Plexxikon Inc. v. Novartis Pharm. Corp.
| Decision Date | 15 March 2021 |
| Docket Number | Case No. 17-cv-04405-HSG |
| Citation | 525 F.Supp.3d 1104 |
| Parties | PLEXXIKON INC., Plaintiff, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant. |
| Court | U.S. District Court — Northern District of California |
Andrew R. Basile, Eddie Dean Woodworth, Jeffrey D. Wilson, Ryan T. McCleary, Pro Hac Vice, Young Basile Hanlon MacFarlane, P.C., Troy, MI, Andrew Treloar Jones, Katherine E. McNutt, Kira A. Davis, Durie Tangri LLP, Los Angeles, CA, David Floyd McGowan, Eugene Novikov, Laura Elizabeth Miller, Matthew Walter Samuels, Raghav R. Krishnapriyan, Daralyn J. Durie, Durie Tangri LLP, San Francisco, CA, for Plaintiff.
Thomas P. Steindler, David Mlaver, Ian Barnett Brooks, Pro Hac Vice, Jennifer Butler Routh, Pro Hac Vice, Michael S. Nadel, Pro Hac Vice, Paul M. Schoenhard, Pro Hac Vice, McDermott Will and Emery LLP, Washington, DC, William G. Gaede, III, McDermott Will & Emery LLP, San Francisco, CA, Katherine Nicole Clouse, Sarah Chapin Columbia, McDermott Will and Emery LLP, Boston, MA, for Defendant.
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. § 102.1 The dispute, as briefed by the parties, centers on the priority date of the Asserted Patents. For the reasons stated below, the Court finds that genuine disputes of fact regarding that priority date remain and therefore DENIES the motion for summary judgment.
Plaintiff Plexxikon Inc. ("Plexxikon") brings this patent infringement action against Novartis Pharmaceuticals Corporation ("Novartis") for infringement of the 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 L1 (circled in blue) connecting a monocyclic heteroaryl at the "3" position. Dkt. No. 393-2 ("Metzker Depo.") at 192:18-23; Metzker Report ¶ 28.2
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 R1, R2, R3, R4, and m. Some of these variables, including R1, R2, and R3, are not part of the scaffold. See Dkt. No. 177-2 ("Baran Decl.") ¶ 14. Instead, the variables may be one of a number of alternative elements. For instance, R1 may be an optionally substituted lower alkyl or heteroaryl, while R3 may be an optionally substituted lower alkyl or aryl. ’640 Patent at claim 1; ’539 Patent at claim 1. R2 is a hydrogen or halogen. Id. The linker L1 may also be eliminated for a direct bond. Id.
Plexxikon claims a priority date of March 2005.3 See Dkt. No. 179-6 at 8. Although the provisional application for the Asserted Patents was not filed until July 17, 2007, Plexxikon argues that the claimed inventions were conceived on March 14, 2005. Metzker Report ¶ 23. As support, Plexxikon cites an email with the subject line "new scaffold" sent by James Tsai, a co-inventor of the patents, on March 15, 2005, stating as follows:
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.
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.
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."4 "The invention date is the date of conception." Allergan, Inc. v. Apotex Inc. , 754 F.3d 952, 967 (Fed. Cir. 2014). 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. at 967 (citation omitted). Conception is definite when the inventors have "a specific, settled idea" and a "particular solution to the problem at hand." Dawson v. Dawson , 710 F.3d 1347, 1352 (Fed. Cir. 2013) (quoting Burroughs Wellcome Co. v. Barr Labs., Inc. , 40 F.3d 1223, 1228 (Fed. Cir. 1994) ). Conception is complete when "the idea is so clearly defined in the inventor's mind that only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation." Id. For chemical inventions, conception requires both "(1) the idea of the structure of the chemical compound, and (2) possession of an operative method of making it." Oka v. Youssefyeh , 849 F.2d 581, 583 (Fed. Cir. 1988).
It is well-established that conception must...
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