and Kawata. These conclusions can be summarized as follows: 1.) The '081 patent and Kawata use entirely different processes; 2.) the inventor of the '081 patent distinguished Kawata as an entirely different process; 3.) whereas the '081 patent requires a solubilizer, Kawata specifically teaches against the use of any component in Kawata (i.e. PEG 400) as a solubilizer; 4.) the inventor of the '081 patent distinguished Kawata on the ground that Kawata teaches against solubilizers; 5.) Kawata discloses both surfactants and co-solvents (i.e. PEG 400) as possibilities for the optional second component; and 6.) in distinguishing Kawata, the inventor of the '081 patent could not have waived co-solvents (thereby limiting the '081 patent to surfactants) because Kawata discloses both surfactants and co-solvents. See id. at 15-19.
Despite Judge Reed's comprehensive consideration of the Kawata disclaimer issue during claim construction, Defendant now, at the summary judgment stage, raises new arguments relating to Kawata and the prosecution history of the '081 patent.
B. Defendant's New Claim Construction Argument
Now, following Judge Reed's claim construction, in response to Plaintiff's motion for summary judgment, Defendant raises a new issue of claim interpretation, concerning the following phrase within claim 1 of the patent: "a solution or dispersion of an effective amount of the active compound in a semi-solid or liquid nonionic solubilizer." Defendant's new position is that the word "in" should be construed to mean "in and only in." Defendant's Memorandum in Opposition to Plaintiff's Motion for Summary Judgment ("Def.Brief") at 6. Defendant contends that, under the proper interpretation of "in," the patent is limited to a solution in which an effective amount of the active compound is dissolved in and only in the solubilizer, and in nothing else.*fn4
This is significant, Defendant claims, because in Defendant's formulations, the active compound felodipine is "intermixed" with not only PEG 400 (which may or may not function as a solubilizer), but also with one or more additional substances, such as ethanol (a volatile solvent) or polyvinyl pyrrolidone ("povidone" or "PVP"). Id. at 1. Defendant stresses that, in its formulations, the felodipine, the PEG 400, and various other components (i.e. ethanol and PVP) are all mixed together into a "homogenous composition," which is then dried. See id. at 7. Thus, Defendant argues, in its products the felodipine and the PEG 400 "are never intermingled in the absence of another component." Id. Under Defendant's suggested interpretation of the word "in," the '081 patent would cover only formulations in which an "effective amount" of the active compound is entirely dissolved or dispersed in the nonionic solubilizer alone.
Defendant highlights two statements made by the inventor in an amendment filed with the PTO. Defendant claims that these two statements prove the inventor limited its invention to a formulation in which the active compound is entirely dissolved in a solubilizer only, and not in any third substance. See Def. Brief at 6. Both of these statements were apparently made in attempting to distinguish the invention of the '081 patent from the prior art Kawata patent. As explained above, Kawata teaches a "first component" and an optional "second component;" the second component can be, as an example, PEG 400. Though PEG 400 can be used, generally, as a solubilizer, the Kawata patent specifically teaches that solubilizers should not be used. See supra Part III.A.3.
The first statement at issue was made in relation to a May 11, 1988 claim amendment, in response to an initial rejection by the PTO based, in part, on Kawata's prior art. See Def. Brief, Ex. F. The inventor sought to distinguish Kawata by demonstrating that Kawata does not even make use of solubilizers, at least not in any appreciable amount. See id. at 5, lns. 7-11, 19-21. The inventor pointed out, to the PTO, that Kawata teaches against using any "substance improving the solubility in the intestines." Id. (quoting Kawata, United States Patent 4,673,564 (col.3, lns.49-52)). Of course, the use of a solubilizer is a major element in the '081 patent. Thus, the inventor argued, Kawata "provides no guidance toward the present invention." See id., lns. 23-24.
The inventor also argued, in the alternative, that even if the second component in Kawata were used as a solubilizer, the active compound would be "principally" dissolved in the first component.
Only one component of [Kawata's] formulations could
be a "nonionic solubilizer" . . . i.e. Kawata's
optional 2nd component of the basic substance. Even
if the drug in Kawata's formulations can be said to
be dissolved or dispersed, however, it is not in the
2nd component alone, but principally in the required
1st component of the basic substance.
Id., Ex. F at 4-5. Defendant wishes to lift this remark out of context, to show that, in order to overcome Kawata, the '081 patent's inventor limited its coverage to solutions in which the active compound is dissolved entirely in the solubilizer, and not also in something else. More specifically, Defendant suggests that because Kawata describes a solution in which an active compound is mingled with several different components (including a volatile solvent), the '081 patent's inventor was compelled to disclaim any solution in which the active compound is not dissolved 100-percent in the solubilizer alone. This Court is satisfied that the inventor made no such disclaimer.
The inventor's remarks to the PTO were seemingly made in the context of distinguishing Kawata as an entirely different process, in that Kawata did not even utilize solubilizers. The inventor set forth an alternative argument that, even if Kawata used solubilizers, the active compound would not be "principally" in the solubilizer. All that the inventor conceded was that, if Kawata contains a solubilizer as its second component, the Kawata active compound is principally dissolved in the first component, not the solubilizer. That is entirely different from a wholesale disclaimer of all solutions in which the active compound is dissolved in both a solubilizer and another substance, such as a volatile solvent. Accordingly, the prosecution history excerpt relied upon by Defendant does not clearly establish that the inventor surrendered coverage "with reasonable clarity and deliberateness," with respect to solutions in which the active compound is not 100-percent dissolved in the solubilizer alone. Schumer, supra, 308 F.3d at 1313.
Defendant cites a second passage from the same claim amendment filed with the PTO, which Defendant claims establishes a disclaimer of "volatile solvents." In the amendment, the inventor asserted that "manufacture of the preparations of the invention does not involve the use of volatile solvents as does Hegasy [another prior art patent]." Def. Brief, Ex. F, at 8, lns. 16-17. This statement, on its face, demonstrates a limited disclaimer, only in that the '081 patent does not incorporate volatile solvents.
The disclaimer of volatile solvents is consistent with Plaintiff's position, throughout the prosecution and throughout this litigation, that the Kawata patent is distinguishable as an entirely different process from the '081 patent. Just as the inventor pointed out to the PTO that Kawata does not use solubilizers, the inventor also pointed out that Kawata utilizes volatile solvents, whereas the '081 patent does not. But the inventor never told the PTO that the '081 patent should exclude all preparations in which a volatile solvent is used at all.
Claim 1's express limitation, "in a semisolid or liquid nonionic solubilizer" applies to all solutions in which the active compound is dissolved or dispersed in a nonionic solubilizer. The specification and prosecution history do not suggest that a narrower interpretation should apply. Thus, an accused formulation will meet this claim element even though the alleged infringer has also added to the accused formulation some extra ingredients, such as PVP or a volatile solvent like ethanol. Cf. Mannesmann, supra, 793 F.2d at 1283 ("The presence of additional elements is irrelevant if all the claimed elements are present in the accused structure."); A.B. Dick Co. v. Burroughs Corp., 713 F.2d 700, 702 (Fed. Cir. 1983) ("It is fundamental that one cannot avoid infringement merely by adding elements if each element recited in the claims is found in the accused device.").
As noted above, courts interpret claim language with a "heavy presumption" in favor of the "ordinary meaning" of terms. Prima Tek, supra, 318 F.3d 1143, 1147-48. Defendant has failed to cite any case law justifying a conclusion that the preposition "in" is synonymous with the phrase "in and only in;" as every college student studying logic knows, they are not considered synonymous.
Defendant cites Key Pharmaceuticals v. Hercon Laboratories Corp., 161 F.3d 709 (Fed. Cir. 1998), in which the Federal Circuit construed the term "pharmaceutically effective amount." However, the Key Pharmaceuticals decision pertains to a patent for a transdermal adhesive patch, not an oral pharmaceutical formulation. After reviewing the facts and analysis in Key Pharmaceuticals, this Court is convinced that that case is totally inapposite to the question before this Court, i.e., whether the '081 patent, which is limited to an "effective amount" of the active compound "in" a solubilizer, can cover only solutions in which the active compound is totally dissolved in the solubilizer alone.
Likewise, Defendant relies on Hazani v. U.S. Intern. Trade Com'n, 126 F.3d 1473 (Fed. Cir. 1997), in which the court construed the phrase "integrally formed in":
Although the term "integrally formed in" is not
defined in the written description portion of the
specification, the word "integral" means "complete"
or "entire," and the word "in," as used in this
context, means "indicating a point or place thought
of as spatially surrounded or bounded." See Webster's
New International Dictionary 1253, 1290 (2d ed.
Hazani has not given us any reason to depart from the
ordinary meaning of those words. Accordingly, the
term "integrally formed in," as used in claim 14,
requires that the bit line be formed entirely within