Bausch & Lomb Inc. v. Alcon Laboratories, Inc.

• Decision Date: 16 September 1999
• Docket Number: No. 94-CV-6534L.,94-CV-6534L.
• Citation: 64 F.Supp.2d 233
• Court: U.S. District Court — Western District of New York
• Parties: BAUSCH & LOMB INCORPORATED, Plaintiff, v. ALCON LABORATORIES, INC., Defendant.

64 F.Supp.2d 233

BAUSCH & LOMB INCORPORATED, Plaintiff, v. ALCON LABORATORIES, INC., Defendant.

No. 94-CV-6534L.

United States District Court, W.D. New York.

September 16, 1999.

Michael Wolford, Wolford & Leclair LLP, Denis A. Polyn, Jill K. Schultz, Bausch & Lomb, Incorporated, Rochester, NY, Robert L. Baechtold, Scott K. Reed, Dominick A. Conde, Gregory B. Sephton, Daniel R. Cahoy, Fitzpatrick, Cella, Harper & Scinto, New York City, for Bausch & Lomb Incorporated, Plaintiff.

William L. Dorr, Harris, Beach & Wilcox, Rochester, NY, W. Edward Bailey, Kevin J. Culligan, A. Peter Adler, Fish & Neave, New York City, for Alcon Laboratories, Inc., Defendant.

DECISION AND ORDER

LARIMER, Chief Judge.

INTRODUCTION

Plaintiff, Bausch & Lomb Incorporated ("B & L"), commenced this action under 35 U.S.C. § 281, alleging that defendant, Alcon Laboratories, Inc. ("Alcon"), has infringed on United States Patent No. 5,096,607 ("the '607 patent"). The '607 patent claims an invention in a process for simultaneously cleaning and disinfecting contact lenses using a single solution, as opposed to using two separate steps, first to clean the lenses and then to disinfect them.

Several motions are pending before the court. Alcon has filed a motion for summary judgment of indefiniteness, which seeks an order declaring the '607 patent invalid for indefiniteness under 35 U.S.C. § 112. B & L has filed a motion for summary judgment on Alcon's first and second counterclaims, which are respectively based on theories of misappropriation of trade secrets and unfair competition under New York law, and a motion for summary judgment on Alcon's fourth counterclaim, which is based on a constructive-trust theory.

BACKGROUND

The '607 patent is directed to a method for simultaneously cleaning and disinfecting lenses. Prior to the development of such methods and systems, lens wearers had to clean and disinfect their lenses using two separate steps: first an enzymatic cleaning in which the lenses were soaked in a solution to remove protein deposits, followed by disinfection using either heat or a chemical solution. Although a user could have attempted to combine these steps by dissolving an enzymatic cleaning tablet in disinfecting solution, this would not have been very satisfactory, in part because the cleaning enzymes would have tended to reduce the effectiveness of the disinfecting solution, allowing a high level of microbes to remain living on the lens surface.

The patent states that its method for simultaneously cleaning and disinfecting contact lenses "does not substantially inhibit the activity of the antimicrobial agent." Defendant's Motion for Summary Judgment of Indefiniteness Ex. 1. In other words, the presence of the cleaning enzymes does not "substantially inhibit" the effectiveness of the disinfectant. The patent does not, however, define the phrase "substantially inhibit." Alcon maintains that absent some objective, quantifiable parameters by which to determine how effective the disinfectant powers of the solution are, the phrase "substantially inhibit" renders the '607 patent void for indefiniteness. Alcon alleges that B & L deliberately used vague language so that it could avoid prior art yet still bring its competitors' products within the scope of the patent.

B & L contends that the claims are sufficiently definite. According to B & L and its expert, Dr. Barbara Iglewski, those skilled in the art would have understood that a difference of greater than one log order¹ in performance when the cleaning enzyme is added to the disinfecting solution, as compared to the antimicrobial activity of the solution without the enzyme present, would constitute a substantial inhibition.

DISCUSSION

I. Alcon's Motion for Summary Judgment of Indefiniteness

A. General Standards

Paragraph 2 of 35 U.S.C. § 112 states that "[t]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention." Where the claims do not "have a clear and definite meaning when construed in the light of the complete patent document," the patent may be rendered invalid. Miles Labs., Inc. v. Shandon Inc., 997 F.2d 870, 874-75 (Fed Cir.1993), cert. denied, 510 U.S. 1100, 114 S.Ct. 943, 127 L.Ed.2d 232 (1994).

The purpose of the definiteness requirement is twofold. First, a claim that clearly points out and distinctly claims an invention, alerts the public to what the patentee has claimed, so that potential infringers will be on notice of what may constitute infringement. Second, such a claim "makes clear any distinction that is supposed to exist between the patent and the prior art—i.e., it explains why the invention is novel." Aluminum Co. of America v. Reynolds Metals Co., No. 88 C 6019, 1989 WL 165064 *4 (N.D.Ill.Dec. 21, 1989). See also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236, 63 S.Ct. 165, 87 L.Ed. 232 (1942); In re Vamco Mach. and Tool Inc., 752 F.2d 1564, 1577 n. 5 (Fed.Cir.1985).

"A decision as to whether a claim is invalid under [§ 112 ¶ 2] requires a determination whether those skilled in the art would understand what is claimed." Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1217 (Fed.Cir.1991) (citing Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624 (Fed.Cir.1985) (claims must "reasonably apprise those skilled in the art" as to their scope and be "as precise as the subject matter permits"), cert. denied, 474 U.S. 976, 106 S.Ct. 340, 88 L.Ed.2d 326 (1985)), cert. denied, 502 U.S. 856, 112 S.Ct. 169, 116 L.Ed.2d 132 (1991). The degree of precision with which the claims must be stated to meet the definiteness requirement "is a function of the nature of the subject matter." Miles Labs., 997 F.2d at 875. Thus, "[t]he amount of detail required to be included in claims depends on the particular invention and prior art, and is not to be viewed in the abstract ...," but in conjunction with the specifications of the patent. Shatterproof Glass, 758 F.2d at 624. Accordingly, "[t]hat some claim language may not be precise ... does not automatically render a claim invalid. When a word of degree is used the district court must determine whether the patent's specification provides some standard for measuring that degree," such that a person of ordinary skill in the art would understand what is claimed. Seattle Box Co. v. Industrial Crating & Packing, Inc., 731 F.2d 818, 826 (Fed.Cir. 1984). In addition, "[m]athematical precision should not be imposed for its own sake; a patentee has the right to claim the invention in terms that would be understood by persons of skill in the field of the invention." Modine Mfg. Co. v. United States Int'l Trade Comm'n, 75 F.3d 1545, 1557 (Fed.Cir.), cert. denied, 518 U.S. 1005, 116 S.Ct. 2523, 135 L.Ed.2d 1048 (1996).

Under 35 U.S.C. § 282 (1988), a patent is presumed valid, and a party seeking to overcome that presumption has the burden of proving the invalidity of the patent by clear and convincing evidence. See Al-Site Corp. v. VSI Int'l, Inc., 174 F.3d 1308, 1323 (Fed.Cir.1999); Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 881 (Fed.Cir.1998). In determining a motion for summary judgment of indefiniteness, therefore, the court must remain cognizant both of the presumption of validity, and of the heightened standard required of the movant. Id.; National Presto Indus., Inc. v. West Bend Co., 76 F.3d 1185, 1189 (Fed.Cir. 1996).

B. Alcon's Evidence

On the record before me, I find that Alcon has failed to carry its burden of establishing that there are no issues of material fact, and that it is entitled to judgment as a matter of law. Alcon's motion for summary judgment of indefiniteness is therefore denied.

In support of its motion, Alcon has not presented any expert testimony of its own. Instead, Alcon relies almost entirely on alleged contradictions and inconsistencies in the testimony and other statements of B & L's expert, Dr. Iglewski. Dr. Iglewski testified concerning the meaning of the claims in certain proceedings that took place in the United States Patent and Trademark Office ("PTO"). The first of these was a reexamination proceeding that was initiated in December 1995 by Allergan, Inc., another manufacturer of contact lens-related products. On May 24, 1996, the PTO issued an Office Action rejecting the claims of the '607 patent as unpatentable in view of prior art references. Although the patent examiner was precluded from deciding issues of definiteness in that proceeding, see 37 C.F.R. § 1.552(c), he did indicate that he had some difficulty in determining the meaning of "does not substantially inhibit." After stating that "this broad concept requires that the activity of the antimicrobial agent (i.e., disinfectant) in the combined composition not be `substantially' inhibited as compared to the same composition in the absence of the enzyme cleaner," he added that "[w]hether a 10%, 50%, 90%, 99% or 99.9% reduction in antimicrobial activity would be considered `substantial' in the claimed methods cannot be determined by this Examiner based on the present record." Defendant's Motion for Summary Judgment of Indefiniteness ("MSJI") Ex. 4-A at 4. However, the patent examiner further stated that based on standards set forth by the Food and Drug Administration ("FDA"),

if the inclusion of the recited enzyme cleaning component caused a 2 or 3 log reduction in antimicrobial efficiency, ... FDA approval could still be possible to obtain. Accordingly, for purposes of these proceedings, a log reduction of 2 or 3 or even more will not be considered to be `significant' unless the claims are amended to define "significant" to mean when the activity reduction is more than some specific numerical value under recited test conditions ....

Id. at 5.

As stated, the patent examiner then went on to find that the claims of the '607 patent were unpatentable due to prior art. B...