Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Prometheus Laboratories Inc. v. Roxane Laboratories, Inc.

United States District Court, Third Circuit

December 16, 2013

PROMETHEUS LABORATORIES INC., Plaintiff,
v.
ROXANE LABORATORIES, INC., et al., Defendants.

OPINION

FAITH S. HOCHBERG, District Judge.

I. INTRODUCTION

Defendants Roxane Laboratories, Inc. and Cipla Ltd. ("Roxane" and "Cipla, " collectively referred to as "Defendants") bring a motion for summary judgment of non-infringement of the '014 patent, and Cipla brings a motion for summary judgment seeking to invalidate the '770 patent under 35 U.S.C. § 305. Plaintiff Prometheus Laboratories, Inc. ("Prometheus" or "Plaintiff") opposes both motions and brings a motion for summary judgment of no invalidity under § 305 for the '770 patent. The Court held a hearing on November 21, 2013 to address the parties' outstanding motions. During the November 21, 2013 hearing, the parties resolved their dispute with respect to the '014 patent. That patent is no longer at issue in this matter.

The parties have also filed the following motions:

• Defendants' Motion in Limine No. 1 Regarding Magnet and Rubicon
• Plaintiff's Motions in Limine Regarding Dr. Howden's "Single Actor" Testimony, Clinical Studies Evidence, Label Preparation Evidence, and Reexamination Evidence
• Both parties' motions to seal the courtroom during trial

II. BACKGROUND[1]

Prometheus filed the current actions against Defendants alleging that Defendants have or will infringe U.S. Patent No. 6, 284, 770 ("the '770 patent") under 35 U.S.C. §§ 271(a), 271(b), 271(c), and 271(e)(2)(A) and that Defendants have or will infringe U.S. Patent No. 6, 175, 014 ("the '014 patent") under 35 U.S.C. §§ 271(b) and 271(g). (Am. Compl., ¶¶ 38, 42-44, 49, 50 [Dkt. No. 67].)[2] Prometheus holds an approved New Drug Application ("NDA") under § 505(a) of the FFDCA, 21 U.S.C. § 355(a), for alosetron hydrochloride tablets (NDA No. 21-107), selling under the brand name LOTRONEX®.[3] (DS ¶ 45; PR ¶ 45.) Prometheus acquired LOTRONEX® and the '770 patent in 2007. (DS ¶ 43; PR ¶ 43.)

Prometheus' claims arise from Roxane's filing of an Abbreviated New Drug Application ("ANDA") with the FDA seeking approval to commercially market a generic version of Prometheus' LOTRONEX® drug product prior to the expiration of the '770 patent. (Am. Compl., ¶ 1.) Cipla manufactures the active pharmaceutical ingredient ("API"), i.e., alosetron hydrochloride, used in Roxane's ANDA products. (PCS ¶¶ 2, 3; DRC ¶¶ 2, 3.) Cipla admits that it has entered into supply contracts with generic pharmaceutical companies in the United States, and a portion of Cipla's export sales are derived from the United States. (Cipla Answer, ¶ 7 [Dkt. No. 175].)

On September 4, 2001, the USPTO issued the '770 patent titled "Medicaments for the treatment of non-constipated female irritable bowel syndrome." (DS ¶ 36; PR ¶ 36.) In 2007, Prometheus purchased the LOTRONEX® franchise from GSK, which included the '770 patent and the right to market LOTRONEX®. (DS ¶ 43; PR ¶ 43.) Prometheus contends it currently owns the '770 patent. (DS ¶ 44; PR ¶ 44.)

On August 3, 2009, Prometheus filed a request with the USPTO for ex parte reexamination of the '770 patent pursuant to 37 C.F.R. § 1.510. (DS ¶ 47; PR ¶ 47.) This request attached and identified "Magnet"[4] and "Rubicon"[5] as non-patent literature documents. (DS ¶ 48; PR ¶ 48.) In the request for reexamination Prometheus argued that "[b]ecause Magnet and Rubicon were published more than one year before October 5, 1998, they raise a substantial new question of patentability." (DS ¶ 49; PR ¶ 49.) Prometheus' request for reexamination did not cite any prior art references other than Magnet and Rubicon. (DS ¶ 52; PR ¶ 52.) On October 1, 2009, the USPTO mailed an order denying Prometheus' request for reexamination of the '770 patent. (DS ¶ 54; PR ¶ 54.) In their petition for further review of the reexamination, Prometheus stated that Magnet and Rubicon were prior art and should be given weight by a reexaminer as such because they raised a substantial question of patentability. (DS ¶¶ 60, 61; PR ¶¶ 60, 61.) On December 30, 2009, the USPTO granted Prometheus' petition seeking review of the denial of its request for reexamination. (DS ¶ 62; PR ¶ 62.) On February 24, 2010, the USPTO rejected claims 2, 3, 5, 6, and 8-18 under 35 U.S.C. § 103(a) as being unpatentable over Rubicon in view of the Magnet, Bardhan, Hsyu, Drossman, and Saxena[6] references. (DS ¶ 63; PR ¶ 63.) On April 23, 2010, Prometheus filed an amendment to the '770 patent "[i]n response to the Office Action mailed February 24, 2010...." (PCS ¶ 46; DRC ¶ 46.) During the subsequent reexamination, all of the original claims of the '770 patent were either cancelled (claims 1-4 and 7-9) or amended (claims 5-6) in response to the February 24, 2010 office action. (DS ¶ 67; PR ¶ 67; PCS ¶¶ 50, 56; DRC ¶¶ 50, 56.) The reexamination certificate of the '770 patent was issued on October 19, 2010 with amended claims 5-6 and new claims 10-16. (DS ¶ 68; PR ¶ 68.) The '770 patent was subsequently listed in the Orange Book with respect to LOTRONEX®. (DS ¶ 70; PR ¶ 70.)

The parties now agree that Rubicon and Magnet are not prior art. (DS ¶¶ ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.