Biacore v. Thermo Bioanalysis Corp.

• Decision Date: 30 December 1999
• Docket Number: No. CIV.A.97-274 SLR.,CIV.A.97-274 SLR.
• Citation: 79 F.Supp.2d 422
• Parties: BIACORE, AB, and Biacore, Inc., Plaintiffs, v. THERMO BIOANALYSIS CORP., Defendant.
• Court: U.S. District Court — District of Delaware

79 F.Supp.2d 422

BIACORE, AB, and Biacore, Inc., Plaintiffs, v. THERMO BIOANALYSIS CORP., Defendant.

No. CIV.A.97-274 SLR.

United States District Court, D. Delaware.

December 30, 1999.

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Edward M. McNally, and Richard D. Kirk of Morris, James, Hitchens & Williams, Wilmington, Delaware, for plaintiffs. Of Counsel: Marc R. Labgold of Long, Aldridge & Norman, Washington, D.C., and Arthur I. Neustadt, Jeffrey B. McIntrye, Ron Myers of Oblon, Spivak, McClelland, Maier & Neustadt, P.C., Arlington, Virginia.

Rudolph E. Hutz, N. Richard Powers, and Richard D. Levin of Connolly, Bove, Lodge & Hutz, Wilmington, Delaware, for defendant.

OPINION

ROBINSON, District Judge.

I. INTRODUCTION

Plaintiffs Biacore, AB and Biacore, Inc. (collectively "Biacore") filed this suit pursuant to 35 U.S.C. § 271 against defendant Thermo Bioanalysis Corporation ("Thermo") on May 29, 1997, seeking damages (lost profit damages) and an injunction for alleged infringement of a patent that is directed to a matrix coating suitable for use in a biosensor. (D.I.1) Specifically, Biacore charges that Thermo willfully infringed U.S. Patent No. 5,436,161 (the "'161 patent") entitled "Matrix Coating for Sensing Surfaces Capable of Selective Biomolecular Interactions, To Be Used in Biosensor Systems," issued July 25, 1995.¹ (D.I.1) Biacore also alleges that Thermo is inducing infringement of the patent-in-suit.

Thermo denies infringement and has counterclaimed for a declaratory judgment of invalidity and noninfringement of the '161 patent. Thermo challenges the validity of the '161 patent under 35 U.S.C. §§ 102 ("anticipation"), 103 ("obviousness"), and 112 ("written description"). Specifically, Thermo charges that: (1) the patented invention was described in a printed, prior art publication before its development by the patentee (§ 102); (2) the differences between the patented invention and the prior art are such that the claims would have been obvious to one of ordinary skill in the pertinent art (§ 103); and (3) the subject matter of the '161 patent is not disclosed in sufficient detail in the written description of the grandparent application (§ 112).²

The court has jurisdiction over this matter pursuant to 28 U.S.C. § 1338(a).

The parties tried this matter to the court from October 26, 1998 to November 2, 1998. Despite having identified in the pre-trial order claims 1-5, 9-11, and 15 as allegedly infringed by Thermo (D.I.96), "for purposes of trial" Biacore reduced the number of claims, asserting only claims 4 and 5. (D.I. 103 at 4) The following constitutes the court's findings of fact and conclusions of law pursuant to Fed.R.Civ.P. 52(a).

II. FINDINGS OF FACT

A. The Parties

1. Biacore, AB is a Swedish corporation with its principal place of business in Uppsala, Sweden. (D.I. 103 at 80; D.I. 1, ¶ 2) Prior to October 1996, Biacore, AB was a subsidiary of the Swedish company Pharmacia AB, operating under the name Pharmacia Biosensor, AB. (D.I. 103 at 78-79) In 1996, Pharmacia AB merged with UpJohn Pharmaceuticals and Biacore, AB was spun off. (D.I. 103 at 78-79) Biacore, AB's business is totally dedicated to the development, manufacturing, and marketing of affinity biosensors. (D.I. 103 at 80) Since 1990, it has sold its optical biosensor systems in the United States under the trade name BIAcore™. Biacore, AB is the owner of the '161 patent. (D.I. 96 at 2)

2. Biacore, Inc. is a Delaware corporation with its principal place of business in Piscataway, New Jersey. (D.I.1, ¶ 2) It is the U.S. subsidiary of Biacore, AB and is responsible for the marketing and selling of BIAcore™ optical biosensors in the United States. (D.I. 103 at 79) The BIAcore™ biosensors sold by Biacore, Inc. are manufactured in Biacore, AB's facilities in Uppsala, Sweden. (D.I. 103 at 80)

3. Thermo is a Delaware corporation with its principal place of business in Santa Fe, New Mexico.³ (D.I.1, ¶ 3) Since 1994, Thermo has marketed and sold its optical biosensor systems in the United States under the trade name IAsys™ through its Affinity Sensors⁴ division. (D.I. 105 at 413-14)

B. The Field of the Invention

4. Biosensors. The subject matter of the '161 patent relates to "the field of biosensors." (Plaintiffs' Exhibit ("PX") 1, col. 1, lns. 15-16) A biosensor is

an analytical device comprising a biological or biologically derived sensing element which is either intimately associated with or integrated within a physical chemical transducer where the transducer may be, for example, optical, electrochemical, piezoelectric, thermoelectric or magnetic.

(D.I. 104 at 266) Generally,

[t]he usual aim [of a biosensor] is to produce a digital electronic signal which is proportional to the concentration of a specific chemical or set of chemicals.

(Defendant's Exhibit ("DX") 574 at 3) Biosensors are employed in biomolecular interaction analysis, i.e., the study and characterization of the interactions between biologically active molecules. (D.I. 103 at 74-75) For example, in the pharmaceutical industry, biosensors are used to study the binding of a novel drug to the targeted receptor. (D.I. 103 at 75) Biosensors also are employed in the fermentation and bioprocessing, petro- and agrochemical, and pollution industries. (DX 513 at 19-20)

5. A biosensor is composed of two essential elements: (1) a biorecognition system and (2) a transducer. (PX 1, col. 1, lns. 23-27; DX 513 at 20) In general, biosensors function by first immobilizing on a surface within the instrument ligands or receptors (e.g., whole cells, enzymes, lectins, antibodies, or receptor proteins) that are able to recognize target molecules (analytes⁵) over a host of other biomolecules. (D.I. 103 at 183; D.I. 104 at 219-20; DX 513 at 20) The bound ligands then are contacted with a solution or suspension containing analytes having specific recognition sites such that they will bind to the ligands. (D.I. 104 at 218-20) Generally speaking, the binding of an analyte to a ligand (i.e., the biological recognition event) results in a change in one or more parameters associated with the interaction. (DX 513 at 22) The transducer element of the biosensor functions to respond to the products of the biological recognition event,⁶ converting the physio-chemical signal into a signal (e.g., an electrical output) that can be either visualized or processed in some fashion, e.g., via a computer. (D.I. 104 at 267; DX 513 at 22)

6. Biosensors employ a number of different types of transduction technologies. These technologies include thermister, electrochemical, potentiometric, optical, piezoelectric crystal, and amperometric transduction. (DX 574 at 3-4; DX 960; D.I. 106 at 759-60) Particularly relevant to the case at bar, optical biosensors employ an optical transducer that "detect[s] the change which is caused in the optical properties of a surface layer due to the interaction of the receptor with the surrounding medium." (PX 1, col. 1, lns. 28-31; D.I. 104 at 267) One type of optical biosensor, an evanescent wave optical biosensor, exploits the energy that is propagated beyond a reflecting surface, i.e., the evanescent wave.⁷ These biosensors "bring[] about or effect[] changes in the reflecting light as a result of interacting with the evanescent field," i.e., by "taking advantage of the change in refractive index causing differences in the light signal." (D.I. 104 at 267-68)

7. One type of evanescent wave technology relies on the phenomenon of surface plasmon resonance ("SPR"). SPR "is a quantum optical-electrical phenomenon that arises from the interaction of light with a suitable metal or semiconductor surface." (D.I. 27, Ex. K at 516) Under certain conditions, the photon's energy is transferred to plasmons on the surface of the metal or semiconductor. (D.I. 27, Ex. K at 516) The wavelength that excites the plasmons, the resonance wavelength, can be calculated by measuring the amount of light reflected from the surface. (D.I. 27, Ex. K at 516) The resonance wavelength is determined by the interaction between the plasmon's electric field and the matter within the field; thus, any change in the composition of the matter alters the resonance wavelength. (D.I. 27, Ex. K at 516-17) The magnitude of the change in the resonance wavelength is directly proportional to the change in composition of the surface. (D.I. 27, Ex. K at 516-17) As a result, SPR can be "exploited as a direct optical sensing technique that allows the real-time measurement of interfacial refractive index (dielectric) changes ... made at suitable metal or dielectric surfaces ... without the use of labels or probes." (D.I. 27, Ex. K at 518) SPR optical biosensor technology, therefore, is a method whereby "changes in the refractive index in a layer close to a thin metal film are detected by consequential changes in the intensity of a reflected light beam." (PX 1, col. 1, Ins. 44-47) Biacore's biosensors employ SPR technology.

8. Another type of evanescent wave system technology employs "an integrated optical chip called the resonant mirror (RM)," which "comprises a glass prism with the top surface coated with a low refractive index silica spacer layer which is in turn coated with a thinner high refractive index monomode wave-guide of titania, hafnia or silicon nitride. This is then coated with the bioselective layer." (D.I. 27, Ex. K at 519) In operation, a laser light directed at the prism "is repeatedly swept through an arc of specific angles," generating, inter alia, an evanescent wave at the waveguide surface that penetrates into the sample. (D.I. 27, Ex. K at 519-20) "This wave detects surface binding events by detecting the changes in the refractive index which in turn change the resonance angle that is tracked by diode arrays." (D.I. 27, Ex. K at 520) Thermo's biosensors employ a resonant mirror.

9. Hydrogel. The '161 patent specifically discloses a matrix coating that is comprised of a hydrogel. A...