JOEL A. PISANO, District Judge.
These are patent infringement actions brought by plaintiff Warner Chilcott Company, LLC against defendants Lupin Ltd, Lupin Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC, Amneal Pharmaceuticals of NY, LLC, Inc. with respect to U.S. Patent No. 7, 704, 984 ("the '984 patent"). A seven-day bench trial was held during the period of October 7 through October 17, 2013, and the issue for trial was defendants' assertion that the '984 patent was invalid based on obviousness. This Opinion constitutes the Court's findings of fact and conclusions of law. After careful consideration of the evidence before it, the Court finds in favor of Plaintiffs.
A. The Parties and the Nature of the Case
These are actions for patent infringement under 35 U.S.C. § 271(e)(2)(A). Plaintiff Warner Chilcott Company, LLC ("Warner" or "Plaintiff") is a limited liability company organized and existing under the laws of Puerto Rico. Final Pretrial Order ("FPO") at 4. Warner is the holder of New Drug Application ("NDA") No. 22-501, for Lo Loestrin Fe (referred to herein as "Lo Loestrin"), an oral female contraceptive product.
Defendant Lupin Limited is a corporation organized and existing under the laws of India. Id. Defendant Lupin Pharmaceuticals, Inc. is a wholly-owned subsidiary of Lupin Ltd., and is a corporation organized and existing under the laws of the State of Virginia. Id. Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, "Lupin") filed an Abbreviated New Drug Application ("ANDA") No. 20-3113 with the U.S. Food and Drug Administration ("FDA") seeking approval to market a product that is the subject of Lupin's ANDA, which Lupin contends is bioequivalent to, and refers to, Warner's Lo Loestrin. Pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), Lupin's ANDA certified to the FDA that the '984 patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of Lupin's ANDA Product. FPO at 5. Pursuant to 21 U.S.C. § 355(j)(2)(B), in a letter dated July 19, 2011, Lupin notified Warner that Lupin had filed its ANDA, which included a Paragraph IV Certification with respect to the '984 patent. Id.
On September 1, 2011, Warner filed a complaint against Lupin alleging that the filing of Lupin's ANDA infringed the '984 patent under 35 U.S.C. § 271(e)(2)(A). Lupin has since stipulated that the manufacture, use, offer for sale or sale of Lupin's ANDA product within the United States or importation of Lupin's ANDA product into the United States would infringe claims 1-9 of the '984 patent, assuming the claims are not invalid and are enforceable. Id. at p. 6. Lupin has asserted counterclaims against Warner alleging that the '984 patent, including all of its claims, are invalid. Id.
Amneal Pharmaceuticals of NY, LLC, Inc. and its parent Amneal Pharmaceuticals, LLC (collectively "Amneal") are also defendants in this matter. By Stipulation and Order dated October 7, 2013, Amneal was substituted as a defendant in Civil Action 12-2928 for Watson Laboratories, Inc. ("Watson"). Civ. Action No. 12-2928, D.E. No. 79. Watson had filed an ANDA (No. 20-2982) with the FDA, seeking approval to market a product ("Watson's ANDA Product") that Watson contended is bioequivalent to, and refers to, Lo Loestrin. FPO at 6. Pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), Watson's ANDA certified to the FDA that the '984 patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of Watson's ANDA Product. Id. Pursuant to 21 U.S.C. § 355(j)(2)(B), in a letter dated April 4, 2012, Watson notified Warner that Watson had filed its ANDA, which included a Paragraph IV Certification with respect to the '984 patent. Id. On May 16, 2012, Warner filed the instant action against Watson.
On or about October 1, 2013, Watson sold the ANDA for the Watson ANDA Product to Amneal. Id. Amneal has stipulated that it stands in the shoes of Watson for purposes of this litigation. Civ. Action No. 12-02928, D.E. No. 79. Further, Amneal has adopted "everything that Lupin has done through the trial as if Amneal had presented that evidence" and agreed that "whatever decision comes down in the Lupin case with respect to the validity of the patent-in-suit... will also be entered in the Amneal suit with Warner Chilcott." Tr. 994:14-22.
B. The '984 Patent
The '984 patent, entitled "Extended Estrogen Dosing Contraceptive Regimen" was issued by the United States Patent and Trademark Office on April 27, 2010. FPO at 7-8. The 11/112, 290 application that led to the '984 patent was filed on April 22, 2005. Id. at 8. Roger M. Boissonneault is the named inventor of the '984 patent. Id.
The '984 patent is directed to a method of contraception with three compositions for administration:
the first composition containing a progestin and ethinyl estradiol;
the second composition containing only ethinyl estradiol; and
a final composition containing no active ingredient (progestin or estrogen), but optionally containing an iron supplement.
JTX-1 at col. 2, ll.33-46, col. 3, ll.56-63.
The nine claims of the '984 patent read as follows:
1. A method of contraception comprising the steps of sequentially administering to a female of child-bearing age: (a) a first composition containing a progestin in an amount equivalent to about 0.3 to about 1.5 mg norethindrone acetate wherein the progestin is selected from norethindrone acetate or norethindrone and 5 to 15 03bcg of ethinyl estradiol for 24 days; (b) a second composition containing 5 to 15 03bcg of ethinyl estradiol and substantially free of a progestin for 2 days; and (c) a third composition that is a placebo, wherein the sequential administration of the first composition, the second composition and the third composition, is performed on a daily basis over a 28 day cycle.
2. The method according to claim 1, wherein the sequential administration is repeated beginning the day after completion of the 28 day cycle.
3. The method according to claim 1, wherein the progestin in the first composition is norethindrone acetate.
4. The method according to claim 3, wherein the amount of norethindrone acetate in the first composition is about 1 mg.
5. The method according to claim 1, wherein the placebo contains about 75 mg of ferrous fumarate.
6. The method according to claim 4, wherein the amount of ethinyl estradiol in the first and second composition is the same.
7. A method of contraception comprising the steps of sequentially administering to a female of child-bearing age: (a) a first composition containing about 0.3 to about 1.5 mg norethindrone acetate and 5 to 15 03bcg ethinyl estradiol for 24 days; (b) a second composition containing 5 to 15 03bcg of ethinyl estradiol and substantially free of progestin for 2 days; (c) a third composition that is a placebo for 2 days, wherein the sequential administration of the first composition, the second composition and the third composition is performed on a daily basis over a 28 day cycle.
8. The method according to claim 7, wherein the first composition contains about 1 mg of norethindrone acetate.
9. The method according to claim 7, wherein the amount of ethinyl estradiol in the first and second composition is the same.
Id. at col. 6, ll. 23-64. All nine claims are asserted in this case.
C. Lo Losestrin Fe
Lo Loestrin is an embodiment of the '984 patent, and the '984 patent is listed in FDA's Orange Book as a patent covering the use of Lo Loestrin. DTX-335. As noted above, Warner is the holder of the NDA for Lo Loestrin, which contains the active ingredients norethindrone acetate (also referred to herein as "NA") and ethinyl estradiol (also referred to herein as "EE"). Lo Loestrin was approved by the FDA on October 21, 2010, and is indicated for use by women to prevent pregnancy. FPO at 8. Lo Loestrin is sold as a 28-day oral contraceptive regimen which includes administering on a daily basis over a 28 day cycle (i) 24 active tablets comprising 1 mg norethindrone acetate and 10 micrograms (03bcg) ethinyl estradiol, followed by (ii) 2 active tablets comprising 10 03bcg ethinyl estradiol, followed by (iii) 2 nonhormonal placebo tablets containing 75 mg ferrous fumarate that do not serve any contraceptive purpose. Id.
D. Witnesses at Trial
Defendants presented expert testimony from Dr. Kurt Barnhart, Dr. Jesse David, and Dr. David Blackburn. Plaintiff responded with expert testimony from Dr. Philip Darney, Dr. Risa Kagan, Dr. Ronald Thisted, and Mr. Raymond Sims. The parties also submitted testimony from Roger Boissoneault, Herman Ellman, and Hiran Patel via video deposition testimony.
Kurt T. Barnhart, M.D.
The Court recognized Dr. Barnhart as an expert in the fields of obstetrics and gynecology and clinical epidemiology and biostatistics. Tr. 55:5-10. Dr. Barnhart is a Professor at the University of Pennsylvania. He holds an M.D. from the Mt. Sinai School of Medicine. Dr. Barnhart opined that the invention claimed in the '984 patent was obvious.
Jesse David, Ph.D.
The Court recognized Dr. David as an expert in economics and the economic issues associated with patents. Tr. 254:18-23. Dr. David is a member of Edgeworth Economics. Tr. 252:1-18. He opined that the commercial success of Lo Loestrin is not probative of nonobviousness.
David Blackburn, Ph.D.
The Court recognized Dr. Blackburn as an expert in the field of economics and intellectual property issues relating to economics. Tr. 379:16-21. Dr. Blackburn is a Vice-President at NERA, an economic consulting firm. DTX-256. He opined that the commercial success of Lo Loestrin is not related to the invention claimed in the '984 patent.
Philip A. Darney, M.D., Ms.C.
The Court recognized Dr. Darney as an expert in gynecology, family planning, and contraception. Tr. 613:5-11. Dr. Darney is a Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco. He is the Director of the Bixby Center for Reproductive Health at UCSF and is the Chief of the Department of Obstetrics, Gynecology and Reproductive Services at San Francisco General Hospital. FPO at 26; PTX-130A. Dr. Darney testified regarding the nonobviousness of the '984 patent.
Risa Kagan, M.D.
The Court recognized Dr. Kagan as an expert regarding clinical aspects of gynecologic practice and contraception management. Tr. 971:22-972:1. Dr. Kagan is a Clinical Professor for the University of California, San Francisco and a member of the East Bay Physicians Medical Group, an OB/GYN practice in the Bay area. PTX-128; Tr. 968:4-969:23. Dr. Kagan testified with respect to how clinicians select which oral contraceptive to prescribe, and about her clinical experience with Lo Loestrin.
Ronald A. Thisted, Ph.D.
The Court recognized Dr. Thisted as an expert in statistical methods used in the fields of medicine, biology, and pharmaceutical science. Tr. 487:19-25. 34. Dr. Thisted holds a Ph.D. in Statistics from Stanford University and is a Professor in the Department of Health Studies at the University of Chicago. PTX-129. Dr. Thisted performed statistical analyses related to the Pearl Index calculations for Lo Loestrin and Loestrin 24 Fe ("Loestrin 24"). He also performed calculations related to the number of regimens encompassed by certain prior art patents.
The Court recognized Mr. Sims as an expert in intellectual property research and analysis regarding whether a patented product is a commercial success. Tr. 320:9-15. Mr. Sims is a Vice President at Charles River Associates, an international business and economic consulting firm. He testified regarding the commercial success of Lo Loestrin.
Roger Boissonneault is the inventor of the '984 patent. He is the President and CEO of Warner Chilcott. FPO at 18. His testimony was ...