ORDER DENYING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT
Re: Dkt. No. 177
HAYWOOD S. GILLIAM, JR., United States District Judge.
Pending before the Court is Defendant Novartis Pharmaceuticals Corporation's motion for partial summary judgment that certain claims of U.S. Patent Nos. 9,469,640 (the "'640 Patent") and 9,844,539 (the "'539 Patent") (together, the "Asserted Patents") are invalid as anticipated under 35 U.S.C. § 102.
Plaintiff Plexxikon Inc. ("Plexxikon") brings this patent infringement action against Novartis Pharmaceuticals Corporation ("Novartis") for infringement of the '640 and '539 Patents. Plexxikon accuses Novartis' melanoma cancer drug Tafinlar, which treats melanoma by inhibiting a protein called B-Raf kinase. The Asserted Patents cover a class of molecular compounds having the following molecular structure:
Dkt. No. 177-16 ('640 Patent) at claim 1; Dkt. No. 210-17 ('539 Patent) at claim 1.
As analyzed by Plexxikon's expert, Dr. Michael Metzker, the claimed molecular structure has a "1,2,3-substituted" pattern of sulfonamide, fluorine, and a monocyclic heteroaryl. See Dkt. No. 399-2 ("Metzker Report") ¶ 30. Specifically, as illustrated by Plexxikon below, the claimed structure has a phenyl ring (shown as a hexagon) having a sulfonamide (circled in red) at the "1" position, followed by a fluorine (circled in green) at the "2" position, and a linker L
Dr. Metzker refers to this combination as a "scaffold." Id. In addition to the scaffold, the claimed molecular structure also includes a number of variables, marked as R
Plexxikon claims a priority date of March 2005.
Dkt. No. 212-4 ("March 2005 Email").
Dr. Metzker opines that the March 2005 email discloses the claimed scaffold. Metzker Report ¶¶ 29-33. In particular, the email shows five compounds that have a phenyl ring with a sulfonamide at the "1" position, a fluorine at the "2" position, and an "X" in the "3" position. Id. ¶ 30. The "X" is a variable. Id. The email states that "Chao's first suggestion at X is a Pyr," which the inventors interpreted as a pyridine —a monocyclic heteroaryl. Id. ¶¶ 32, 44, 46. In addition, the email describes a variable "Z" attached to the sulfonamide, which the drawings show as certain alkyl and phenyl groups. Id. ¶ 31; see also Dkt. No. 219 ("Ibrahim Decl.") ¶ 5.
Jiazhong Zhang, another named inventor of the Asserted Patents, synthesized a compound as "proof of concept" of the ideas in the March 2005 email, which Plexxikon designated P-0001, between March 16 and March 18, 2005. Metzker Report ¶ 35. Plexxikon synthesized two other compounds, designated P-0007 and P-0012, in December 2006 and January 2007, respectively. Id. Dr. Metzker opines that each of these compounds falls within the scope of the claims, but does not provide any details regarding their implementation. Id.
II. LEGAL STANDARD
A. Summary Judgment
A motion for summary judgment should be granted where there is no genuine issue of material fact and the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56; Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The purpose of summary judgment "is to isolate and dispose of factually unsupported claims or defenses." Celotex v. Catrett, 477 U.S. 317, 323-24, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The moving party has the initial burden of informing the Court of the basis for the motion and identifying those portions of the pleadings, depositions, answers to interrogatories, admissions, or affidavits which demonstrate the absence of a triable issue of material fact. Id. at 323, 106 S.Ct. 2548.
If the moving party meets its initial burden, the burden shifts to the non-moving party to present facts showing a genuine issue of material fact for trial. Fed. R. Civ. P. 56; Celotex, 477 U.S. at 324, 106 S.Ct. 2548. The Court must view the evidence in the light most favorable to the nonmovant, drawing all reasonable inferences in its favor. T.W. Elec. Serv., Inc. v. Pac. Elec. Contractors Ass'n, 809 F.2d 626, 630-31 (9th Cir. 1987). Summary judgment is not appropriate if the nonmoving party presents evidence from which a reasonable jury could resolve the disputed issue of material fact in the nonmovant's favor. Anderson, 477 U.S. at 248, 106 S.Ct. 2505. Nonetheless, "[w]here the record taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no genuine issue for trial." Matsushita Elec. Indus. Co. v. Zenith Radio, 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (internal quotation mark omitted).
Novartis argues that certain compounds synthesized in 2007 anticipate some claims of the Asserted Patents. Plexxikon does not directly dispute that these compounds fall within the scope of the claims. Instead, Plexxikon argues that the compounds are not prior art for two reasons. First, Plexxikon argues, citing Rule 131 case law, that the compounds were obvious variations of Plexxikon's own inventions in the form of the P-0001, P-0007, and P-0012 compounds. Second, Plexxikon claims entitlement to an earlier priority date based on conception of the species shown in the March 2005 email. Novartis responds that Plexxikon's evidence is not sufficient to support these arguments, and that even if it was, conception of a species cannot establish priority for a claimed genus absent evidence of "generic applicability."
As explained further below, the Court finds that Rule 131 law does not apply to the current dispute. The Court therefore considers only (1) whether Plexxikon has produced enough evidence to show prior conception of a claimed species, and (2) whether such evidence may suffice to establish priority for the claims as a matter of law.
A. Legal Standard
1. Establishing Priority
Under 35 U.S.C. § 102(g), a patent is invalid if "before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it."
It is well-established that conception must include each claimed limitation. See REG Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 962 (Fed. Cir. 2016) ("Conception must include every feature or limitation of the claimed invention."); Cumberland Pharma. Inc. v. Mylan Inst. LLC, 846 F.3d 1213, 1218 (Fed. Cir. 2017) ("Conception is keyed to the claimed invention: `A conception must encompass all limitations of the claimed invention.'" (emphasis in original) (citation omitted)); Taurus IP, LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed. Cir. 2013) (rejecting conception for failure to demonstrate the evidence "satisfie[d] all the limitations, as necessary to demonstrate conception"). For inventions of chemical compounds, the compound must be conceived "with all of [its] component substituents." Bd. of Edu. ex rel. Bd. of Tr. of Fla. State Univ. v. Am. Bioscience, Inc., 333 F.3d 1330, 1340 (Fed. Cir. 2003).
Where a patent claims a genus, conception of a species may constitute conception of a genus. Jolley, 308 F.3d at 1322 & n.2; Oka, 849 F.2d at 584; In re Taub, 348 F.2d 556, 562 (C.C.P.A. 1965). The Federal Circuit has never expressly held that it does. Jolley, 308 F.3d at 1322 n.2.
In Jolley, a party in an interference proceeding claimed a "two-component system" comprising (1) a refrigerant, and (2) certain esters.
In Bosies v. Benedict, on the other hand, the Federal Circuit found that the party failed to meet its burden to show conception. 27 F.3d 539, 544 (Fed. Cir. 1994). There, the claims recited a chemical compound having an "A" group with a hydrocarbon chain of two to eight carbons. Id. at 540. A party attempted to establish priority by introducing a laboratory notebook that showed the same compound, but that had a variable "n" for the number of carbons. Id. at 541. The Federal Circuit found that the notebook did not establish conception because there was insufficient evidence that the inventors considered appropriate values for "n." Id. at 542; see also Prutton, 230 F.2d at 464 (rejecting conception where the evidence contained "disclosures of a scope which embraces the specific compositions recited by the claims" among others, but did not "fairly suggest any preference for the claimed compositions").
Because conception is a mental act, an inventor's testimony alone is insufficient to prove conception absent corroboration. NFC Tech., LLC v. Matal, 871 F.3d 1367, 1371 (Fed. Cir. 2017). "There is no particular formula that an inventor must follow in providing corroboration," which is evaluated under a flexible "rule of reason" that considers "all pertinent evidence."
A party challenging patent validity has the burden to prove by clear and convincing evidence that an invalidating reference is prior art. Allergan, 754 F.3d at 967. However, the burden of production may shift in the course of that determination. See id. Thus, where a party makes a prima facie case of invalidity, the burden of production shifts to the patentee to provide evidence and argument supporting an earlier priority date. Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir. 2008). Once that showing is made, the burden shifts back to the party challenging validity to "convince the court that [the patentee] is not entitled to the benefit of the earlier [priority] date." Id. at 1328. The ultimate burden of persuasion—and thus the "risk of decisional uncertainty"—never shifts from the party challenging validity. Id. at 1327.
2. Rule 131 Cases
Notwithstanding the clear standard set out above, both parties attempt to import additional requirements from Rule 131 of the Patent and Trademark Office ("PTO"). See Opp. at 8:2-11:3; Reply at 9:16-10:10.
37 C.F.R. § 1.131(a). This rule has been described as a "swearing back" or "swearing behind" provision because it allows a patentee to antedate prior art by "swearing" in an affidavit that its invention occurred earlier. Iancu, 920 F.3d at 1369. In contrast to modern conception law, the predecessor court to the Federal Circuit required a Rule 131 affidavit to show priority "with respect to only so much of the claimed invention as the references disclose" or "only so much as to render the claimed invention obvious." See Scheiber,
Neither party establishes that Rule 131 cases apply to the current proceedings, and multiple factors suggest they should not. First, Rule 131 is an administrative rule that, on its face, applies only to reexaminations. Reexamination proceedings do not generally determine priority. See Slip Track Sys., Inc. v. Metal Lite, Inc., 159 F.3d 1337, 1340 (Fed. Cir. 1998). Moreover, courts routinely reject any applicability of PTO proceeding decisions to district court litigation, and vice versa, given the different burdens and presumptions of validity. See In re Baxter Int'l, Inc., 678 F.3d 1357, 1364 (Fed. Cir. 2012) ("[T]he PTO in reexamination proceedings and the court system in patent infringement actions `take different approaches in determining validity and on the same evidence could correctly come to different conclusions.'") (quoting Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1428 (Fed. Cir. 1988)); In re Swanson, 540 F.3d 1368, 1377 (Fed. Cir. 2008) ("PTO examination procedures have distinctly different standards, parties, purposes, and outcomes compared to civil litigation.").
Second, the predecessor court to the Federal Circuit stated that "[t]he purpose of filing a 131 affidavit is not to demonstrate prior invention per se, but merely to antedate the effective date of the reference." In re Eickmeyer, 602 F.2d 974, 978 (CCPA 1979). Under that standard, the court construed Rule 131 "liberally" and "in one respect contrary to its express terms" in order to assure patentees their rights. See In re Mulder, 716 F.2d 1542, 1545-46 (Fed. Cir. 1983). However, it expressly rejected any similarity between this liberal construction and the substantive standards for conception and reduction to practice under 35 U.S.C. § 102(g). See In re Moore, 444 F.2d 572, 580 (C.C.P.A. 1971) (characterizing any parallel as "one of convenience rather than of necessity").
Third, even if Rule 131 applied, it might not change the analysis. Each of the cases cited by the parties stems from the seminal decision in In re Stempel, 241 F.2d 755 (C.C.P.A. 1957), which held that a patent applicant may overcome a reference as to generic claims by showing priority to the species shown in that reference. The broad language of Stempel was later clarified in In re Tanczyn, 347 F.2d 830 (C.C.P.A. 1965), which stated:
Id. at 833; see Isco Int'l, Inc. v. Conductus, Inc., 279 F.Supp.2d 489, 495 n.3 (D. Del. 2003).
In other words, the Rule 131 cases still require a patentee to show conception of a species of the invention—not some compound outside the claims that merely renders the invention obvious.
Under Jolley and the cases analyzed above, conception of a species may suffice to establish conception for a genus. Rule 131 imposes the same standard, but potentially adds requirements for generic applicability or prior art obviousness. Pernix, 2018 WL 2225113, at *14. The Court interprets these additional requirements as persuasive authority, but finds them not binding for the reasons stated above. Accordingly, Rule 131 case law does not directly apply to this litigation.
1. Conception of a Species
Turning to the merits, the Court first considers whether Plexxikon submits sufficient evidence that its inventors conceived a species of the claims before 2007. Plexxikon relies primarily on the March 2005 email to argue that they did. The Court has created the following graphic to illustrate the differences between the email figures and the claimed compounds. See Ibrahim Decl. ¶¶ 7-9 (mapping email to claim limitations).
As shown above, Novartis does not dispute that the email shows a phenyl ring attached to a sulfonamide at the "1" position and a fluorine in the "2" position.
With respect to "X," the inventors testified that they conceived "X" to include "any moiety that could interact with the hinge region of the kinase." Metzker Report ¶ 32 (citing testimony). Plexxikon proffers declarations attesting that this includes all groups corresponding to L
Novartis separately argues that even if Plexxikon conceived the structure, it lacked an operative method for making the compounds where L
Accordingly, the Court finds that Plexxikon meets its burden of production to show conception of a species by proffering the March 2005 email, and Novartis has not shown the evidence to be insufficient for this purpose.
2. Priority for the Genus
Novartis argues, however, that conception of a species cannot show conception of the claimed genus in this case. Novartis cites Rule 131 reduction to practice cases stemming from Clarke, 356 F.2d at 992, to argue that the evidence must also suggest "generic applicability." See DaFano, 392 F.2d at 284. In Clarke, the court found that reduction to practice of two species having methyl and phenyl R groups was insufficient to establish priority for a genus where R could be a large number of alternative elements. See 356 F.2d at 988-89, 992-93. Contrary to Novartis' suggestion, Clarke expressly recognizes that "in an appropriate case[,] a single species could be sufficient" for antedation, even for broad claims. Id. at 992; see id. ("Claims do define `the invention,' but in a given case may be of varying scope while still defining the same invention."). However, in that case, the inventors themselves did not appear to consider any elements besides methyl to be appropriate R groups having equivalent properties. Id. at 992-93.
Novartis has not, however, shown this to be the case here. According to Dr. Metzker, the key feature of the claimed compounds that distinguishes it from other B-Raf inhibitors lies in the use of a monocyclic heteroaryl, in place of an azaindole, for the scaffold. See Metzker Report ¶¶ 26-28. Plexxikon introduces evidence that the inventors conceived of this feature in March 2005, including, for example, in a "weekly summary report" that proposed "to use [a] single ring to replace the azaindole." Id. ¶ 28. This evidence plausibly suggests the inventors had a "specific, settled idea" and "particular solution" at the time. Dawson, 710 F.3d at 1352; see also Amgen, 927 F.2d at 1206 (requiring conception to define a compound through "whatever characteristics sufficiently distinguish it"). As for the other variables, Novartis has not shown that more than ordinary skill would be required to determine the equivalence of additional halogens and hydrogens for R
Accordingly, on this record, the Court cannot conclude that Plexxikon's conception of a species is insufficient to show conception of the claimed genus. Cf. DaFano, 392 F.2d at 284 (finding of single species sufficient for antedation where the inventors appreciated that "other resinsoluble copper salts would behave similarly").
For the foregoing reasons, the Court