Biogen, Inc. v. Amgen Inc.

• Decision Date: 25 September 2000
• Docket Number: No. CIV.A.95-10496-RGS.,CIV.A.95-10496-RGS.
• Citation: 115 F.Supp.2d 139
• Parties: BIOGEN, INC. v. AMGEN INC.
• Court: U.S. District Court — District of Massachusetts

115 F.Supp.2d 139

BIOGEN, INC. v. AMGEN INC.

No. CIV.A.95-10496-RGS.

United States District Court, D. Massachusetts.

September 25, 2000.

John Sylvia, Patrick T. Clendenen, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C., Boston, MA, Eric R. Hubbard, Fish & Neave, New York, NY, James F. Haley, Kenneth B. Herman, Jane A. Massaro, Kathleen M. Walker, Fish & Neave, New York, NY, for plaintiff.

Thomas R. Murtagh, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C., Boston, MA, Jan Van Gysegem, Cleary, Gottlieb, Steen & Hamilton, New York, NY, Paul F. Ware, Eileen M. Herlihy, Goodwin, Procter & Hoar, Boston, MA, Karen J. Kramer, Robert M. Galvin, Ricardo Rodriguez, Gary H. Ritchey, Darren B. Mitchell, Karen A. Gibbs, Cooley Godward LLP, Palo Alto, CA, Steven M. Odre, Karol M. Pessin, Thousand Oaks, CA, Lloyd R. Day, Jr., Vernon M. Winters, Day Casebeer Madrid Winters & Batchelder LLP, Cupertino, CA, for defendant.

MEMORANDUM AND ORDER ON (1) AMGEN'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT (DOCKET # 861) AND (2) AMGEN'S MOTION FOR SUMMARY JUDGMENT OF NON-EQUIVALENCE (DOCKET # 882)

STEARNS, District Judge.

In an August 6, 1998 Markman order (docket # 854), claim 1 of the '702 patent was construed as follows.

To be covered by the patent, a plasmid vector must contain the entire P_LO_L of bacteriophage λ as represented in Figure 6 of the patent and at least one endonuclease recognition site inserted at the converted Hae lll site at 73.1% of bacteriophage λ or at another site downstream of Hae lll, said endonuclease recognition site being within 300 base pairs of the Hinc ll site at -33, and prior to any sequences of λ DNA downstream of the Hae lll site.

Based on this construction, defendant Amgen, Inc., moves for summary judgment, contending that its accused vector neither literally infringes Biogen, Inc.'s '702 patent, nor infringes under the doctrine of equivalents.

LITERAL INFRINGEMENT

A comparison of the material differences between the structure of Amgen's plasmid vector¹ and that of the vectors claimed by Biogen in the '702 patent establishes literal non-infringement.² As described in Figure 6 of the '702 patent the prototypical Biogen vector consists of 247 base pairs of bacteriophage λ DNA spanning the sequence beginning at the Sau 3A site at -133 and extending to the converted Eco RI (Hae lll) endonuclease recognition site at + 114. The sequence contains five structural elements: (1) the leftward promoter P_L;³ (2) the leftward operator O_L;⁴ (3) a transcription start site (+1); (4) the N utilization site (nut L) (+34 to +63); and (5) the Hae lll site.⁵ Figure 6 also shows a 114 base pair DNA fragment terminating at the Hae lll site, the earliest point at which translation occurs.

The Amgen vector by contrast, while initiating at Sau 3A, terminates at the Xba l site at +13. The Amgen vector thus does not contain nut L or the Hae lll site. As opposed to the 114 base pair DNA fragment depicted in Figure 6, the DNA fragment in Amgen's vector consists of 13 base pairs. The Hae lll recognition site depicted in Figure 6 is inserted outside of the P_LO_L sequence, while Amgen's endonuclease recognition site is inserted within P_L O_L. And finally, Amgen's vector inserts non-λ DNA in P_LO_L between base pair positions +4 and +13. Because there can be no dispute that Amgen's vector does not contain the entire sequence described in Figure 6 of the '702 patent, under the court's Markman construction Amgen is entitled to summary judgment on the claim of literal infringement. See Litton Systems, Inc. v. Honeywell, Inc., 140 F.3d 1449, 1454 (Fed.Cir.198) ("Literal infringement requires that the accused device contain each limitation of the claim exactly; any deviation from the claim precludes a finding of literal infringement.")

DOCTRINE OF EQUIVALENTS

A product or composition may not literally read on a patent claim and may yet infringe under the doctrine of equivalents. Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 25, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). The doctrine of equivalents is not above reproach, given its propensity to assume "a life of its own, unbounded by the patent claims." Id., at 28-29, 117 S.Ct. 1040. "In reconciling the uncertainty surrounding application of the doctrine of equivalents with the definitional and public-notice functions of the statutory claiming requirement, the Supreme Court [in Warner-Jenkinson] endorsed an element-by-element analytical framework for infringement." Litton Systems, 140 F.3d at 1454. "Each element contained in a patent claim is deemed material to defining the scope of the patented invention, and thus the doctrine of equivalents must be applied to individual elements of the claim, not to the invention as a whole." Warner-Jenkinson, 520 U.S. at 29, 117 S.Ct. 1040.

While Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605, 70 S.Ct. 854, 94 L.Ed. 1097 (1950), set out what has become the familiar "triple identity" test of equivalence, comparing "the function served by a particular claim element, the way that element serves that function, and the result thus obtained by that element, ... the particular linguistic framework used is less important than whether the test is probative of the essential inquiry: Does the accused product or process contain elements identical or equivalent to each claimed element of the patented invention?" Warner-Jenkinson, 520 U.S. at 39-40, 117 S.Ct. 1040.

The first task in applying the "all-elements" rule is to identify the material limitations of the disputed claim. An illustration is provided by Litton Systems. There the district court construed the specification of a "Kaufman-type ion beam source" to include "[a]ny broad-beamed, multiapertured, gridded ion beam source, which includes any hollow cathode gun and any radio frequency gun." Id. at 1454. The Federal Circuit disagreed. Looking more closely to the specification, the Court identified the components of an ion beam gun of the "Kaufman-type" to include "a hot-wire cathode, an anode, grids, and magnets."⁶ Because the Litton Systems jury had been instructed to consider whether the accused product incorporated a generic ion beam source rather than an ion beam gun with the essential components of the Kaufman-type gun described in the patent, its finding of infringement by equivalents could not stand under the all-elements rule. Id. at 1455.

Infringement under the doctrine of equivalents is ordinarily a question of fact. Bayer AG v. Elan Pharmaceutical Research Corp., 212 F.3d 1241, 1251 (Fed.Cir. 2000). "Thus summary judgment may be granted [only] when no material fact is in dispute, or when no reasonable trier of fact could find facts whereby the nonmoving party could prevail, even when all justifiable factual inferences are drawn in favor of the nonmovant." Canton Bio-Medical v. Integrated Liner Technologies, Inc., 216 F.3d 1367, 1369 (Fed.Cir.2000). As will be noted, the material facts necessary for a resolution of this case are not in dispute, although many other facts are.

Turning to claim 1 of the '702 patent, it is not enough, as Warner-Jenkinson and Litton Systems teach, to simply say that it describes a bacteriophage λ DNA vector with a leftward promoter and operator. More precisely, as depicted in Figure 6, the constituent structures of Biogen's vector are: (1) the leftward promoter (P_L); (2) the three leftward operator sequences (O_L1, O_L2, and O_L3); (3) a transcription start site; (4) the N utilization site (nut L); and (5) an endonuclease (Hae lll) recognition site.⁷ That there are substantial similarities between Biogen's and Amgen's vectors is self-evident. Both rely on P_LO_L to mediate gene expression. Both contain the components essential for P_L to function, specifically the -35 region, the -10 region (the Pribnow box), the +1 transcription start site, and the three O_L sequences, all identically spaced.⁸ Both use an artificially constructed endonuclease recognition site to insert the gene to be expressed. Both locate that site within 300 base pairs of Hinc ll to avoid transcription of contiguous downstream λ DNA.⁹ Where the vectors differ is that Biogen's contains the nut L sequence (from +34 to +63), while Amgen's does not. Whether this is a substantial difference requires an explanation of what the inventors (Fiers and Remaut) intended by including nut L in their claimed vectors.¹⁰

As Biogen's Dr. Losick pointed out, nut L was the only DNA sequence downstream of +1 in Figure 6 "that was known [at the time the '702 patent application was filed] to have an effect, under some circumstances, on expression." Losick Decl. ¶ 67. The "circumstances" that Dr. Losick referred to are those in which either the host cell or the plasmid vector contains an active N gene. When either does, nut L interacts with the N gene to override downstream termination sequences that would otherwise abort transcription. Chamberlain Decl., Ex. B ¶ 63.¹¹ Fiers explained that he and Remaut were concerned that unanticipated termination sites in cloned eukaryotic genes¹² might preclude expression if the N gene were present. "It was not known, and this is precisely the reason that we anticipated possible transcriptional termination regions in the eukaryotic gene and therefore we developed the system which could be used plus or minus the N gene." Fiers Dep., June 11, 1997, at 1550-1551. Fiers and Remaut did so by placing the endonuclease recognition site at Hae lll, downstream of nut L. The ability of the '702 vector to express DNA despite the presence of an active N gene in the host cell was specified in the patent as one of its attributes.

The preferred vectors of this invention are also those in which active N genes ... are absent. Therefore, by choice of an appropriate host, i.e., one containing or lacking an active chromosomal N gene, any of the vectors of the invention may be employed for expression of DNA sequences in the presence or in the absence...