Forest Laboratories, Inc. v. Abbott Laboratories

239 F.3d 1305, 2001 WL 118291
Court of Appeals for the Federal Circuit·Decided February 13, 2001·No. Nos. 99-1494, 99-1495 and 99-1512·Published·Cited by 5 cases

Opinion

LOURIE, Circuit Judge.

Abbott Laboratories and Tokyo Tanabe Co., Ltd. appeal from the decision of the United States District Court for the Western District of New York granting ONY Inc. and Forest Laboratories, Inc.’s motion for judgment as a matter of law (“JMOL”) following a jury verdict of infringement of Tokyo Tanabe’s U.S. Patents 4,338,301 and 4,397,839. Because the jury’s verdict was not supported by substantial evidence, the district court did not err in granting JMOL of non-infringement. Accordingly, we affirm.

BACKGROUND

Tokyo Tanabe is the assignee of the '301 and '839 patents, which relate to a lung surfactant composition for treating Respiratory Distress Syndrome (“RDS”) in premature babies. Forest Labs. v. Abbott Labs., No. 96-CV-159A, slip op. at 2 (W.D.N.Y. Aug. 3, 1998) (deciding claim construction) (“Forest I”). The claims are reproduced below in relevant part:

1. Surface active material containing phospholipid, neutral lipid, total cholesterol, carbohydrate, protein and water, which material is obtained from lung tissue of a mammal with or without further phospholipid, characterized in that the phospholipid content is 75.0-95.5%, the neutral lipid content is 1.8-14.0%, the total cholesterol content is 0.0-3.0%, the carbohydrate content is 0.1-1.5%, the protein content is 0.5-5.0% and water content is 1.7-6.0%, all based on the dried weight of said material....

'301 patent, col. 17, 11. 59-68 (emphasis added).

7. A pharmaceutical composition useable for the treatment of hyaline-mem-brane disease [RDS] comprising an effective amount of surface-active material as set forth in claim 1 and a pharmaceu-tically acceptable non-toxic carrier thereof [sic, therefor].

Id. at col. 18, 11. 32-59 (emphasis added).

1. A surface active material comprising (1) phospholipid, neutral fat, total cholesterol, free fatty acids, carbohydrate, protein and water, all of which are obtained from the lung tissue of a mammal ... characterized in that the overall phospholipid content is 68.6-90.7%, the overall neutral fat content is 0.3-13.0%, the total cholesterol content is 0.0-8.0%, the overall free fatty acid content is 1.0-27.7%, the carbohydrate content is 0.1-2.0%, the protein content is 0.0-3.5%, and the water content is 2.1-5.2%, all based on the dry weight of the material....

'839 patent, col. 17, 11. 13-25 (emphasis added).

9. A pharmaceutical composition useable for the treatment of respiratory distress syndrome comprising an effective amount of a surface active • material as set forth in claim 1 and a pharmaceuti-cally acceptable carrier thereof [sic, therefor).

Id. at col. 18, 11. 15-19 (emphasis added).

Abbott developed a commercial product known as “Survanta®” after receiving an exclusive U.S. license to these patents from Tokyo Tanabe. Forest I at 2. ONY [1308] developed a competing product for treating RDS, which it called “Infasurf®”; it entered into an agreement with Forest under which Forest would further develop and market Infasurf®. Id. at 3. ONY and Abbott maintained collaborative contacts throughout the development of these products from 1983 until Abbott received FDA approval to market Survanta® in 1991, during which time ONY maintains that Abbott gave it no reason to believe that its Infasurf® product would infringe any patents of Abbott. Forest Labs. v. Abbott Labs., No. 96-CV-159A, slip op. at 11, 33 (W.D.N.Y. June 23, 1999) (deciding equitable estoppel) (“Forest II”). In fact, Abbott performed a patentability search for ONY in 1984 and informed ONY that ONY’s Infasurf® was not patentable. Id. at 25-26. In contrast, in 1994, Abbott informed ONY that it had reason to believe that Infasurf® might infringe the Tokyo Tan-abe patents under which Abbott was exclusively licensed. Id. at 14.

In 1996, ONY and Forest (hereinafter collectively “ONY”) sued Abbott, seeking a declaratory judgment of non-infringement and patent invalidity. Abbott counterclaimed for infringement of claims 1-12 of the '301 patent and claims 1, 2, 8, 9, and 11-15 of the '839 patent. After suit was brought, ONY added Tokyo Tanabe as a defendant, which also counterclaimed for infringement. ONY later raised the additional defense of equitable estoppel, alleging that Abbott had led ONY to believe that Abbott would not assert the Tokyo Tanabe patents against it.

Following a Markman hearing, the court construed a disputed term, “surface active material,” in claim 1 of the '301 and '839 patents. Forest I at 1. The court accepted ONY’s construction of the term, concluding that it refers to the lung surfactant extract material in dry form before it is suspended in physiological saline to form a “pharmaceutical composition” and that the chemical composition of the “surface active material” must be determined for infringement purposes before it is made into a “pharmaceutical composition.” Id. at 17. Thus, the court distinguished between the “surface active material” of claim 1 of the '301 and '839 patents and the “pharmaceutical compositions” of claims 7 and 9 of those patents, respectively. Id. In its view, the surface active material was only a “part or a subset” of the pharmaceutical compositions. Id. at 18. The court also interpreted the expression “based on the dry weight”1 as meaning the dry weight of the lung surfactant extract before it is combined with a pharmaceutical carrier. Id. at 26.

At trial, Abbott and Tokyo Tanabe (hereinafter collectively “Abbott”) introduced evidence of the percentages of all of the ingredients2 of the accused product, with one exception: water. Forest Labs. v. Abbott Labs., No. 96-CV-159A, slip op. at 10 (W.D.N.Y. June 23, 1999) (granting JMOL of non-infringement) (“Forest III”). The specification of each patent states that the water content was measured by the Karl Fischer method. '301 patent, col. 5, 11. 17-19; '839 patent, col. 3, [1309]*130911. 49-50. Abbott’s expert testified that he had never measured the percentage of water in CLSE (“Calf Lung Surfactant Extract,” the “dry” form of Infasurf®) by any method, let alone the Karl Fischer method. Forest III at 10-11. Rather than measuring the percentage of water in CLSE, Abbott assumed water to be present in the claimed percentages and calculated what the percentages of the other components would be at the limits of the claimed water concentrations. Id. at 11-12. To show infringement under the doctrine of equivalents, Abbott presented testimony that the percentage of water in the surface active material is irrelevant; ONY countered with testimony from the primary inventor of CLSE/Infasurf®, Dr. Egan, that the percentage of water affects CLSE’s physical and biological properties. Id. at 12, 13 n. 6.

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Forest Laboratories, Inc. v. Abbott Laboratories, 239 F.3d 1305, 2001 WL 118291 (Fed. Cir. 2001).

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