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SmithKline Beecham Corp. v. Apotex Corp.

United States Court of Appeals for the Federal Circuit

April 8, 2005, Decided

03-1285, 03-1313


 [*1333]  RADER, Circuit Judge.

Following a bench trial, the United States District Court for the Northern District of Illinois determined that the generic paroxetine [**2]  hydrochloride anhydrate  [*1334]  product to be produced by Apotex Corp., Apotex, Inc., and TorPharm, Inc. (collectively Apotex) will not infringe claim 1 of U.S. Patent No. 4,721,723 ('723 patent) owned by SmithKline Beecham Corp. and Beecham Group, P.L.C. (collectively SmithKline). SmithKline Beecham Corp. v. Apotex Corp., 247 F. Supp. 2d 1011, 1052 (N .D. Ill. 2003). Based on this court's revision of the trial court's erroneous claim construction, Apotex's product would infringe claim 1 of the '723 patent. Nonetheless, because claim 1 of the '723 patent is invalid as anticipated under 35 U.S.C. § 102(b), this court affirms the district court's judgment in favor of Apotex.

In the late 1970s, a British company, Ferrosan, invented a new class of compounds, including a compound that became known as paroxetine. See U.S. Patent No. 4,007,196 ('196 patent). The '196 patent claims paroxetine and its salts and discloses their antidepressant properties. Ferrosan eventually developed a process to produce the crystalline hydrochloride salt of paroxetine, or paroxetine hydrochloride (PHC). In 1980, Ferrosan licensed the '196 patent and its other PHC-related [**3]  technology to SmithKline. SmithKline began manufacturing PHC in its Harlow plant in England.

In March 1985, Alan Curzons, a chemist in SmithKline's Worthing, England laboratory, discovered a new crystalline form of PHC while attempting to improve PHC production. Curzons's test results established that the new product was the hemihydrous form of PHC (PHC hemihydrate). Ferrosan's original form was anhydrous PHC (PHC anhydrate). PHC anhydrate comprises crystals of PHC without bound water molecules. PHC hemihydrate comprises PHC crystals with one bound water molecule for every two PHC molecules. PHC hemihydrate proved more stable, and thus more easily packaged and preserved, than PHC anhydrate.

SmithKline filed a patent application in the British Patent Office on October 25, 1985 relating to "crystalline paroxetine hydrochloride, its preparation and its uses as a therapeutic agent." The British applicati on identified the invention as both the hemihydrate and the anhydrate form of PHC, as well as mixtures that contain a major portion of either form. One year later, on October 23, 1986, SmithKline filed a U.S. application claiming priority to the British application that issued as the [**4]  '723 patent in 1988. The '723 patent does not claim PHC anhydrate and does not claim mixtures of the two PHC forms. The only claim at issue in this case is claim 1, which reads in its entirety: "Crystalline paroxetine hydrochloride hemihydrate."

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403 F.3d 1331 *; 2005 U.S. App. LEXIS 5675 **; 74 U.S.P.Q.2D (BNA) 1396

SMITHKLINE BEECHAM CORPORATION and BEECHAM GROUP, P.L.C., Plaintiffs-Appellants, v. APOTEX CORP., APOTEX, INC., and TORPHARM, INC., Defendants-Cross Appellants.

Subsequent History: Rehearing denied by, Rehearing, en banc, denied by Smithkline Beecham Corp. v. Apotex Corp., 2005 U.S. App. LEXIS 14121 (Fed. Cir., June 15, 2005)

Later proceeding at SmithKline Beecham Corp. v. Apotex Corp., 126 S. Ct. 1133, 163 L. Ed. 2d 852, 2006 U.S. LEXIS 25 (U.S., 2006)

US Supreme Court certiorari denied by, Motion granted by SmithKline Beecham Corp. v. Apotex Corp., 126 S. Ct. 2887, 165 L. Ed. 2d 938, 2006 U.S. LEXIS 4871 (U.S., June 19, 2006)

Prior History:  [**1]  Appealed from: United States District Court for the Northern District of Illinois. Judge Richard A. Posner.

SmithKline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, 2004 U.S. App. LEXIS 8107 (Fed. Cir., 2004)

Disposition: AFFIRMED.


patent, hemihydrate, anhydrate, district court, paroxetine, infringement, seeded, invention, anticipation, manufacture, polymorph, crystalline, conversion, compound, hydrochloride, subject matter, invalid, plant, prior art, molecules, convert, indefinite, skilled, products, laboratory, specification, scientific, trace amount, disappearing, amounts

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