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

United States District Court, D. Delaware

March 20, 2018

INTEGRA LIFESCIENCES CORP., INTEGRA LIFESCIENCES SALES LLC, CONFLUENT SURGICAL, INC., and INCEPT LLC, Plaintiffs,
v.
HYPERBRANCH MEDICAL TECHNOLOGY, INC., Defendant.

          REPORT AND RECOMMENDATION

          CHRISTOPHER J. BURKE UNITED STATES MAGISTRATE JUDGE.

         In this action filed by Plaintiffs Integra LifeSciences Corp., Integra LifeSciences Sales LLC, Confluent Surgical, Inc. and Incept LLC (collectively, "Plaintiffs" or "Integra") 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 are: (1) HyperBranch's motion for summary judgment of non-infringement of claim 20 of the '034 patent, claim 4 of the '566 patent, and claims 8 and 23 of the '418 patent (the "Predetermined Thickness" claims), (D.I. 393) ("HyperBranch's Motion");[2] and (2) Plaintiffs' motion for summary judgment of infringement of the Predetermined Thickness claims, (D.I. 399) ("Plaintiffs' Motion").[3] The Court recommends that HyperBranch's Motion be DENIED and Plaintiffs' Motion be DENIED, for the reasons set out herein.

         I. BACKGROUND

         A. The Parties and the Accused Products

         The Court incorporates by reference its recent discussion of the parties and of the accused products at issue here (HyperBranch's Adherus Dural Sealant, Adherus Spinal Sealant, Adherus Auto Spray Dural Sealant, and Adherus Auto Spray Extended Tip (ET) Dural Sealant (the "Accused Products")), which was set out in the Court's Report and Recommendation dated February 20, 2018. (D.I. 508 at 2-3) The Court also notes the following additional pertinent facts with respect to the Accused Products.

         HyperBranch manufactures the Accused Products in North Carolina. (D.I. 429, ex. 82 at ¶ 6) HyperBranch then sells the Adherus AutoSpray Dural Sealant and Adherus AutoSpray Extended Tip (ET) Dural Sealant products to distributors in the United States, who in turn sell the products directly to end customers (i.e., hospitals and physicians). (Id. at ¶ 24; see also id, ex. 2 at 9; id, ex. 3 at 142; id, ex. 6 at Responses 23, 25) With respect to the remaining Accused Products, HyperBranch sells or sold them (as well at least Adherus AutoSpray Dural Sealant) to distributors abroad, who then sell the products to end customers. (Id., ex. 82 at ¶¶ 11-12; id., ex. 3 at 142; id, ex. 6 at Responses 26-28; D.I. 456, ex. 13 at ¶ 48)

         The Accused Products provide the materials, solutions and an applicator that a physician can use to make hydrogels. (D.I. 429, ex. 42 at ¶ 48) The Accused Products contain the same chemical formulation, although the Adherus Dural Sealant and the Adherus Spinal Sealant differ in the amounts of the components. (Id., ex. 2 at 11-12, 23, 34-35) The Accused Products come with different applicator devices. (Id., ex. 42 at ¶¶ 45, 148) The applicators for the Adherus AutoSpray Dural Sealant and Adherus AutoSpray Extended Tip (ET) Dural Sealant include a powered air-assist feature with a micro-pump that actively sprays the materials (the "AutoSpray device"), while the Adherus Dural Sealant and Adherus Spinal Sealant are deposited manually by applying pressure to plungers on the applicator ("manual applicator"). (Id. at ¶¶ 45-46) It is not in dispute that the use of the AutoSpray device's powered air-assist feature creates air bubbles in the hydrogels that are deposited by such a device. (D.I. 403, ex. A at ¶ 402; D.I. 429, ex. 76 at ¶ 91)

         Each package of the Accused Products contains Instructions for Use ("IFU"). (D.I. 429, ex. 3 at 152) HyperBranch also trains its distributors to instruct physicians and their staff on how to assemble and use the Accused Products. (Id., ex. 2 at 13; id, ex. 4 at 30, 38) Upon request from a distributor, personnel from HyperBranch will join the distributor in demonstrating the use of the products in operating rooms. (Id., ex. 2 at 15-16; id, ex. 4 at 33-34, 37, 41) The Accused Products have been used in the United States and abroad to make hydrogels for dural repair. (Id., ex. 6 at Responses 23, 25, 26, 27, 28)

         B. The '418, '566 and '034 Patents

         The asserted patents all come from the same patent family. They are directed to biocompatible crosslinked polymers (i.e., hydrogels) having certain features and methods for their preparation and use. (D.I. 246, exs. A-F)[4]

         The '418, '566 and '034 patents contain the Predetermined Thickness claims that are at issue in this Report and Recommendation. The '418 patent is a continuation of the '566 patent, which is a continuation of the '034 patent. (See Plaintiffs' Claim Construction Presentation, Slide 2) It is entitled "Biocompatible Crosslinked Polymers with Visualization Agents" and it issued with 30 claims. ('418 patent) The '566 patent has the same title and issued with 38 claims. ('566 patent) The '034 patent is entitled "Biocompatible Crosslinked Polymers" and issued with 22 claims. ('034 patent) These three patents are directed to the following technological area:

Biocompatible crosslinked polymers, and methods for their preparation and use, are disclosed in which the biocompatible crosslinked polymers are formed from water soluble precursors having electrophilic and nucleophilic functional groups capable of reacting and crosslinking in situ. Methods for making the resulting biocompatible crosslinked polymers biodegradable or not are provided, as are methods for controlling the rate of degradation. The crosslinking reactions may be carried out in situ on organs or tissues or outside the body. Applications for such biocompatible crosslinked polymers and their precursors include controlled delivery of drugs, prevention of post-operative adhesions, coating of medical devices such as vascular grafts, wound dressings and surgical sealants. Visualization agents may be included with the crosslinked polymers.

(See, e.g., '034 patent, Abstract)

         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 Motions was completed on December 21, 2017, (D.I. 463, 465), and the Court heard oral argument on the Motions (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)

         II. STANDARD OF REVIEW

         The Court incorporates by reference its prior discussion of the legal standards for resolving summary judgment motions and for establishing patent infringement, which was also found in its February 20, 2018 Report and Recommendation. (D.I. 508 at 4-7)

         III. DISCUSSION

         The parties have filed cross-motions for summary judgment regarding HyperBranch's alleged direct infringement under 35 U.S.C. § 271(a) of the Predetermined Thickness claims. (D.I. 393, 399) Plaintiffs also move for summary judgment that HyperBranch has infringed certain of these claims under 35 U.S.C. §§ 271(b), 271(c), and 271(f). (D.I. 400 at 1) The Court will address direct infringement first, and will then turn to Plaintiffs' other claims.

         A. Direct Infringement

         A party directly infringes a patent if it "makes, uses, offers to sell, or sells" the patented invention without permission. 35 U.S.C. § 271(a). Plaintiffs allege that HyperBranch is liable for direct infringement of claim 20 of the '034 patent and claims 8 and 23 of the '418 patent, all method claims, by developing and manufacturing the Accused Products. (See D.I. 400 at 1) Plaintiffs allege that HyperBranch has directly infringed claim 4 of the '566 patent, which claims a "polymeric coating for a substrate, " ('566 patent, col. 39:2, 26-27), by making hydrogels used in the Accused Products, (D.I. 400 at 1).

         The Court construed multiple terms found in each of these claims, including:

Claim Term

Court's Construction

"visualization agent"

"a substance or material that is detectable by the human eye and that imparts a color or obscures the optical clarity of the hydrogel"

"observable change"

"change in the color or transparency of the hydrogel observable to the human eye"

"predetermined thickness"

"a thickness (which can be a singular thickness or a range of thickness), determined before application of the hydrogel, for a particular application"

(D.I. 307 at 55; D.I. 379 at 2-6) In accordance with the Court's constructions, the Predetermined Thickness claims require a "visualization agent" that causes a visually "observable change" that is correlated with a thickness of hydrogel, such that the "observable change" can be used to indicate that a "predetermined thickness" of the hydrogel has been deposited (i.e., the "predetermined thickness requirement"). (See D.I. 400 at 15; D.I. 441 at 16) The Court's claim construction orders explained that "air or air bubbles alone" could not constitute a visualization agent. (D.I. 307 at 13; D.I. 379 at 5) Plaintiffs allege that HyperBranch directly infringes the Predetermined Thickness claims either literally or under the doctrine of equivalents. (See, e.g., D.I. 443 at 24)

         1.Literal Infringement

         a. Claim 20 of the '034 Patent

         Claim 20 of the '034 patent, which depends from claim 16, recites:

16. A method for formulating a polymer composition that crosslinks to form a hydrogel, the method comprising selecting a concentration of visualization agent for the polymer composition such that the visualization agent causes a visually observable change that indicates that a crosslinked hydrogel having a predetermined thickness has been formed on the tissue of a patient wherein the polymer composition comprises electrophilic functional groups and nucleophilic functional groups that crosslink to each other.
20. The method of claim 16, wherein the polymer composition crosslinks to form a hydrogel within about 60 seconds after being applied to a substrate.

('034 patent, col. 40:41-49, 58-60 (emphasis added))[5] Plaintiffs note that there is one relevant affirmative step in this method claim: selecting a concentration of visualization agent for the polymer composition, such that the visualization agent will cause an "observable change" that is correlated with a thickness of hydrogel, and can therefore be used to indicate that a predetermined thickness of the hydrogel has been deposited. (Tr. at 28)

         Here, it does not appear to be disputed that HyperBranch selects for the Accused Products, in advance, an amount of blue and yellow dye that ultimately forms a green dye, in the amount of approximately 120 ppm. (D.I. 429, ex. 73 at HBMT0447921; id, ex. 39 at 18-19)[6] It also does not appear to be disputed that HyperBranch teaches users of its products to apply the hydrogels in the Accused Products at a thickness of between 1-2 mm. (D.I. 400 at 16) Indeed, HyperBranch's IFUs for the Accused Products instruct the user to "[c]ontinue applying the [Adherus sealant system] until a thin coating (approximately 1-2 mm) is formed." (D.I. 429, ex. 8 at 10; id, ex. 9 at 6; id, ex. 10 at 4; id, ex. 11 at 12; id, ex. 12 at 10) Thus, it is Plaintiffs' position that a coating of 1-2 mm is the relevant "predetermined thickness" for purposes of their infringement arguments-that is, a '"thickness (which can be a singular thickness or a range of thickness), determined before application of the hydrogel, for a particular application.'" (See D.I. 400atl6)[7]

         The crux of the infringement dispute between the parties with respect to claim 20 is whether HyperBranch selects a concentration of colorant dye in the Accused Products such that this "visualization agent" causes a visually "observable change" that is correlated with the predetermined thickness of 1-2 mm. (Tr. at 19 (Plaintiffs' counsel explaining that "[t]he only disputed issue[] with respect to the [Predetermined [T]hickness claims is whether or not the observable change is caused by the colored dye" in the Accused Products); Plaintiffs' Motion for Partial Summary Judgement Presentation, Slide 21; D.I. 441 at 15-16 ("HyperBranch ... is entitled to summary judgment of non-infringement in light of the Court's claim constructions and the absence of evidence that any 'visualization agent' in the accused hydrogels causes an 'observable change' that is correlated with a predetermined thickness of the hydrogel") (emphasis omitted)) For the reasons discussed below, the Court finds that a reasonable jury, drawing all inferences in the light most favorable to Integra, could (but need not) find that HyperBranch directly infringes claim 20 of the '034 patent by formulating and manufacturing the Accused Products.

         The Court will first discuss the evidence that Plaintiffs rely upon in establishing their infringement position, and explain why it at least establishes a genuine dispute of fact as to whether HyperBranch infringes claim 20. Then, the Court will assess HyperBranch's arguments and evidence and explain why, in the Court's view, it could also lead a factfinder to find noninfringement of claim 20.

         (1) Plaintiffs' Evidence

         For their part, Plaintiffs assert that the amount of green dye selected by HyperBranch for the Accused Products "causes an observable change [in color and transparency of the hydrogel] that is correlated with a thickness of hydrogel, such that the change can be used to indicate that a predetermined thickness of the hydrogel [of 1-2 mm] has been deposited on the substrate." (D.I. 400 at 16; see also D.I. 465 at 11) As an initial matter, Plaintiffs assert that it is "notable" that HyperBranch decided to use the exact same concentration of dye in its Accused Products as is used in the patented DuraSeal products.[8] (Tr. at 16; see also D.I. 465 at 11; D.I. 400 at 16 n.l 1) The patents themselves discuss the significance of the selection of the concentration of visualization agent, (Tr. at 16-17; see also D.I. 429, ex. 76 at ¶ 53):

One embodiment is to introduce a concentration of visualization agent into the hydrogel so that the user applies the hydrogel until the microvasculature is no longer visible through the hydrogel, at . which point the hydrogel is a desired thickness. Another suitable method is to apply the hydrogel until the underlying tissue is obscured. An appropriately selected concentration of visualization agent is used so that the hydrogel obscures the tissue features when the hydrogel achieves a predetermined thickness.

('034 patent, col. 7:28-36). In arguing that there are no genuine disputes of material fact here (and that HyperBranch thus directly infringes claim 20 of the '034 patent), Plaintiffs rely on a few different categories of evidence.

         First, Plaintiffs point to certain of HyperBranch's own documents. (D.I. 400 at 16-17; D.I. 443 at 19-20; D.I. 465 at 11-12) For instance, several HyperBranch NuSeal 100[9] product training presentations explain that "[w]hen applied ... [the] [g]reen colorant allows for visualization of gel coverage and thickness." (D.I. 429, ex. 62 at HBMT0490731 (slide 40) (emphasis added); see also id, ex. 63 at HBMT0448156 (slide 12); id, ex. 64 at HBMT0190029; id, ex. 3 at 213-14) Relatedly, a HyperBranch document recording Meeting Minutes for a conference call with the United States Food and Drug Administration ("FDA") indicates that an FDA participant stated "that removing the color [of the NuSeal 100 product] could be a problem, because it provides a visual cue to the user regarding coverage and thickness." (Id., ex. 65 at HBMT0448539 (emphasis added); see also id, ex. 3 at 230)

         Additionally, HyperBranch's IFUs for the Accused Products instruct users that to "[g]aug[e] [t]hickness[, ]" the user should "[e]nsure that all suture knots are completely covered with hydrogel sealant.... [c]omplete knot coverage ensures that the minimum thickness of application [1-2 mm] is achieved." (Id., ex. 8 at 11; id, ex. 9 at 7; id, ex. 10 at 5; id, ex. 11 at 12; id, ex. 12 at 10; see also id, ex. 3 at 64 (HyperBranch's 30(b)(6) witness explaining that "we want to be able to see where the gel is placed and then you want to be able to estimate thickness, and we do that by .. . covering the suture knots")) Plaintiffs' expert, Dr. Jimmy Mays, summarizes Plaintiffs' view of how ...


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