Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

REGENTS OF UNIVERSITY OF CA v. MONSANTO COMPANY

December 16, 2005.

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, a California Public Corporation, Plaintiff,
v.
MONSANTO COMPANY, a Delaware Corporation, Defendant.



The opinion of the court was delivered by: PHYLLIS HAMILTON, District Judge

ORDER GRANTING SUMMARY JUDGMENT IN PART AND DENYING SUMMARY JUDGMENT IN PART
The parties' cross-motions for summary judgment came on for hearing on October 26, 2005 before this court. Plaintiff, the Regents of the University of California (the "UC Regents"), appeared through its counsel, Gerald Dodson, Erik Olson, and Erica Wilson. Defendant Monsanto Company ("Monsanto") appeared through its counsel, Adrian Pruetz, John B. Quinn, Victoria Maroulis, John D. Van Loben Sels, Irvin E. Tyan, and Robert B. Wilson. Having read all the papers submitted and carefully considered the relevant legal authority, the court hereby GRANTS the motions for summary judgment in part and DENIES the motions for summary judgment in part, for the reasons stated at the hearing, and as follows.

BACKGROUND

  The UC Regents is the assignee and owner of U.S. Patent No. 6,692,941 ("the `941 patent"), which covers bovine growth hormone ("bGH"), bovine pre-growth hormone, and the DNA molecules that allow for expression of bovine growth hormone and pre-growth hormone.

  The `941 patent was issued in February 2004, and was the result of four prior patent applications: (1) the `348 application filed in 1980; (2) the `557 application filed in 1983; (3) the `937 application filed in 1987; and (4) the `745 application filed in 1990. Under the rules espoused by the Patent and Trademark Office ("PTO"), the `941 patent is deemed to relate back to the filing date of the first application, i.e., 1980.

  Monsanto makes, uses, and sells POSILAC, a veterinary drug whose active ingredient is bovine growth hormone. In order to make POSILAC, Monsanto engages in an extensive production process that includes the use of two bacterial strains, W3110G[pBGH1] and LBB557[pXT757]. These strains include the recombinant plasmids pBGH1 and pXT757, which in turn include the DNA sequences that allow the bacteria to express commercial levels of sometribove, the recombinant form of bGH that comprises POSILAC.

  A. The `941 Patent Claims

  Only claims 1-10 of the `941 patent are at issue here. These claims are directed to isolated DNA and recombinant DNA molecules that encode bGH amino acid nos. 2-191; recombinant DNA vectors that can express a DNA segment encoding bGH amino acid nos. 2-191; and bacteria that contain these DNA vectors. The claims are also directed to bacteria containing the bGH protein, and methods for making bGH protein using claimed bacteria or vectors.

  Specifically, the `941 patent claims:
1. "A composition of DNA molecules which consists of DNA molecules encoding bovine growth hormone comprising the amino acid sequence: [sequence]"
2. "A recombinant DNA molecule which comprises a segment encoding a protein in a condition substantially free of DNA encoding bovine pituitary protein other than bovine growth hormone, wherein said segment encodes a protein comprising the amino acid sequence: [sequence]"
3. "The recombinant DNA molecule of claim 2 wherein said segment comprises the nucleotide sequence: [sequence]"
4. "A microorganism transformed with the DNA molecule of claim 3"
5. "The recombinant DNA molecule of claim 2 which further comprises sequences capable of effecting the expression of said segment when contained in a microorganism"
6. "A microorganism transformed with the DNA molecule of claim 5"
7. "A method to produce bovine growth hormone which method comprises culturing the microorganism of claim 6 under conditions wherein said expression is effected to produce said bovine growth hormone; and recovering bovine growth hormone from the culture"
8. "A microorganism transformed with the DNA molecule of claim 2"
9. "A microorganism that contains bovine growth hormone which hormone has the amino acid sequence: [sequence]"
10. "A method to produce bovine growth hormone which method comprises recovering the bovine growth hormone from the microorganism of claim 9"
On March 9, 2005, the court held a hearing on the issue of claim construction. On March 17, 2005, the court issued its order construing the disputed terms in the above claims. See Claim Construction Order.

  B. Procedural History

  The instant action was filed against Monsanto on February 17, 2004, asserting a claim for patent infringement under 35 U.S.C. § 1 et seq. and seeking damages accordingly. Monsanto answered and counterclaimed, seeking a declaration that the `941 patent is invalid, unenforceable, that the UC Regents are guilty of inequitable conduct, and that no infringement of the `941 patent has occurred. Monsanto also asserted the affirmative defense of prosecution laches.

  Both parties now move for summary judgment. Specifically, the UC Regents move for summary judgment as to: (1) validity; (2) inequitable conduct; and (3) prosecution laches. Monsanto moves for summary judgment as to (1) non-infringement; (2) invalidity and unenforceability; and (3) damages. Monsanto has also moved to preclude the testimony of the UC Regents' damages expert, Dr. Jeffrey Leitzinger. DISCUSSION

  I. Summary Judgment Standard

  Summary judgment is appropriate when the evidence shows 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 (1986).

  II. Infringement

  Monsanto seeks a declaration that none of the plasmids, bacteria, or culturing and purification methods it uses in producing POSILAC infringe claims 1-10 of the `941 patent. It asserts that no infringement occurs, either literally, or under the doctrine of equivalents.

  A. Legal Standard

  The court engages in a two-step process in evaluating a motion for summary judgment on infringement. First, the court determines the scope and meaning of the claims via claim construction; then, the court compares that construction of the patent against the accused products. See, e.g., Business Objects, S.A. v. Microstrategy, Inc., 398 F.3d 1366, 1371 (Fed. Cir. 2004) (citations omitted).

  While claim construction is a matter of law, infringement itself is a question of fact. See, e.g., Frank's Casing Crew and Rental Tools, Inc. v. Weatherford International, Inc., 389 F.3d 1370,1376 (Fed. Cir. 2004) (citations omitted). Therefore, a plaintiff is only entitled to summary judgment on the question of infringement "if the facts and inferences, when viewed in the light most favorable to [defendant], would not persuade a reasonable jury to return a verdict in favor of . . . the non-moving party." Business Objects, 398 F.3d at 1371.

  Infringement may be proven under two different theories. First, a claim can be "literally infringed" if each properly construed claim element directly reads on the accused product or process. See Jeneric/Pentron Inc. v. Dillon Co., 205 F.3d 1377, 1382 (Fed. Cir. 2000). Second, under the doctrine of equivalents, a court may find infringement when an accused product or process is the substantial equivalent of the patented invention — i.e., where the accused product or process performs substantially the same function in substantially the same way to accomplish substantially the same result as the claimed product or process. See Graver Tank & Mfg. Co. v. Linde Air Prod. Co., 339 U.S. 605, 608 (1950); Optical Disc Corp. v. Del Mar Avionics, 208 F.3d 1324, 1335-37 (Fed. Cir. 2000).

  B. Preliminary Issues

  Preliminarily, there are two distinct issues that must be resolved prior to resolution of the infringement issue on the merits. First, whether the infringement analysis requires that all claims of the `941 patent be construed in light of the technology that was known and available to one of ordinary skill in the art as of 1980, when the initial `941 patent application was filed. Second, whether prosecution history estoppel applies to prevent application of the doctrine of equivalents.

  1. Known and Available Limitation

  Monsanto asserts that all claims are to be construed in light of the technology that was known and available to one of ordinary skill in the art as of 1980, either by operation of this court's claim construction order, in which the court construed claim 7 to require this limitation, or by operation of law via legal precedent. The UC Regents disputes this assertion, arguing that this court read the known and available limitation into claim 7 only, and that legal precedent demands otherwise.

  The court relied on Bayer AG v. Biovail Corp., 279 F.3d 1340, 1348 (Fed. Cir. 2002), in its claim construction order. See Claim Construction Order at 13. Bayer AG explicitly sets forth the proposition that claims must be construed with regards to "what was known to one of ordinary skill in [the] art . . . at the time of filing, in addition to the claims, the specification, and the prosecution history." Bayer AG, 279 F.3d at 1348. In the Bayer AG case, the claims at issue covered a composition of pharmaceutical chemicals, and a treatment method involving that same pharmaceutical composition. Bayer AG held that the "known and available" limitation on claims construction applied to both claims.

  The UC Regents attempts to distinguish Bayer AG by asserting that it was limited to the issue of collateral estoppel. It also cites to Bio-Technology Gen. Corp. v. Genentech, Inc., 80 F.3d 1553 (Fed. Cir. 1996) and Amgen Inc. v. Hoescht Marion Roussel, Inc., 314 F.3d 1313, 1335 (Fed. Cir. 2003) as support for the fact that no "known and available" requirement should be mandated. While its written advocacy is persuasive, its legal arguments are not. A reading of Bayer AG demonstrates that the court was considering claims construction with respect to the infringement issue specifically (and even reversed the district court's grant of summary judgment as to non-infringement), and held that the known and available limitation applied to product and process claims alike.

  Other case law also supports this notion. See, e.g., Schering Corp. v. Amgen Inc., 222 F.3d 1347, 1353 (Fed. Cir. 2000) ("th[e] court must determine what the [claim] term meant at the time the patentee filed the [] application"); Markman v. Westview Instr., Inc., 52 F.3d 967, 968 (Fed. Cir. 1995) ("[T]he focus in construing disputed terms in claim language is not the subjective intent of the parties to the patent contract when they used a particular term. Rather the focus is on the objective test of what one of ordinary skill in the art at the time of the invention would have understood the term to mean.").

  Moreover, Bio-Technology Gen. Corp. does not directly support the UC Regents' argument. While true that the court in that case found infringement of a process claim directed to a recombinant DNA method for producing hGH, the court made no specific statement holding that literal infringement — or claim construction — is to be decided regardless whether the accused infringer's methods used later-developed technology. As for Amgen Inc., the court there construed claims covering DNA sequences for the protein erythropoietin ("EPO") to include both exogenous and endogenous DNA. Although the UC Regents is correct that the accused infringer in that case made exogenous DNA through a process involving later-developed technology, the court's actual holding in construing the claims focused only on the plain meaning of the claims, and found that exogenous DNA was encompassed by the claims since the claims themselves did not specify that they covered one or the other. As with Bio-Technology Gen. Corp., the Amgen Inc. court made no specific holding that claim construction is to be decided regardless without reference to what was known and available as of the time the patent application was filed.

  Accordingly, the court finds that, as a matter of law, the construction of the `941 patent claims — as set forth in the court's claim construction order — is made with reference to what those claims meant as of 1980, when the `941 patent was filed.

  In so holding, the court is not unmindful of the policy arguments made by counsel for the UC Regents at the hearing on the instant motions. Specifically, counsel pointed out that the value in seeking pioneering patents — such as those that opened up the biotechnology industry — would be rendered worthless, if the claims of those patents are to be construed in accordance with what was known and available at the time those patent applications were filed. To this, however, the court responds that the proper place to address such a concern is at the second stage of the infringement analysis — i.e., the point at which, having construed the claims, the court must decide whether the accused product or process either literally, or under the doctrine of equivalents, reads on the properly construed claim. As is made clear by the case law, this question of infringement itself — specifically under the doctrine of equivalents — is measured under a "time of infringement" approach, and does encompass later-developed technology. See, e.g., Smithkline Beecham Corp. v. Excel Pharm., Inc., 356 F.3d 1357, 1364 (Fed. Cir. 2004) (noting "after-arising technology" as the "quintessential example of an enforceable equivalent"); DeMarini Sports, Inc. v. Worth, Inc., 239 F.3d 1314, 1333 (Fed. Cir. 2001) ("there is no requirement that equivalents be unknown to science at the time of the application"); Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1581 (Fed. Cir. 1984) ("It is not a requirement of equivalence . . . that those skilled in the art know of the equivalence when the patent application is filed or the patent issues. That question is determined as of the time infringement takes place.").

  In sum, while the "known and available" limitation is properly taken into account at the claim construction stage, and can serve to limit the literal scope of claims to what was known and available at the time of filing, it does not prevent the court from taking later-developed technology into account in determining whether infringement of a claim has occurred. 2. Prosecution History Estoppel

  Monsanto also argues that, with respect to claims 1-2 in particular — which cover DNA molecules encoding bGH — the UC Regents cannot succeed in proving infringement under the doctrine of equivalents. This is because, under the doctrine of prosecution history estoppel, the UC Regents allegedly "surrendered" any claims directed to synthetic DNA molecules encoding bGH. Naturally, the UC Regents disputes this assertion, and argues that any arguments it made to the PTO examiner regarding synthetic DNA were directed to whether the prior art was enabling, not the scope of any patent claims.

  Prosecution history estoppel operates when a patent applicant gives up some limitation or subject matter during the patent's prosecution to obtain allowance of the patent. Having done so, the doctrine precludes the patent applicant from recapturing, through the doctrine of equivalents, what he/she expressly disclaimed during prosecution. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 20 (1997). As Monsanto correctly points out, prosecution history estoppel applies to matter surrendered either as a result of amendments to overcome patentability rejections, or as a result of argument to secure allowance of a claim. See, e.g., Deering Precision Instr., LLC v. Vector Distrib. Sys., Inc., 347 F.3d 1314, 1324-25 (Fed. Cir. 2003).

  Monsanto offers no proof of amendment based estoppel. As to argument based estoppel, Monsanto offers into evidence several written communications that the UC Regents sent to the PTO during prosecution, which communications show that the UC Regents addressed several possible rejections on the basis of prior art references. See Declaration of Van Loben Sels in Support of Monsanto's Motion for Summary Judgment re Non-Infringement ("Van Loben Sels Decl."), Exs. AA, BB, CC. The UC Regents, in their communications, argued that the prior art references did not support a conclusion that one skilled in the art could have synthesized a DNA sequence encoding bGH. See id.

  These communications, however, are insufficient to establish prosecution based estoppel. From them, it appears clear that the UC Regents' arguments to the PTO examiner were directed to specific prior art references and the limited issue of whether those prior art references rendered the patent obvious or anticipated. Specifically, the UC Regents argued that the prior art, which disclosed a complete amino acid sequence encoding for bGH, as well as methods for chemically synthesizing DNA, did not render obvious or anticipated the UC Regents' patent claims to the DNA sequence encoding bGH. This is not the same as arguing that the claims themselves did not cover any synthetic DNA sequence encoding bGH, and Monsanto points to no evidence that the UC Regents actually argued that the claims covering the DNA sequence encoding bGH were limited to non-synthetic DNA. Indeed, the proffered evidence actually presumes that the claims did cover synthetic DNA, for as the UC Regents points out, it would be non-sensical for the examiner to have initially rejected claims in view of prior art disclosing synthetic DNA, if the claims did not actually cover synthetic DNA in the first place.

  In short, it cannot be said that Monsanto has affirmatively proven the existence of subject matter limitations as to the claims of the `941 patent during prosecution history, such that prosecution history estoppel could be held to apply. Accordingly, the court finds that it does not.

  Having dispensed with the above preliminary issues, the court now turns its attention to the merits of the infringement analysis.

  C. Infringement Analysis

  1. Claims 1-2

  Claims 1 and 2 cover all DNA and recombinant DNA molecules encoding bGH. See, e.g., Claim Construction Order at 8. Claim 1 specifically refers to any "composition" of such molecules. See Van Loben Sels Decl., Ex Z.

  Monsanto claims that it does not infringe claims 1 and 2, literally or under the doctrine of equivalents, because (1) it does not make, use, or sell any "composition" of its plasmids pBGH1 or pXT757 and (2) its plasmid pXT757 has a completely synthetic DNA encoding bGH. a. Use of pBGH1 and pXT757

  Monsanto asserts that it has not made, used, or sold any "composition" of pBGH1 and pXT757 since prior to issuance of the `941 patent. In so arguing, Monsanto misses the point. The question is not whether Monsanto has made, used, or sold any "compositions" of pBGH1 or pXT757. The question is whether Monsanto has made, used, or sold any cDNA or DNA molecules that encode for bGH. Since Monsanto admits that the recombinant plasmids pBGH1 and pXT757 contain the DNA molecules that encode bGH, see Opening Brief re Non-Infringement at 3:21-22, the question is simply whether Monsanto has made, used, or sold pBGH1 and/or pXT757.

  pBGH1. Monsanto presents evidence that it stopped using pBGH1 altogether in September 2003. See Van Loben Sels Decl., Ex. B. In response, the UC Regents submits evidence that purportedly proves Monsanto's use of pBGH1 in the making of "old strain" powder after September 2003. See Declaration of Timur Engin in Support of UC Regents' Opposition to Motion for Summary Judgment re Non-Infringement ("Engin Decl."), Exs. H; I at 261:6-10.

  The UC Regents' evidence fails to raise a material disputed fact. The UC Regents sets forth an alleged "breakdown" of "formulation batches," with no affirmative proof that any particular batch set forth in the breakdown pertains to pBGH1 specifically, nor any proof that such a batch, if it exists, was made after February 2004 — which is the relevant date for infringement purposes. Nor can the deposition testimony relied on by the UC Regents provide the missing link: that testimony asserts only that old strain powder was formulated as of February 2004, but provides no corresponding link to whether pBGH1 was an ingredient of that old strain powder. In short, without more, the UC Regents cannot assert Monsanto's infringement of claims 1-2 by virtue of its use of the pBGH1 plasmid, which the evidence demonstrates was not actually in use as of the time of infringement.

  Accordingly, summary judgment on the issue of whether Monsanto's use of pBGH1 infringes claims 1-2 of the `941 patent is GRANTED as to Monsanto.*fn1

  pXT757. Monsanto also presents evidence that it has not used its pXT757 plasmid since making its master cell bank prior to February 2004. See Van Loben Sels Decl., Exs. P at CA-BST-098427; X at ¶ 94. In response, the UC Regents asserts that pXT757 is used daily during the fermentation and manufacturing of bGH, and that the creation of working cell banks, which occurs every one and a half to two years, involves the testing of the DNA sequence that is the subject of claims 1-2. See, e.g., Engin Decl., Ex. F; Declaration of Richard Flavell in support of UC Regents' Oppositions to Motions for Summary Judgment ("Flavell Opp. Decl."), ¶ 10.

  Contrary to the evidence it proffers with respect to pBGH1, with the above evidence, the UC Regents has presented a disputed material fact with respect to Monsanto's use of pXT757. Accordingly, summary judgment on this issue is DENIED as to Monsanto.

  b. Synthetic DNA

  Monsanto asserts that, even if it is deemed to make or use pXT757, it still does not infringe claims 1 and 2 because pXT757 is completely synthetic. According to Monsanto, a completely synthetic DNA sequence is outside the scope of claims 1 and 2, literally and under the doctrine of equivalents.

  First, Monsanto asserts that pXT757 does not literally infringe claims 1-2 because synthetic DNA molecules encoding bGH were not known and available to a person of ordinary skill in the art in 1980; construing the claims to cover only what the ordinary level of skill in the art covered, Monsanto contends that the literal scope of claims 1-2 cannot cover synthetic DNA sequences.

  As to this, however, the parties have a material dispute, with the UC Regents asserting that chemical synthesis of small strands of DNA was known to skilled artisans prior to August 1980, although the method of making longer DNA molecules developed afterwards. See Flavell Opp. Decl., ¶¶ 19-20; cf. Van Loben Sels Decl., Ex. X, ¶ 96. In essence, this is a battle of experts and must be decided by the trier of fact.

  Second, Monsanto asserts that no infringement occurs under the doctrine of equivalents, "in light of the prosecution history estoppel." Since the court has already determined, however, that prosecution history estoppel does not apply, Monsanto's argument to this effect is unpersuasive. Applying, therefore, the doctrine of equivalents, the issue whether Monsanto's synthetic DNA molecules infringe on claims 1-2 is a question of fact. See generally Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (1997). Again, the parties dispute whether a synthetic DNA molecule would have been substantially the same as a regularly isolated DNA molecule. See Van Loben Sels Decl., Ex. X; Flavell Opp. Decl., ¶¶ 19-20. As this dispute is material, summary judgment is inappropriate.

  Accordingly, for all the above reasons, summary judgment on the issue of whether Monsanto's use of pXT757 infringes claims 1-2 of the `941 patent is DENIED as to Monsanto.

  2. Claims 3 and 4

  Claim 4 is dependent on claim 3. Together, claims 3 and 4 cover the recombinant DNA molecules encoding bGH that comprise a specific nucleotide sequence, as well as any bacteria that contains those recombinant DNA molecules. Since the nucleotide sequence in claim 3 is not literally identical to the nucleotide sequence used by Monsanto in its plasmid pXT757, the UC Regents does not assert literal infringement of claims 3-4. Rather, it relies solely on the doctrine of equivalents to prove infringement.

  The issue, then, is whether pXT757 performs substantially the same function in substantially the same way, and to accomplish substantially the same result, as the DNA sequence listed in claim 3. See Zelinski v. Brunswick Corp., 185 F.3d 1311, 1316-17 (Fed. Cir. 1999) (an accused product is equivalent to a claimed element if the accused product performs substantially the same function in substantially the same way to accomplish substantially the same result as the claimed element). In this, the parties disagree, and resort to conflicting expert testimony for support. For example, Monsanto asserts that the function of claim 3 is to require expression of the bGH protein; the UC Regents disputes this, claiming that the purpose is merely to provide a blueprint for bGH. See Van Loben Sels Decl., Ex. X; Flavell Decl. In Support of Regents' Oppositions to Motions for Summary Judgment, ¶ 12. In addition, Monsanto asserts that the cDNA sequence of claim 3 does not express at commercial levels; the UC Regents assert that it does. Id.

  Each of these disputes presents a material factual dispute as to the issue of equivalence, and is enough to defeat summary judgment on these claims.

  Accordingly, summary judgment on the issue of whether Monsanto's use of pXT757 infringes claims 3 and 4 is DENIED as to Monsanto.

  3. Claim 5

  Claim 5 is dependent on claim 2 and covers the recombinant DNA vectors that can express a DNA segment encoding bGH amino acid nos. 2-191. Monsanto resurrects its previous arguments as to claims 1-4 in favor of non-infringement, including the argument that pXT757 functions in a substantially different way from what is claimed — i.e., it functions to commercially express bGH.

  Accordingly, and for the same reasons that there are material disputed facts with respect to claims 1-4, see above, summary judgment on the issue of whether Monsanto's use of pXT757 infringes claim 5 is DENIED.

  4. Claim 6

  Claim 6 is dependent on claim 5, and covers bacteria that contain DNA vectors that encode for bGH. Monsanto asserts that it does not infringe claim 6, either literally or under the doctrine of equivalents, for the reasons already discussed.

  Accordingly, for the same reasons that there are material disputed facts with respect to the above claims, summary judgment on the issue of whether Monsanto's ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.