Opinion ID: 2743726
Heading Depth: 3
Heading Rank: 1

Heading: A method to monitor the ability of a pro-

Text: moter to promote expression in an animal of an endogenous gene that is controlled by said pro- moter, which method comprises: a) delivering, to an animal, cells containing a nucleic acid encoding a fluorophore operatively linked to the promoter of said endogenous gene whose ability to promote expression is to be ana- lyzed; and b) observing the presence, absence or intensity of the fluorescence generated by said fluorophore at various locations in said animal by whole-body external fluorescent optical imaging, whereby the ability of said promoter to pro- mote expression is monitored, and wherein said fluorophore is a protein that is autofluorescent such that no substrates or cofactors are needed for it to fluoresce. ANTICANCER, INC. v. PFIZER, INC. 15 With its Contentions for the ’159 patent, AntiCancer incorporated the Pfizer publication entitled “Defects in Embryonic Development of EGLN1/PHD2 Knockdown Transgenic Mice are Associated with Induction of Igfbp in the Placenta,” published at 390 Biochemical and Biophysical Research Communications 370 (2009). This article describes experiments using green fluorescent protein imaging of gene expression in mouse embryos. In its claim charts, AntiCancer included Figure 2 from that publication, captioned “Embryoplacenta l effects of the localization of intense (+++) GFP fluorescence in EGNLI RNAi hairpin treated embryos,” showing mouse embryos with these effects. The ’337 patent is directed to a mouse model in a process called “surgical orthotopic implantation,” in which fragments of human tumors are implanted into the corresponding organ of a living mouse. Claim 1 of the ’337 patent as reissued recites: 1. A nude mouse model for progression of human neoplastic disease, the progression of said disease being characterized by growth of a prima- ry tumor site and metastasis to secondary tumor sites, wherein said mouse has histologically intact human neoplastic tissue of at least 1 mm in size transplanted onto an organ of said mouse which corresponds to the human organ from which said tissue is originally obtained; and has sufficient immuno-deficiency to allow said transplanted neoplastic tissue to grow at said primary site and metastasize to said secondary tumor sites, so as to mimic the progression of the neoplastic disease including the metastatic behavior of said neoplastic disease in humans. With its Contentions for the ’337 patent, AntiCancer included a Pfizer-Crown Bioscience poster presentation ANTICANCER, INC. v. PFIZER, INC. 17 Pfizer’s Mem. P. & A. Supp. Mot. Summ. J. Noninfringement Based on Defective Infringement Contentions 11, AntiCancer (S.D. Cal. Mar. 12, 2012), ECF No. 38-1. The district court held that AntiCancer’s claim charts did not provide all of the information the Patent Local Rules require. The district court held that the claim charts were deficient as to three elements: the “promoter monitoring” and “delivering cells” elements of the ’159 patent, and the “metastasis to a second site” element of the ’337 patent. AntiCancer argues that the Contentions and claim charts adequately showed the connection between these claim elements and the information in the Pfizer and Crown Bioscience publications, and showed, prima facie, the presence of these elements in the accused activities. AntiCancer states that the degree of specificity in its Contentions and claim charts was in accordance with the Patent Local Rules, and further specificity and detail will require discovery of the defendants’ non-public, internal activities. AntiCancer stresses that the Patent Local Rules contemplate that discovery will follow from the Preliminary Infringement Contentions, and that it is not expected or intended that the Contentions must provide complete proof of infringement before the patentee has a meaningful opportunity to conduct discovery. On the role of discovery in the specificity of the Preliminary Infringement Contentions, it cannot be ignored that AntiCancer’s Preliminary Contentions were required to be filed within two months of the district court’s Case Management Conference Order and just five days after AntiCancer filed its First Amended Complaint adding the infringement counts and party-defendant Crown Bioscience, with nearly ten months remaining until the close of fact discovery pursuant to the original Case Management Conference Order. The commentary on preliminary infringement contentions in those district courts that 18 ANTICANCER, INC. v. PFIZER, INC. have adopted similar local rules is that the contentions precede discovery and are intended to facilitate discovery. This court, in O2 Micro, mentioned “the broad discovery regime under the Federal Rules of Civil Procedure, especially given the particular importance of discovery in complex patent cases.” 467 F.3d at 1365. We note the limiting language of Patent Local Rule 3.1, requiring the plaintiff to identify the accused products, instrumentalities, or acts “of which the party is aware”; and to be “as specific as possible,” with the name or model number of the accused product, device, or apparatus “if known.” These requirements harmonize the Local Rule with the discovery provided by the Federal Rules and warrant consideration when reviewing the district court’s fee-shifting sanction. Turning to the three claim elements for which the district court found AntiCancer’s Preliminary Infringement Contentions deficient, we review compliance with Patent Local Rule 3.1 in the context of the condition the district court imposed on AntiCancer’s ability to supplement the Contentions. In the end, considering the language and purposes of the Local Rule, and the record of what AntiCancer disclosed in its Contentions and the limited, specific criticisms of the Contentions’ sufficiency, we conclude that there is no reasonable basis for making the finding of bad faith that would be required to sustain the fees sanction, without which summary judgment here is improper. Indeed, we do not see how revised Contentions could be insufficient if AntiCancer added to them the brief explanations it provided in its opposition to summary judgment. 1. promoter monitoring Each asserted ’159 patent claim includes the clause “whereby the ability of said promoter to promote expression is monitored.” See ’159 patent col. 24 l. 44 - col. 26 l. 12. The district court observed that “in support of its ANTICANCER, INC. v. PFIZER, INC. 19 allegation of infringement” of the promoter monitoring element, AntiCancer’s Contentions identified Figure 2 and the Pfizer publication’s statement that “[t]he localization and intensity of GFP fluorescence in conceptuses from both treatment groups was varied.” The district court concluded that “[o]n its face, the text from the paper says nothing about ‘promoters’ or ‘monitoring.’” Dist. Ct. Op. at 8. The court found that the citations to portions of the Pfizer publication, or the incorporation of its full text, did not “suppl[y] sufficient information for how Pfizer allegedly practiced the Promoter Monitoring element,” Dist. Ct. Op. at 8, and stated that “AntiCancer needs to connect the dots for how Pfizer’s research . . . reads on the asserted claim language,” id. at 9. AntiCancer states that further specificity would be obtained with discovery and faults the district court for granting summary judgment before there was claim construction “or a comparison of the properly construed claims to the accused methods.” Appellant Br. at 19. See, e.g., Ameranth, Inc. v. Papa John’s USA, Inc., 946 F. Supp. 2d 1049, 1057-61 (S.D. Cal. 2013) (denying motion for summary judgment and holding that defendant’s allegation that preliminary infringement contentions lacked sufficient specificity “turns the issue into one of claim construction rather than sufficiency of the PICs [preliminary infringement contentions],” and was thus premature); Network Caching, 2003 WL 21699799, at  (“Patent LR 3–1 does not require [the plaintiff] to produce evidence of infringement . . . .”). AntiCancer continues to stress that its Preliminary Infringement Contentions stated that the disclosures and claim charts “identify to the extent possible based on information currently in AntiCancer’s possession where each element of each asserted claim is found within each accused instrumentality of which AntiCancer is aware.” Appellant Br. at 24-25. AntiCancer had argued in its brief opposing the motion for summary judgment that “it 20 ANTICANCER, INC. v. PFIZER, INC. would be clear to any competent scientist or even a layman, that measuring the ‘intensity’ of any process is another way of saying that the process is being ‘monitored,’” and provided the declaration of its founder and President, Dr. Robert M. Hoffman, explaining this science. The Hoffman declaration states that “it is impossible to measure the intensity of a process without monitoring it, since intensity refers to a degree of measurement which is monitored over time.” Decl. Robert M. Hoffman at 3, AntiCancer (S.D. Cal. Apr. 2, 2012), ECF No. 40-1. Dr. Hoffman explained that the Pfizer publication clearly indicates that the promoter was monitored in this experiment. Fluorescence intensity was graded as either “0, +, ++, or +++.” Therefore, ex- pression of GFP varied from “0” at the lowest end to “+++” at the highest end, which means the ac- tivity (intensity) of the promoter linked to GFP was varied. The scientist conducting this experiment could only have rated the varying intensity of the GFP promoter by monitoring it. Id. The district court apparently gave weight to the inclusion of additional explanation in AntiCancer’s opposition brief and the Hoffman declaration, and remarked that AntiCancer was “capable” of making the “connection” between the Pfizer publication and the claim elements. Dist. Ct. Op. at 9. The court observed that AntiCancer’s brief contained more details than its Contentions, and stated: Indeed, in its opposition brief [AntiCancer] makes this connection: “[I]t is the signal of GFP fluorescence which indicates the activity of the promoter, and the ‘localization and intensity’ of such fluorescence, and thereby of the promoter, is determined ANTICANCER, INC. v. PFIZER, INC. 21 by viewing or imagining the subject over time – in other words, by monitoring it.” Id. (quoting AntiCancer’s brief in opposition to motion for summary judgment of noninfringement). The district court thus suggested that this information should have been included in the Preliminary Infringement Contentions. AntiCancer does not object to such inclusion, but objects to the fee-shifting condition placed on this inclusion. As we review the nature of the deficiencies that were found by the district court, and the condition imposed on AntiCancer’s supplementation of the Contentions, AntiCancer reasonably argues that its “infringement theories were as crystallized as they could be under the circumstances, five (5) days after it had filed its First Amended Complaint with its infringement claims.” Appellant Br. at 13. AntiCancer argues that there was no uncertainty as to the subject matter that was charged with infringement, and that the supplemental information sought by the district court would be obtained by discovery, as contemplated by the Patent Local Rules, as well as the broad discovery regime provided for by the Federal Rules of Civil Procedure. The district court referred to the requirement that “the degree of specificity under Local Rule 3–1 must be sufficient to provide reasonable notice to the defendant why the plaintiff believes it has a ‘reasonable chance of proving infringement.’” Shared Memory Graphics, 812 F. Supp. 2d at 1025 (quoting View Eng’g, Inc. v. Robotic Vision Sys., Inc., 208 F.3d 981, 986 (Fed. Cir. 2000)). However, the question on appeal is not whether the district court properly required additional specificity in these Contentions, but whether a feeshifting sanction was appropriately attached to the court’s authorization to supplement the Contentions. Ninth Circuit precedent negates the imposition of a fee-shifting sanction absent an explicit finding of bad 22 ANTICANCER, INC. v. PFIZER, INC. faith. Although the district court described the Contentions as “woefully insufficient” and “vague,” and described AntiCancer as “act[ing] unreasonably” and “disingenuous” in submitting the Contentions, Dist. Ct. Op. at 14, there is no explicit finding of bad faith. Indeed, the district court’s observation that AntiCancer’s brief in opposition to the motion for summary judgment and the Hoffman declaration might meet the court’s concerns weighs against any inference of bad faith. We thus conclude that a feeshifting sanction conditioned on AntiCancer’s supplementation for the “promoter monitoring” element cannot be sustained.