Merck Sharp & Dohme B.V. v. Warner Chilcott Co.

212 F. Supp. 3d 531, 2016 WL 4497054
CourtDistrict Court, D. Delaware
DecidedAugust 26, 2016
DocketCivil Action No. 13-2088-GMS
StatusPublished

This text of 212 F. Supp. 3d 531 (Merck Sharp & Dohme B.V. v. Warner Chilcott Co.) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Merck Sharp & Dohme B.V. v. Warner Chilcott Co., 212 F. Supp. 3d 531, 2016 WL 4497054 (D. Del. 2016).

Opinion

MEMORANDUM OPINION

GREGORY M. SLEET, UNITED STATES DISTRICT JUDGE

I. INTRODUCTION

In this patent infringement action, plaintiff Merck Sharp & Dohme B.V. (“Merck”) alleges that a pharmaceutical product proposed by defendants Warner Chilcott Company, LLC and Warner Chilcott (US), LLC (collectively “Warner Chilcott”) infringe the asserted claims of U.S. Patent No. 5,989,581. (D.I. 1.) The court held a four-day bench trial in this matter on January 19 through January 22, 2016. 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. (D.I. 140-141.)

[534]*534Pursuant to Federal Rule of Civil Procedure 52(a), and having considered the entire record in this case and the applicable law, the court concludes that (1) the asserted claims of the ’581 patent are not invalid as anticipated under 35 U.S.C. § 102(b); (2) the asserted claims of the ’581 are invalid as obvious under 35 U.S.C. § 103; and (3) each of the parties’ Rule 52(e) 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 FACT1

A. The Parties

1. Plaintiff Merck Sharp & Dohme B.V. (“Merck”) is a corporation organized and existing under the laws of the Netherlands with its principal place of business at Waarderweg 39, Haarlem, Netherlands 2031 BN. (D.I. 1.)

2. Plaintiff is a wholly owned subsidiary, through intervening affiliated companies, of Merck & Co., Inc., a Delaware corporation. (D.I. 1.)

3. Warner Chilcott Company LLC is a limited liability company organized and existing under the laws of Puerto Rico, having a place of business at Union Street, Road 195, Km 1.1, Fajardo, Puerto Rico 00738-1005. (D.I. 11.)

4. Warner Chilcott (US), LLC is a limited liability company organized and existing under the laws of Delaware, having a place of business at 100 Enterprise Drive, Suite 280, Rockaway, New Jersey 07866. (D.I. 11.)

5. Warner Chilcott Company LLC and Warner Chilcott (US) LLC are collectively referred to herein as “Warner Chilcott” or “Defendants.”

6. The court has subject matter jurisdiction, as well as personal jurisdiction over all parties.

B. Background

7. Organon USA Inc., a company affiliated with the Plaintiff, holds an approved New Drug Application (“NDA”) No. 21-187, under Section 505(a) of the Federal Food, Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for ethinyl estradiol and etonogestrel vaginal ring, 0.015 mg/ day and 0.12 mg/day, which is sold under the trade name NuvaRing. (D.I. 1.)

8. NuvaRing was approved by the FDA in October 2001 as a contraceptive and is indicated for the prevention of pregnancy.

9. The Plaintiff and its corporate predecessors have been marketing and selling NuvaRing since 2002.

10. The active pharmaceutical ingredients of NuvaRing are etonogestrel, a pro-gestogenic steroid, and ethinyl estradiol, an estrogenic steroid.

11. The ’581 patent is currently listed the Orange Book with respect to NuvaR-ing.

12. The current NuvaRing prescribing information states that NuvaRing “is a [535]*535non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonoges-trel (13-ethyl-17-hydroxy-ll-methylene-18,19-dinor-17a-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17a-pregna-l,3,5(10)-trien-20-yne-3, 17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etono-gestrel and 0.015 mg/day of ethinyl estra-diol over a three-week period of use.”

C. The Patent-in-Suit

13. U.S. Patent No. 5,989,581 (“the ’581 patent”), which is entitled “Drug Delivery System for Two or More Active Substances” and lists Rudolf Johannes Joseph Groenewegen as the sole inventor, issued on November 23,1999.

14. The ’581 patent issued from U.S. Patent Application No. 09/056,700, filed in the United States Patent and Trademark Office (“USPTO”) on April 8,1998.

15. U.S. Patent Application No. 09/056,-700 purports to claim priority to European Patent Office Application No. 97/201,098 (“the ’098 application”), filed on April 11, 1997.

16. The.’581 patent is assigned to Akzo Nobel N.V.

17. According to FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), the ’581 patent expires on April 8, 2018.

D. The Asserted Claims

18. The claims of the ’581 patent that are asserted in this action are 2-4 and 8-11.

19. Claim 2 of the ’581 patent recites: “A drug delivery system according to claim l,2 wherein the delivery system has a substantially ring-shaped form and is intended for vaginal administration of the mixture of the progestogenic and estrogenic compounds.”

20. Claim 3 of the ’581 patent recites: “A drug delivery system according to claim 1, wherein at least the skin material comprises ethylene-vinyl acetate copolymer as the thermoplastic polymer.”

21. Claim 4 of the ’581 patent recites: “A drug delivery system according to claim 1, wherein the amount of progesto-genic compound dissolved in the thermoplastic core material is 2 to 5 times the amount necessary for obtaining saturation concentration.”

22. Claim 6 of the ’581 patent recites:
A drug delivery system according to claim 5,3 wherein the thermoplastic poly[536]*536mer used for the core material is an ethylene-vinylacetate copolymer, the thermoplastic polymer used for the skin material is an ethylene-vinylacetate co-polymer, the thermoplastic polymer used for the skin material is an ethylene-vinylacetate copolymer, said core comprising a mixture of a progestogenic compound etonogestrel and an estrogenic compound ethinyl estradiol in a ratio of 10 parts to 2-A parts, said core comprising from 0.8 up to about 1% by weight of etonogestrel and from about 0.05 to about 0.3% by weight of ethinyl estradiol.

23. Claim 8 of the ’581 patent recites: “A drug delivery system according to claim 6, characterised in that the skin is an ethylene-vinylacetate copolymer skin having a thickness ranging from 40 to 300 pm and a vinylacetate content ranging from 5 to 15%.”

24. Claim 9 of the ’581 patent recites: “A drug delivery system according to claim 8, characterised in that the skin thickness is 80 to 150 pm and the vinyl acetate content is 9-10%.”

25.

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Bluebook (online)
212 F. Supp. 3d 531, 2016 WL 4497054, Counsel Stack Legal Research, https://law.counselstack.com/opinion/merck-sharp-dohme-bv-v-warner-chilcott-co-ded-2016.