Genentech, Inc. v. Amgen, Inc., 01-1098.
| Decision Date | 29 April 2002 |
| Docket Number | No. 01-1098.,01-1098. |
| Citation | 289 F.3d 761 |
| Parties | GENENTECH, INC., Plaintiff-Appellant, v. AMGEN, INC., Defendant-Appellee. |
| Court | U.S. Court of Appeals — Federal Circuit |
Leora Ben-Ami, Clifford Chance Rogers & Wells, of New York, NY, argued for plaintiff-appellant. With her on the brief was John E. Kidd. Of counsel on the brief were John S. Skilton; M. Patricia Thayer; and Elizabeth A. Brown, Heller Ehrman White & McAuliffe LLP, of San Francisco, CA.
Lloyd R. Day, Jr., Day Casebeer Madrid & Batchelder LLP, of Cupertino, CA, argued for defendants-appellees. On the brief were William G. Gaede, III; Andrew A. Kumamoto; Madison C. Jellins; and Monica K. Hoppe, Cooley Godward LLP, of San Francisco, CA. Of counsel on the brief were Jackie N. Nakamura; and Jeffrey K. Lee, Day Casebeer Madrid & Batchelder LLP, of Cupertino, CA.
Before MICHEL, RADER, and SCHALL, Circuit Judges.
On summary judgment, the U.S. District Court for the Northern District of California determined that Amgen, Inc. (Amgen) did not literally infringe Genentech, Inc.'s (Genentech's) U.S. Patent Nos. 4,704,362 (the '362 patent), 5,221,619 (the '619 patent), and 5,583,013 (the '013 patent). Genentech, Inc. v. Amgen, Inc., No. C 96-03752 WHA, slip op. at 1-2 (N.D.Cal. Oct. 12, 2000) (Amended Summary Judgment Order). The district court also barred Genentech from proceeding on a theory of infringement under the doctrine of equivalents. Id. Because the district court did not abuse its discretion, this court affirms the district court's decision to preclude Genentech from asserting infringement under the doctrine of equivalents. The district court, however, relied on an erroneous claim construction in granting Amgen's motion for summary judgment. Accordingly, this court vacates and remands for a determination of infringement under this court's revised claim construction.
Genentech owns the '362, '619 and '013 patents. These patents claim methods and cloning vehicles for the introduction and expression of genetic information, i.e., deoxyribonucleic acid (DNA) or genes, in unicellular organisms that do not naturally contain or express that genetic information. The patents thus enable introduction of a DNA sequence, such as a synthetic gene that expresses a usable protein, into cells via a cloning vehicle. The cells then express this sequence through the endogenous protein-making machinery of the cell. The inventions thus enable harvesting valuable proteins from single cell "factories."
Inside a bacterial cell, the expression of a gene into a protein involves a two-step process. First, the cell transcribes the DNA sequence into messenger ribonucleic acid (mRNA) by an enzyme called RNA polymerase. The RNA polymerase then binds to a specific sequence within the DNA known as a "promoter" upstream from the DNA sequence encoding the usable protein. To control transcription, and therefore protein expression, the DNA sequence upstream from the usable gene also contains a site called an "operator." The operator controls transcription by binding a protein known as a "repressor." When the repressor binds to the operator, the repressor prevents the RNA polymerase from binding to the promoter, and therefore blocks transcription.
After transcribing a DNA sequence into mRNA, the cell engages in the second step, translation of the mRNA into protein. Specifically, a ribosome, which is a cellular structure involved in converting mRNA to polypeptides, binds to an upstream portion of the mRNA sequence known as the "ribosome binding site." This binding triggers translation of the mRNA into a linear chain of amino acids — a protein.
The three patents at issue, which contain nearly identical specifications, describe the use of a recombinant cloning vehicle (e.g., a plasmid, comprising a circular piece of non-chromosomal double-stranded DNA) to transform a unicellular organism host such as the bacterium E. coli to enable that organism to make large amounts of a protein that it would not otherwise produce. The first claim in all three patents sets forth the invention:
'362 claim 1:
A recombinant DNA cloning vehicle suited for transformation of a microbial host comprising
(a) a homologous control region which regulates expression of a structural gene and
(b) a DNA insert comprising ... in that the DNA insert is ... and the host transformed thereby is capable of expressing... under the control of the said control region and in recoverable form.
'619 claim 1:
A process for the production of a polypeptide comprising a preselected functional mammalian polypeptide or polypeptide intermediate therefor in a microbial cell culture, said process comprising
I. effecting expression of said polypeptide in a microorganism transformed with a replicable cloning vehicle comprising DNA encoding said polypeptide which DNA is under the control of an expression control region homologous to said microorganism; and
(ii) recovering the polypeptide from said cell culture.
'013 claim 1:
A process for the production of a polypeptide comprising ... effecting expression of said polypeptide in a microorganism transformed with a replicable cloning vehicle comprising DNA encoding said polypeptide which DNA is under the operative control of an expression control region functional in E. coli comprising operatively linked promoter, operator and ribosome binding site DNA.
(Emphasis added.)
In its 17 May 1999 claim construction order, the district court (Judge Smith) construed the relevant terms in the claims. Genentech, Inc. v. Amgen, Inc., No. C96-3752 FMS, slip op. at 1 (Order). The district court determined that the "control region," which regulates gene expression, contains at least three control elements: a promoter, an operator, and a ribosome binding site. Id. at 24. As construed by the district court, the "control region" in all three patents must be taken from a single "operon" (i.e., DNA comprising a control region and the gene whose expression is regulated by that control region).1 Id. at 20-23. Variation from the native control region of the untransformed host is permissible as long as the control region remains operable, i.e., the control region need not be intact. Id. at 20.
The court construed "homologous" in the '362 and '619 patents to mean that the control region DNA sequence is taken from, and ordinarily is endogenous to, the host DNA in its untransformed state. Id. at 12. To be endogenous to the host, DNA must be either part of the chromosomal host DNA, part of the plasmid DNA native to the host, or part of the chromosomal or plasmid DNA native to a "bacteriophage" (i.e., a bacterial virus from which one may derive a plasmid) ordinarily found in the bacterial host cell. Id. A control region is not homologous if it includes any alterations in the endogenous sequence, with the single exception of a promoter mutation described in the patent, namely, deletion of the catabolite activator protein (CAP) binding site. Id. at 10-12; '362 patent, col. 2, ll. 31-35.2
The district court construed the term "functional in E. coli" to mean that the control region performs in E. coli. Although operative in E. coli, the term does not mean that the control region must be homologous to E. coli. Id. at 15. The district court also interpreted the term "operatively linked" to mean that the promoter, operator, and ribosome binding site (P, O, and RBS) are sufficiently connected to direct and regulate expression. Id. at 34. This term does not require that the P, O, and RBS appear in any particular order.
As to the term "ribosome binding site," the district court originally construed it to mean "a DNA sequence that is an irreducible constituent of the expression control region that, when transcribed into mRNA, is bound by the ribosome, and is thus required for the initiation of translation." Id. at 50. After Judge Smith issued the 17 May 1999 claim construction order, the case was transferred to Judge Alsup. In its 12 October 2000 amended order granting Amgen's motion for partial summary judgment, the district court elaborated: "Judge Smith's requirement that the ribosome binding site be `bound' by the ribosome is best understood to mean that the ribosome binding site consists of the entire sequence encompassed (or bound) by the two RNA sites with which the ribosome interacts to initiate translation." Amended Summary Judgment Order at 13.
Amgen makes and sells Neupogen®, a recombinant methionyl human granulocyte colony stimulating factor (methGCSF) protein. This protein accelerates the replication of human white blood cells. Amgen employs E. coli to produce Neupogen® with a recombinant plasmid containing the gene for met-hGCSF. Original Summary Judgment Order, at 2. The regulatory region (P, O, and RBS) of Amgen's plasmid is derived in part from the bacteriophage lambda. The first 72 base pairs of the Amgen regulatory region are identical to the first 72 base pairs of the endogenous lambda regulatory region. These 72 base-pairs encompass the promoter and operator in both regulatory regions. Id. at 4. As noted by the district court, the RBS includes, at minimum, a Shine-Dalgarno (S-D) sequence (a conserved sequence of five nucleotides in this case) and a start codon, ATG (the first three nucleotides translated into an amino acid). Id. The ribosome binds the mRNA at these two sequences. The S-D sequence and the start codon are separated by "linker" base-pairs (usually about 10 base-pairs) that do not actually bind the ribosome. The district court found, however, that these linker base-pairs, like the S D sequence and the start codon, are necessary for the initiation of translation. Id.
Importantly, the base-pairs linking the S D sequence and the start codon in Amgen's plasmid are different in number and identity from the linker base-pairs in the endogenous lambda sequence:
bacteriophage...
To continue reading
Request your trial
-
B-K Lighting, Inc. v. Vision3 Lighting
...981 (Fed.Cir.2007) (Unpub. Disp.), cert. denied, 552 U.S. 940, 128 S.Ct. 48, 169 L.Ed.2d 242 (2007). Cf. Genentech, Inc. v. Amgen, Inc., 289 F.3d 761, 773–74 (Fed.Cir.2002) (affirming the district court's decision to preclude plaintiff from proceeding with an infringement claim under the do......
-
U.S. Gypsum Co. v. Lafarge North America, Inc.
...because the litigants had failed to assert such a theory in certain discovery documents. See id. at *32 (citing Genentech, Inc. v. Amgen, Inc, 289 F.3d 761, 773-74 (Fed.Cir.2002); Nike Inc. v. Wolverine World Wide, Inc., 43 F.3d 644, 648 (Fed.Cir.1994)). Revlon distinguished those cases in ......
-
Semiconductor Energy Lab. v. Chi Mei Optoelect.
...were properly disclosed. The application of Local Rules is within the discretion of the District Court. Genentech, Inc. v. Amgen, Inc., 289 F.3d 761, 768 (Fed.Cir.2002). Reviewing the Invalidity Contentions and expert report, it is apparent that CMO has provided detailed citations to prior ......
-
On Track Innovations Ltd. v. T-Mobile USA, Inc.
...rules in view of the trial court's need to control the parties and flow of litigation before it.") (quoting Genentech, Inc. v. Amgen, Inc., 289 F.3d 761, 774 (Fed.Cir.2002) ).The Court's decision not to accept T–Mobile's invitation back down the rabbit hole of renewed claim construction is ......