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Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc.

United States Court of Appeals, Federal Circuit

November 10, 2015

PROMETHEUS LABORATORIES, INC., Plaintiff-Appellant
v.
ROXANE LABORATORIES, INC., CIPLA, LTD., Defendants-Appellees

Appeals from the United States District Court for the District of New Jersey in Nos. 2:11-cv-00230-FSH-MAH, 2:11-cv-01241-FSH-MAH, Judge Faith S. Hochberg.

Page 1093

NEAL KUMAR KATYAL, Hogan Lovells U.S. LLP, Washington, DC, argued for plaintiff-appellant. Also represented by JACLYN DILAURO, MATTHEW A. SHAPIRO; THOMAS SCHMIDT, New York, NY.

HENRY C. DINGER, Goodwin Procter LLP, Boston, MA, argued for defendants-appellees. Also represented by KEITH A. ZULLOW, MARTA E. GROSS, MICHAEL B. COTTLER, TIMOTHY J. DOYLE, New York, NY; WILLIAM M. JAY, Washington, DC.

Before DYK, TARANTO, and HUGHES, Circuit Judges.

OPINION

Page 1094

[116 U.S.P.Q.2d 1943] Dyk, Circuit Judge.

Prometheus Laboratories, Inc. (" Prometheus" ) appeals a judgment of the U.S. District Court for the District of New Jersey holding the amended claims of U.S. Patent No. 6,284,770 (" the '770 patent" ) invalid. The district court found the claims would have been obvious over the prior art or, in the alternative, invalid on grounds of obviousness-type double patenting over U.S. Patent No. 5,360,800 (" the '800 patent" ). We affirm the district court's decision because the claims of the '770 patent are invalid as obvious over the '800 patent and other prior art, and do not reach the issue of double patenting.

Background

Irritable bowel syndrome (" IBS" ) is a condition defined and diagnosed by its constellation of symptoms. Patients may suffer from diarrhea-predominant IBS (" IBS-D" ), constipation-predominant IBS (" IBS-C" ), or, less often, mixed IBS (" IBS-M" ) or alternating IBS (" IBSA" ). A patient's symptoms define the type of IBS with which a patient is diagnosed.

In this case, Prometheus, the owner of the '770 patent, sued Roxane Laboratories, Inc. (" Roxane" ) and Cipla, Ltd. (" Cipla" ) (together " defendants" ), alleging infringement of claims 5, 6, 10, 13, and 14 of the '770 patent. As described below, the '770 patent claims a method of treatment for IBS-D utilizing alosetron (known by the

Page 1095

brand name Lotronex). The question is whether these claims of the '770 patent would have been obvious over various prior art references or are invalid for obviousness-type double patenting over the prior '800 patent.

Prometheus also owns the '800 patent, which also covers the use of alosetron for treatment of IBS. The '800 patent issued on November 1, 1994, and has now expired.[1] The '800 patent is prior art to the '770 patent asserted here. Claim 17 of the '800 patent is directed to " [a] method of treating a condition [such as IBS] which is ameliorated by antagonism of 5-HT[3] receptors which comprises administering to a patient an effective amount of [alosetron]." '800 patent col. 38 ll. 7-12. Claim 27 of the '800 patent covers " [a] method according to claim 17 for the treatment [116 U.S.P.Q.2d 1944] of irritable bowel syndrome." Id. at col. 38 ll. 50-51.

The '770 patent, entitled " Medicaments for the Treatment of Non-Constipated Female Irritable Bowel Syndrome," is also directed to a method of treating IBS patients using alosetron. The '770 patent has a priority date of October 7, 1997. After the '770 patent issued, Prometheus initiated an ex parte reexamination of the '770 patent, and a reexamination certificate was issued on October 19, 2010. During reexamination, Prometheus amended claim 5 to add new claim limitations (those new limitations are underlined below) and added, inter alia, claims 10 and 13.

Reexamined claims 5, 10, and 13 provide:
5. A method for treating a diarrhea-predominant female IBS patient, while excluding those with predominant constipation, said method comprising:
assessing whether said diarrhea-predominant female IBS patient has experienced symptoms for at least six months; and administering an effective amount of alosetron or a pharmaceutically acceptable derivative thereof to said patient who has experienced symptoms for at least six months, wherein said effective amount is dependent on the condition of the patient and is at the discretion of the attendant physician.
10. The method for treating according to claim 5, further comprising assessing whether said female IBS patient has experienced at least moderate pain prior to administration of alosetron.
13. A method for treating a diarrhea-predominant female IBS patient, while excluding those with predominant ...

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