Opinion
8:99CV473
May 20, 2002
MEMORANDUM AND ORDER
The matters before the court are Streck Laboratories' (Streck's) Motion for Summary Judgment of Literal Infringement, Filing No. 212; Beckman Coulter and Coulter Corporation's (Coulter's) Motion for Summary Judgment of Patent Invalidity under 35 U.S.C. § 112(1) ¶ 1, Filing No. 231; and Coulter's Motion for Summary Judgment of Patent Invalidity under 35 U.S.C. § 102 and of Non-infringement under the Doctrine of Equivalents, Filing No. 235. A hearing was held on the matter on February 14, 2002. For the reasons set forth below, the court finds Streck's motion for summary judgment of infringement should be granted, and Coulter's motions for summary judgment should be denied.
I. Background
This action involves hematology control products — products for use in testing the proficiency of hematology instruments that measure certain properties of blood. There are six patents at issue in this case: 1) U.S. Patent Number 5,262,327 (the '327 patent); 2) U.S. Patent Number 5,270,208 patent (the '208 patent); 3) U.S. Patent Number 5,672,474 (the '474 patent); 4) U.S. Patent Number 5,677,145 (the '145 patent); 5) U.S. Patent Number 5,731,205 (the '205 patent); and 6) U.S. Patent Number 5,981,282 patent (the '282 patent). All of these patents were issued to Streck Laboratories, Inc., as assignee for inventor Wayne L. Ryan.
This court earlier granted a summary judgment of invalidity to Streck regarding Coulter's '933 patent. The claims that were determined invalid in the '933 patent were the claims involving hematology controls that used fixed white blood cells. The court found that Coulter's patent regarding those products was invalid under 35 U.S.C. § 102(b) which denies patent protection to an invention that was "on sale" more than a year before the patent application. Memorandum and Order dated September 10, 2001, Filing No. 208. The court found that Streck had shown that its fixed white blood cell product was on sale more than a year before Coulter's patent application. Id.
In its motion for summary judgment, Streck asserts that the undisputed evidence shows that Coulter has literally infringed four of these patents: the '474 patent, the '145 patent, the '205 patent, and the '282 patent. In response, Coulter contends that it has not literally infringed, and in turn moves for summary judgment asserting that the patents are invalid. Coulter also moves for a summary judgment of invalidity for failure to comply with ¶ 1 of 35 U.S.C. § 112(1), which requires an adequate description of the patented product.
Streck also alleges that Coulter has infringed the other two patents under the doctrine of equivalents. Those patents are not addressed in these motions.
A. Facts
The facts set forth in the court's earlier order are incorporated herein. The evidence establishes that Coulter manufactures and sells hematology instruments, which are machines that test or measure certain properties of human blood. One such instrument is the Coulter STKS instrument. In 1990, Coulter manufactured the instruments, but did not manufacture a control product for use with the STKS instrument. At some time during 1990 and 1991, both Streck and Coulter developed control products for use with the STKS instrument. The two competing products at issue are the Streck "STak-Chex," which Streck began selling in May 1991 and the Coulter "5C Cell Control," which Coulter began selling in May 1992.
In June 1990, Streck purchased a Coulter STKS instrument for use in its development of a hematology control product for use with that instrument. (Streck's evidentiary material in support of Streck's brief in opposition to Beckman Coulter's Motion for Summary Judgment of Patent Invalidity under 35 U.S.C. § 102(g), attached to Filing No. 336, Exhibit 8, Deposition of Dr. Wayne L. Ryan at 167) (hereinafter, "evidence attached to Filing No. 336"). It was necessary for the control product to mimic the properties of fresh human blood while maintaining shelf stability in order to properly test the instruments. In addition, in order to properly test the STKS instrument, the control product had to properly position a five-part white blood cell differential on a histogram. While developing its hematology control product sometime in late 1990, Streck's founder, Dr. Wayne L. Ryan, discovered that the key to correctly positioning white blood cells on a histogram, so as to mimic fresh human blood, was the addition of an effective amount of lipoprotein. ( Id. at 332-334). As noted in the court's earlier Memorandum and Order, Dr. Ryan informed individuals from the College of American Pathologists ("CAP") that Streck had developed a control product that would work on the Coulter STKS instrument in December 1990. Streck shipped a control product to CAP on March 4, 1991. There is no dispute that a sample of Streck's product was sent to Coulter on February 21, 1991. (Evidence attached to Filing No. 336, Exhibit 39).
Internal documents produced by Coulter demonstrate that Coulter continued to experience problems with the control product that it was developing as late as early 1991. A memo outlining weekly objectives dated January 6, 1991, indicates that an objective was to research the "lipoprotein solubility" of the product. ( Id., Exhibit 10). A Research and Development report dated January 31, 1991, states that the finalization of the five-part differential control continued but that "the suspending solution is being evaluated for lipid content and identity" and that "changes in the formulation [were] being optimized to provide long-term stability," acknowledging that "previous test lots have shown that these lipids do, in fact, improve stability," and noting that "stability testing is continuing." ( Id., Exhibit 11). The problems were eventually solved by changing the lipoprotein component of the product to greatly increase the percentage of lipoprotein in the solution. ( Id., Exhibits 14, 19, 20, 22, and 34). Coulter's "5C Cell control" was not transferred from the research department to the product development department until February 1992 and was not marketed until March 1992. (Evidence attached to Filing No. 336, Exhibit 23).
Streck and Coulter both applied for and were granted patents on various types of control products for the STKS machine. In May 1991, Streck filed its '331 application, which evolved into the '327 patent. (Streck's evidentiary material submitted in opposition to Beckman Coulter's Motion for Summary Judgment of Patent Invalidity under 35 U.S.C. § 112, attached to Filing No. 328, Exhibit 6) (hereinafter, "evidence attached to Filing No. 328"). The novel part of the '327 patent was the addition of lipoprotein. (Evidence attached to Filing No. 328, Exhibit 7, Declaration of Warren Groner). The patent was granted in November 1993. (Evidence attached to Filing No. 336, Exhibit 6). Streck's later patents were improvements upon and enhancements to this first patent for a STKS control product. Each of the Streck patents at issue requires a surrogate, analog, or a blood cell that, in combination with a sufficient amount of lipoprotein, "gives a white blood cell histogram profile that is substantially that of whole blood." (Id., Exhibits 2, 3, 4, 5, 6, and 7).
Streck filed the application that evolved into the '474 patent in January 1994, and it was granted in September 1997. The '474 patent uses fixed or stabilized red blood cells as a white blood cell surrogate. The '145 patent uses fixed or stabilized white blood cells or surrogates thereof. The '205 patent is directed to methods of using the control to produce a white blood cell profile that resembles whole blood and the '282 patent uses fixed or stabilized white blood cells to produce a white blood cell profile with certain characteristics. (Evidence attached to Filing No. 336, Exhibits 2, 3, 4, and 5).
The evidence further shows that one skilled in the art would recognize upon reading the Streck patents that the addition of lipoprotein was the novel part of the invention and that "art-recognized" analogs for fresh white blood cells could be used for the invention. (Evidence attached to Filing No. 328, Exhibits 7 and 26). Use of analogs for fresh white blood cells are described in Streck's patent specification, disclosing a fixed white blood cell as one type of analog. (Evidence attached to Filing No. 328, Exhibit 7 at 7-8). The undisputed evidence also shows that one who wished to make white blood cell analogs for a control would readily have thought of red blood cells as a source and that use of various types of analogs for white blood cells had been known for about twenty years. ( Id. at 7-8). Use of animal red blood cells as white blood cell analogs was not novel at the time Streck filed its patent application and there are several examples of patents issued for such analogs in the prior art. ( Id., Exhibits 7, 8, 10, 18, 19, 20, 21, and 22).
II. DISCUSSION A. Summary judgment
Summary judgment is appropriate when there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). On motion for summary judgment, the court views the evidence and any disputed factual issues in the light most favorable to the party opposing the motion. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). A patent is presumed to be valid, 35 U.S.C. § 282 (1994), and this presumption can only be overcome by facts supported by clear and convincing evidence to the contrary, WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1355 (Fed. Cir. 1999).
B. Literal infringement
One who, without a patent owner's authority, makes, uses, sells, imports, or offers to sell a patented invention within the United States, infringes the patent. 35 U.S.C. § 271(a). Infringement analysis involves two steps: (1) the court first construes the scope of the asserted claims; and then (2) compares the accused device to the properly construed claims to determine whether each and every limitation of a claim is present, either literally or equivalently, in the accused device. Tate Access Floors, Inc. v. Interface Architectural Resources, Inc., 279 F.3d 1357, 1365 (Fed. Cir. 2002). The construction of the terms in a patent is a matter of law reserved entirely for the court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996). Comparing the accused product to the asserted claims is a question of fact. Tate Access Floors, Inc., 279 F.3d at 1372.
Claim interpretation begins, as always, with the language of the claims. Tate Access Floors, 279 F.3d at 1370 (noting that a court must presume that the terms in the claim mean what they say, and, unless otherwise compelled, give full effect to the ordinary and accustomed meaning of claim terms). The actual language of the claims is given its ordinary meaning as understood by one skilled in the art. Hockerson-Halberstadt, Inc. v. Avia Group Int'l, Inc., 222 F.3d 951, 955 (Fed. Cir. 2000). This ordinary meaning controls unless the patentee clearly defines a word differently in the specification or the prosecution history. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Thus, the strong presumption in favor of the ordinary meaning of claim language as understood by one of ordinary skill in the art may be overcome only where: 1) the patentee has chosen to become his or her own lexicographer by clearly and explicitly defining the claim term; or 2) where "the claim term would render the claim devoid of clarity such that there is `no means by which the scope of the claim may be ascertained from the language used.'" Tate Access Floors, 279 F.3d at 1370 (quoting Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001)).
To construe a claim, the court begins with "intrinsic evidence," i.e., the patent itself (including the specification — all the text and figures preceding the numbered patent claims) and the prosecution history, if it is in evidence. Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331-32 (Fed. Cir. 2000). If, after this analysis, a claim limitation still isn't clear, the court then looks to extrinsic evidence, such as dictionaries, technical articles, expert testimony, or the inventor's testimony. Dow Chemical Co. v. Sumitomo Chemical Co., 257 F.3d 1364, 1372-73 (Fed. Cir. 2001). Claim language should generally be construed to preserve validity, if possible. Tate Access Floors, 279 F.3d at 1369.
If the accused product is covered by, or within the scope of, a particular patent claim, the product infringes that claim, and consequently, the patent. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995) (noting that only one claim of a patent needs to be infringed for the patent to be infringed). Although comparing the accused product to the patented product is a factual determination, summary judgment is appropriate where the facts are not in dispute and resolution depends on construction of a claim. K-2 Corp. v. Salomon, S.A., 191 F.3d 1356, 1362 (Fed. Cir. 1999) (noting that where parties disagree over claim interpretation, the question of literal infringement collapses into one of claim construction and is thus amenable to summary judgment).
With those standards in mind, the court finds that claims of the patents at issue can properly be construed as including analogs or surrogates for white blood cells in its coverage. The terms "analog" and "surrogate" should be afforded their ordinary meanings and construed as any substitute for fresh human white blood cells. Analog is commonly understood to mean something that is analogous to or similar to something else. See, e.g., Webster's II New Riverside University Dictionary 104 (1984). "Surrogate" means one taking the place of another, or substitute. Id. at 1166. In its own documents Coulter has used the terms "analog" and "surrogate" to mean substitutes for white blood cells. (Evidence attached to Filing No. 336, Exhibit 27; evidentiary materials submitted in support of Streck's Motion for Summary Judgment of Literal Infringement, attached to Filing No. 214, Exhibit A at 766, Exhibit B at 791; evidentiary materials submitted in support of Streck's Reply to Coulter's Opposition to Streck's Motion for Summary Judgment of Literal Infringement, Attached to Filing No. 243, Exhibit C (hereinafter, "evidence attached to Filing No. 243")). The definition of "analog"or "surrogate" found in Coulter's own patent documents does not differ significantly from these ordinary meanings. Id., Exhibits F, G, and H (i.e., "a particle which simulates one physical or biological property of a target population," an example being simulated white blood cells from red blood cells). Moreover, the evidence establishes that the terms "analog" and "surrogate" are understood by persons of ordinary skill in the art to mean any substitute for human blood cells.
Construed as including analogs or surrogates, the court finds that the uncontroverted evidence shows Coulter's 5C Cell Control contains all the elements of at least one claim of each of the four patents it alleges have been literally infringed (the '474, the '145, the '205, and the '282). ( See evidence outlined in Appendix to Streck's Separate Statement of Material Facts, attached to Filing No. 214). Each of these patents involves a product with lipoprotein, and each enhanced Streck's original '327 patent. It is not controverted that Coulter has made, used, and sold the infringing product in the United States. (Evidence attached to Filing No. 214, Exhibit A, Deposition of William D. Lewis, at 588). Streck has thus established that it is entitled to a judgment of literal infringement.
Coulter's argument that its 5C product does not infringe Streck's patent since its product uses animal red blood cells as a white blood cell analog is rendered meaningless by this construction of "analog." Coulter's reliance on defenses of prior invention under 35 U.S.C. § 102(g) and insufficient written description under 35 U.S.C. § 112 are rejected for the reasons discussed below.
In addition, "practicing the prior art" as a defense is applicable only to claims alleging infringement under the doctrine of equivalents, and not to literal infringement claims. Tate Access, 279 F.3d at 1366 (noting the doctrine of equivalents is an equitable doctrine that expands the reach of claims beyond their literal language; this expansion is guided and constrained by the prior art because it would not be equitable to allow a patentee to claim a scope of equivalents encompassing material that had been previously disclosed by someone else).
C. Written Description Requirement
The statute provides: "The application must contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. . . ." 35 U.S.C. § 112 ¶ 1. The object of the statute is to require the patentee to describe his invention so that others may construct and use it after the expiration of the patent, and to inform the public during the life of the patent of the limits of the monopoly asserted, so that it may be known which features may be safely used or manufactured without a license and which may not. Schriber-Schroth Co. v. Cleveland Trust Co., 305 U.S. 47, 57 (1938).One challenging a patent under the written description requirement must still overcome the patent's presumed validity with clear and convincing evidence. See, e.g., Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 1017 (Fed. Cir. 2002). Compliance with the written description requirement is a question of fact. Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993). The claims as filed are part of the specification, and may provide or contribute to compliance with § 112. Id. The sufficiency of the written description is measured from the point of view of one with ordinary skill in the art at the time the description is filed. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1346 (Fed. Cir. 2000).
Minutiae of descriptions or procedures perfectly obvious to one of ordinary skill in the art, yet unfamiliar to laymen, need not be set forth. Hyatt v. Boone, 146 F.2d 1248, [ 146 F.3d 1348], 1353 (Fed. Cir. 1998). The written description must include the limitations of the claim with sufficient clarity and specificity that persons of ordinary skill in the art will recognize from the disclosure that a process including those limitations has been invented. Id. at 1355. Thus, missing subject matter in a description can be shown to be part of the prior art that would be understood as part of the description of the subject matter of the claim. Id. at 1353.
Under those standards, the court is unable to find that the patents violate the written description requirements of 35 U.S.C. § 112. The claim is not so devoid of clarity that there is no means by which those skilled in the art could ascertain the scope of the claim. The evidence shows that there was no need to describe "analogs" or "surrogates" in Streck's patent documents because the use of an analog or surrogate for white blood cells in hematology control devices was commonly known in the industry at the time of Streck's invention. The evidence shows that use of such analogs in controls was well known in the art: because actual human white blood cells lack stability, any control would necessarily require an analog for human white blood cells. The evidence further establishes that animal red blood cells were used as analogs for white blood cells in other patents. The Patent Office addressed and resolved these concerns before issuing Streck's patent. Evidence attached to Filing No. 328, Exhibit 26. These conclusions apply as well to Coulter's arguments regarding the sufficiency of Streck's enabling language.
Coulter's reliance on Enzo Biochem as support for its written description assertions is misplaced. Enzo Biochem involved the emerging and specialized areas of genetic engineering and biotechnology. Id. 285 F.3d at 1018 (citing other biotechnology cases and noting that a description of what the genetic material does, rather than what it is will not suffice). Its principles are not applicable to this case.
Coulter has not met its heavy burden of overcoming, by clear and convincing evidence, the patents' presumed validity. The court thus finds Coulter's motion for summary judgment under 35 U.S.C. § 112 should be denied.
D. Priority of Invention
Coulter argues that the undisputed evidence shows that it was the first to invent a control product using lipoprotein. It contends that its 5C product was conceived in March or April 1990. Streck argues that the evidence shows that Coulter had solubility problems with its product until March 1991, and thus did not "solve the problem" that Streck had solved with the addition of lipoprotein until then. Streck also argues that to the extent Coulter has shown discovery of the lipoprotein component before Streck, it is barred from asserting invalidity because of its unreasonable delay in sharing the discovery with the scientific community. Streck further contends that, at the least, material issues of fact preclude summary judgment on this issue.
The Patent Act provides that:
"[a] person shall be entitled to a patent unless . . . before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.35 U.S.C. § 102(g)(2). Priority of invention is a question of law based on underlying factual determinations. Monsanto v. Mycogen Plant Science, Inc., 261 F.3d 1356, 1362 (Fed. Cir. 2001). Under 35 U.S.C. § 282, patents are presumed to be valid and patent challengers are required to prove invalidity by clear and convincing evidence. Id. at 1362. The presumption remains intact and on the challenger throughout the litigation, and the clear and convincing standard does not change. Hybridtech, Inc., v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1375 (Fed. Cir. 1986).
Section 102(g) has been interpreted to provide that priority of invention goes to the first party to reduce an invention to practice unless the other party can show that it was the first to conceive the invention and that it exercised reasonable diligence in later reducing that invention to practice. Id. Reduction to practice and conception are legal determinations. Hybridtech, 802 F.2d at 1376. "Conception is the `formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.'" Id. ( quoting 1 Robinson on Patents 532 (1990)) (emphasis added). Actual reduction to practice requires that the claimed invention work for its intended purpose. Id.
The undisputed evidence shows that Streck had reduced its invention to practice — had a claimed invention that worked for its intended purpose — by February 20, 1991, at the latest. There is no dispute that data and information on the invention, as well as samples, were sent to Coulter on that date. Common sense dictates that the product was conceived before then and the evidence supports the assertion that the complete and operative invention was conceived sometime in the fall of 1990.
Coulter argues that it conceived of the invention in early 1990 and proceeded with reasonable diligence thereafter to develop its product. Coulter may have shown that it conceived of adding lipoprotein to a control product in early 1990, but has not shown that it conceived of adding "lipoprotein in sufficient quantities" to make the product work until after it was provided with information, data and a sample of Streck's control product. Coulter's own documents show that Coulter continued to experience problems with the lipoprotein component of its product well into 1991. Thus it has not shown "formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention." See Hybridtech, 802 F.2d at 1376. Because Coulter has not produced clear and convincing evidence that it conceived the invention before Streck did, the court need not address whether its efforts can be considered diligent. Coulter has not shown by clear and convincing evidence that Streck's patents are invalid under 35 U.S.C. § 102(g). Accordingly, the court finds Coulter's motion for summary judgment of patent invalidity under section 102(g) should be denied.
Even if it had shown that it was the first to conceive the invention, Coulter would have difficulty proving the requisite diligence. The diligence inquiry is concerned with whether a party exercised reasonable diligence; such reasonableness determinations are a standard task for juries. Monsanto, 261 F.3d. at 1367. Abandonment, suppression, or concealment by a prior inventor may be inferred based upon the prior inventor's unreasonable delay in making the invention publicly known. Dow Chem. Co. v. Astro-Valcour, Inc., 267 F.3d 1334, 1339 (Fed. Cir. 2001). The failure to file a patent application, to describe the invention in a published document, or to use the invention publicly within a reasonable time after first making the invention may constitute abandonment, suppression, or concealment. Id. There are no strict time limits regarding the minimum or maximum periods between a prior inventor's first making of the invention and the subsequent disclosure of the invention necessary to establish or infer suppression or concealment. Id. Although unreasonable delay in bringing knowledge of the invention to the public may raise an inference of suppression or concealment, mere delay, without more, is not sufficient to establish suppression or concealment and each case involving the issue of suppression or concealment must be considered on its own particular set of facts. Id.
IT IS HEREBY ORDERED:
1. Colter's motion for leave to file a reply to Streck's motion for summary judgment (Filing No. 355) is granted.
2. Streck's Motion for Summary Judgment of Literal Infringement of U.S. Patent Number 5,672,474; U.S. Patent Number 5,677,145; U.S. Patent Number 5,731,205; and U.S. Patent Number 5,981,282 (Filing No. 212) is granted.
3. Coulter's motions for summary judgment (Filing Nos. 231 and 235) are denied.