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BOEHRINGER INGELHEIM ANIMAL HEALTH, INC. v. SCHERI

April 27, 1998

BOEHRINGER INGELHEIM ANIMAL HEALTH, INC., Plaintiff,
v.
SCHERING-PLOUGH CORPORATION and SCHERING CORPORATION, Defendants.



The opinion of the court was delivered by: ACKERMAN

OPINION

 Ackerman, D.J.

 This matter comes before the court on motions for summary judgment filed by both parties in this patent litigation and upon plaintiff's renewed motion for a preliminary injunction. For the reasons detailed below, the motions are DENIED.

 I. Background

 These motions follow the court's recent denial of plaintiff's motion for a preliminary injunction. See Boehringer Ingelheim v. Schering, 984 F. Supp. 239 (D.N.J. 1997). Both parties have come in conflict because of their interest in developing a vaccine for a disease known as Porcine Reproductive Respiratory Syndrome ("PRRS"). Boehringer alleges that Schering has infringed upon its patent. The patent in question, Patent No. 5,476,778 ("the '778 Patent"), covers a method which, Boehringer believes, is instrumental to the development of a PRRS vaccine. The '778 Patent makes five claims, two of which are at issue here:

 
1. A method of growing and isolating swine infertility and respiratory syndrome virus, ATCC-VR2332, which comprises inoculating the virus on a full or partial sheet of simian cells in the presence of serum in a suitable growth medium and incubating the inoculated cell sheet at about 34 [degrees] C. to 37 [degrees] C. until CPE is observed.
 
2. The method as recited in claim 1 wherein the simian cell line is MA-104.
 
Id. at 244.

 Using the patented method, Boehringer developed two PRRS vaccines, RespPRRS TM and RespPRRS/Repro TM. In the instant case, plaintiff charges that Schering has infringed upon the patent in developing its own PRRS vaccine.

 In June 1997, the court held a hearing on plaintiff's motion for a preliminary injunction. At the same time, it conducted a Markman hearing to conclusively interpret the claim language and its subsequent opinion defines each element of the '778 Patent. See Id. The court denied plaintiff's preliminary injunction motion because it held that Schering had raised a substantial defense on the issue of obviousness and therefore, Boehringer had failed to satisfy its burden of proving likelihood of success. See Id. at 258-259. In other words, Schering had raised a substantial question as to the validity of the patent under § 103(a). See 35 U.S.C. § 103(a) ("Patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 . . . if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains."). Based upon its resolution of the validity issue, the court did not need consider the likelihood of Boehringer's success regarding infringement, either literally or under the doctrine of equivalents. See Id. at 262. Additionally, plaintiff did not establish irreparable harm. See Id. at 264. For those reasons, the court declined to issue a preliminary injunction. In the wake of that denial, Schering filed this summary judgment motion. Boehringer responded with its own summary judgment motion and a renewed motion for a preliminary injunction.

 II. Summary Judgment Standard

 Federal Rule of Civil Procedure 56 provides that summary judgment may be granted only if the pleadings, supporting papers, affidavits, and admissions on file, when viewed with all inferences in favor of the nonmoving party, demonstrate that there is no genuine issue of material fact and that the movant is entitled to judgment as a matter of law. Fed. R. C.V.. P. 56(c). See also Todaro v. Bowman, 872 F.2d 43, 46 (3d Cir. 1989); Chipollini v. Spencer Gifts, Inc., 814 F.2d 893, 896 (3d Cir.), cert. dismissed, 483 U.S. 1052, 97 L. Ed. 2d 815, 108 S. Ct. 26 (1987). In other words, "summary judgment may be granted if the movant shows that there exists no genuine issue of material fact that would permit a reasonable jury to find for the nonmoving party." Miller v. Indiana Hospital, 843 F.2d 139, 143 (3d Cir.), cert. denied, 488 U.S. 870, 102 L. Ed. 2d 147, 109 S. Ct. 178 (1988).

 The substantive law will identify which facts are "material." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-248, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986). Therefore, "only disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment." Id. An issue is "genuine" if a reasonable jury could possibly hold in the nonmovant's favor with regard to that issue. Id.

 The party seeking summary judgment always bears the initial burden of production, i.e., of making a prima facie showing that it is entitled to summary judgment. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986). This may be done either by demonstrating there is no genuine issue of fact and that as a matter of law, the moving party must prevail or by demonstrating the nonmoving party has not produced evidence relating to an essential element of the issue for which it bears the burden. Id. at 322-23. Once either showing is made, the burden shifts to the nonmoving party who must demonstrate facts supporting each element for which it bears the burden as well as establish the existence of genuine issues of material fact. Id. at 324.

 However, at the summary judgment stage, a court may not weigh the evidence or make credibility determinations--these tasks are left to the factfinder. Petruzzi's IGA v. Darling-Delaware, 998 F.2d 1224, 1230 (3d Cir.), cert. denied, 510 U.S. 994, 126 L. Ed. 2d 455, 114 S. Ct. 554 (1993). Therefore, to raise a genuine issue of material fact, "'the [summary judgment] opponent need not match, item for item, each piece of evidence proffered by the movant,' but simply must exceed the 'mere scintilla' standard." Id. See also Anderson, 477 U.S. at 252 ("The mere existence of a scintilla of evidence in support of the [nonmovant's] position will be insufficient; there must be evidence on which the jury could reasonably find for the [nonmovant]."). "Although a 'scintilla of evidence' supporting the non-movant's case is not sufficient to defeat a motion for summary judgment, it is clear that a district court should not weigh evidence and determine the truth of the matter itself, but instead should determine whether there is a genuine issue for trial." Country Floors, Inc. v. Country Tiles, 930 F.2d 1056, 1061-2 (3d Cir. 1990).

 If the court determines that there is no genuine issue of material fact and the movant is entitled to judgment as a matter of law, then summary judgment may be granted.

 III. Discussion

 A. Infringement

 There are two steps in patent infringement analysis: "the first being the construction of the claim and the second being the determination as to whether the accused method infringes the asserted claim as properly construed." Boehringer, 984 F. Supp. at 245 (citing Markman v. Westview, 52 F.3d 967 (Fed Cir. 1995) (en banc), affirmed, 517 U.S. 370, 116 S. Ct. 1384, 134 L. Ed. 2d 577 (1996)). At the time of the preliminary injunction hearing, the court, in a Markman hearing, conclusively interpreted the claim language. 984 F. Supp. at 247-53. Thus, all that remains is a "determination as to whether the accused method infringes the asserted claim as properly construed." 984 F. Supp. at 245. Schering has brought this summary judgment motion arguing that as a matter of law, its vaccine production process does not incubate the inoculated cell sheet "until CPE is observed" as this court has construed that element. CPE means cytopathic effect which is "change in the microscopic appearance of a cell after infection with a virus" or the killing of inoculated cells. Boehringer alleges that it should be granted summary judgment because there are no genuine issues of material fact as to any of the patent's elements. Because there are genuine issues of material fact as to whether Schering has infringed upon the element "until CPE is observed," this court will only focus upon that element.

 1. The Claim Language

 The claimed method uses the term "until CPE is observed" as a "timing device" to instruct the reader on how to calculate when the incubation period is completed. See Boehringer, 984 F. Supp. at 252. CPE means cytopathic effect which is "change in the microscopic appearance of a cell after infection with a virus" or the killing of inoculated cells. The incubation occurs "until CPE is observed." In its Markman hearing, the court faced the question of whether the language dictated that the process terminate at the initial observation of CPE, at some degree of CPE, or at a time period to be determined independently of any degree of CPE. Ultimately, this court construed the patent language as focusing upon the occurrence of CPE where some significant degree of CPE, either "strong" or "good" will trigger the termination of the process rather than the initial observation or some independent factor. See Id. The process's preferred level of CPE is somewhat inexact and not amenable to further precision. The moment contemplated by the '778 Patent is subject to a more "qualitative determination." See Id.

 2. Generally: Infringement

 a. Literal Infringement

 To succeed in its infringement claim, Boehringer must be able to prove that the Schering process infringed its patent, either literally or under the doctrine of equivalents. A defendant literally infringes where every limitation set forth in a patent claim is found in the accused process, exactly. See Southwall Technologies, Inc. v. Cardinal IG Company, 54 F.3d 1570, 1575 (Fed. Cir.), cert. denied, 516 U.S. 987, 133 L. Ed. 2d 424, 116 S. Ct. 515 (1995). Infringement is a fact issue. See Id.

 b. Doctrine of Equivalents

 Even if the accused process does not literally infringe, infringement might exist under the doctrine of equivalents. See Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17, 117 S. Ct. 1040, 137 L. Ed. 2d 146 (1997) (reaffirming the doctrine's vitality). Under this doctrine, "a product or process that does not literally infringe upon the express terms of a patent 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." 117 S. Ct. at 1045 (citing Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605, 94 L. Ed. 1097, 70 S. Ct. 854 (1950)). Guided by Graver Tank, supra, which was the Supreme Court's last consideration of the doctrine, the Court reiterated that an equivalency analysis is not a formulaic one, but rather, a contextual one which focuses on the patent, the prior art and the particular circumstances of the case. See 117 S. Ct. at 1047 (citing Graver Tank, 339 U.S. at 609). As the Court explained:

 
Consideration must be given to the purpose for which an ingredient is used in a patent, the qualities it has when combined with the other ingredients, and the function which it is intended to perform. An important factor is whether persons reasonably skilled in the art would have known of the interchangeability of an ingredient not continued in the patent with one that was.
 
Id.

 Although the Supreme Court remains committed to the doctrine of equivalents, it has expressed concern that in the past, lower courts have employed such an overbroad interpretation that the doctrine "has taken on a life of its own, unbounded by patent claims." 117 S. Ct. at 1048-49. Thus, in order to steer the doctrine back on course, the court explained that the doctrine "must be applied to individual elements of the claim, not to the invention as a whole" because it is each element which is "material to defining the scope of the patented invention." Id. at 1049. The Court adopted this approach because it feared that any other approach, e.g. looking at the invention as a whole, could effectively eliminate a material element in its entirety. See Id.

 According to the Federal Circuit, infringement under the doctrine of equivalents is an issue of fact to be submitted to the jury. Hilton Davis Chemical Co, supra. The Supreme Court has not conclusively decided this issue, but there is "ample support" for that holding and "no other decision of the Supreme Court necessitates otherwise." Warner-Jenkinson, supra, at 1053. For our purposes, that means that this court will only grant a motion for summary judgment "where the evidence is such that no reasonable jury could determine two elements to be equivalent." Id. at 1053 n. 8.

 i. The Linguistic Framework

 Federal courts have employed different linguistic frameworks in evaluating "equivalence." The Supreme Court has expressed its reluctance with "micromanaging" the Federal Circuit's word choice and has not indicated whether it prefers the "triple identity" test -- "focusing on the function served by a particular claim element, the way that element serves that function, and the result thus obtained by that element" -- or the "insubstantial differences" approach. See Warner-Jenkinson, supra, at 1054. Suffice it to say that this court is aware that the traditional "triple identity" test might not be "the test" and in some instances, may not end the inquiry. See Hilton Davis, 62 F.3d 1512 at 1518, 1521-22; see also Sofamor Danek Group v. Depuy-Motech, 74 F.3d 1216 at 1222. The "equivalents" inquiry requires proof of insubstantial differences which be informed by other factors such as evidence of copying, designing around or evidence that persons reasonably skilled in the art would have known of the interchangeability elements. See Hilton-Davis, 62 F.3d at 1518, 1521-22; see also Sofamor Danek Group, supra, at 1222.

 Ultimately, the "particular linguistic framework used is less important than whether the test is probative of the essential inquiry: Does the product or process contain elements identical or equivalent to each claimed element of the patented invention?" Warner-Jenkinson, 117 S. Ct. at 1054. As the Supreme Court has noted:

 
Different linguistic frameworks may be more suitable to different cases, depending on their particular facts. A focus on individual elements and a special vigilance against allowing the concept of equivalence to eliminate completely any such elements should reduce considerably the imprecision of whatever language is used. An analysis of the role played by each element in the context of the specific patent claim will thus inform the inquiry as to whether a substitute element matches the function, way, and result of the claimed element, or whether the substitute element plays a role substantially different from the claimed element.
 
Id.

 Eventually, the Supreme Court anticipates that the Federal Circuit will "refine the formulation of the test . . . in the orderly course of case-by-case determinations." Id. At this time, this court will follow the standards established in Hilton-Davis and Sofamor.

 3. The Instant Case

 In the instant case, Schering has directed the court's attention to the element "until CPE is observed." That element dictates that the patented process terminate at the moment some significant degree of CPE, either "strong" or "good," is observed. Whether significant CPE exists is a "qualitative determination." According to Schering, by focusing upon maximum yield or titer rather than CPE, its process does not infringe upon the '778 Patent, either literally or under the doctrine of equivalents. Whereas the patented method incubates until a significant degree of CPE is observed, the Schering process operates for a fixed time period of XX hours. *fn1" ...


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