judgment, the nonmoving party must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita, 475 U.S. at 586-87; see also Podobnik v. U.S. Postal Serv., 409 F.3d 584, 594 (3d Cir. 2005) (party opposing summary judgment "must present more than just bare assertions, conclusory allegations or suspicions to show the existence of a genuine issue") (internal quotation marks and citation omitted). The "mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986) (emphasis in original): Facts that could alter the outcome are "material, " and a factual dispute is genuine only where "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. at 248. "If the evidence is merely colorable ... or is not significantly probative ... summary judgment may be granted." Id. at 249-50 (internal citations omitted). A party asserting that a fact cannot be-or, alternatively, is-genuinely disputed must support the assertion either by citing to "particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials"; or by "showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact." Fed.R.Civ.P. 56(c)(1)(A) & (B).

         B. Infringement

         The patent infringement analysis consists of two steps. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995). First, the court must determine the meaning and scope of the patent claims asserted to be infringed. Id. Claim construction is generally a question of law, although subsidiary fact finding is sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015). Second, the trier of fact must compare the properly construed claims to the allegedly infringing device. Markman, 52 F.3d at 976. This second step is a question of fact. ActiveVideo Networks, Inc. v. Verizon Commc'ns, Inc., 694 F.3d 1312, 1319 (Fed. Cir. 2012).

         "Literal infringement of a claim exists when every limitation recited in the claim is found in the accused device." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir. 1998). If any claim limitation is absent from the accused product, there is no literal infringement as a matter of law. Amgen Inc. v. F. Hoffinan-La Roche Ltd, 580 F.3d 1340, 1374 (Fed. Cir. 2009). A product that does not literally infringe a patent claim may still infringe under the doctrine of equivalents if the differences between the claimed invention and the accused product are insubstantial. See Warner-Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 24, 40 (1997); Virnetx, Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1322 (Fed. Cir. 2014).

         The patent owner has the burden of proving infringement, and must do so by a preponderance of the evidence. SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988). When an accused infringer moves for summary judgment of noninfringement, such relief is only appropriate if, viewing the facts in the light most favorable to the patentee, no reasonable jury could find that every limitation recited in the properly construed claim is found in the accused device, either literally or under the doctrine of equivalents. See Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1376 (Fed. Cir. 2005); see also Bell Atl. Network Servs., Inc. v. CovadCommc'ns Grp., Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001) ("[S]ummary judgment is proper only if no reasonable jury could return a verdict for the nonmoving party.") (internal quotation marks and citation omitted).


         The asserted claims of the '5705 patent, which recite methods of making a biocompatible degradable hydrogel formed "in situ in a patient" to treat a medical condition, require that "the biodegradable groups of the hydrogel consist of the esters" (the "esters limitation"). HyperBranch argues that its Accused Products do not infringe the asserted claims of the '5705 patent, either literally or under the doctrine of equivalents, because the Accused Products form hydrogels that have biodegradable amide linkages, and they therefore do not read on the esters limitation. (D.I. 402 at 2)[4]

         The Court will first provide background information regarding claim construction of the esters limitation. Then, the Court will assess the ...

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