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SYNTEX PHARMS. INTL., LTD. v. K-LINE PHARMS.

September 18, 1989

SYNTEX PHARMACEUTICALS INTERNATIONAL, LTD., Plaintiff,
v.
K-LINE PHARMACEUTICALS, LTD. and DRUG GUILD DISTRIBUTORS, INC., Defendants. T.J. ROACO, LTD., Plaintiff, v. SYNTEX PHARMACEUTICALS INTERNATIONAL, LTD., v. LAURA BLACKMAN and FRED KLAP, Additional Counterclaim Defendants



The opinion of the court was delivered by: WOLIN

 This case demonstrates the danger of a legitimate attempt to design around a patent. If one misreads the patent, one may very well end up squarely within the claims of the patent that one has carefully sought to avoid. Because the Court finds no material issue of fact and finds that the accused product literally infringes the patent-in-suit, the Court will grant the patent holder's motion for summary judgment of infringement. As an initial matter, the Court will also deny a motion by two of the proponents of the accused product for summary judgment based on patent invalidity. *fn1"

 FACTS AND ALLEGATIONS

 Syntex Pharmaceuticals International, Ltd. ("Syntex"), a Bermuda corporation with its principal place of business in Hamilton, Bermuda, is the assignee of U.S. Patent No. 3,592,930 ("the '930 patent"), which issued on July 13, 1971 and expired on July 13, 1988. The '930 patent claims a novel fatty alcohol/glycol solvent (FAPG) *fn2" composition for topical (i.e., to the skin) application of medicaments such as anti-inflammatory corticosteroids. The main purpose of the invention is therapeutic, that is, to preserve the activity of the medicament and to effectively release it into the skin. Under claim 8 of the patent, Syntex has successfully marketed a product called Lidex 0.05% fluocinonide FAPG cream, whose active ingredient is the steroid fluocinonide. Lidex is prescribed by physicians for the topical treatment of skin disorders such as psoriasis and other dermatoses. The fluocinonide FAPG cream developed under the '930 patent has proved to be a scientific and medical breakthrough. It has provided a medical product that is so effective and well tolerated by patients that patients often experience striking improvement within a few days of the start of therapy. Moreover, it has for the first time enabled many psoriasis patients to be effectively treated without occlusive bandages and wrappings.

 K-Line Pharmaceuticals, Ltd. ("K-Line"), a Canadian corporation with its principal place of business in Downsview, Ontario, manufactures a fluocinonide product under the mark Vasoderm. Vasoderm is sold in the United States by T.J. Roaco, Ltd. ("Roaco"), a New York corporation with its principal place of business in Toronto, Ontario, and distributed in New Jersey by Drug Guild Distributors, Inc., a New Jersey corporation that does business out of Secaucus.

 Alleging that Vasoderm falls within the claims of the '930 patent, Syntex filed suit against K-Line and Drug Guild, who deny infringement and who challenge the validity of the patent by way of affirmative defense and a summary judgment motion. Roaco brought a separate action against Syntex for a declaratory judgment of noninfringement. The two actions have been consolidated. K-Line, Roaco and Drug Guild have now moved for summary judgment of noninfringement. Syntex has opposed that motion and has cross-moved for summary judgment of infringement.

 The only claim of the '930 patent asserted by Syntex is claim 8, which is indirectly dependent on claim 1. *fn3" After accounting for the limitations added by the intermediately dependent claims (i.e., claims 6 and 7), claim 8 of the patent recites a "substantially anhydrous" composition having an effective amount of fluocinonide medicament and a vehicle "consisting essentially of":

 
(a) 15 to 45% fatty alcohol ("FA");
 
(b) 45 to 85% glycol solvent ("PG"); *fn4"
 
(c) 0 to 15% compatible plasticizer;
 
(d) 0 to 15% compatible coupling agent; and
 
(e) 0 to 20% penetrant.

 The patent specification states that "the fatty alcohol and glycol solvent ingredients are the principle components and are satisfactory as the sole vehicle components in the composition of this invention." '930 patent, col. 2, lines 54-56.

 K-Line, Roaco and Drug Guild concede that the accused Vasoderm product *fn5" contains the fluocinonide called for in claim 8 and meets (a) and (b) of the vehicle requirements. Elements (d) and (e) are not present in Vasoderm and therefore fall literally within the recited 0-15% and 0-20% claim ranges, respectively. The only issue with regard to literal infringement, then, is whether Vasoderm meets requirement (c) above, that is, whether the vehicle *fn6" contains 0 to 15% by weight compatible plasticizer. K-Line and Roaco admit that Vasoderm contains about 9% PEG 800-20,000, 21% glycerin and 0.5% 1,2,6 hexanetriol. These three ingredients, collectively, make up about 30% of the Vasoderm product. K-Line et al. contend that all three are compatible plasticizers *fn7" and that the concentration of compatible plasticizer in Vasoderm thus exceeds by a factor of two the upper allowable limit of 15%. The '930 patent specifications, K-Line et al. note, caution against exceeding the 15% upper limit called for in the claims: "The plasticizer concentration can be within the range of from 0 to 15 percent. Concentrations above 15 percent may provide a composition which has a consistency unsuitable for normal applications or cause instability of the vehicle mixture and some separation of the components." '930 patent, col. 3, lines 9-13. In "Table A" the specifications list an "operable" range of 0 to 15 and a "preferred" range of 2 to 10 percent by weight of compatible plasticizer. Id. col. 2, lines 8-18. The specifications state that "it is also intended that the chemical compounds in each class of ingredients discussed hereinafter be limited to pharmaceutically acceptable compounds in the concentrations indicated." Id. col. 2, lines 21-25 (emphasis added). K-Line, Roaco and Drug Guild admit that the inventor of Vasoderm, Subhan Lakhani, specifically designed around the '930 patent by attempting to substantially exceed the upper limit on compatible plasticizer concentration claimed by the patent. Since Lakhani has successfully done so, they contend, Vasoderm does not literally infringe the '930 patent as a matter of law.

 Syntex argues that the Vasoderm vehicle does indeed contain no more than 15% by weight compatible plasticizer. While conceding that the PEG 800-20,000 and the 1,2,6 hexanetriol in Vasoderm, which together comprise approximately 9.5% by weight of the vehicle, function as compatible plasticizers, *fn8" Syntex argues that only a small portion of the 21%-by-weight glycerin in Vasoderm actually functions as a compatible plasticizer. The remaining portion of the glycerin, according to Syntex, functions in some other way: as a humectant or a solvent. Thus Syntex contends that Vasoderm literally infringes the '930 patent.

 In rebuttal, K-Line et al. argue that all of the glycerin in Vasoderm functions as a compatible plasticizer. In addition, they point out that the only suggested use of glycerin (or glycerol, as it is also called) in the patent is as a compatible plasticizer. See '930 patent, col. 2, lines 66-69; id. claim 4.

 DISCUSSION

 On a motion for summary judgment, the moving party bears the burden of showing that there are no genuine issues of material fact and that the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56; Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S. Ct. 2548, 2552-53, 91 L. Ed. 2d 265 (1986). In evaluating the merits of a summary judgment motion, the Court must view all the evidence before it in the light most favorable to the nonmovant and must draw all reasonable inferences from that evidence in favor of the nonmovant. United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S. Ct. 993, 994, 8 L. Ed. 2d 176 (1962).

 The Court of Appeals for the Federal Circuit has confirmed the use of summary judgment in patent cases. See, e.g., Porter v. Farmers Supply Service, Inc., 790 F.2d 882, 884, 229 U.S.P.Q. (BNA) 814 (Fed. Cir. 1986); Brenner v. United States, 773 F.2d 306, 307, 227 U.S.P.Q. (BNA) 159 (Fed. Cir. 1985); Builders Concrete, Inc. v. Bremerton Concrete Products Co., 757 F.2d 255, 257, 225 U.S.P.Q. (BNA) 240 (Fed. Cir. 1985); Prodyne Enterprises, Inc. v. Julie Pomerantz, Inc., 743 F.2d 1581, 1583, 223 U.S.P.Q. (BNA) 477 (Fed. Cir. 1984).

 I. Validity of the '930 Patent

 K-Line and Drug Guild have filed motions for summary judgment on the ground that the '930 patent is allegedly invalid for obviousness under 35 U.S.C. ยง 103. *fn9" That section provides in part that a patent may not be obtained "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." There are four factual inquiries relevant to the question of obviousness: (1) the level of skill in the art, (2) the scope and content of the prior art, (3) the differences between the prior art and the claimed subject matter as a whole, and (4) objective indicia of nonobviousness, such as commercial success, long felt but unsolved needs, the failure of others to meet those needs, etc. Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 S. Ct. 684, 693-94, 15 L. Ed. 2d 545 (1966); Panduit Corp. v. Dennison Manufacturing Co., 810 F.2d 1561, 1566, 1 U.S.P.Q.2D (BNA) 1593 (Fed. Cir.), cert. denied, 481 U.S. 1052, 95 L. Ed. 2d 843, 107 S. Ct. 2187 (1987). In determining obviousness, one must consider the invention as a whole; small differences between the claims and the prior art can therefore give rise to patentability. See, e.g., Jones v. Hardy, 727 F.2d 1524, 1529, 220 U.S.P.Q. (BNA) 1021 (Fed. Cir. 1984). A combination of prior art features will only be deemed obvious if the prior art references contain a suggestion for so combining their teachings; the hindsight afforded by the invention cannot be used to negate its insight. In re Fine, 837 F.2d 1071, 1075, 5 U.S.P.Q.2D (BNA) 1596 (Fed. Cir. 1988); Panduit, 810 F.2d at 1568; ACS Hospital Systems, Inc. v. Montefiore Hospital, 732 F.2d 1572, 1577, 221 ...


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