Allergan, Inc. v. Watson Labs., Inc.
| Decision Date | 31 March 2012 |
| Docket Number | C.A. No. 09–cv–511 (GMS). |
| Citation | 869 F.Supp.2d 456 |
| Parties | ALLERGAN, INC., Allergan USA, Inc., Allergan Sales, L.L.C., Endo Pharmaceuticals Solutions Inc., and Supernus Pharmaceuticals, Inc., Plaintiffs, v. WATSON LABORATORIES, INC.—FLORIDA, Sandoz Inc., and Paddock Laboratories, Inc., Defendants. |
| Court | U.S. District Court — District of Delaware |
OPINION TEXT STARTS HERE
William J. Marsden, Jr., Gregory Robert Booker, A. Martina Tyreus Hufnal, Fish & Richardson, P.C., Wilmington, DE, Jonathan E. Singer, for Plaintiffs.
Travis Steven Hunter, Chad Michael Shandler, Richards, Layton & Finger, PA, John W. Shaw, Shaw Keller LLP, David Ellis Moore, Richard L. Horwitz, Potter Anderson & Corroon, LLP, Wilmington, DE, Rachel K. Zimmerman, Merchant & Gould, PC, Brian J. Robinson, Charles A. Weiss, Cynthia Hardman, John W. Bateman, Anders T. Aannestad, Brian M. Kramer, David C. Doyle, Marc D. Sharp, Thomas C. Chen, Thomas M. Mueller, Jeffrey S. Ward, Shane A. Brunner, Wendy M. Ward, for Defendants.
I. INTRODUCTION
In this consolidated patent infringement action, plaintiffs Allergan, Inc., Allergan USA, Inc., Allergan Sales, LLC, Endo Pharmaceuticals Solutions Inc., and Supernus Pharmaceuticals, Inc. (collectively, “the plaintiffs”) allege that pharmaceutical products proposed by defendants Watson Laboratories, Inc.—Florida, Sandoz, Inc., and Paddock Laboratories, Inc. (collectively, “the defendants”) infringe the asserted claims of the patents-in-suit. (D.I. 1.) The court held a seven-day bench trial in this matter on May 2 through May 10, 2011. (D.I. 204–210.) Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning the validity of the patents-in-suit and whether the defendants' proposed products infringe the patents-in-suit. (D.I. 201–203.)
Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire record in this case and the applicable law, the court concludes that: (1) all asserted claims of the patents-in-suit are invalid due to obviousness; (2) the asserted claims of the patents-in-suit are not invalid due to anticipation; (3) claim 1 of the '978 Patent and claim 1 of the '449 Patent are not invalid due to indefiniteness; (4) claim 1 of the '359 Patent is not invalid due to written description; (5) the defendants' proposed products infringe the asserted claims of the patents-in-suit; and (6) each of the parties' Rule 52(c) motions are granted in part and denied in part. These findings of fact and conclusions of law are set forth in further detail below.
II. FINDINGS OF FACT1A. The Parties
“Allergan”) are corporations organized and existing under the laws of the State of Delaware, with their principal place of business at 2525 Dupont Drive, Irvine, California 92612.
6. Defendant Sandoz, Inc. (“Sandoz”) is a corporation organized and existing under the laws of the State of Colorado, having its principal place of business at 506 Carnegie Center, Suite 400, Princeton, New Jersey 08540.
7. Defendant Paddock Laboratories, Inc. (“Paddock”) is a corporation organized and existing under the laws of the State of Minnesota, with headquarters at 3940 Quebec Avenue North, Minneapolis, Minnesota 55427.
8. Watson, Sandoz, and Paddock will be collectively referred to as “defendants.”
9. The court has subject matter jurisdiction, as well as personal jurisdiction over all parties.
B. Background
10. Trospiumchloride (a quaternary ammonium compound with the chemical name of spiro [8–azoniabicyclo[3,2,1]octane–8, 1?–pyrrolidinium]–3–[ (hydrozydiphenyl–acetyl)–oxy] chloride (1a,3ß,5a)-(9C1)) is an antagonist at muscarinic cholinergic receptors.
11. In the 1990s, trospiumchloride (hereafter, “trospium”), oxybutynin, and tolterodine were the three main pharmaceutical treatments for overactive bladder (“OAB”), a condition which affects approximately thirty-three million people in the United States.
12. In 2002, Ditropan (oxybutynin) and Detrol (tolterodine) were the two mainstay OAB treatments and were once-a-day formulations approved by the Food and Drug Administration (the “FDA”).
13. Unlike oxybutynin and tolterodine, trospium is a quaternary ammonium compound, rendering it permanently positively charged.
14. Though trospium had been used in the immediate release formulation of OAB pharmaceutical products for years, SANCTURA XR® is the only product that uses a quaternary ammonium compound in its once-a-day formulation.
C. The Patents–in–Suit
15. United States Patent Number 7,410,978 (“the '978 Patent”), entitled “Once Daily Dosage Forms Of Trospium,” naming Argaw Kidane, Henry H. Flanner, Padmanabh Bhatt, and Arash Raoufinia as inventors, was issued on August 12, 2008.
16. United States Patent Number 7,759,359 (“the '359 Patent”), entitled “Method Of Treating Bladder Dysfunction With Once–a–Day Trospium Salt Formulation,” naming Argaw Kidane, Henry H. Flanner, Padmanabh Bhatt, and Arash Raoufinia as inventors, was issued on July 20, 2010.
17. United States Patent Number 7,781,448 (“the '448 Patent”), entitled “Once Daily Dosage Forms Of Trospium,” naming Argaw Kidane, Henry H. Flanner, Padmanabh Bhatt, and Arash Raoufinia as inventors, was issued on August 24, 2010.
18. United States Patent Number 7,763,635 (“the '635 Patent”), entitled “Once Daily Dosage Forms of Trospium,” naming Argaw Kidane, Henry H. Flanner, Padmanabh Bhatt, and Arash Raoufinia as inventors, was issued on July 27, 2010.
19. The applications that matured into the '359, '448, '449, and '635 Patents are continuations of Application Number 10/980,818, which matured into the '978 Patent.
20. Supernus is the assignee of the '978, '359, '448, '449, and '635 Patents (“the patents-in-suit”). Allergan and Endo hold licensing, development, and commercialization rights to the patents-in-suit.
21. The patents-in-suit are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) at the FDA in connection with SANCTURA XR®.
22. SANCTURA XR® is a commercial version of trospium and is available in the United States.
23. Allergan markets SANCTURA XR®, which is covered by at least one asserted claim of each of the patents-in-suit.
24. SANCTURA XR® is a 60 mg once-daily trospium extended-release formulation capsule for the treatment of OAB, and is comprised of both extended release (“XR1”) and delayed release (“DR2”) pellets.
25. The XR1 pellets are coated with release controlling ethylcellulose polymer to provide for a slow and steady release and the DR2 pellets are coated with Eudragit FS30D, enteric polymer designed to release at a pH 7.0, such that it will release in the colon and the lower gastrointestinal (“GI”) tract.
26. Dissolution data in SANCTURA XR®'s New Drug Application (“NDA”) and blood level data from clinical trials reported in the patents-in-suit are consistent with release in the lower GI tract.
27. The SANCTURA XR® label contains single dose pharmacokinetic data obtained from NDA study IP631–020 and the corresponding steady state Cmin blood level is 418.6 pg/ml and steady state Cmax blood level is 1873 pg/ml, which occurs at a Tmax of 4.796 hours. These blood levels are within the range of approximately 0.5 ng/ml to about 6.0 ng/ml, with a Cmin above about 0.5 ng/ml and a Cmax below about 6.0 ng/ml, and a Cmax below 24000 ng/ml.
28. SANCTURA XR® has comparable efficacy to SANCTURA®, the twice-a-day immediate release 20 mg trospium product, but has a better “safety profile,” including a reduction in “dry mouth.” The incidence of dry mouth reported on the SANCTURA XR® label is 10.7%, which is about half that of the immediate release trospium product SANCTURA®.
29. The plaintiffs are asserting claims 1, 2, 4, 18, 19, and 20 of the '978 Patent against all defendants.
30. The plaintiffs are asserting claims 1, 10, and 16 of the '448 Patent against all defendants.
31. The plaintiffs are asserting claims 1, 10, and 18 of the '449 Patent against all defendants.
32. The plaintiffs are asserting claim 1 of the '359 Patent against all defendants.
33. The plaintiffs assert that the claims of the '978 and '448 Patents are directed to pharmaceutical compositions, which the defendants directly infringe.
34. The plaintiffs assert that the claims of the '359 and '449 Patents are method claims, which the defendants infringe by inducement.
35. Claim 1 of the '978 Patent reads:
A pharmaceutical composition suitable for once-a-day administration of trospiumchloride comprising controlled release solid, trospium chloride-bearing particulates, at least a portion of which releases trospiumchloride in the lower gastrointestinal (GI) tract, such that once-a-day administration of said pharmaceutical composition provides steady state blood levels of trospium that are comparable to steady state blood levels of trospium achieved with twice daily administration of 20 mg immediate release trospiumchloride tablets, said particulates comprising at least one polymer selected from enteric polymers, release controlling polymers, or combinations thereof.
36. Claim 2 of the '978 Patent reads: The composition of claim 1, in which once-a-day administration...
To continue reading
Request your trial
-
Purdue Pharm. Prods. L.P. v. Actavis Elizabeth LLC
...that the in vitro system adequately modeled the results that would be derived from in vivo conditions. Allergan, Inc. v. Watson Labs., Inc.-Florida, 869 F. Supp. 2d 456, 500 (D. Del.) aff'd, 470 F. App'x 903 (Fed. Cir. 2012). Because the Court finds (and explains below) that at trial, Plain......
-
Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.
...context, “a showing of copying ... is not compelling evidence [of nonobviousness].” Id. at 373;see also Allergan, Inc. v. Watson Labs., Inc.-Florida, 869 F.Supp.2d 456, 485 (D.Del.2012); Aventis Pharma S.A. v. Hospira, Inc., 743 F.Supp.2d 305, 349 (D.Del.2010). In affirming the Purdue Pharm......
- Halebian v. Berv
-
Supernus Pharms. Inc. v. Actavis Inc.
...Pharm. Corp. v. Watson Labs., Inc., 611 F. App'x 988, 996 (Fed. Cir. 2015). Defendants rely upon Allergan, Inc. v. Watson Labs., Inc. - Florida, 869 F. Supp. 2d 456, 483 (D. Del.) aff'd, 470 F. App'x 903 (Fed. Cir. 2012) to demonstrate that an absorption window impediment is no impediment a......