Wesley Jessen Corp. v. Bausch & Lomb, Inc.

Citation209 F.Supp.2d 348
Decision Date26 June 2002
Docket NumberNo. CIV.A. 01-294-RRM.,CIV.A. 01-294-RRM.
PartiesWESLEY JESSEN CORPORATION, Plaintiff, v. BAUSCH & LOMB, INC., Defendant.
CourtU.S. District Court — District of Delaware

Andre G. Bouchard, Karen L. Pascale, Bouchard, Margules & Friedlander, Wilmington, Delaware; Raphael V. Lupo, Charles R. Work, Kenneth L. Cage, Thomas P. Steindler, Daniel Bucca, McDermott, Will & Emery, Washington, D.C.; counsel for Wesley Jessen Corporation.

Jack B. Blumenfeld, Morris, Nichols, Arsht & Tunnell, Wilmington, Delaware; Edward W. Remus, Priscilla F. Gallagher, Alejandro Menchaca, Troy A. Groetken, McAndrews, Held & Malloy, Ltd., Chicago, Illinois; counsel for Bausch & Lomb, Inc.

OPINION

MCKELVIE, District Judge.

This is a patent case. Plaintiff Wesley Jessen Corporation is a Delaware corporation, with its principal place of business in Des Plaines, Illinois. Wesley Jessen is the owner of U.S. Patent No. 4,711,943 (the '943 patent), which relates to a monomer for making contact lenses and contact lens materials.

Defendant Bausch & Lomb, Inc. is a New York corporation with its principal place of business in Rochester, New York. Bausch & Lomb manufactures and sells an extended wear contact lens under the trade name PureVision.

By a complaint filed on May 3, 2001, Wesley Jessen alleges that by manufacturing and selling its PureVision line of contact lenses Bausch & Lomb is wilfully infringing ten claims of the '943 patent. Bausch & Lomb answered the complaint by denying infringement, asserting certain affirmative defenses and counterclaiming for a declaratory judgment it does not infringe and that the asserted claims are invalid and unenforceable.

Pursuant to an agreement between the parties, this case was tried to the court, beginning on May 29, 2002. During the trial, Wesley Jessen presented evidence and argument in support of its contention Bausch & Lomb infringed certain claims of the patent either literally or under the doctrine of equivalents, and as a remedy sought injunctive relief and an award of fees and costs based on Bausch & Lomb's alleged willful conduct. Bausch & Lomb responded by presenting evidence and argument in support of its contention that it does not infringe the claims of the patent, either literally or under the doctrine of equivalents, and that the claims of the patent are invalid as anticipated by U.S. Patent No. 4,260,725 issued to Keogh, et al. (the '725 or Keogh patent), and as obvious in light of a number of patents, including Keogh and U.S. Patent Nos. 4,235,985 issued to Tanaka (the '985 or Tanaka patent). Bausch & Lomb also offered evidence and argument in support of its contention that the claims of the '943 patent are invalid for failure to disclose the best mode, for lack of enablement, for lack of utility, and for indefiniteness of the claims. Last, Bausch & Lomb offered evidence and argument in support of its contention the claims of patent should be unenforceable for the inventor's inequitable conduct in failing to disclose material information to the examiner during the prosecution of the patent. Wesley Jessen responded to each of these defenses. The parties completed presenting evidence on June 3, 2002 and submitted closing arguments the following day.

This is the court's post trial opinion.

I. FACTUAL AND PROCEDURAL BACKGROUND

The court draws the following facts from the pretrial order and from the evidence presented at trial, including the evidence presented during the April 5, 2002 claim construction hearing.

A. The Field of the Invention and the '943 Patent

The application that led to the '943 patent was filed in 1985 and relates to contact lens materials and contact lenses fabricated therefrom that have a combination of properties not achieved prior to the invention. The '943 patent addressed problems experienced in the contact lens industry in the early eighties that related to developing a comfortable contact lens that could be worn for longer periods of time.

As noted in the background section of the '943 patent, the contact lens market in the early 1980s consisted of three basic types of contact lenses: (1) rigid, non-gas permeable lenses, (2) soft hydrogels, and (3) rigid, gas-permeable lenses. As detailed below, each of these contact lenses had certain deficiencies that made them generally unsuitable for extended wear use. Lenses suitable for extended wear must be optically transparent, possess chemical and thermal stability, be wettable to tears, permeable to oxygen, and be comfortable, durable, and easy to handle.

The first contact lenses developed as a substitute for eyeglasses were rigid and non-gas permeable lenses, which were made from materials such as polymethyl methacrylate (PMMA or polyMMA). Rigid PMMA lenses have acceptable surface wettability when used in conjunction with wetting solutions, and excellent durability, but lack sufficient oxygen permeability for extended wear. Because there is a lack of blood vessels within the cornea, the cornea must obtain oxygen directly from the atmosphere. If a contact lens does not have sufficient oxygen permeability, placing it over the cornea will result in corneal swelling and discomfort. Although the PMMA lenses blocked the natural flow of oxygen to the cornea, sufficient oxygen would usually be transported to the wearer's cornea by tear film generated between the lens and the cornea through normal blinking. Oxygen deprivation was a problem, however, when the wearer was asleep and, therefore, not blinking.

In the late 1970's and early 1980's, people in the content lens industry began to develop extended wear contact lenses from soft hydrogel materials, such as poly (2-hydroxyethyl)methacrylate (HEMA). These lenses improved oxygen permeability by significantly increasing the water content of the materials. They also possessed excellent wetting characteristics, which made them very comfortable to wear. However, the high water content caused the lenses to soften, drape, and sag in a way that good optical resolution was difficult, and they tended to tear when handled and were subject to increased protein deposits on the lenses.

People in the industry also sought to develop rigid, gas-permeable lenses made primarily with siloxane-containing components. These lenses were not a commercial success. They would dry and irritate the eye, as the siloxane materials tended to be hydrophobic, which meant water would bead on the lens rather than form a film on its surface.

Thomas B. Harvey, III filed an application with the United States Patent and Trademark Office ("PTO") on April 26, 1985, entitled "Hydrophilic Siloxane Monomers1 and Dimers for Contact Lens Materials and Contact Lenses Fabricated Therefrom." Harvey sought to combine the desirable properties of the three aforementioned types of lens materials into one contact lens material that had the dimensional stability of rigid non-gas-permeable lenses, the comfort of silicone hydrogels, and the oxygen permeability of gas-permeable lenses. In his patent application, Harvey reviewed the history of developments relating to contact lenses and limitations that were restricting the uses of extended wear lenses. This history demonstrated that attaining a combination of desirable properties in a single material had been particularly problematic since the addition of one component to improve a desirable property, such as adding a siloxane to improve oxygen permeability, had tended to adversely affect other desirable properties, such as wearer comfort.

The invention of the '943 patent sought to solve these problems by teaching the making of siloxane-containing hydrogel monomer for making contact lenses having both improved oxygen permeability and dimensional stability. Harvey described his invention as including the use of a monomer that combined a hydrophilic group and a siloxane into a single monomer to form a strong, highly oxygen-permeable silicone hydrogel material that did not depend solely on water content for its oxygen permeability. The hydrophilic group could be an amid or a carbamate. He reported that the invention made it possible to maintain high oxygen permeability without having the high water content of earlier extended wear lenses and the problems of physical deformation that normally accompanied high water content lenses. Harvey characterized his claimed contact lens materials as having a specified range of (i) water content, (ii) Oxygen permeability, (iii) tear strength, and (iv) percent elongation.

Harvey summarized the objects of the invention as follows:

An object of the present invention is to provide new and useful hydrophilic siloxane-containing monomers for making contact lenses.

Another object of the invention is to prepare hydrogels from the monomers of the foregoing type which have moderate water contents (about 15-60%), but high oxygen permeabilities [greater than about Dk 25 × 10-10 (Dk is measured in units of cm3 (O2) cm/cm2 sec. cm Hg)]. A further object of the invention is to provide a contact lens having improved wettability, characterized by a receding contact angle of less than that of contact lenses made of polyMMA.

Still another object of the invention is to provide a hydrophilic siloxane copolymer, suitable for the fabrication of extended wear contact lenses, and having the following characteristics:

(1) moderate water content [about 15-60%] (2) high oxygen permeability [Dk greater than about 25×10-10];

(3) tear strength greater than about 1.0 g/mm2;

(4) percent elongation greater than or equal to about 80%;

(5) wettable; and

(6) minimal protein deposit formation.

'943 patent, col. 3, l. 49 — col. 4, 1. 8.

B. Prosecution History of the '943 Patent

The '943 patent was originally filed as Application Serial No. 06/727,501 on April...

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