Purdue Pharma v. Faulding Inc

Citation230 F.3d 1320
Parties(Fed. Cir. 2000) PURDUE PHARMA L.P. and THE PURDUE FREDERICK COMPANY, Plaintiffs-Appellants, v. FAULDING INC., FAULDING PHARMACEUTICAL CO., FAULDING SERVICES, INC., and PUREPAC PHARMACEUTICAL CO., Defendants-Cross Appellants, and ZENECA INC., Defendant. 99-1416, -1433 DECIDED:
Decision Date25 October 2000
CourtUnited States Courts of Appeals. United States Court of Appeals for the Federal Circuit

Appealed from: United States District Court for the District of Delaware

Chief Judge Joseph J. Farnan, Jr. S. Leslie Misrock and Victor N. Balancia, Pennie & Edmonds LLP, of New York, New York, argued for plaintiffs-appellants. With them on the brief was Todd A. Wagner, and Stanton T. Lawrence, III, Pennie & Edmonds LLP, of Washington, DC.

Steven J. Lee, Kenyon & Kenyon, of New York, New York, argued for defendants-cross appellants. With him on the brief were Paul H. Heller, Edward J. Handler, III, Charles A. Weiss, William G. James, II, and Mark I. Koffsky. Of counsel on the brief was E. Brendan Magrab, Faulding, Inc., of Elizabeth, New Jersey. Of counsel were Jack B. Blumenfeld, and Karen Jacobs Louden, Morris, Nichols, Arsht & Tunnell, of Wilmington, Delaware.

Before PLAGER, Circuit Judge, SMITH, Senior Circuit Judge, and BRYSON, Circuit Judge.

BRYSON, Circuit Judge.

Purdue Pharma L.P. and The Purdue Frederick Company (collectively Purdue) own U.S. Patent No. 5,672,360 (the '360 patent), which is drawn to methods of treating pain in patients by administering an opioid, such as morphine, once a day. Purdue brought a patent infringement suit against Faulding Inc., Faulding Pharmaceutical Co., Faulding Services, Inc., and Purepac Pharmaceutical Co. (collectively Faulding) in the United States District Court for the District of Delaware. After a bench trial, the district court found that Faulding had infringed the asserted claims of the '360 patent but that the claims were invalid. Purdue appeals from the finding of invalidity, and Faulding cross-appeals from the finding of infringement. We uphold the court's ruling invalidating the asserted claims of the '360 patent; we do not reach Faulding's cross-appeal on the issue of infringement.

I

In 1984 Purdue introduced a sustained-release, twice-a-day oral morphine formulation. Sustained-release formulations represent a significant advance over immediate-release morphine formulations because immediate-release formulations need to be administered every four hours, a schedule that interferes with the patient's sleep and subjects the patient to cycles of pain that are difficult to control.

After its success with its twice-a-day formulation, Purdue sought to develop a sustained-release oral morphine formulation that would need to be administered only once a day. The work of its researchers initially led to the issuance of U.S. Patent No. 5,478,577 (the '577 patent), which discloses a once-a-day formulation exhibiting a rapid initial rise in the opioid concentration in the patient's blood.

During the same period, Faulding was developing long-lasting opioid anti-pain formulations as well. In 1996, Faulding began marketing its oral sustained-release morphine formulation in the United States under the trade name Kadian. The package insert accompanying Kadian states that it may be administered either once or twice a day.

Shortly after Faulding began selling Kadian in this country, Purdue brought suit against Faulding and Zeneca Inc., alleging that the manufacture, sale, and use of Kadian as a once-a-day morphine formulation infringed the '577 patent. At the time the suit was filed, the inventors of the '577 patent had pending before the Patent and Trademark Office U.S. Patent Application Serial No. 08/578,688 (the '688 application), which claimed priority to the application that led to the '577 patent.

While the litigation over the '577 patent was pending, Purdue's counsel canceled the pending claims of the '688 application and amended the application to add all new claims. The application was allowed as amended, and it issued as the '360 patent on September 30, 1997. No art rejections were made against the issued claims. The only prosecution history is contained in a handwritten interview summary in which the examiner stated that the "new claims are supported by the specs."

Purdue asserts that the once-a-day formulation described in the treatment method of the '360 patent, which results in a substantial fluctuation in the opioid concentration in the patient's blood between the maximum concentration level and the concentration level at the end of the 24-hour dosage period, was contrary to the prevailing view at the time that sustained-release formulations should produce minimal fluctuations in the opioid concentration level during the dosing interval. That aspect of the invention is reflected in each of the claims of the '360 patent, including claims 2, 4, and 11, the three asserted claims at issue in this case. Claims 1 and 9, on which the three asserted claims depend, both contain a limitation requiring that the maximum plasma concentration of the opioid be more than twice the plasma level of the opioid 24 hours after administration of the drug. The pertinent claims of the '360 patent at issue in this case read as follows:

1. A method of effectively treating pain in humans, comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage form containing an opioid analgesic or salt thereof which upon administration provides a time to maximum plasma concentration (Tmax) of said opioid in about 2 to about 10 hours and a maximum plasma concentration (Cmax) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which dosage form provides effective treatment of pain for about 24 hours or more after administration to the patient.

2. The method of claim 1, wherein the Tmax occurs in about 2 to about 8 hours after oral administration of said dosage form.

4. The method of claim 1, wherein said opioid analgesic is morphine sulfate.

9. A method of effectively treating pain in humans, comprising orally administering to a human patient on a once-a-day basis an oral sustained release dosage form containing an opioid analgesic or salt thereof which at steady-state provides a time to maximum plasma concentration (Tmax) of said opioid in about 2 to about 10 hours and a maximum plasma concentration (Cmax) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form, and which dosage form provides effective treatment of pain for about 24 hours or more after administration to the patient.

11. The method of claim 9, wherein said opioid analgesic is morphine sulfate.

Shortly after the '360 patent issued, Purdue amended the complaint in the pending litigation against Faulding and Zeneca by dropping its claims under the '577 patent and asserting infringement of the '360 patent. Faulding and Zeneca asserted various counterclaims, including non-infringement and invalidity, and a bench trial was held on liability. During trial, the district court dismissed the claims against Zeneca. Following the trial, the court held that Faulding's production and sale of Kadian infringed the asserted claims of the '360 patent, but that the claims were invalid because they lacked the written description required by 35 U.S.C. 112, first paragraph. The court then entered final judgment on the tried issues under Fed. R. Civ. P. 54(b).

II

The validity issue in this case is whether the limitation "a maximum plasma concentration (Cmax) which is more than twice the plasma level of said opioid at about 24 hours after administration of the dosage form [C24]" was adequately described in the disclosure of the '688 application as originally filed. The trial court found that it was not.

In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1570, 39 USPQ2d 1895, 1904 (Fed. Cir. 1996). Nonetheless, the disclosure "must . . . convey with reasonable clarity to those skilled in the art that . . . [the inventor] was in possession of the invention." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). Put another way, one skilled in the art, reading the original disclosure, must "immediately discern the limitation at issue" in the claims. Waldemar Link GmbH & Co. v. Osteonics Corp., 32 F.3d 556, 558, 31 UPSQ2d 1855, 1857 (Fed. Cir. 1994). That inquiry is a factual one and must be assessed on a case-by-case basis. See Vas-Cath, 935 F.2d at 1561, 19 USPQ2d at 1116 ("Precisely how close the original description must come to comply with the description requirement of 112 must be determined on a case-by-case basis."). When the question whether a patent satisfies the written description requirement is resolved by a district court sitting as the trier of fact, we review the court's decision for clear error. See Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158, 47 USPQ2d 1829, 1832 (Fed. Cir. 1998); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1479, 45 USPQ2d 1498, 1502 (Fed. Cir. 1998).

Purdue contends that the district court made various legal errors in its analysis of the written description issue and that its factual finding on that issue was clearly erroneous. Turning first to the district court's factual analysis, we conclude that the court's finding on the written description issue did not constitute clear error.

A

The district court found that the specification of the '360 patent fails to convey that the Cmax/C24 limitation was encompassed within Purdue's original invention. Purdue attacks that finding on several fronts, but its arguments are unpersuasive.

Purdue first argues that the Cmax/C24 limitation is supported by the portion of the specification that describes the...

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