Corning Inc. v. Sru Biosystems

Decision Date15 November 2005
Docket NumberNo. CIV.A. 03-633-JJF.,CIV.A. 03-633-JJF.
Citation400 F.Supp.2d 653
PartiesCORNING INCORPORATED, et al., Plaintiffs, v. SRU BIOSYSTEMS, et al., Defendants.
CourtU.S. District Court — District of Delaware

Richard L. Horwitz, David E. Moore, of Potter Anderson & Corroon LLP, Wilmington, DE, Foley & Lardner, Washington, DC (Kenneth E. Krosin, Andrew E. Rawlins, Larry L. Shatzer, and George C. Best, of counsel), for Plaintiffs.

Steven J. Balick, John G. Day, of Ashby & Geddes, Wilmington, DE, McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL (John J. McDonnell, Daniel A. Boehnen, Matthew J. Sampson, Richard A. Machonkin, Patrick G. Gattari, of counsel), for Defendants.

MEMORANDUM OPINION

FARNAN, District Judge.

This action was brought by Corning Incorporated and Artificial Sensing Instruments ASI AG (collectively "Corning") against SRU Biosystems, LLC, SRU Biosystems, Inc. and SRU Biosystems Holdings, LLC (collectively, "SRU") for infringement of U.S. Patent No. 4,815,843 (the "'843 patent"). Corning contends that SRU directly infringed and induced infringement of the '843 patent. SRU denies infringement and has filed counter-claims for declaratory judgment that the '843 patent is not infringed and is invalid for lack of a written description and obviousness, and unenforceable as a result of inequitable conduct. SRU also contends that it is entitled to attorneys' fees, because this case is an "exceptional case" under 35 U.S.C. § 285.

The Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331 and 1338, because this action arises under the patent laws of the United States. In addition, the Court has subject matter jurisdiction over SRU's counter-claims pursuant to 28 U.S.C. §§ 1338, 2201 and 2202, because SRU seeks declaratory judgment with regard to claims arising under the patent laws of the United States.

The Court conducted a five-day bench trial on the claims, counterclaims and defenses raised by the parties. This Memorandum Opinion constitutes the Court's Findings of Fact and Conclusions of Law on the issues tried before the Court.

BACKGROUND
I. Procedural Background

On July 10, 2003, Corning filed this action alleging direct, induced, and contributory infringement of claims 1, 2, 23, 24, 25, and 30 of the '843 patent and seeking monetary damages. On August 29, 2003, SRU answered the Complaint and filed counterclaims for breach of contract, trade secret misappropriation, tortious interference with advantageous relationship, and declaratory judgments of noninfringement and invalidity of the '843 patent and U.S. Patent No. 5,071,248 (the "'248 patent"). On June 14, 2004, SRU requested leave to amend its Answer to add an affirmative defense and counterclaim asserting inequitable conduct. The Court granted SRU's motion for leave to amend its answer. (D.I.237).

On September 14, 2004, the Court entered a Stipulated Order dismissing with prejudice SRU's breach of contract, trade secret misappropriation, and tortious interference counterclaims (D.I.197). On November 5, 2004, the Court entered an Order granting SRU's Motion For Summary Judgment regarding claims 23, 24, 25, and 30 of the '843 patent. (D.I.234). On November 16, 2004, the Court entered a Stipulated Order dismissing SRU's counterclaims on the '248 patent. (D.I.256). As a result, the only remaining issues to be resolved by the Court are the issues of infringement, validity, and enforceability of claims 1 and 2 of the '843 patent. Further, Plaintiffs no longer seek monetary damages, but only injunctive relief. (D.I.236).

II. Factual Background
A. The Parties

Plaintiff Artificial Sensing Instruments ASI AG ("ASI") is a corporation organized and existing under the laws of Switzerland, with offices in Zurich, Switzerland. ASI is the owner, by assignment from the inventors, of the '843 patent. Plaintiff Corning Incorporated is a New York corporation with offices in Corning, NY. Corning Incorporated is the exclusive licensee of the '843 patent throughout the United States.

Defendant SRU Biosystems, LLC and Defendant SRU Biosystems Holdings, LLC are Delaware limited liability companies with offices in Woburn, Massachusetts. Defendant SRU Biosystems, Inc., is the successor in interest to these limited liability companies, and all three entities have conducted their business under the name "SRU Biosystems."

B. The Technology Generally

This action arises in connection with technology used in the pharmaceutical industry for identifying chemical compounds which may be useful drugs. Drugs work in the body by binding to certain target molecules to affect the function and operation of that molecule. A molecule that binds to another molecule is referred to as a ligand. A ligand and its target molecule are shaped complementary such that they fit together like a hand in a glove. Tr. 52-107. In a healthy person, a naturally occurring ligand in the environment binds to a target molecule to produce a normal physiological response. For example, a pollen ligand binds to a histamine receptor to cause an immune response. In a person suffering from a disease, a ligand similarly binds to a target molecule, but the target molecule transmits an excessive signal, causing an abnormal physiological response. Id.

In the drug discovery process, pharmaceutical companies look for drugs that will bind with the malfunctioning target molecules. Such binding can block the natural ligand from binding and thus prevent the abnormal physiological response. Id. Pharmaceutical companies keep libraries of up to 2 million different drug compounds. Thus, efficient drug discovery requires that each drug be tested quickly. Tr. at 61:12-15.

To identify which compounds might solve a particular problem, companies use a process called high-throughput screening ("HTS") to screen large numbers of compounds against a particular target molecule. Tr. at 96:20-23. Until recently, pharmaceutical companies used only one form of HTS, a process called label dependent detection. Such detection uses radioactive or fluorescent labels to observe binding. First, researchers attach labels to the ligands. Next, the researchers attach the labeled ligands to the target molecules. The drug candidate is then introduced. If a positive reaction occurs, the labeled ligand is knocked off the target and replaced by the drug candidate. Binding is detected by determining whether the label is still present in the sample after the drug candidate is introduced. Tr. at 68:10-17, 69:13-19. Problems associated with label dependent technology include health and safety concerns from the use of radioactive labels, difficulty attaching fluorescent tags to natural ligands, and difficulty reading fluorescent tags accurately because many compounds fluoresce at the same wavelength as the tags. Tr. 67:19-68:9.

The technology at issue in this case utilizes a newer form of HTS called label independent detection ("LID"). LID can detect binding without preparing and attaching labels, and thus, LID requires fewer steps and takes less time. Tr. at 77:16-79:13, 69:24-70:10. LID technology also overcomes the problems associated with using radioactive or fluorescent material as tags. LID utilizes optics to determine whether binding has occurred. A light sensor measures a structure's refractive index, a physical property that affects the speed of light. By measuring the refractive index before and after the introduction of a drug candidate, the sensor can determine whether binding has occurred.

C. The '843 Patent

The '843 patent was issued on March 28, 1989. In relevant part, it claims:

1. An optical sensor for detecting chemical, biochemical or biological substances in a sample, comprising:

a waveguiding structure formed by a waveguiding film covering a substrate, wherein the waveguiding film has a refractive index at least 1% higher than the refractive index of the substrate;

a diffraction grating contained in the waveguiding structure; and

a chemo-responsive layer covering the waveguiding film in a region around the diffraction grating, wherein said chemo-responsive layer is capable of binding with the substances to be assayed and has a thickness of less than one wavelength.

2. An optical sensor according to claim 1, wherein the waveguiding structure outside the region around the diffraction grating is covered by a protective layer.

The parties disputed six terms used in the claims of the '843 patent. The Court has construed those terms as follows:

a) "Waveguiding structure" is used interchangeably with "waveguide" and is defined as: "A structure formed by a waveguiding film and a substrate and containing a diffraction grating";

b) "Waveguide film" means: "A film which, in combination with a sample having a lower index of refraction and a substrate can guide light along a path";

c) "Diffraction grating" means: "Any arrangement in the waveguiding structure that imposes a periodic variation of amplitude and/or phase on an incident wave";

d) "Wavelength" means: "A wavelength of light at which the optical sensor, including the waveguiding structure, waveguiding film, and diffraction grating, detects chemical, biochemical or biological substances in the sample";

e) "Effective index" means: "A number that relates the propagation velocity of light guided in a waveguide to the speed of light in a vacuum";

f) "Measuring the effective index and effective index change" means: "determining the effective index" and "determining the effective index change."

(D.I.156).

DISCUSSION
I. Infringement Of The '843 Patent
A. Applicable Law

A patent is infringed when a person "without authority makes, uses or sells any patented invention, within the United States during the term of the patent ...." 35 U.S.C. § 271(a). Determining infringement requires a two step inquiry. Step one requires a court to construe the disputed terms of the patent at issue. Step two requires a court to compare the accused...

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