United States District Court, D. Delaware
[Copyrighted Material Omitted]
For AbbVie Inc., Plaintiff: Mary B. Graham, LEAD ATTORNEY, Derek James Fahnestock, Jeremy A. Tigan, Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE; David P. Frazier, Krista E. Bianco, Robert F. Shaffer, Shana K. Cyr, PRO HAC VICE.
For Hospira Inc., Defendant: Melanie K. Sharp, LEAD ATTORNEY, Monte Terrell Squire, Young, Conaway, Stargatt & Taylor LLP, Wilmington, DE; Aparnaa Saini, Heather M. Schneider, Michael W. Johnson, Sara Kapner, Thomas J. Meloro, PRO HAC VICE.
For AbbVie Inc., Counter Defendant: Mary B. Graham, LEAD ATTORNEY, Derek James Fahnestock, Jeremy A. Tigan, Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
For Hospira Inc., Counter Claimant: Melanie K. Sharp, LEAD ATTORNEY, Monte Terrell Squire, Young, Conaway, Stargatt & Taylor LLP, Wilmington, DE.
GREGORY M. SLEET, UNITED STATES DISTRICT JUDGE.
In this patent infringement action, plaintiff AbbVie Inc. (" AbbVie" ) alleges that a pharmaceutical product proposed by defendant Hospira, Inc. (" Hospira" ) infringes the asserted claims of the patent-in-suit. (D.I. 1.) The court held a two-day bench trial in this matter on November 12 through November 13, 2013. (D.I. 195-196.) Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning the validity of the patent-in-suit, specifically whether Hospira's proposed product infringes the patent-in-suit and whether the asserted claims are invalid as obvious under 35 U.S.C. § 103. (D.I. 190-191.)
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) the asserted claims of the patent-in-suit are not invalid due to obviousness; (2) Hospira's proposed product does not infringe U.S. Patent Number 6,136,799 (" the '799 Patent" ); and (3) the parties' Rule 52(c) motions (D.I. 190-191) 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 FACT
A. The Parties
1. Plaintiff AbbVie Inc. (" AbbVie" ) is a corporation organized and existing under the laws of the state of Delaware, having its headquarters and principal place of business at 1 North Waukegan Road, North Chicago, Illinois 60064. AbbVie was substituted for Abbott Laboratories (" Abbott" ) as a plaintiff in this action pursuant to the court's order of April 10, 2013. (D.I. 163.)
2. Defendant Hospira Inc. (" Hospira" ) is a corporation organized and existing under the laws of the state of Delaware, having its principal place of business at 275 North Field Drive, Lake Forest, Illinois 60045.
3. The court has subject matter jurisdiction, as well as personal jurisdiction over all parties.
4. AbbVie is the current holder of approved New Drug Application (" NDA" ) No. 20-819 for injectable paricalcitol products.
5. Under the trade name Zemplar® , AbbVie sells paricalcitol injectable products in 2 mcg/mL, 5 μ /mL, and 10 μ /2 mL (5 μ /mL) formulations.
6. Zemplar® injection is indicated for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (" CKD" ) Stage 5.
7. Zemplar® injection was approved by the United States Food and Drug Administration (" FDA" ) on April 17, 1998.
8. The active pharmaceutical ingredient of Zemplar® injection is paricalcitol, a synthetically manufactured vitamin D analog. Paricalcitol is known as 1α , 25-dihydroxy-19-nor-vitamin D2 or 19-nor-1α ,3α ,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene.
9. The inactive ingredients in Zemplar® injection are 20% (v/v) ethanol, 30% (v/v) propylene glycol, and 50% (v/v) water.
10. The '799 patent is currently listed in the FDA publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations (the " Orange Book" ) with respect to Zemplar® injection.
11. On January 22, 2010, AbbVie submitted a supplement to NDA 20-819 seeking approval to change the use and labeling of the Zemplar® injection 10 μ /2 mL presentation from a single-dose to a multi-dose vial.
C. The Patents-in-Suit
12. United States Patent Number 6,136,799 (" the '799 Patent" ), entitled " Cosolvent Formulations," naming Lukchiu Li, Edward Anthony Pec, Daniel H. Robinson, Dennis A. Stephens, Kathee Jantzi, Thomas Barton May, and John Paul Oberdier as inventors, was issued on October 24, 2000.
13. AbbVie is the owner by assignment of the '799 Patent and has standing to bring suit on the '799 patent.
14. U.S. Application No. 09/057,143, which issued as the '799 patent, was filed with the PTO on April 8, 1998.
1. The Asserted Claims
15. AbbVie asserts claims 7-9 of the '799 patent.
i. '799 Patent, Claim 7
16. Claim 7 of the '799 patent depends on claim 6, which depends on claim 1. Read together, claim 7 states:
A sterilized, self-preserved, aqueous pharmaceutical composition for parenteral administration consisting essentially of a therapeutically effective amount of par[i]calcitol or calcitriol, about 50% (v/v) of an organic solvent selected from the group consisting of ethanol in the range of about 15% to about 30% (v/v) and propylene glycol in the range of about 20% to about 35% (v/v), and about 50% (v/v) water.
ii. '799 Patent, Claim 8
17. Claim 8 of the '799 patent reads: The composition of claim 7 wherein the vitamin D compound is present between about 2 ...