Opinion
No. C 97-04203 CRB
December 22, 2000
MEMORANDUM AND ORDER
Plaintiff Amersham Pharmacia Biotech, Inc. ("Amersham") alleges that defendant Perkin-Elmer Corporation ("Perkin-Elmer") sells products which infringe the 5,688,648 ("the `648"), a patent relating to a method of identification and detection of nucleic acids by using energy transfer coupled dyes as labels. Now before the Court are the following motions: (1) Amersham's motion for summary adjudication of infringement of claims 1-3 of the `648, (2) Perkin-Elmer's motion for summary judgment of invalidity of the `648 based on anticipation by the Haugland reference, (3) Perkin-Elmer's motion for summary adjudication that the Kanbara reference discloses and enables claims 1-3 of the `648, and (4) Amersham's motion for summary adjudication that the `648 is enabled. The Court heard oral argument on Amersham's motion for summary judgment of infringement on November 17, 2000 and on the remaining motions on December 18, 2000.
BACKGROUND
Amersham is the exclusive licensee to the `648, issued on November 18, 1997. It accuses Perkin-Elmer of infringing the `648 by manufacturing and selling energy transfer dye products, including the ABI PRISM BigDye Primer Cycle Sequencing Ready Reaction Kit, and by using such products in DNA sequencing methods covered by the `648. The DNA sequencing methods disclosed in the `648 use at least two different energy transfer labels that each contain a donor dye and an acceptor dye bonded to a backbone chain to allow energy transfer from the donor dye to the acceptor dye.
The three claims of the `648 patent are directed to methods of identification and detection of nucleic acids found in a multi-nucleic acid mixture. Claims 1-3 read as follows:
1. A method of identification and detection of nucleic acids in a multi-nucleic acid mixture employing delectably different fluorescent labels to detect at least two nucleic acids of interest, wherein said labels are characterized by: (1) having a donor-acceptor fluorescent pair where said donor and said acceptor are each covalently bonded to a backbone chain at specific locations thereon with energy transfer from said donor to said acceptor; and (2) each of the labels absorbs at substantially the same wavelength an d emits at a different wavelength;
said method comprising:
covalently bonding different labels to different nucleic acids of said multi-nucleic acid mixture of [sic] form labeled nucleic acids;
detecting each of said labeled nucleic acids by irradiating at the absorption wavelength of said donor and detecting the fluorescence of each of said labels.
2. A method according to claim 1, wherein said donor absorbs light in the wavelength range of 350-800 nm and said acceptor emits light in the wavelength range of 450-1000 nm
3. A method according to claim 2, wherein said donor-acceptor pair are 9-phenylxanthenes.
The central dispute during the claim construction proceedings was whether the `648 encompasses DNA sequencing processes. The Court held that it does. The parties now move for partial summary adjudication of various issues concerning infringement and validity.
I. STANDARD FOR SUMMARY JUDGMENT
Summary judgment is appropriate when the "pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). An issue is "genuine" only if there is sufficient evidence for a reasonable fact finder to find for the non-moving party. See Anderson v. Liberty Lobby. Inc., 477 U.S. 242, 248-49 (1986). A fact is "material" if the fact may affect the outcome of the case. See id. at 248. "In considering a motion for summary judgment, the court may not weigh the evidence or or make credibility determinations, and is required to draw all inferences in a light most favorable to the non-moving party." Freeman v. Arpaio, 125 F.3d 732, 735 (9th Cir. 1997). A principal purpose of the summary judgment procedure is to identify and dispose of factually unsupported claims. See Celotex Corp. v. Cattrett, 477 U.S. 317, 323-24 (1986).
The party moving for summary judgment bears the initial burden of identifying those portions of the pleadings, discovery, and affidavits which demonstrate the absence of a genuine issue of material fact. See id. at 323. Where the moving party will have the burden of proof on an issue at trial, it must affirmatively demonstrate that no reasonable trier of fact could find other than for the moving party. See id. Once the moving party meets this initial burden, the non-moving party must go beyond the pleadings and by its own evidence "set forth specific facts showing that there is a genuine issue for trial." Fed. K. Civ. P. 56 (e). The non-moving party must "identify with reasonable particularity the evidence that precludes summary judgment." Keenan v. Allan, 91 F.3d 1275, 1279 (9th Cir. 1996) (quoting Richards v. Combined Ins. Co., 55 F.3d 247, 251 (7th Cir. 1995), and noting that it is not a district court's task to "scour the record in search of a genuine issue of triable fact"). If the non-moving party fails to make this showing, the moving party is entitled to judgment as a matter of law. See Celotex, 477 U.S. at 323.
II. AMERSHAM'S MOTION FOR SUMMARY ADJUDICATION OF INFRINGEMENT
Amersham moves for partial summary adjudication of infringement; it seeks a judicial determination that Perkin-Elmer's BigDye products infringe claims 1-3 of the `648. In its moving papers it offers evidence that Perkin-Elmer's products infringe each element of claims 1-3 of the `648. Amersham also seeks a determination that Perkin-Elmer induced its customers to infringe the `648.
Perkin-Elmer makes three arguments in opposition to Amersham's motion. First, Perkin-Elmer asks the Cort to construe the phrase "nucleic acids of interest" as used in the `648 in such a way as to prevent a finding of infringement. Second, it contends that under the doctrine of "reverse equivalency" some of the accused products do not literally infringe. Finally, it argues that the evidence is insufficient to support summary adjudication of inducing infringement.
A. Nucleic Acids of Interest
Perkin-Elmer argues that the "nucleic acids of interest" in the phrase "employing delectably different fluorescent labels to detect at least two nucleic acids of interest" mean the DNA template strand, that is, the original DNA strand to which the DNA primer attaches. if Perkin-Elmer is correct, the `648 does not encompass DNA sequencing; the sequencing process works by attaching labels to the complementary DNA strands created from the primer DNA, rather than attaching labels to the DNA template.
As the Court has previously held, however, the `648 does encompass DNA sequencing. Thus, Perkin-Elmer's construction of "nucleic acids of interest" must be rejected, especially since there is nothing in the language of the claims which suggest that "nucleic acids of interest" refer to the DNA template. Moreover, as support for its construction of "nucleic acids of interest," Perkin-Elmer cites references in the `648 to the "DNA of interest." The DNA of interest is not the "nucleic acid of interest" described in the patent. The DNA of interest is the original DNA strand; the DNA template. The "nucleic acid of interest," in contrast, is the nucleic acid that is being detected by labels on the complementary DNA strand after the process of electrophoresis.
B. Reverse Doctrine of Equivalency
Perkin-Elmer next contends that there is a genuine dispute as to whether there is no infringement under the "reverse doctrine of equivalency doctrine," an equitable doctrine invoked in applying properly construed claims to an accused device. "Just as the purpose of the `doctrine of equivalents' is to prevent `pirating' of the patentee's invention, . . . so the purpose of the `reverse' doctrine is to prevent unwarranted extension of the claims beyond a fair scope of the patentee's invention." Scripps Clinic Research Foundation v. Genentech. Inc., 927 F.2d 1565, 1581 (Fed. Cir. 1991).
The doctrine is based on the Supreme Court's statement in Graver Tank that an accused article may avoid infringement, even if it is within the literal words of the claim, if it is "So far changed in principle from a patented article that it performs the same or a similar function in a substantially different way." Graver Tank v. Linde Air Co., 339 U.S. 605, 608-09 (1950). "Application of the doctrine requires that facts specific to the accused device be determined and weighed against the equitable scope of the claims, which in turn is determined in light of the specification, the prosecution history, and the prior art." Scripps Clinic Research Foundation, 927 F.2d at 1581. In particular,
[w]hen a patentee establishes literal infringement, the accused infringer may undertake the burden of going forward to establish the fact of non-infringement under the reverse doctrine of equivalents. If the accused infringer makes a prima facie case, the patentee, who retains the burden of persuasion on infringement, must rebut that prima facie case. . . . The reverse doctrine of equivalents is a factual determination. "That fact question is simple and direct: Is the accused product so far changed in principle that it performs the function of the claimed invention in a substantially different way?"
Jewish Hosp. of St. Louis v. IDEXX Labs., 973 F. Supp. 24, 28 (D. Me. 1997) (citation omitted).
In the Sanger method of sequencing there are two locations on the nucleic acid strand where the label can be placed: (1) on the terminating nucleotide itself, or- (2) on the primer. Under the terminator-labeled method, the label directly "identifies" the terminating nucleotide, while under the primer method the label indirectly identifies the terminating nucleotide. Regardless of whether one is using the primer-labeled or terminator-labeled DNA sequencing, the donor and acceptor fluorophores have to somehow become attached. The `648 claims that its labels are characterized by "having a donor-acceptor fluorescent pair where said donor and acceptor are each covalently bonded to a backbone chain at specific locations thereon." Thus, the `648 does not describe with what chemistry the fluorescent pair should be bonded to the backbone, other than that it has to be covalently bonded in a way that allows for bonding at "specific locations" on the backbone chain.
Despite the fact that the `648 does not claim any particular method of bonding the fluorescent pair to the backbone chain, Perkin-Elmer claims that the `648 inventors' professed improvement over the prior art was the use of conventional chemistry to permit bonding at specific locations. The Perkin-Elmer BigDye product. in contrast, uses a novel chemistry (which it has patented) to bond the fluorescent pair to the backbone chain. Thus, argues Perkin-Elmer, the BigDye porduct is far changed in this principle from the `648 and therefore does not infringe. Perkin-Elmer also contends that the `648 does not permit terminator-labeled DNA sequencing, and only permits primer-labeled sequencing. The "change" in the BigDye product (the use of the novel chemistry to attach the donor and acceptor to the backbone) causes the Big-Dye to perlorm the same faction as the `648 — DNA sequencing — in a substantially different way, namely by permitting terminator-labeled sequencing.
There are two fundamental problems with Perkin-Elmer's argument. First, the record does not demonstrate that the "principle improvement" of the `648 is the use of conventional chemistry. Perkin-Elmer cites the applicants' response to the Patent Examiner's citation of the Heller patent to support its claim that the specific method of synthesis used to attach the donor and acceptor to the backbone at specific locations is the "principle" of the `648. The prosecution history, however, reveals that the applicants distinguished the `648 from Heller by emphasizing that the `648 requires the placement of the donor and acceptor at specific locations. While certain methods of synthesis allow for placement of the donor and acceptor at specific locations while other methods do not, the "principle" of the `648 is only that a method that allows for specific placement be used. Since the Big-Dye products use a method of synthesis that covalently bonds the acceptor and donor at specific locations they do not perform the function of the `648 in a substantially different way. Thus, Perkin-Elmer has failed to make a prima facie showing of noninfringement under the doctrine of reverse equivalency.
Perkin-Elmer's contention that the Big-Dye products perform sequencing in a "substantially different way" from the `648 because the BigDye products are used in terminator-labeled sequencing is also unpersuasive. Chief Magistrate Judge Infante held that the `648 encompasses both primer and terminator-labeled sequencing, and the Court adopted that holding. Thus, Perkin-Elmer is simply incorrect as a matter of law when it contends that the BigDye products perform DNA sequencing in a substantially different way from the `648. Its argument is more appropriately addressed in the context of whether the `648 enables terminator-labeled sequencing. Accordingly, Amersham's motion for an adjudication that the accused products literally infringe the `648 must be granted.
C. Inducement Of Infringement
Amersham also contends that it is entitled to summary judgment on its claim that Perkin-Elmer actively induced infringement. There can be no inducement to infringe without actual infringement of the patent claim. See Apple Computer. Inc. v. Articulate Systems. Inc., 991 F. Supp. 1189, 1191 (N.D. Cal 1997). As is set forth above, the Court must grant Amersham's motion for partial summary adjudication that the accused products literally infringe the `648. Accordingly, it is appropriate for the Court to consider Amersham's motion for summary adjudication of its claim of actively inducing infringement.
35 U.S.C. § 271 (b) provides that "[w]hoever actively induces infringement of a patent shall be liable as an infringer." To succeed on a claim of actively inducing infringement, the plaintiff must show that the defendant "knowingly induced infringement." Manville Sales Corporation v. Paramount Systems. Inc., 917 F.2d 544, 552 (1990); see also Apple Computer, 991 F. Supp. at 1191 (recounting that the plaintiff must prove that the defendants knowingly induced infringement). The Federal Circuit has explained a plaintiff's burden as follows:
It must be established that the defendant possessed specific intent to encourage c another's infringement and not merely that the defendant had knowledge of the acts alleged to constitute inducement. The plaintiff has the burden of showing that the alleged infringer's actions induced infringing acts and that he knew or should have known his actions would induce actual infringements.
Manville Sales Corporation, 917 F.2d at 552.
Amersham contends that the undisputed fact that the instructions Perkin-Elmer includes with its BigDye products direct its customers to use the accused products in a way that infringes the `648 is sufficient to prove as a matter of law that Perkin-Elmer actively induced others to infringe the `648. See Apple computer, 991 F. Supp. at 1191(noting that the intent to induce may be inferred from all of the circumstances, such as giving a direct infringer instructions on how to use a patented process).
While Amersham may have submitted evidence sufficient to support a finding that Perkin-Elmer possessed a specific intent to encourage its customers to use the Big-Dye products in a way that infringes the `648, such evidence is not sufficient to prove that Perkin-Elmer "knowingly" induced infringement; that is, that it possessed specific intent to encourage another's infringement.
The Federal Circuit's decision in Manville disposes of Amersham's motion. There the district court held that corporate officers had actively assisted with the infringing conduct of their corporation and thus should be held personally liable under section 271(b). The Federal Circuit agreed that corporate officers could be held personally liable for actively assisting with their corporation's infringement regardless of whether the "corporate veil" could be pierced. The court disagreed, however, that the evidence supported a finding that the corporate officers "knowingly" induced the corporation's infringement because of the undisputed evidence that the officers were not even aware of the patent until the litigation was initiated. Id. at 553. In other words, the officers could not have known that their conduct would induce infringement if they were not even aware of the patent.
The court also concluded that even though the officers encouraged the corporation to continue to sell the infringing products after the officers became aware of' the patent, they still could not be held liable for actively inducing infringement because they had a good faith belief, based on advice of counsel, that their corporation's product did not infringe. Id; see also Mez Indus., Inc. v. Pacific National Ins. Co., 53 U.S.P.Q.2d 1167, 1176-78, 76 Cal.App.4th 856 (1999) (holding that to be liable for inducing infringement the defendant must have had actual knowledge of the patent and the infringement).
Amersham offers no evidence that Perkin-Elmer knew that its products, when used by its customers as instructed, infringed the `648. Indeed, Perkin-Elmer offers evidence that, like the defendants in Manville, it has been operating under a good faith belief, based on an opinion of counsel, that its products do not induce infringement.
The cases upon which plaintiff relies are unhelpful. In Moleculon Research Corp. v. CBS Inc., 793 F.2d 1261, 1272 (Fed. Cir. 1986) (decided before Manville) the defendant did not argue that it was unaware of the patent, or that it has a good faith belief that its product when used by its customers did not infringe. In Allergan Sales Inc. v. Pharmacia Upjohn. Inc., 41 U.S.P.Q.2d 1283, 1996 WL 806683 (S.D. Cal. Oct. 22, 1996), plaintiff submitted evidence that the defendant knew the patent at issue was strong and that the use of the defendant's product would result in infringement. Id. at * 7. No similar evidence is presented here. Accordingly, the Court must deny Amersham's motion for summary adjudication of its inducing infringement claim.
III. PERKIN-ELMER'S MOTION FOR SUMMARY JUDGMENT OF INVALIDITY BASED ON ANTICIPATION BY THE HAUGLAND REFERENCE
Perkin-Elmer contends that the `648 is invalid because a prior art reference — the "Haugland Final Technical Report" — anticipates the claims of the `648.
A patent is presumed valid, and the burden of establishing invalidity rests on Perkin-Elmer as the party asserting that the patent is invalid. See 35 U.S.C. § 282. To overcome this statutory presumption, Perkin-Elmer must present clear and convincing evidence of invalidity. Sec WMS Gaming Inc. v. International Game Technology, 184 F.3d 1339, 1355 (Fed. Cir. 1999). "Thus, the precise question to be resolved in this case is whether [Perkin-Elmer's] evidence is so clear and convincing that reasonable jurors could only conclude that the claims in issue were invalid." Verdegaal Bros., Inc. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987).
An invention is not eligible for a patent if the invention is anticipated by prior art in the field. See 35 U.S.C. § 102 (outlining various ways in which an invention may be rendered unpatentable by prior art). For a patent claim to fall under section 102, each and every element of the claim must be found in a single prior art reference. See In re Paulsen, 30 F.3d 1475, 1478-79 (Fed. Cir. 1994); see also Verdegaal, 814 F.2d at 631 ("A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference."). The reference must also enable one skilled in the art to make the anticipating subject matter. See PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1566 (Fed. Cir. 1996). Anticipation is a question of fact. See In re Paulsen, 30 F.3d at 1478.
The `648 describes "[a] method of identification and detection of nucleic acids in a multi-nucleic acid mixture employing delectably different fluorescent labels to detect at least two nucleic acids of interest." Thus, the `648 describes a method that employs the or more different energy transfer fluorescent labels. Each label contains a donor dye and an acceptor dye covalently bonded to specific locations on a backbone chain. A "dye" which contains a donor dye and an acceptor dye is known as a "bifluor" or "bifluorphore." Amersham contends that Haugland does not anticipate each limitation of the `648 because, among other things, it does not disclose a method of identifying and detecting nucleic acids using more than one delectably different bifluor.
The parties' experts disagree as to whether Haugland discloses using two or more delectably different bifluors and the reference itself does not explicitly contain such a disclosure. See Motorola. Inc. v. Interdigital Technology Corp., 121 F.3d 1461, 1473 (Fed. Cir. 1997) (holding that the reference must be sufficiently clear so as to prove the existence of each and every element in the reference); see also Novo Nordisk A/S v. Becton Dickinson and Co., 96 F. Supp.2d 309, 312 (S.D.N.Y. 2000) (holding that there were genuine disputes of material fact as to whether a reference teaches each and every element of a claim in light of the contrary expert opinions). Accordingly, the evidence before the Court is not so clear and convincing that reasonable jurors could only conclude that the claims at issue are invalid.
IV. PERKIN-ELMER'S MOTION FOR SUMMARY ADJUDICATION RE: THE KANBARA REFERENCE
Perkin-Elmer also contends that the claims of the `648 are invalidated by the "Unexamined Japanese Patent Application H5-60698 by Kanbara, et al." (Kanbara), dated March 12, 1993.
A. The Appropriateness of Perkin-Elmer's Motion
As a preliminary matter, the parties dispute whether Kanbara constitutes prior art. Amersham contends it does not because the `648 inventors, Dr. Mathies and Dr. Glazer, invented the methods of the `648 prior to the publication of Kanbara. Perkin-Elmer agrees that the inventorship issue — and thus whether Kanbara qualifies as prior art — will have to be tried to the jury. It nonetheless contends that the Court should now decide whether Perkin Elmer has met its burden of proving as a matter of law that Kanbara anticipates each and every element of the `648 so that if the jury finds that Kanbara qualifies as prior art the `648 is invalid. Amersham objects to the Court deciding the motion in light of the genuine dispute as to whether Kanbara qualifies as prior art; it contends that Perkin-Elmer is asking for an advisory opinion on an issue that will not have to be decided if Kanbara is not prior art. While the Court does not necessarily agree that its decision would constitute an "advisory opinion," it agrees that it should not decide Perkin-Elmer's motion at this time.
The cases Perkin-Elmer cited at oral argument are unpersuasive. In Advanced Semiconductor Materials America. Inc. v. Applied Materials. Inc., 1995 WL 419747 (N.D. Cal. June 10, 1995), the defendant objected to the court deciding a motion for summary judgment of infringement on the ground that the patent may be found invalid at trial. The court concluded that it was appropriate to decide the motion because "the purpose of summary judgment is met when the summary adjudication of preliminary issues, such as infringement, helps to focus the issues to be decided." Id. at *4. (The Court notes, with some amusement, that the attorneys for Applied Materials, Inc. who were objecting to the district court deciding the infringement motion are the same attorneys who are now encouraging the court to decide Perkin-Elmer's motion).
Advanced Semiconductor Materials is not this case. The infringement analysis was wholly separate from the invalidity issue; indeed, an accused device can infringe an invalid patent. See Spectra-Physics. Inc. v. Coherent. Inc., 827 F.2d 1524, 1535 (Fed. Cir. 1987) (characterizing the statement that invalid claims cannot be infringed as "nonsense"). Thus, summary judgment of infringement takes the infringement issue out of the trial entirely; the jury is spared days to weeks of trial that it would otherwise have to hear. The issue here, however, is not preliminary; the preliminary issue is whether Kanbara is prior art. Thus a ruling on Perkin-Elmer's motion — regardless of the outcome — will not necessarily focus the issues for trial. Rather, if the jury makes findings on the inventorship issue that render Kanbara not prior art, the jury will not have to address the anticipation issue and the Courts ruling on Perkin-Elmer's motion will have merely advisory.
The Federal Circuit's decision in In re Merck, 800 F.2d 1091 (Fed. Cir. 1986), does not suggest that a ruling by the Court is appropriate. Merck merely held that "additional, although unnecessary, evidence of contemporaneous invention [here, Kanbara] is probative of "the level of knowledge in the art at the time the invention was made." Id. at 1098.
The district court's decision in Novo Nordisk A/S v. Becton Dickinson and Co., 96 F. Supp.2d 309 (S.D.N.Y. 2000) is also inapposite. In Novo Nordisk the defendant moved for summary judgment that a certain reference was prior art and that it anticipated the claims of the patent-in-issue. In other words, it moved for a judgment of invalidity. The court concluded that there was a genuine dispute as to whether the reference qualifies as prior art and a genuine dispute as to whether the reference anticipates the claims of the patent-in-issue. Id. at 310-12. While the court could have declined to address the second part of the defendant's motion, namely, the anticipation argument, there is no indication in the decision that any party argued that it should not. Moreover, since the court concluded that there was a genuine dispute for trial there was no reason for the court to sua sponte decline to address the anticipation issue, especially given the court's brief analysis of the issue.
The Court's conclusion that Perkin-Elmer's motion is premature does not mean that the issue of anticipation will necessarily have to be presented to the jury. The trial may be phased in such a way as to permit the Court to rule on Perkin-Elmer's anticipation argument after a finding that Kanbara is prior art.
B. The Meaning of "Backbone Chain"
Perkin-Elmer's motion has nonetheless highlighted the parties' continuing dispute as to the meaning of "backbone chain," despite the Court's earlier determination, at Amersham's urging, that "backbone chain" means "the entire chain of atoms that separate the donor and acceptor dyes." Perkin-Elmer contends that this broad definition encompasses atoms that are not covalently bonded but instead share hydrogen bonds. Amersham argues that "backbone chain" is limited to chains of atoms which have a covalent bond between each atom.
The Court concludes that this dispute presents a legal issue which was not addressed in the original claim construction proceedings. The issue in the Markman hearing was whether backbone chains encompass polymeric and non-polymeric structures; there simply was no discussion of whether the atoms in the chain must be covalently bonded to each other. Thus, the Court did not explicitly construe "backbone chain" so as not to require that the atoms be covalently bonded; the Court simply never addressed the issue. Magistrate Judge Infante's statement that "[c]ovalent bonds occur between atoms and so the backbone chain is the entire chain of atoms between the donor and acceptor, including any linker arms," Recommended Order at 26, was not a holding as to the meaning of backbone chain. Rather, the court was simply repeating Amersham's argument in favor of its construction of "backbone chain."
The issue of the further meaning of "backbone chain" is a legal issue which must be addressed by the Court before trial. Accordingly, the Court directs each party to file a memorandum, not to exceed five (5) pages, by January 3, 2001, which explains how the intrinsic evidence does or does not support a construction of backbone chain as limited to a chain of covalently-bonded atoms. The Court will take the issue under submission at that time. The Court directs the parties to focus solely on the intrinsic evidence, that is, the language of the claims, the specification, and the prosecution history; the parties' summary judgment memoranda adequately address the extrinsic evidence, including expert testimony and statements made during the claim construction proceedings.
V. AMERSHAM'S MOTION FOR SUMMARY ADJUDICATION THAT THE `648 IS ENABLING
Amersham moves for partial summary judgment of Perkin-Elmer's invalidity defense under 35 U.S.C. § 112, paragraph one.
A patent's specification must enable one with ordinary skill in the art to make and use the invention claimed without having to perform undue experimentation. See 35 U.S.C. § 112 ("The specification shall contain . . . the manner and process of making and using [the invention], 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"); In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993) (describing the undue experimentation requirement). "Naturally, the specification must teach those of skill in the art `how to make and how to use the invention as broadly as it is claimed.'" In Re Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) (citation omitted). Compliance with section 112 is judged as of the filing date — here, February 1994. See United States Steel Corp. v. Phillips Petroleum Co., 865 F.2d 1247, 1251 (Fed. Cir. 1989).
A patent specification is sufficiently enabling "even if a `reasonable' amount of routine experimentation is required in order to practice a claimed invention, but that such experimentation must not be `undue.'" Enzo Biochem. Inc., v. Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999). The Federal Circuit has set forth a number of factors which a court may consider in determining whether a disclosure would require undue experimentation: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Id. All of the factors need not be reviewed when determining whether a disclosure is enabling. Id.
At trial Perkin-Elmer will have the burden of proving by clear and convincing evidence that the `648 is not enabled. Amersham, however, is the moving party on this motion. Thus, to prevail Amersham must show that no reasonable jury could find by clear and convincing evidence that the patent is not enabled.
There is a genuine dispute as to whether the `648 sufficiently enables terminator-labeled sequencing. The Court is unpersuaded that Perkin-Elmer's experts unequivocally testified that the `648 is enabling such that there is no genuine issue for trial. Accordingly, Amersham's motion must be denied.
CONCLUSION
For the foregoing reasons, the Court rules as follows:
(1) Amersham's motion for summary adjudication of infringement of claims 1-3 of the `648 is GRANTED,
(2) Perkin-Elmer's motion for summary judgment of invalidity of the `648 based on anticipation by the Haugland reference is DENIED,
(3) Perkin-Elmer's motion for summary judgment of invalidity of the `648 based on discloses and enables claims 1-3 of the `648 is DISMISSED without prejudice,
(4) Amersham's motion for summary adjudication that the `648 is enabled is DENIED, and
(5) Each party is directed to file a five-page memorandum by January 3, 2001 which identifies the intrinsic evidence which does or does not support a construction of "backbone chain" as limited to a covalent chain of atoms.
IT IS SO ORDERED.