Free Response ( Non Motion ) - District Court of California - California

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KARL J. KRAMER (CA SBN 136433) ERIKA L. YAWGER (CA SBN 234919) MORRISON & FOERSTER LLP 755 Page Mill Road Palo Alto, California 94304-1018 Telephone: 650-813-5600 Facsimile: 650-494-0792 [email protected] Attorneys for Defendant and Counterclaimant SYNAPTICS, INC. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

ELANTECH DEVICES CORPORATION, a corporation existing under the laws of Taiwan, R.O.C., Plaintiff, v. SYNAPTICS, INC., a Delaware corporation; AVERATEC, INC., a California corporation; and PROSTAR COMPUTER, INC., a California corporation, Defendants.

Case No.

C06-01839 CRB

SYNAPTICS'S SUBMISSION IN RESPONSE TO THE COURT'S MARCH 4, 2008 ORDER RE: PENDING MOTIONS AND MARCH 7, 2008 HEARING

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SYNAPTICS'S SUBMISSION IN RESPONSE TO THE COURT'S MARCH 4, 2008 ORDER; CASE NO. C06-01839-CRB pa-1239558

AND RELATED COUNTERCLAIMS

Pursuant to the Court's March 4, 2008 Order re: Pending Motions and March 7, 2008 Hearing, Synaptics provides the following cases referenced by Synaptics counsel at the oral argument on March 7, 2008, each of which establishes that the plaintiff must present evidence that proves irreparable harm regardless of the likelihood of success on the merits of the defenses in the case:

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1. Becton Dickinson and Co. v. Syntron Bioresearch, Inc., No. 97-CV-1634 K (POR), 1998 U.S. Dist. LEXIS 22082 (S.D. Cal, Sep. 24, 1998). 2. Cordis Corp. v. Boston Scientific Corp., 2003 U.S. Dist. LEXIS 21338 (D. Del. Nov. 21, 2003) aff'd Cordis Corp. v. Boston Sci. Corp., 99 Fed. Appx. 928, 936 (Fed. Cir. 2004). 3. Reebok Int'l. v. J. Baker, Inc., 32 F.3d 1552 (Fed. Cir. 1994). 4. Roper Corp. v. Litton Systems, Inc., 757 F.2d 1266, 1272 (Fed. Cir. 1985). 5. Wireless Agents, L.L.C. v. T-Mobile USA, Inc., 2006 U.S. Dist. LEXIS 36590 (N.D. Tex. 2006).

Copies of the above-referenced cases are appended hereto as Appendices 1-5.

Dated: March 7, 2008

KARL J. KRAMER ERIKA L. YAWGER MORRISON & FOERSTER LLP

By:

s/Karl J. Kramer Karl J. Kramer Email: [email protected] Attorneys for Defendant and Counterclaimant SYNAPTICS, INC.

SYNAPTICS'S SUBMISSION IN RESPONSE TO THE COURT'S MARCH 4, 2008 ORDER; CASE NO. C06-01839-CRB pa-1239558

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Caution As of: Mar 07, 2008 BECTON DICKINSON AND COMPANY, Plaintiff, vs. SYNTRON BIORESEARCH, INC., Defendant. CASE NO. 97-CV-1634 K (POR) UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF CALIFORNIA 1998 U.S. Dist. LEXIS 22082; 51 U.S.P.Q.2D (BNA) 1722

December 19, 1998, Decided December 21, 1998, Filed SUBSEQUENT HISTORY: July 8, 1999. [*1] Counsel Amended at that point. The court opined that although plaintiff demonstrated that it was likely to succeed in its efforts to demonstrate the validity of its patent and infringement of that patent by defendant, it failed to show that irreparable harm existed or that the balance of hardships weighed in its favor. OUTCOME: The court denied plaintiff patent holder's motion for a preliminary injunction preventing defendant manufacturer from infringing on plaintiff's patent where plaintiff failed to demonstrate that the extraordinary remedy of a preliminary injunction was warranted. The court held that plaintiff failed to demonstrate, as a prerequisite to a preliminary injunction, that plaintiff would suffer irreparable harm or hardships weighed in plaintiff's favor. LexisNexis(R) Headnotes

DISPOSITION: Plaintiff's motion for preliminary injunction DENIED. Defendant's Motion to Preclude DENIED. CASE SUMMARY:

PROCEDURAL POSTURE: Plaintiff patent holder filed a motion for preliminary injunction against defendant manufacturer to enjoin defendant from manufacturing and selling a product that infringed on plaintiff's patent. OVERVIEW: Plaintiff patent holder invented technology that enabled the manufacture of diagnostic test kits. An application of plaintiff's invention was home pregnancy tests. Defendant manufacturer sold a wide variety of products, including home pregnancy tests. Plaintiff attempted to persuade defendant to take a license, but defendant refused. Defendant asserted that it designed a patent of its own. Plaintiff filed a complaint against defendant for patent infringement. Defendant alleged that its patent was unique and plaintiff's patent was unenforceable. Plaintiff filed for a preliminary injunction to enjoin defendant from manufacturing, selling, using, or exporting and importing products, which infringed on its patent. The court denied the preliminary injunction, finding that plaintiff failed to demonstrate that the extraordinary remedy of a preliminary injunction was warranted

Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions Patent Law > Remedies > Equitable Relief > Injunctions [HN1] Under 35 U.S.C.S. § 283, the issuance of a preliminary injunction in a patent infringement action is a matter for the discretion of the district court.

Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions

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Patent Law > Remedies > Equitable Relief > Injunctions [HN2] See 35 U.S.C.S. § 283.

Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions Patent Law > Remedies > Equitable Relief > Injunctions [HN3] No factor of 35 U.S.C.S. § 283 taken individually is dispositive; the court must weigh and measure each factor against the other factors and against the form and magnitude of the relief requested. The Federal Circuit has cautioned that a preliminary injunction is a drastic and extraordinary remedy that is not to be routinely granted.

Patent Law > Remedies > Equitable Relief > Injunctions [HN6] To sustain its burden on this motion for a preliminary injunction, plaintiff must establish a reasonable likelihood that defendant would fail to meet its burden at trial of proving, by clear and convincing evidence, that plaintiff's patents are invalid.

Patent Law > Anticipation & Novelty > Elements Patent Law > Infringement Actions > Defenses > General Overview [HN7] The defense of anticipation is only invoked if the alleged infringer can demonstrate that a single prior art reference discloses each and every element that is expressly or inherently found in the claimed invention.

Patent Law > Claims & Specifications > Description Requirement > General Overview Patent Law > Infringement Actions > Doctrine of Equivalents > Elements > General Overview [HN4] Under doctrine of equivalents, a product or process that does not literally infringe upon the express terms of a patent claim may nonetheless be found to infringe if there is equivalence between the elements of the accused product or process and the claimed elements of the patented invention. The doctrine is applied to each element of the patent claim rather than to the invention as a whole, and is not allowed such broad play as to effectively eliminate that element in its entirety. The essential inquiry is does the accused product contain elements identical or equivalent to each claimed element of the patented invention. The doctrine of equivalents, however, does not allow a patentee to claim coverage where that patentee has surrendered coverage in order to avoid overlapping with prior art patents.

Evidence > Procedural Considerations > Burdens of Proof > Clear & Convincing Proof Patent Law > Inequitable Conduct > Burdens of Proof Patent Law > Inequitable Conduct > Effect, Materiality & Scienter > Effect of Inequitable Conduct [HN8] To prove inequitable conduct and render a patent unenforceable, defendant must establish by clear and convincing evidence that there was a material misrepresentation or omission of information, and must establish a threshold level of intent. To be guilty of inequitable conduct, one must have intended to act inequitably. Materiality and intent must be considered together; the more material the misrepresentation or omission, the less intent is necessary to show inequitable conduct. The courts have warned about charges of inequitable conduct, stating that the habit of charging inequitable conduct in almost every major patent case has become an absolute plague.

Civil Procedure > Remedies > Injunctions > Elements > Likelihood of Success Patent Law > Inequitable Conduct > Effect, Materiality & Scienter > General Overview Patent Law > Infringement Actions > Burdens of Proof [HN5] Although a patent is presumed to be valid under 35 U.S.C.S. § 282, at the preliminary injunction stage, the patentee has the burden of showing the likelihood of success on the merits with respect to the patent's validity, enforceability, and infringement.

Civil Procedure > Pleading & Practice > Pleadings > Amended Pleadings > General Overview [HN9] After a court has construed the claims in a patent case, the rules of the game change, thereby allowing for amendment of the arguments in the case.

Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions Patent Law > Inequitable Conduct > General Overview

Civil Procedure > Discovery > Disclosures > Mandatory Disclosures Civil Procedure > Discovery > Methods > General Overview [HN10] Fed. R. Civ. P. 26(e) requires that parties supplement or correct discovery responses in order to make sure that both parties are aware of changes in the case. Rule 26(e) requires supplementation of disclosures at appropriate intervals and seasonable amendments of prior discovery responses if the earlier responses are

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found to be inaccurate or incomplete. With regard to expert testimony, such disclosures must be made at appropriate intervals and at least 30 days prior to trial. The Advisory Committee Notes regarding Rule 26(e) note that supplementations need not be made as each new item of information is learned but should be made at appropriate intervals during the discovery period, and with special promptness as the trail date approaches.

principal value of a patent is its statutory right to exclude, the nature of the patent grant weighs against holding that monetary damages will always suffice to make the patentee whole. Moreover, the presumption arises because of the finite term of the patent, which is not suspended during patent litigation, and because the passage of time may work irremediable harm.

Civil Procedure > Discovery > Disclosures > Mandatory Disclosures Civil Procedure > Discovery > Misconduct [HN11] The Federal Rules of Civil Procedure are designed to eliminate surprise and to achieve substantial justice. When determining whether preclusion is proper or not, the presence of surprise and prejudice are central to the inquiry. The court, therefore, turns to whether Fed. R. Civ. P. 26(e) has been violated, and if so, whether defendant was surprised or suffered prejudice.

Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions Patent Law > Ownership > Conveyances > Licenses Patent Law > Remedies > Equitable Relief > Injunctions [HN15] Evidence that the patent holder has offered a license to the alleged infringer indicates that it is clear that the movant is willing to forgo its patent rights for compensation and suggests that any injury suffered by the movant would be compensable in damages assessed as part of the final judgment.

Civil Procedure > Judgments > Preclusion & Effect of Judgments > Estoppel > Judicial Estoppel [HN12] Under the doctrine of judicial estoppel the court may, at its discretion, preclude a party from taking inconsistent positions in the same litigation. The Ninth Circuit, like the majority of circuits, has recently held that the court may apply judicial estoppel only if the court has relied upon the party's previously inconsistent position.

Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions Patent Law > Remedies > Equitable Relief > Injunctions [HN13] The district court may find that, even giving movant the benefit of the presumption of irreparable harm, the non-moving party has presented evidence sufficient to rebut the presumption. In such a case, the movant has not established irreparable harm and is not entitled to a preliminary injunction.

Civil Procedure > Remedies > Injunctions > Elements > Irreparable Harm Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions Patent Law > Remedies > Equitable Relief > Injunctions [HN16] Delay is one factor that should be considered in determining irreparable harm. A demonstration that plaintiff delayed in bringing this suit does not preclude, as a matter of law, a determination of irreparable harm. In certain circumstances, however, a showing of delay may be so significant as to preclude a determination of irreparable harm. Though other factors are examined, delay in seeking a remedy is an important factor bearing on the need for a preliminary injunction. A plaintiff's delay in bringing suit indicates a lack of urgency and undermines the need for a preliminary injunction. Substantially shorter time periods have demonstrated to courts that the facts favor the denial of a preliminary injunction.

Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions Governments > Legislation > Statutory Remedies & Rights Patent Law > Remedies > Equitable Relief > Injunctions [HN14] The patent statute, 35 U.S.C.S. § 283, provides injunctive relief to preserve the legal interests of the parties against future infringement which may have market effects never fully compensable in money. Because the

Patent Law > Infringement Actions > Infringing Acts > General Overview [HN17] A finding of willful infringement is to be made only after consideration of the totality of the circumstances because there are no hard and fast per se rules in respect of willingness.

Civil Procedure > Judgments > Relief From Judgment > Extraordinary Circumstances

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Civil Procedure > Remedies > Injunctions > Preliminary & Temporary Injunctions Patent Law > Remedies > Equitable Relief > Injunctions [HN18] Neither the difficulty in calculating losses in market share, nor speculation that such losses might occur, amount to proof of special circumstances justifying the extraordinary relief of an injunction prior to trial. COUNSEL: For BECTON DICKINSON AND COMPANY, plaintiff: Robert D Rose, Lorenz Alhadeff Cannon and Rose, LLP, San Diego, CA. Edward F. Mullowney, Vicki S. Veenker, Petrina S. Hsi, Brian C. Cannon, Fish & Neave, Palo Alto, CA. For SYNTRON BIORESEARCH INC, defendant: Raymond J Coughlan, JR, Coughlan Semmer and Lipman, San Diego, CA. For SYNTRON BIORESEARCH INC, defendant: Bernd W Sandt, Dow Chemical Company, Midland, MI. For SYNTRON BIORESEARCH INC, defendant: Keith D Nowak, Larissa A Rippa, Arthur M Lieberman, Lieberman and Nowak, New York, NY. For SYNTRON BIORESEARCH INC, defendant: James P Lynn, Leiberman and Nowak, New York, NY. For BECTON DICKINSON AND COMPANY, counterdefendant: Robert D Rose, Lorenz Alhadeff Cannon and Rose, LLP, San Diego, CA. Edward F. Mullowney, Vicki S. Veenker, Petrina S. Hsi, Brian C. Cannon, Fish & Neave, Palo Alto, CA. For SYNTRON BIORESEARCH INC, counterclaimant: Raymond J Coughlan, JR, Coughlan Semmer and Lipman, San Diego, CA. For SYNTRON BIORESEARCH INC, counterclaimant: James P Lynn, Leiberman and Nowak, New York, NY. JUDGES: Judith N. Keep, District Judge, United States District Court. OPINION BY: Judith N. Keep OPINION ORDER DENYING PLAINTIFF'S MOTION FOR A PRELIMINARY INJUNCTION AND DENYING DEFENDANT'S MOTION TO PRECLUDE Plaintiff Becton Dickinson [*2] and Company moves this court for a preliminary injunction. Defendant

Syntron Bioresearch, Inc. opposes. Defendant Syntron moves to preclude one of Becton Dickinson's theories of liability. Both parties are represented by counsel. I. BACKGROUND Plaintiff invented technology that enables the manufacture of diagnostic test kits. A significant commercial application of plaintiff's invention has been home pregnancy tests in which the user applies a liquid sample to one end of a test strip, then reads the visible test result after the liquid moves across the strip. Plaintiff has obtained two patents on this invention, United States Patent Nos. 4,703,017 ("the Campbell patent") and 5,591,645 ("the Rosenstein patent"). The Campbell patent describes and claims a process and product for visually determining the presence of an analyte by using a tracer and a binder on a solid support. The Rosenstein patent is not at issue in this motion. Plaintiff states that it currently receives $ 9 million in royalties annually. Defendant manufactures a wide variety of products, including home pregnancy tests. Plaintiff has attempted to persuade defendant to take a license, but defendant has [*3] not done so. Defendant asserts that it has carefully designed around the patents in suit, and has a patent of its own, U.S. Patent No. 5,384,264. On September 5, 1997, plaintiff filed a Complaint against defendant for patent infringement. The Complaint seeks relief for defendant's alleged infringement of the Campbell and Rosenstein patents. On September 26, 1997, defendant served its Answer with Counterclaims. Among its affirmative defenses, defendant asserted the unenforceability of plaintiff's patents. By order of December 8, 1997, the court granted a motion to strike defendant's affirmative defenses relating to unenforceability for failure to plead with particularity. By that same order, the court also dismissed defendant's declaratory judgment counterclaims relating to unenforceability for failure to plead with particularity. Defendant filed an Amended Answer and Amended Counterclaim on January 2, 1998. On May 7, 1998, the court issued an order denying plaintiff's motion for a preliminary injunction. On August 6, 7, and 10, 1998, the court presided over an evidentiary hearing pursuant to Markman v. Westview, 52 F.3d 967 (Fed. Cir. 1995), aff'd, 517 U.S. 370, 134 L. Ed. [*4] 2d 577, 116 S. Ct. 1384, (1996) ("Markman hearing"), concerning the proper construction of the patent claims asserted in this litigation: claims 1 and 3 of the Campbell patent, U.S. Patent No. 4,703,017; and claims 1 and 8 of the Rosenstein patent, U.S. Patent No. 5,591,645. On August 11, 1998, the court construed the elements of these claims in an oral ruling, and on the same

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date, the court issued a written order which incorporated by reference the reasoning announced in the oral ruling. Plaintiff Becton Dickinson now moves for preliminary injunction, seeking to enjoin Syntron from manufacturing, selling, using, or exporting and importing products which infringe the Campbell patent held by Becton Dickinson. Syntron filed an opposition and Becton Dickinson filed a reply brief. The matter presently before the court involves assessing whether the requisite showing to support the issuance of a preliminary injunction has been made by Becton Dickinson. II. LEGAL STANDARD [HN1] Under 35 U.S.C. § 283, the issuance of a preliminary injunction in a patent infringement action is a matter for the discretion of the district court. See Intel Corp. v. ULSI System Technology, [*5] Inc., 995 F.2d 1566, 1568 (Fed. Cir. 1993), cert. denied, 510 U.S. 1092, 127 L. Ed. 2d 216, 114 S. Ct. 923 (1994). 1 [HN2] The party seeking a preliminary injunction under 35 U.S.C. § 283 must establish a right to such relief in light of the following factors: (1) reasonable likelihood of success on the merits; (2) irreparable harm; (3) the balance of hardships tipping in its favor; and (4) the impact of the injunction on the public interest.

[*6] III. DISCUSSION A. LIKELIHOOD OF SUCCESS 1. INFRINGEMENT OF THE CAMPBELL PATENT Becton Dickinson avers that it is likely to succeed on the merits because Syntron infringes the Campbell patent. Becton Dickinson provides three theories under which the patent is infringed. A showing of likelihood of success on any one of these three theories is sufficient to support a finding that Becton Dickinson is likely to succeed on the merits in this matter. At the earlier preliminary injunction, Syntron raised three claims of noninfringement of the Campbell patent. In the present motion, Syntron essentially concedes two of those claims and focus extensively on a third claim of noninfringement: Syntron's argument that its pregnancy test assay is not infringing because it contains a visible particulate label (VPL) that is a sac. Becton Dickinson counters that Syntron's assay infringes the Campbell patent because the visible particulate label is not a sac, but instead consists of a solid particle: colloidal gold. Becton Dickinson further contends that if the VPL is construed as a sac, it is a type of sac that infringes the Campbell patent. As an initial [*7] matter, the court will review the basic coverage of the patent. The Campbell patent covers assays that are comprised of an analyte, a binder, and a tracer. The binder and analyte elements are not disputed presently. The elements of the tracer, however, are at issue. The relevant language in the Campbell patent, contained in Claim 1, reads: said tracer being comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visible dye, said sac is selected from the group consisting of liposomes and microcapsules..., See, Campbell Patent, Col. 15-16. Thus, a tracer consists of a ligand labeled with a visible particulate label. It is undisputed that the ligand in Syntron's assay is the antibody to hCG. A visible particulate label is covered under the Campbell patent if it is a visible particle or it is a sac which contains a dye and is comprised of liposomes or microcapsules. A sac which contains a dye and is not comprised of liposomes or microcapsules is not covered by the patent. This court, in the August 11, 1998 order subsequent to a Markman hearing, construed a "sac including a visible dye" to mean "an enclosure [*8] that contains the visible dye even if the ligand is attached to the dye material so long as the dye material remains enclosed within the sac."

See Hybritech Inc. v. Abbott Laboratories, 849 F.2d 1446, 1451 (Fed. Cir. 1988). [HN3] No factor taken individually is dispositive; the court "must weigh and measure each factor against the other factors and against the form and magnitude of the relief requested." Id. The Federal Circuit has cautioned that "a preliminary injunction is a drastic and extraordinary remedy that is not to be routinely granted." Intel, 995 F.2d at 1568. 1 Federal Circuit law governs the issuance of injunctions pursuant to 35 U.S.C. § 283. Hybritech Inc. v. Abbott Laboratories, 849 F.2d 1446, 1451 n.12 (Fed. Cir. 1988) ("Because the issuance of an injunction pursuant to this section enjoins 'the violation of any right secured by a patent, on such terms as the court deems reasonable,' a preliminary injunction of this type, although a procedural matter, involves substantive matters unique to patent law and, therefore, is governed by the law of this court."). Purely procedural questions involving the issuance of such preliminary injunctions are controlled by the law of the Ninth Circuit. See id.

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In examining whether the Syntron assay infringes the Campbell patent the court applies a two step process under the preponderance of the evidence standard. See Kegel Co. v. AMF Bowling, Inc., 127 F.3d 1420, 1425 (Fed. Cir. 1997)(citations omitted). The first step, construing the language in the patent claims, was largely completed in the August 11, 1998 decision. See Hybritech, Inc. v. Abbott Labs., 849 F.2d 1446, 1455 (Fed. Cir. 1988). The second step is deciding whether the claims, as construed, indicate that the product at issue infringes the patent. See Bell & Howell Document Mgt. Co. v. Altek Systems, 132 F.3d 701, 705 (Fed. Cir. 1997). Becton Dickinson must "show that, in light of the presumptions and burdens that will inhere at trial, it will likely prove..." that the Campbell patent was infringed. Id. The court now turns to the arguments advanced by the parties. a. The Syntron Assay Contains a Solution of Analyte and a Tracer In the August 11, 1998 order, this court construed the claim language of "contacting [*9] a binder...with a solution of analyte and a tracer," to include both "sandwich assays" and "competition assays." Syntron does not dispute that its pregnancy assay is a sandwich assay which contains a solution of analyte and a tracer, and is therefore consistent with the Campbell patent. b. The Syntron Assay Condition Is Consistent With the Campbell Patent In the August 11, 1998 order, this court construed the language Claim 1 language about "assay conditions" to refer to the environmental conditions under which the assay is performed. The court held that those conditions may vary in different assays, but that the "only condition that must be consistent under this claim is that the binder must be supported in a concentration of at least 1 microgram/cm2." Syntron does not dispute that its assay contains binder concentration of at least 2.9 micrograms/cm<2>, and is therefore consistent with the Campbell patent. c. Becton Dickinson is Likely to Succeed in Showing That The Syntron Visible Particulate Label is not a Sac, and Therefore the Syntron VPL Infringes the Campbell Patent In the August 11, 1998 order this court construed the claim language regarding a "tracer" [*10] to mean that a "visible particulate labels are either (1) solid particles or (2) a sac including a visible dye." Examples of a the first type of particulate label covered by the patent included "ferritin, phycoerrythrins or phycobili-proteins; precipitated or insoluble metal alloys..." See Campbell Patent, Col. 5, ll. 14-18. In addressing the second type of visible

particulate label, the court noted that the patent covered only sacs "consisting of liposomes and microcapsules." The court further held that a sac is an enclosure. The court continued by stating that "Even if the ligand attaches to the material contained in the sac, rather than to the surface of the sac itself, it is the 'sac including a visible dye' that is the label, so long as the dye material remains within the sac." Becton Dickinson argues that under this definition, the Syntron tracer element is a ligand, the antibody to hCG, that is attached to a visible particulate label that is a solid particle: colloidal gold. Plaintiff argues that the Syntron tracer is, therefore, not a sac. Accordingly, Becton Dickinson argues, the visible particle label falls under the Campbell patent, as does the tracer. Syntron argues [*11] that the tracer element is properly understood to include a ligand, the anti-body to hCG, attached to a visible particulate label that is a sac including a visible dye. Syntron argues that the dye, the gold particle, is covered by a sac consisting of bovine serum albumin (BSA) and polyethelene glycol (PEG). This BSA/PEG covering coats approximately 50% of the surface of the much larger gold particle, with the other 50% being covered by the ligand. Alternatively, Syntron argues that the sac consists of the BSA/PEG coating and the ligand, which surrounds the dye, the gold particle. Under either interpretation, Syntron argues, the sac is not a "sac consisting of liposomes or microcapsules" and is therefore not covered under the Campbell patent. Syntron uses colloidal gold, microscopic particles of gold which are larger than individual gold molecules, but small enough to not settle out of a solution. See McDermott Decl. at P 12. Syntron then attaches the ligand, antibodies, to the surface of each gold particle. Many antibodies attach to each gold particle, as the gold is much larger than the antibody. See C. Decl, Exhibit C. at 45. The antibody coated particle is then coated with [*12] BSA/PEG, which covers the portions of the gold particle not covered by antibodies. The BSA/PEG keeps the many gold particles that will be present in each assay from sticking together. See C. Decl., Exhibit E at 101. Becton Dickinson's argument that this coating cannot be a sac is two-fold. First, Becton Dickinson argues that the ligand cannot be considered to be a part of the sac according to a clear reading of the claim. The claim states that a tracer consists of a ligand and a visible particulate label. Where the visible particulate label is a sac, the ligand must be a separate element and cannot be viewed as a part of the sac. Becton Dickinson quotes the court's language in the August 11, 1998 order to support this contention. The court noted that "in construing the term "sac" to include any structure that encloses a visible dye, even if the ligand attaches to the material contained

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in the sac rather than to the surface of the sac itself, it is the sac including the visible dye that is the label, so long as the dye material remains within the sac." Becton Dickinson contends that the court's language clearly precludes a reading wherein the ligand is a constituent element of [*13] a sac. Becton Dickinson avers that the ligand, as discussed in the patent, is a discreet portion of a tracer element which also contains a separate sac; therefore the ligand cannot be a part of sac. Syntron, in contrast, argues that the exact same language "unambiguously" indicates that the court intended that the ligand, i.e. an antibody, may attach to the dye, i.e. the gold, as part of a sac. Thus, Syntron argues, the court "clearly contemplates the ligand being part of the sac as long as it does not cause the release of the dye." Syntron contends that the court adopted a broad definition of "sac" in its August 11, 1998 order, thereby indicating that the coating on the gold in this case should be a sac. The court is not persuaded by Syntron's argument. Although the court undoubtedly adopted a broader construction of sac than Becton Dickinson urged, the court's finding that a sac was an enclosure cannot be read so broadly as to encompass any coating that covers any dye. To accept Syntron's argument that a sac may be 50% comprised of the ligand would render meaningless the patent's definition of the tracer element. A tracer is defined by its two parts: a ligand and a visible particulate [*14] label. The reading that Syntron urges upon this court would leave the tracer with only a visible particulate label in the form of a sac. That visible particulate label, a sac, would not be not "labeled" with a ligand, but in fact partially constructed out of the ligand. The ligand element of a tracer, therefore, would be rendered superfluous by Syntron's reading. This court finds that the plain meaning of the patent much more strongly supports a construction wherein the ligand, i.e. an antibody, is attached to a distinct visible particulate label that takes the form of a solid particle: colloidal gold. Becton Dickinson's contention that the BSA/PEG/ligand coating around the colloidal gold is not a sac is further supported by the declaration of an Syntron's expert, Dr. Ehrenkranz, submitted in opposition to Becton Dickinson's previous injunction for preliminary injunction. In that declaration, Dr. Ehrenkranz discussed a tracer, disclosed in the Leuvering patent, that was comprised of colloidal gold partially covered with an antibody. The covering was completed with BSA/PEG. This portion of the tracer is exactly the same as the tracer element used in Syntron's present assay. See [*15] C. Decl., Exhibit K at 240, Col. 4, lines 1-6. Another Syntron expert, Dr. Lee, indicated that the antibody and BSA/PEG coating discussed by Dr. Ehrenkranz is consistent with the current Syntron coating. See C. Decl.,

Exhibit E, at 100 P8. Dr. Ehrenkranz explicitly averred that this tracer, which is identical to Syntron's tracer, is a "ligand labeled with a visible particulate label." In his chart summarizing the claims by Syntron, Dr. Ehrenkranz notes that the "tracer comprises anti-hCG antibody (ligand) labeled with a visible gold sol particulate." See C. Decl, Ex. J at 223. Further, Dr. Ehrenkranz's chart does not include any suggestion that the tracer element depicted, one that is identical to Syntron's, is a sac. See id. Syntron argues that the declaration by Dr. Ehrenkranz does not involve Syntron products. Syntron does not deny, however, that the tracer element discussed by its experts is exactly the same as the tracer element used by Syntron in its pregnancy assay. Thus, Dr. Ehrenkranz's conclusions regarding an identical tracer element apply with equal force to Syntron's tracer element. Syntron's own experts support a finding that the tracer element in Syntron's [*16] pregnancy assay does not contain a sac. Indeed, they aver that the tracer element involves a ligand, an antibody, and a solid particle that is the visible particulate label: colloidal gold. Such a finding places the Syntron tracer element squarely within the corners of the Campbell patent. This court finds that Becton Dickinson is likely to succeed in convincing a factfinder, by a preponderance of the evidence, that the Syntron tracer element does not contain a sac. Becton Dickinson is likely to succeed in proving that the tracer element is comprised of a ligand and antibodies, labeled with a visible particulate label that is a solid particle; in this case colloidal gold. Thus, Becton Dickinson is likely to prove that the Campbell patent has been infringed. d. Becton Dickinson is Likely to Succeed in Showing That if the Syntron's Visible Particulate Label is a Sac that Infringes the Campbell Patent Becton Dickinson avers that even if a jury were to interpret the covering of BSA/PEG to be a sac, the Campbell patent would still have been infringed by Syntron. Moreover, Becton Dickinson avers that if a compound covering of BSA/PEG and the ligand was found to be a sac, the [*17] Campbell patent would still be infringed. Becton Dickinson argues that the BSA/PEG sac, or a BSA/PEG/ligand sac, would infringe the patent because they are sacs "consisting of liposomes or microcapsules" and are therefore consistent with the Campbell patent. As an initial matter, the court must note that Syntron has moved to preclude Becton Dickinson's argument that if a sac is found to exist in the tracer element, that sac infringes the Campbell patent. As will be discussed at length below, the court is not persuaded that Becton

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Dickinson's argument should be precluded. The court will, therefore, examine the argument. Becton Dickinson argues that even if the coating of antibodies and BSA/PEG around the colloidal gold is found to be a sac, the sac is comprised of "microcapsules" or the equivalent thereof. Becton Dickinson makes two arguments in support of this construction. First, that the claim directly covers the "sac" here because it is comprised of microcapsules in a manner covered by the text of the patent. Second, Becton Dickinson argues that under the doctrine of equivalents, the sac infringes the patent because the difference between Syntron's "sac" and the sac described [*18] in the patent is insubstantial. Therefore, the sac would fall within the scope of the Campbell patent. Syntron answers with three arguments: 1) that Becton Dickinson's argument should be precluded, as noted above; 2) that the patent language should read "polymer microcapsules" rather than "microcapsules," and that the Syntron sac is not comprised of polymer microcapsules; 3) that the patent is too broad if the "polymer" language is not present. In sum, Syntron argues that its sac it does not infringe. 1. Literal Infringement Becton Dickinson argues that the language of the patent, specifically a reference to the Vandegaer text, indicates that "microcapsule" sacs may include coatings that do not possess independent structural integrity. See Campbell Patent, Col. 4, ll. 22-24. Becton Dickinson argues that under the court's broad sac definition, wherein a sac is an enclosure, Syntron's coating would be a sac covered by the patent because it consists of microcapsules. See C. Decl., Ex. FF at 745. The Vandegaer text, incorporated into the patent by reference, provides a broad definition of "microcapsule." This definition includes coatings that are formed from compounds, [*19] such as PEG, and various protein structures. See id. Thus, if the Syntron coating is a sac, argues Becton Dickinson, it is a microcapsule sac that directly infringes on the patent. See McDermott Decl. at PP34-36. Syntron answers by alleging that the patent language should have modified microcapsule with "polymer." Syntron avers that Becton Dickinson misled the patent examiner, resulting in the omission of the language. Syntron seems to argue, therefore, that this court should read the "polymer" language back into the patent text. Syntron's argument conflates an argument of literal infringement with an argument of patent invalidity. Syntron does provide letters in which Becton Dickinson's counsel and the patent examiner discuss the "polymer" modifier to microcapsules. These letters, however, fall short of providing the clear and convincing evidence of

either material misrepresentation, or intent to mislead on the part of Becton Dickinson, that is required before this court may invalidate the patent because the examiner was misled. Thus, the argument for patent invalidity is not strong. Other than a suggestion that misrepresentations were made to the patent examiner, Syntron [*20] provides no support for a suggestion that the "polymer" language must be read into the patent. The court now looks to the language of the patent to decide if literal infringement has occurred. The court finds that if a factfinder were to find that the BSA/PEG/antibody compound used by Syntron is a sac, then it would likely find that it is a sac comprised of microcapsules. The microcapsule coating described in the Vandegaer text bonds to a substrate, such as colloidal gold, with compounds that are similar to the compound used by Syntron. See id. Syntron does not dispute that the compound of, BSA/PEG/antibody is a microcapsule; it simply avers that the compound is not a "polymer" compound. At this point, the court refuses to read "polymer" into the patent. Therefore, the court finds that Becton Dickinson is likely to succeed in proving to a factfinder that if the Syntron coating is a sac it is a microcapsule sack that is covered by the Campbell patent. 2. Infringement under the Doctrine of Equivalents Additionally, Becton Dickinson urges that a factfinder is likely to find that the patent is infringed under the doctrine of equivalents. [HN4] Under this doctrine "a product [*21] or process that does not literally infringe upon the express terms of a patent claim may nonetheless be found to infringe if there is 'equivalence' between the elements of the accused product or process and the claimed elements of the patented invention." WarnerJenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 21, 117 S. Ct. 1040, 1043, 137 L. Ed. 2d 146 (1997)(citing Graver Tank v. Linde Air Prod. Co., 339 U.S. 605, 94 L. Ed. 1097, 70 S. Ct. 854 (1950)). The doctrine is applied to each element of the patent claim rather than to the invention as a whole, and "is not allowed such broad play as to effectively eliminate that element in its entirety." 117 S. Ct. at 1048. The essential inquiry is "does the accused product contain elements identical or equivalent to each claimed element of the patented invention." Id. at 1054. The doctrine of equivalents, however, does not allow a patentee to claim coverage where that patentee has "surrendered" coverage in order to avoid overlapping with prior art patents. For example, where a patentee has narrowed a definition in order to avoid overlapping with a prior art, the patentee may not use the doctrine of equivalents to make [*22] a claim of infringement re-

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garding the surrendered process. See id. at 1049. The patentee may not recapture, by use of the doctrine of equivalents, any subject matter that was expressly surrendered in order to complete a valid patent. See Litton Systems, Inc. v. Honeywell, Inc., 140 F.3d 1449, 1455 (Fed. Cir. 1998). Becton Dickinson avers that the "consisting of liposomes and microcapsules" language was added to modify "sac" because of a concern that the prior language would overlap with the prior art of the Sharon Patent. See C. Decl., Ex. M at 365. The Sharon Patent involved the use of a red blood cell. Thus the modification to the language of the Campbell patent was made in order to avoid overlapping with the red blood cell technology used by the Sharon Patent. As such, Becton Dickinson may not use the doctrine of equivalents to claim that red blood cells, or their equivalents, are covered by the patent. Syntron avers that Becton Dickinson "now attempts to unilaterally impose a construction of the term [microcapsule] which is so broad that it would now include either directly or as equivalents liposomes and erythrocytes." Opposition Memo at 8. Becton Dickinson, however, [*23] does not use the doctrine of equivalents to claim that red blood cells, or any similar structure, are covered under the patent. At issue here is a coating process that is completely unlike a red blood cell. The doctrine of equivalents, therefore, is properly applied to prove that the product used by Syntron is the equivalent of the "microcapsule" sac discussed in the Campbell Patent. The difference between the Syntron coating product and the coating product in the Campbell patent is insubstantial. The Syntron coating performs substantially the same function as the coating referred to in the patent: providing protection for the enclosed substrate. Additionally, the Syntron coating performs that function in substantially the same way as the patent, by coating the substrate with a compound of antibodies and BSA/PEG. The patent refers to coatings which cover the substrate with a compound of various proteins and polymers, such as PEG. See McDermott Decl. at PP34-36. Finally, the result achieved is substantially the same: coating the substrate with a compound. The court finds that Becton Dickinson is likely to succeed in proving to a factfinder that the patent was infringed if it were [*24] to apply the doctrine of equivalents to the factual scenario presented in this matter. Becton Dickinson has presented evidence that would likely convince a factfinder that the Campbell patent covers Syntron's Pregnancy Assay. At this stage, it appears that this evidence would likely convince the factfinder under three different theories: 1) that Syntron's tracer element of the assay does not contain a sac, and is there covered by the Campbell patent; 2) that if the tracer element is found to contain a sac, that sac is covered by

the Campbell patent as being comprised of microcapsules; 3) that if literal infringement is not found the Campbell patent is still infringed under the doctrine of equivalents. Becton Dickinson need not show that it is likely to succeed on the merits of all three theories in order to have established that it is likely to succeed in showing that the patent is infringed; a showing of likelihood of success on any of the above mentioned theories is sufficient. The fact that it appears that Becton Dickinson is likely to succeed on all three theories merely indicates that its case is very strong. 2. INVALIDITY Plaintiff argues that it is likely to succeed [*25] on the merits of its patent infringement claims because the underlying patents are presumed to be valid and defendant will likely not be able to carry its burden of proving invalidity. [HN5] Although a patent is presumed to be valid under 35 U.S.C. § 282, at the preliminary injunction stage, the patentee has the burden of showing the likelihood of success on the merits with respect to the patent's validity, enforceability, and infringement. See Nutrition 21 v. U.S., 930 F.2d 867, 869 (Fed. Cir. 1991). Defendant challenges the validity of the Campbell patent on a number of grounds. [HN6] To sustain its burden on this motion for a preliminary injunction, Becton Dickinson must establish a reasonable likelihood that Syntron would fail to meet its burden at trial of proving, by clear and convincing evidence, that Becton Dickinson's patents are invalid. See H.H. Robertson, Co. v. United Steel Deck, Inc., 820 F.2d 384, 387 (Fed.Cir. 1987). a. Anticipation and Invalidation by the Gribnau Patent Syntron first argues that the Gribnau Patent, U.S. Patent No. 4,373,932 discloses an immunoassay technique that is similar to the one disclosed in the Campbell patent. The Gribnau patent involves [*26] an earlier version of the pregnancy test. Unlike the Campbell patent at issue, the Gribnau patent requires the use of solvents. Even with the use of solvents, though, the Gribnau patent cannot detect hCG, the indicator of pregnancy, at the low levels that exist at the early stage of pregnancy and which are visibly apparent by the technique described by the Campbell patent. The ability to visually determine low levels of hCG without the use of other instruments or solvents distinguished the Campbell patent from other assays in the field. See U.S. Patent 4,703,017 at Cannon Decl., Exhibit F, p.114, col. 1, lines 28-41 (describing other assays). As noted, a distinction between the Gribnau patent and the Campbell patent because of the Campbell invention's ability to detect significantly lower levels of ana-

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lyte such as hCG compared to the Gribnau patent. The inventors of the Campbell patent discovered that when the binder is supported in a concentration of at least 1 [mu] g/cm<2>, the tracer is visible without further treatment, such as a solution treatment, even when the hCG level is low. This court noted the importance of the Campbell patent's disclosures regarding support of the [*27] binder in a concentration of at least 1 [mu] g/cm<2>. When describing the assay conditions for this patent in the patent construction ruling, this court stated that "the only condition that must be consistent under this claim is that the binder must be supported in a concentration of at least one microgram/cm2." Cannon Decl, Exhibit H at 150. With the high degree of sensitivity of the Campbell invention, visual detection can occur at hCG levels on the order of 50 mlU/ml. See Cannon Decl., Exhibit O at p. 420, line 7 to p. 421, line 1 (Ehrenkranz Deposition); Cannon Decl., Exhibit N at p. 400, line 5 to p. 401, line 25 (O'Connell Deposition). The Campbell patent therefore permits detection of pregnancy even at its earliest stages; hCG levels are generally on the order of 25-50 mlU/ml on the first day of a missed period. See Cannon Decl., Exhibit N at p. 409-410. The Gribnau invention, in contrast, did not permit visual detection at test concentrations of 65-80 mlU/ml, even with the addition of the color-enhancing solvent step. See Gribnau Patent, Cannon Decl. at Exhibit Q, p. 439. Visual results were obtained with the Gribnau invention only at very high hCG, concentrations [*28] of 4000 mlU/ml. Even at these high concentrations, an additional solvent was required to create a visible signal. The Gribnau invention, then, can only detect pregnancy significantly later in the term, when the hCG levels reach those higher concentrations. The Gribnau assay was unable to achieve visual detection of 50 mlU/ml, and thus was unable to detect pregnancy in its earliest stages, as the Campbell invention is able to do. Therefore, the Gribnau patent does not anticipate and invalidate the Campbell patent. Syntron argues that Becton Dickinson limits the scope of Gribnau to a single example and ignores all other examples and the "general teachings" of Gribnau. Opposition at 11. Syntron cites to a report of Dr. Eisen, prepared for other litigation. The Eisen report does not indicate that the Gribnau procedure produces results at the levels of hCG discussed above, however. See Exhibit 10 at P 24 (stating merely that the assays produced a visually observable color signal.). And while the Eisen report appears to state that the addition of a solvent is an optional method of intensifying the visual effect, see id. at P 21, there is no indication that the extra use of the solvent [*29] is not necessary to allow visual detection at the extremely low levels of hCG at which visual detection is possible with the Campbell patent. The distinc-

tions between the Campbell invention and the prior art discussed herein indicate that Campbell improved on the prior art because hCG is visible at the earliest stages of pregnancy without the use of solvents: these distinctions have not been rebutted by Syntron. Therefore, Becton Dickinson has demonstrated that it is reasonably likely that it will succeed in defeating Syntron's claim that the patent is invalid because it is anticipated by the Gribnau invention. Moreover, Becton Dickinson points out that Dr. Eisen has not been retained as an expert in this case. The report was prepared for a separate lawsuit that has since settled by an agreement stating that the Campbell patent is valid and enforceable. See Reply at 5. Dr. Eisen has not offered a report in this case. Because the issue has not been briefed and because it is not essential to the court's decision, the court will not issue a holding concerning whether that report is inadmissable hearsay, as Becton Dickinson maintains, or would be admissible because Dr. Ehrenkranz [*30] appears to rely on the report. An expert may testify to an opinion based on information not admissible as evidence, provided that the information is of the type reasonably relied upon by experts in the field. See American Bearing Co., Inc. v. Litton Indus., Inc., 540 F. Supp. 1163, 1169 (E.D.Pa 1982), aff'd 729 F.2d 943 (3rd Cir. 1984), cert. denied 469 U.S. 854, 83 L. Ed. 2d 112, 105 S. Ct. 178 (1984). b. The Leuvering Patent Syntron also argues that the Leuvering Patent, U.S. Patent No. 4,313,734, anticipates the Campbell patent. Like the Gribnau patent, the Leuvering invention does not use a porous surface that is capable of supporting a binder in a concentration of at least 1 [mu] g/cm<2>. The Leuvering patent, similar to the Gribnau invention, describes an assay in which a binder is coated on the walls of microwells. To detect a bound, gold-labeled tracer, a solvent is added. Also, unlike the Campbell patent, the Leuvering patent then uses an instrument, called a spectrophotometer, to detect color changes. The Leuvering invention does not create a signal visible to the naked eye. Syntron submits a declaration of Dr. Ehrenkranz, who states that the assay [*31] procedures of Leuvering gave rise to visual color signals in the presence of even low concentrations of analyte. See Ehrenkranz Decl. at P 17, Syntron's Exhibit 11. The experiments relied upon by Dr. Ehrenkranz and Syntron contained significant departures from the process disclosed in the Leuvering patent. The Syntron experiments did not follow the exact procedures detailed in the Leuvering patent; in fact, the scientist conducting the experiments was not even sure as to what antibody/reactants he was using in the experiments. Dr. Ehrenkranz testified that he used three antibodies

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provided to him by Syntron, but did not know what those antibodies were. See Cannon Decl. at Exhibit O, p. 417, line 11 to p. 418, line 23; p.419, line 19 to p. 420, line 1. According to Dr. McDermott, "the use of antibodies rather than receptor proteins is a significant deviation from the Leuvering patent and biases the experiments in Syntron's favor," McDermott Decl. at P 60. In addition, Dr. Ehrenkranz admitted that two of the three antibodies he used did not yield a visual signal at the 50 mlU/ml concentration that is achieved with the Campbell patent. See Cannon Decl. at Exhibit O, p. [*32] 420, line 15 to p. 420, line 1. Dr. Ehrenkranz stated that the two of the Leuvering type tests were not comparable to the Campbell patent. See id. at p.420, lines 20-22. The inconsistent results achieved by Syntron, even using the selected antibody binders, overcomes Syntron's claim that the Leuvering test inherently gives visible results and anticipates the Campbell patent. See Glaxo, Inc. v. Novopharm Ltd., 830 F. Supp. 871, 874 (E.D.N.C. 1993) ("In order for a claim to be inherent in the prior art it is not sufficient that a person following the disclosure sometimes obtain the result set forth in the claim, it must invariably happen.") (citing Standard Oil v. Montedison, 664 F.2d 356, 372 (3rd Cir. 1981)), aff'd, 52 F.3d 1043 (Fed. Cir. 1995), cert. denied 516 U.S. 988 (1995). Syntron also avers that Becton Dickinson has drastically changed its position from the earlier preliminary injunction. At that time, Syntron states that Becton Dickinson described the important part of the Campbell invention as being a discovery that a visible result could be obtained with a particulate label that was attached to a ligand using a solid support. Syntron claims that Becton [*33] Dickinson now alleges that it discovered the use of particular concentrations of analyte requiring a binder concentration of 1 [mu] g/cm<2>. It is not clear how Syntron concludes that this argument will invalidate the patent. On this record, it appears that the use of the 1 [mu] g/cm<2> binder concentration permits the detection of the visible signal at low levels of hCG concentrations and demonstrates that the Campbell patent is not anticipated by either the Gribnau or Leuvering patents. Syntron also argues that the invention now alleged is not disclosed in the patent and that the new issue becomes not whether 1 [mu] g/cm<2> is claimed, but whether that concentration is capable of detecting low hCG levels. Syntron maintains that the Campbell patent did not disclose that hCG levels at 25-50 mlU/ml can be detected by the 1 [mu] g/cm<2> binder concentration, or that those levels can be detected at the first day of a missed period, regardless of the concentration level. The Campbell patent, however, recites that analyte concentrations that are very low, e.g. 10 MlU/ml, can be

detected without instrumentation or treatment of the label. See McDermott Supp. Decl. at P 7 (citing [*34] col. 8, line 61 and co. 9, lines 13-14 of the Campbell patent). Moreover, the 1 [mu] g/cm<2> concentration level makes the detection of low levels of hCG detectible with the naked eye, and without the additions of solvents or the use of instruments. [HN7] "The defense of anticipation is only invoked if the alleged infringer can demonstrate that a single prior art reference discloses each and every element that is expressly or inherently found in the claimed invention." Al-Site Corp. v. Opti-Ray, Inc., 841 F. Supp. 1318, 1324 (E.D.N.Y. 1993) (citing Minnesota Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1565 (Fed.Cir. 1992)). Syntron provides no authority for the proposition that the earlier patents anticipate the key elements in the Campbell patent. Becton Dickinson's claim that the Campbell patent is valid, despite Syntron's claims regarding anticipation by the Gribnau and Leuvering patents, is bolstered by other considerations as well. First, Gribnau and Leuvering were both considered by the Patent Examiners, whose decision is afforded deference regarding anticipation. See American Hoist & Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1359 (Fed. [*35] Cir. 1984), cert. denied, 469 U.S. 821, 83 L. Ed. 2d 41, 105 S. Ct. 95. Moreover, as the court discussed in the earlier motion for preliminary injunction, the fact that other companies have taken licenses does constitute some evidence that others in the industry believe the patent to be valid. See Gillette Co. v. S.C. Johnson & Son, Inc., 919 F.2d 720 (Fed. Cir. 1990) (discussing commercial success in the nonobviousness context); Studiengesellschaft Kohle mb H v. Dart Indus., Inc., 549 F. Supp. 716, 736 (D.Del. 1982), aff'd, 726 F.2d 724 (Fed.Cir. 1984). Hence, this court finds that Becton Dickinson is likely to succeed in demonstrating that its Campbell patent is not invalidated because of anticipation by the Gribnau and Leuvering patents. c. The Hybritech Patent In a seven-line discussion, Syntron asserts that the Campbell patent are also anticipated by Hybritech's UK application 2 086 041. Syntron argues that, like the Campbell patent, a visible colored signal is obtained. As Becton Dickinson argues, however, the plastic or glass surfaces on which the binder is absorbed in the portion cited by Syntron could not support antibody in a concentration of 1 [*36] [mu] g/cm<2> as required by the Campbell patent. See McDermott Supp. Decl. at P 4. Syntron does not provide the court with any evidence or analysis upon which to base a decision that the requisite concentration is present, or that the Hybritech patent anticipates the Campbell patent despite the binder concentration requirement. Moreover, it is unclear, both in Syntron's papers and in the submitted exhibits, whether the visual determination that occurs in the Hybritech

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invention takes place without, or prior to, treatment or instrumentation. See id. The court holds that both the binder concentration and the Campbell patent's ability to create visual detection at low levels of hCG without the use of a solvent and/or instrumentation demonstrate that the prior art did not anticipate the Campbell invention. Therefore, Syntron's arguments concerning the Hybritech patent also fail. Becton Dickinson has established a reasonable likelihood that Syntron will not succeed in invalidating the Campbell patent on the basis of anticipation. d. Misrepresentation of the Prior Art to the Patent Office Syntron also argues that the patent is unenforceable because Dr. O'Connell and [*37] Becton Dickinson's patent attorney, misrepresented the Gribnau patent and the Leuvering patent to the Patent Office. In the previous preliminary injunction, Syntron supported its argument with the expert report of Dr. Eisen and a declaration from Dr. Ehrenkranz. As explained above, Dr. Eisen's report was submitted as part of a separate challenge to the Campbell patent made by a different defendant. Syntron argues that Becton Dickinson made two misrepresentations: selecting tests to distinguish over the references, and using the tests in such a way as to knowingly present a false result. [HN8] To prove inequitable conduct and render a patent unenforceable, Syntron must establish by clear and convincing evidence that there was a material misrepresentation or omission of information, and must establish a threshold level of intent. See Akzo N.V. v. U.S. Intern. Trade Comm'n, 808 F.2d 1471, 1481 (Fed.Cir. 1986), cert denied, 482 U.S. 909, 96 L. Ed. 2d 382, 107 S. Ct. 2490 (1987). "To be guilty of inequitable conduct, one must have intended to act inequitably." Kingsdown Medical Consultants v. Hollister, Inc., 863 F.2d 867 (Fed.Cir. 1988) (quoting FMC Corp. v. Manitowoc Co., [*38] Inc., 835 F.2d 1411, 1415 (Fed.Cir. 1987)), cert. denied, 490 U.S. 1067 (1989). Materiality and intent must be considered together; the more material the misrepresentation or omission, the less intent is necessary to show inequitable conduct. See Akzo N.V., 808 F.2d at 1481-1482. The Federal Circuit has warned courts about charges of inequitable conduct, stating that "the habit of charging inequitable conduct in almost every major patent case has become an absolute plague." Burlington Industries, Inc. v. Dayco Corp., 849 F.2d 1418, 1422 (Fed.Cir. 1988). Syntron argues that instead of performing an actual assay disclosed in the references, Dr. O'Connell performed a test that did not conform to the Gribnau process, though he was representing that it did, and that he knew would fail. This would allegedly persuade the Pat-

ent Examiners that the Campbell patent was not anticipated by the Gribnau invention. See Opposition at 12. Syntron states that Dr. O'Connell's tests did not contain the presence of a binder on the test tubes, the use of an analyte capable of binding to the binder, and the use of a label conjugated to a ligand capable of reacting with the analyte. [*39] See id. According to Syntron, all of these elements were required for the actual assays. Syntron also cites Dr. Eisen's report for the proposition that a colored signal would have been obtained if the tests had been performed accurately. Syntron charges that Dr. O'Connell presented those tests to the Patent Office for the purpose of distinguishing over the Gribnau and Leuvering references, and that he chose test conditions designed to give misleading results. Syntron also alleges that Dr. O'Connell discussed those tests with the his patent attorney in order to distinguish over the references. Becton Dickinson argues that Dr. O'Connell performed the test to respond to an assertion made by the Patent Examiners during the Campbell patent prosecution. The Examiners maintained as a "logical deduction" that "[a] label that is visible when taken into solution (in, for example, ethanol as taught by [Gribnau]) must also be visible when bound to the solid surface" of the container or test tube in which the assay is produced. Cannon Decl. at Exhibit M, p. 336, 340 (response to Patent Application) Dr. O'Connell conducted a demonstration at an interview with the Examiners to show that a [*40] dye that is visible in a solution may not necessarily be visible when bound to the surface of a container. Syntron does not meet its burden of demonstrating intent to mislead. The evidence of intent, one of the two showings that Syntron must meet to demonstrate misrepresentation, indicates that Dr. O'Connell acted in good faith. In fact, the evidence Syntron cites indicates that Dr. O'Connell acted so as to produce the best test that he could to answer the concerns of the Patent Examiners. In his deposition, Dr. O'Connell discussed the difficulty in attempting to reproduce someone else's full assay. See Exhibit 14 at 428. There is no indication that he and his attorney attempted to mislead the examiners. Dr. O'Connell testified that the methods and explanations he was using were a fair representation of what the examiner was citing, see id. at 429, and that he provided a "very fair portrayal of what was going on" to the patent examiner. Id. at 430. Dr. O'Connell also testified that he believed it was a fair experiment at that time and that his protocol for the experiment did not change based on anything that was said to him by Becton Dickinson's patent attorney. See [*41] id. at 450-451. The protocol for the demonstration performed at the Patent Office was also Dr. O'Connell's idea, not that of Becton Dickinson's attorney. See id. at 427. The attorney merely confirmed that Dr. O'Connell's portrayal was fair. See id. at 427-

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1998 U.S. Dist. LEXIS 22082, *; 51 U.S.P.Q.2D (BNA) 1722

428. In short, Syntron has not demonstrated by clear and convincing evidence an intent to deceive, nor has Syntron provided evidence to overcome the sworn statements of Dr. O'Connell indicating that there was an affirmative effort to present accurate portrayals to the Patent Office. Syntron argues that because of Dr. O'Connell's knowledge of how to dilute a visible dye to an invisible concentration, he "knew that he could make the tests fail if he used a low enough concentration of the label." Opposition at 13. Even assuming that this assertion is correct, this fact does not demonstrate that a material misrepresentation was made or that there was intent to mislead. Moreover, Dr. O'Connell needed to use a dye that was not visible on the container to prove that such a dye could become vi