Santarus Inc. v. Par Pharm. Inc.

• Decision Date: 14 April 2010
• Docket Number: C.A. No. 07-551-GMS.
• Citation: 720 F.Supp.2d 427
• Parties: SANTARUS, INC., and the Curators of the University of Missouri, Plaintiffs, v. PAR PHARMACEUTICAL, INC., Defendant.
• Court: U.S. District Court — District of Delaware

720 F.Supp.2d 427

SANTARUS, INC., and the Curators of the University of Missouri, Plaintiffs,

v.PAR PHARMACEUTICAL, INC., Defendant.

C.A. No. 07-551-GMS.

United States District Court,D. Delaware.

April 14, 2010.

COPYRIGHT MATERIAL OMITTED.

COPYRIGHT MATERIAL OMITTED.

COPYRIGHT MATERIAL OMITTED.

Jack B. Blumenfeld, James Walter Parrett, Jr., Morris, Nichols, Arsht & Tunnell, Wilmington, DE, for Plaintiffs.

Frederick L. Cottrell, III, Richards, Layton & Finger, PA, Wilmington, DE, Steven J. Fineman, Richards, Layton & Finger, PA, Wilmington, DE, Aziz Burgy, Janine A. Carlan, Timothy W. Bucknell, Pro Hac Vice, for Defendant.

MEMORANDUM

GREGORY M. SLEET, Chief Judge.

I. INTRODUCTION

In this consolidated patent infringement action, plaintiffs Santarus, Inc. (“Santarus”) and the Curators of the University of Missouri (the “University”) (collectively, “the plaintiffs”) allege that defendant Par Pharmaceutical, Inc.'s (“Par”) proposed generic pharmaceutical product infringes the asserted claims of the patents-in-suit. (D.I. 1.) The court held a five-day bench trial in this matter on July 13 through July 17, 2009. (D.I. 168-172.) After the fourth day of trial, the court ruled that Par's proposed products infringed the asserted claims of the patents-in-suit. (See D.I. 171 at 936-941.) Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning the validity and enforceability of the patents-in-suit. (D.I. 173-174.)

Pursuant to Fed.R.Civ.P. 52(a), and after having considered the entire record in this case and the applicable law, the court concludes that: (A) the patents-in-suit are invalid due to obviousness; (B) the patents-in-suit are not unenforceable due to inequitable conduct; and (C) an award for attorneys' fees and costs is not warranted in this case. The court further concludes that certain asserted claims of the patents-in-suit are invalid because they lack a written description, or are not entitled to the filing date of earlier applications because the disclosures in the prior applications do not meet the written description requirement. These findings of fact and conclusions of law are set forth in further detail below.

II. FINDINGS OF FACT A. The Parties

1. Plaintiff Santarus, Inc. is a corporation organized and existing under the laws of Delaware, and has its principal place of business at 3721 Valley Centre Drive, San Diego, CA 92130. (D.I. 152, Tab 1 at ¶ 1.)

2. Plaintiff The Curators of the University of Missouri is the governing body of the University of Missouri, which is a public corporation and body politic having a principal place of business at 321 University Hall, Columbia, Missouri 65211. ( Id. at ¶ 2.)

3. Defendant Par Pharmaceutical, Inc. (“Par”) is a corporation organized and existing under the laws of Delaware, having a principal place of business at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677. ( Id. at ¶ 3.)

B. The Patents In Suit

i. Prosecution History

4. On January 4, 1996, Dr. Phillips filed U.S. Provisional Application No. 60/009,608 (hereinafter “the Provisional Application”). (See JTX-31.)

5. The Provisional Application describes a pharmaceutical composition “referred to as simplified omeprazole solution (SOS).” ( Id. at 8.)

6. On July 15, 1996, Dr. Phillips filed U.S. patent application Ser. No. 08/680,376 (hereinafter, the “'737 Application”), which issued as U.S. Patent No. 5,840,737 (hereinafter, the “'737 patent”) on November 24, 1998. (See JTX-33.)

7. On October 30, 1998, Dr. Phillips filed U.S. patent application Ser. No. 09/183,422 (hereinafter, the “'422 Application”). (See JTX-32.)

8. The Provisional Application, the '737 Application, and the '422 Application (collectively, “the priority applications”) share the following features:

• Each application describes the invention as a “pharmaceutical composition” (JTX-31 at 8; JTX-32 at 16; JTX-33 at 21.)

• The “DETAILED DESCRIPTION OF THE INVENTION” section of each application states that the pharmaceutical composition is prepared by mixing:

• Omeprazole or other substituted proton pump inhibitors; and

• A bicarbonate salt of a Group IA metal

(JTX-31 at 8; JTX-32 at 17; JTX-33 at 21.) The preferred bicarbonate salt is sodium bicarbonate (JTX-31 at 9; JTX-32 at 17; JTX-33 at 22.)

ii. The Patents

9. On December 3, 2002, the United States Patent and Trademark Office (“PTO”) issued U.S. Patent No. 6,489,346 (the “'346 Patent”), entitled “Substituted Benzimidazole Dosage Forms and Method of Using Same” to the University, the named assignee of the named inventor Jeffrey O. Phillips (“Dr. Philips”). (D.I. 152, Tab 1 at ¶ 4.)

10. The face of the '346 Patent states that “[t]his application is a continuation-in-part of U.S. patent application Ser. No. 09/183,422 filed on Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,376 filed on Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Application Serial No. 60/009,608 filed on Jan. 4, 1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference.” The face of the '346 Patent states that it is subject to a terminal disclaimer. ( Id. at ¶ 5.)

11. On November 11, 2003, the PTO issued U.S. Patent No. 6,645,988 (the “'988 Patent”), entitled “Substituted Benzimidazole Dosage Forms and Method of Using Same” to the University, the named assignee of the named inventor Dr. Phillips. ( Id. at ¶ 6.)

12. The face of the '988 Patent states that “[t]his application is a continuation-in-part of U.S. patent application Ser. No. 09/481,207, filed on Jan. 11, 2000, now U.S. Pat. No. 6,489,346 which is a continuation of U.S. patent application Ser. No. 09/183,422, filed Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,376, filed on Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Application Ser. No. 60/009,608 filed on Jan. 4, 1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference to the extent permitted by law.” The face of the '988 Patent states that it is subject to a terminal disclaimer. ( Id. at ¶ 7.)

13. On March 2, 2004, the PTO issued U.S. Patent No. 6,699,885 (the “'885 Patent”), entitled “Substituted Benzimidazole Dosage Forms and Methods of Using Same” to the University, the named assignee of the named inventor Dr. Phillips. ( Id. at ¶ 8.)

14. The face of the '885 Patent states that “[t]his application is a continuation-in-part of U.S. patent application Ser. No. 09/901,942, filed on Jul. 9, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/481,207, filed on Jan. 11, 2000, now U.S. Pat. No. 6,489,346, which is a continuation-in-part of U.S. patent application Ser. No. 09/183,422, filed on Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,376, filed on Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Application Serial No. 60/009,608, filed on Jan. 4, 1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference.” The face of the '885 Patent states that it is subject to a terminal disclaimer. ( Id. at ¶ 9.)

15. On or about August 22, 2005, a third party requested that the PTO reexamine the '885 Patent. On September 18, 2007, after concluding reexamination proceedings, the PTO issued an Ex Parte Reexamination Certificate for the '885 Patent. ( Id. at ¶ 10.)

16. On August 24, 2004, the PTO issued U.S. Patent No. 6,780,882 (the “ ‘'882 Patent’ ”), entitled “Substituted Benzimidazole Dosage Forms and Methods of Using Same” to the University, the named assignee of the named inventor Dr. Phillips. ( Id. at ¶ 11.)

17. The face of the '882 Patent states that “[t]his application is a continuation of U.S. patent application Ser. No. 09/481,207, filed on Jan. 11, 2000, now U.S. Pat. No. 6,489,346 which is a continuation of U.S. patent application Ser. No. 09/183,422, filed Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,376, filed on Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Application Ser. No. 60/009,608, filed on Jan. 4, 1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference.” The face of the '882 Patent states that it is subject to a terminal disclaimer. ( Id. at ¶ 12.)

18. On July 15, 2008, the PTO issued U.S. Patent No. 7,399,772 (the “'772 Patent”), entitled “Substituted Benzimidazole Dosage Forms and Method of Using Same” to the University, the named assignee of the named inventor Dr. Phillips. ( Id. at ¶ 13.)

19. The face of the '772 Patent states that “[t]his application is a continuation of U.S. patent application Ser. No. 10/068,437 filed Feb. 5, 2002 now abandoned, which is a continuation of U.S. patent application Ser. No. 09/481,207 filed Jan. 11, 2000, now U.S. Pat. No. 6,489,346, which is a continuation-in-part of U.S. patent application Ser. No. 09/183,422 filed Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,376, filed Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Patent Application No. 60/009,608 filed Jan. 4, 1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference.” ( Id. at ¶ 14.)

20. On November 24, 1998, the PTO issued United States Patent No. 5,840,737 (“the'737 Patent”), entitled “Omeprazole Solution and Method for Using Same” to the University, the named assignee of the named inventor Dr. Phillips. ( Id...