Amgen, Inc. v. Ariad Pharmaceuticals, Inc.
Amgen, Inc. v. Ariad Pharmaceuticals, Inc.
Opinion of the Court
MEMORANDUM ORDER
INTRODUCTION
This is a patent case. A detailed recitation of the convoluted procedural posture of this case is unnecessary. A brief recitation follows. On April 20, 2006, Amgen, Inc., and related entities (collectively “Am-gen”), filed a Complaint for Declaratory Judgment of Patent Invalidity and Non-Infringement of U.S. Patent No. 6,410,516 (“the '516 patent”). An amended complaint was filed on April 13, 2007. On April 14, 2007, ARIAD Pharmaceuticals, Inc., and others (collectively “ARIAD”), filed an answer to the amended complaint and a counterclaim alleging infringement of the '516 patent. On May 3, 2007, Am-gen filed an a answer to ARIAD’s counterclaim which included, among others, an affirmative defense of unenforceability based on purported inequitable conduct during the prosecution of the application that issued as the '516 patent and purported inequitable conduct during the reexamination of the '516 patent. On February 12, 2008, Amgen filed an amended answer to ARIAD’s counterclaim adding to its un-enforceability defense additional alleged inequitable conduct during the reexamination of the '516 patent. The parties briefed various issues to the court, including claim construction. The court issued its claim construction opinion on September 19, 2008.
Currently before the court is Amgen’s motion for summary judgment of non infringement.
LEGAL STANDARDS
Summary Judgment
Summary Judgment is appropriate if the “pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and the moving party is entitled to a judgment as a matter of law.”
The moving party bears the initial burden of identifying portions of the record which demonstrate the absence of a genuine issue of material fact.
If the moving party has demonstrated an absence of material fact, the nonmoving party must then “come forward with specific facts showing that there is a genuine issue for trial.”
Although Amgen has the burden to prove no genuine issue of material fact exists,
Infringement
To determine infringement, the court must first ascertain the scope and meaning of the asserted claims by construing those terms.
Indirect Infringement: Inducement and Contributory Infringement
35 U.S.C. § 271(b) provides that whoever actively induces infringement of a patent is liable as an infringer. To establish inducement, the patentee must show that: 1) a direct infringement has occurred; and, 2) the accused infringer knowingly induced infringement or had the requisite intent.
Contributory infringement occurs when one “sells within the United States ... a combination or composition ... constituting a material part of the invention knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use____”
POSITIONS OF THE PARTIES
Amgen moves for summary judgment of non-infringement of asserted claims 6, 18, 70-72 and 183-184 of the '516 patent based on three independent grounds. First, it argues that if the court construes the claim limitation “reducing NF-kB activity in [the] cells” as requiring that the action to reduce be taken inside cells, it cannot infringe because its accused product, Enbrel, acts outside of the cell. Second, Amgen contends that ARIAD made certain disclaimers of claim scope to the PTO during the ongoing reexamination proceeding of the '516 patent. Amgen maintains that under any claim construction consistent with those disclaimers, summary judgment of noninfringement is warranted because, at most, Enbrel functions in a manner purportedly disclaimed. Third, and final
ARIAD responds to Amgen’s first argument by insisting that it is based on an improper construction of the claim limitation “reducing NF-kB activity in [the] cells.” Notably, ARIAD makes no argument that the administration of Enbrel infringes under Amgen’s proposed construction, rather ARIAD asserts that the claims cover intracellular and extracellular methods of reducing NF-kB activity in cells.
DISCUSSION
ARIAD asserts that Amgen’s Enbrel product infringes seven claims of the '516 patent, including independent claim 6 and its dependent claims 70-72, and independent claim 18 and its dependent claims 183-84. Each of the claims at issue require the limitation “reducing NF-kB activity in [the] cells.”
NF-kB is an intracellular messenger found in the cytoplasm of many eucaryotic cells and is involved in, inter alia, the regulation of the inflammatory / immune response.
ARIAD’s infringement expert, Caíame, testified that Enbrel only acts extracellu-larly, or outside a cell, and that Enbrel never enters the cell:
Q. You agree with me that Enbrel’s impact on activity within cells is derived from its binding of TNF outside of the cell?
A. That I agree with.
Q. Okay. So, if TNF induces whatever activities inside a cell, it’s your understanding that binding up of TNF would reduce those activities; correct?
A. That would be my understanding.36
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Q. Now, you agree with me that your understanding of the way Enbrel works is Enbrel never goes inside of a cell; correct?
A. That is my understanding.
Q. Enbrel merely interacts with TNF-alpha outside of cells?
A. No. It reacts .with the — yes, right. And it keeps — it competitively takes the TNF-alpha so that it can’t react with its receptor on the cell, yes.
Q. But Enbrel only interacts with TNF-alpha outside of cells as opposed to inside cells; correct?
A. Enbrel reacts with soluble TNF-alpha, correct.
Q. And that’s outside of a cell?
A. Yes. However, the machinery that’s set in motion is an intracellular response.37
Finally, while making clear that she was not testifying about claim construction, Ca-íame acknowledged that she could not think of an infringement argument should
NF-kB activity in [the] cells.”
Q. Let’s look at, specifically, the construction for reducing NF-kappaB activity in the cell....
A. Yes.
Q. You can see there that [Amgen’s] proposal is that it requires taking action inside the cell to directly inhibit, interfere or block an NF-kappaB activity. Do you see that?
A. Yes.
Q. My question to you is: Assuming that this proposal of Amgen concerning the claim construction is adopted by the Court, and the claims require action be taken inside a cell to directly inhibit, interfere or block [a]n NF-kappaB activity, would you agree with me that a patient taking
Enbrel would not infringe the claims of the patent?
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A. With the big caveat that I have not analyzed the claim construction arguments in detail, that you should ask Jeff Ravetch, I do understand that if the Court said that it only — the claim construction was such that it had to happen inside the cell, then there would be more difficulty. It’s still — you know, we all agree that things are happening inside the cell as a result of something on the exterior of the cell binding to the receptor. But if the Court decided that the only activity of Enbrel had to be inside the cell, then that would be a difficulty, I agree. But, please, do understand that I am not rendering a definitive claims construction conclusion here.
Q. I understand that you’re not providing any opinions regarding claim construction. I am just trying to ask you to take these proposed claim constructions and confirm for me that if the claims require taking action inside the cell to reduce NF-kappaB activity, you agree with me that a patient taking Enbrel doesn’t do that; right?
A. I think that we’ve discussed that my understanding is Enbrel works outside the cell.
Q. Okay. So there would be no infringement in that situation?
A. Well, I can’t think how there would be.38
The evidence demonstrates that the use of Enbrel does not satisfy the limitation “reducing NF-kB activity in [the] cells,” as the court has construed that term because Enbrel’s action occurs extracellularly rather than intracellularly. Therefore, neither independent claims 6 and 18 of the '516 patent, nor the remaining asserted claims that depend therefrom, are directly infringed by the use of Enbrel.
CONCLUSION
For the reasons stated above:
It is ORDERED AND ADJUDGED that the Amgen Entities’ Motion for Summary Judgment of Noninfringement of U.S. Patent No. 6,410,516 (D.I.587) is GRANTED.
. Fed.R.Civ.P. 56(c).
. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
. Id. at 323, 106 S.Ct. 2548.
. Id.
. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
. Celotex, 477 U.S. at 323, 106 S.Ct. 2548.
. Id.
. Id. at 325, 106 S.Ct. 2548.
. Fed.R.Civ.P. 56(c).
. Yeager’s Fuel v. Pennsylvania Power & Light Co., 22 F.3d 1260, 1273 (3d Cir. 1994).
. Anderson, 477 U.S. at 248, 106 S.Ct. 2505.
. Id. at 249, 106 S.Ct. 2505.
. Id.
. Id. at 250, 106 S.Ct. 2505.
. Barmag Barmer Maschinenfabrik AG v. Murata Mach. Ltd., 731 F.2d 831 (Fed.Cir. 1984).
. Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed.Cir. 2000); LP Matthews LLC v. Bath & Body Works, Inc., 458 F. Supp 2d 189, 193 (D.Del. 2006).
. Centricut, LLC v. Esab Group, Inc., 390 F.3d 1361, 1367 (Fed.Cir. 2004).
. Markman v. Westview Instruments, Inc., 52 F.3d 967, 970-71 (Fed.Cir. 1995) (en banc).
. Id. at 976.
. Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17, 29, 40, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997).
. Id.
. Fuji Photo Film Co., Ltd. v. Jazz Photo Corp., 394 F.3d 1368, 1377 (Fed.Cir. 2005); Insituform Techs., Inc. v. CAT Contracting, Inc., 385 F.3d 1360, 1378 (Fed.Cir. 2004).
. Metro-Goldwyn-Mayer Studios v. Grokster, Ltd., 545 U.S. 913, 125 S.Ct 2764, 162 L.Ed.2d 781 (2005).
. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed.Cir. 1990).
. Fuji Photo Film Co., Ltd. v. Jazz Photo Corp., 394 F.3d 1368, 1379 (Fed.Cir. 2005) (citing Allen Organ Co. v. Kimball Intl., Inc., 839 F.2d 1556, 1567 (Fed.Cir. 1988)).
. 35 U.S.C. § 271(c).
. DSU Medical Corp. v. JMS Co., Ltd., 471 F.3d 1293, 1303 (Fed.Cir. 2006); Golden Blount, Inc. v. Robert H. Peterson Co., 365 F.3d 1054, 1061 (Fed.Cir. 2004).
. ARIAD acknowledges that “available evidence indicates that Enbrel acts extracellularly"
. Claim 6: A method for diminishing induced NF-KB-mediated intracellular signaling comprising reducing NF-kB activity in cells such that NF-KB-mediated intracellular signaling is diminished, (emphasis added).
Claim 70: The method of claim 6, carried out on mammalian cells.
Claim 71: The method of claim 6, carried out on human cells.
Claim 72: The method of claim 70 or 71, carried out on immune cells.
Claim 18: A method for reducing Interleukin-1 or Tumor Necrosis Factor-a activity in mammalian cells comprising reducing NF-kB activity in the cells so as to reduce intracellular signaling caused by Interleukin-1 or Tumor Necrosis Factor-a in the cells, (emphasis added).
Claim 183: The method of claim 18, carried out on human cells.
Claim 184: The method of claim 18 or 183, carried out on immune cells.
. The court also construed “NF-kB activity” to mean: "the ability of NFkB to act as an intracellular messenger by being released from IkB; translocating into the nucleus; and regulating the transcription of particular genes by binding to specific DNA recognition sequences in those genes,” i.e., activities that occur inside a cell.
. The section of ARIAD's brief in opposition to Amgen's motion addressing Amgen's first argument is restricted to disputing that this claim element is limited to intracellular methods of reducing NF-kB activity and that “Amgen admits that whether it is entitled to summary judgment on this ground is entirely contingent upon a ruling from this Court adopting the constructions of the asserted claims that Amgen has proposed.”
. D.I. 639, Ex. 25, ¶¶ 24-25 (Expert Report of Jeffrey V. Ravetch, M.D., Ph. D.).
. D.I. 639, Ex. 25, ¶ 27; D.I. 590, Ex. A at 16 (Declaration of Alisa Erika Koch, M.D.). Cytokines are soluble proteins cells released into intercellular fluid that act to signal or communicate with target cells and may interact with receptors on a target cell's surface causing certain events to then occur inside the cell.
. D.I. 639, Ex. 25, ¶¶ 27, 31; D.I. 590, Ex. A at 16-17.
. D.I. 590, Ex. A at 31; D.I. 589, Ex. B at 223:13-17 (Caíame Dep.) ("Q. [T]he way En-brel works is to prevent this inducing stimuli, TNF-alpha from inducing intracellular signaling inside the cell via the NF-kappaB pathway? A. That is my understanding”).
. D.I. 589, Ex. B at 144:5-13.
. D.I. 589, Ex. B at 146:3-21. Caíame also testified that Enbrel does not directly interact with NFkB: "Q. We agree that Enbrel does not directly interact with NF-kappaB in any way; correct? A. Molecularly, of course we agree on that.” D.I. 589, Ex. B at 241:7-10.
. D.I. 589, Ex. B at 271:3-272:25.
. Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1211 (Fed.Cir. 1998) (In order to prevail on a claim of literal infringement, “the patentee must show that the accused products contain every limitation in the asserted claims. If even one limitation is missing or not met as claimed, there is no literal infringement.”) (citations omitted); Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed.Cir. 1989) (“It is axiomatic that dependent claims cannot be found infringed unless the claims from which they depend have been found to have been infringed. ...”).
.Joy Technologies, Inc. v. Flakt, Inc., 6 F.3d 770, 774 (Fed.Cir. 1993) (“Liability for either active inducement of infringement or for contributory infringement is dependent upon the existence of direct infringement.”).
. During her deposition, Caíame was asked "Now, you have not offered any opinions in this case under what’s called the Doctrine of Equivalents]; is that correct?” Caíame answered "I don't even know what that its.” D.I. 589, Ex. B at 273:2-5. After further colloquy, Counsel for ARIAD stated that "I will stipulate that we're asserting only the direct contributory inducement infringement theories that are addressed in her report.” Id., Ex. B at 274:10-13.
. In light of this determination, it is unnecessary for the court to address the parties' arguments concerning Amgen’s alternative bases for its motion.
Reference
- Full Case Name
- AMGEN, INC., Immunex Corporation, Amgen USA Inc., Amgen Manufacturing Limited, and Immunex Rhode Island Corporation v. ARIAD PHARMACEUTICALS, INC., and The Whitehead Institute for Biomedical Research, Defendants Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, The President and Fellows of Harvard College, and The Whitehead Institute for Biomedical Research, Counterclaim v. Amgen Inc., Immunex Corporation, Amgen USA Inc., Amgen Manufacturing Limited, Immunex Rhode Island Corporation, and Wyeth, Counterclaim
- Status
- Published