Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust

• Decision Date: 20 June 2013
• Docket Number: No. 11 Civ. 2541(PAC).,11 Civ. 2541(PAC).
• Citation: 956 F.Supp.2d 429
• Parties: ABBVIE INC. and Abbvie Biotechnology Limited, Plaintiffs–Counterclaim–Defendants, v. The MATHILDA AND TERENCE KENNEDY INSTITUTE OF RHEUMATOLOGY TRUST, Defendant–Counterclaim–Plaintiff.
• Court: U.S. District Court — Southern District of New York

956 F.Supp.2d 429

ABBVIE INC. and Abbvie Biotechnology Limited, Plaintiffs–Counterclaim–Defendants,
v.
The MATHILDA AND TERENCE KENNEDY INSTITUTE OF RHEUMATOLOGY TRUST, Defendant–Counterclaim–Plaintiff.

No. 11 Civ. 2541(PAC).

United States District Court,
S.D. New York.

June 20, 2013.

[956 F.Supp.2d 432]

Gerald Gordon Paul, Grant Alan Shehigian, Flemming Zulack Williamson Zauderer, LLP, New York, NY, Casey Lynn Dwyer, Cora Renae Holt, David P. Frazier, Jennifer A. Johnson, John T. Battaglia, Michael A. Morin, Robert F. Shaffer, Finnegan Henderson Farabow Garrett & Dunner LLP, Washington, DC, Steven P. O'Connor, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., Reston, VA, for Plaintiffs–Counterclaim–Defendants.

John Patrick White, Norman H. Zivin, Robert Thomas Maldonado, Cooper & Dunham LLP, Charles Joseph Boudreau, Gibson Dunn & Crutcher LLP, New York, NY, Azar Mouzari, Timothy P. Best, pro hac, vice, Wayne M. Barsky, Gibson, Dunn & Crutcher LLP, Los Angeles, CA, for Defendant–Counterclaim–Plaintiff.

FINDINGS OF FACT AND CONCLUSIONS OF LAW
PAUL A. CROTTY, District Judge:

TABLE OF CONTENTS

FINDINGS OF FACT
434

I.	THE PARTIES	434
II.	II. RHEUMATOID ARTHRITIS AND ITS TREATMENT	434

A.	Rheumatoid Arthritis	434
B.	Treatment of Rheumatoid Arthritis	435
C.	Methotrexate	435
D.	Treatment of Rheumatoid Arthritis with Combination Therapy	436
E.	Anti–Tumor Necrosis Factor Alpha Antibodies	437

III. KENNEDY'S DISCOVERIES
438

A.	Kennedy's Early Work with cA2	438
B.	Kennedy's Open Label cA2 Study	440
C.	Kennedy's Anti–CD4 and Anti–TNFa Combination Study	440
D.	Kennedy's Extension Study of cA2 in Humans	441
E.	The Double–Blind Placebo–Controlled Trials of cA2	442

IV. OTHER RESEARCH AND PUBLICATIONS
442

A.	Schwieterman Discussion of Combination Treatment	442
B.	The Rankin CDP571 Trial	444
C.	Higgins Report on CDP571 and Methotrexate Combination Treatment	444

V.	THE T–14 STUDY	445
VI.	KENNEDY'S PATENTS	448

A.	The '248 Application	448
B.	The '766 Patent	449
C.	The Claims of the '766 Patent	449
D.	The Specification of the '766 Patent	450
E.	Prosecution History of the '766 Patent	454
F.	The '004 Application	461
G.	The '631 Application	463
H.	The '442 Patent and Specification	470
I.	The Claims of the '442 Patent	470

VII. THE INSTANT DISPUTE
472

A.	Humira	472
B.	Abbott's Sublicenses to Kennedy's Patents	472

CONCLUSIONS OF LAW
473

I.	JURISDICTION	473
II.	OBVIOUSNESS–TYPE DOUBLE PATENTING	473
A. The Doctrine of Obviousness–Type Double Patenting	473
B. Claim Construction	474
C. Patentably Distinct Claims	476
III.	THE PERSON OF ORDINARY SKILL IN THE ART	477
IV.	THE SIMILARITIES AND DIFFERENCES BETWEEN THE CLAIMS OF THE '766 AND '442 PATENTS	478

A.	Construction of Claims 8 through 14 of the '766 Patent	478
B.	Construction of Claims 1 through 7, 13, 14, and 17 through 20 of the '442 Patent	482
C.	The Differences Between Claims 8 through 14 of the '766 Patent and Claims 1 and 2 of the '442 Patent	484
D.	The Differences Between Claims 8 through 14 of the '766 Patent and Claims 3 through 7, and 13 of the '442 Patent	488
E.	The Differences Between Claims 8 through 14 of the '766 Patent and Claims 14 and 17 through 20 of the '442 Patent	491

CONCLUSION
493

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Plaintiffs–Counterclaim–Defendants Abbvie Inc. and Abbvie Biotechnology Limited (collectively, “Abbott”) bring this action against Defendant–Counterclaim–Plaintiff The Mathilda and Terence Kennedy Institute of Rheumatology Trust (“Kennedy”) for a declaratory judgment that each of claims 1 through 7, 13, 14, and 17 through 20 of Kennedy's U.S. Patent No. 7,846,442 (the “'442 patent”) is invalid for obviousness-type double patenting over claims 8 through 14 of U.S. Patent No. 6,270,766 (the “'766 patent”). Kennedy denies that these claims of the '442 patent are invalid for obviousness-type double patenting and counterclaims for a declaratory judgment that each of these claims of the '442 patent is not invalid.¹ The Court held a four-day bench trial in this action from September 18 through September 21, 2012.² After considering the parties' arguments,

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pretrial memoranda of law, and proposed findings of fact and conclusions of law, and evaluating the evidence produced at trial, including the documentary record and the testimony of the witnesses, the Court sets forth its Findings of Fact and Conclusions of Law pursuant to Federal Rule of Civil Procedure 52(a). For the following reasons, the Court concludes that each of claims 1 through 7, 13, 14, and 17 through 20 of the ' 442 patent is invalid for obviousness-type double patenting and that Kennedy has failed to prove its counterclaim that these claims of the ' 442 patent are not invalid.

FINDINGS OF FACT I. THE PARTIES

1. As of the initiation of this action, Abbott Laboratories was an Illinois corporation with a principal place of business in Illinois and conducted business in this District.³ (Compl. ¶ 2, ECF No. 1.) Pursuant to Federal Rule of Civil Procedure 25 and a Stipulation and Order Substituting Parties entered on January 11, 2013, Abbvie Inc. was substituted for Abbott Laboratories for all purposes with respect to Plaintiffs' claims and Defendant's counterclaims in this action. (ECF No. 119.) Abbvie Biotechnology Limited (formerly named Abbott Biotechnology Limited) is a corporation organized under the laws of Bermuda, with a place of business in Hamilton, Bermuda. Through intermediate organizations, Abbott Biotechnology Limited was formerly owned by Abbott Laboratories. (Compl.¶ 3.) The Court refers to the Plaintiffs–Counterclaim–Defendants collectively as “Abbott” throughout these Findings of Fact and Conclusions of Law. At all relevant times, Abbott was engaged in the development, sale, and distribution of a broad range of pharmaceuticals and other health-care products. ( Id. ¶ 2.)

2. The Mathilda and Terence Kennedy Institute of Rheumatology Trust is organized and exists under the laws of the United Kingdom, with a place of business in London, England. Kennedy is the owner of certain United States patents, including the '766 patent and the '442 patent. ( Id. ¶ 5; Am. Answer ¶ 5, ECF No. 40.)

II. RHEUMATOID ARTHRITIS AND ITS TREATMENTA. Rheumatoid Arthritis

3. Rheumatoid arthritis is an autoimmune disease characterized by inflammation of the joints. This inflammation, if left untreated, may result in joint pain and swelling, cartilage and bone destruction, deformity, incapacity, and potentially life-threatening complications. It may reduce life expectancy by up to a decade. At present, there is no cure for rheumatoid arthritis. Rheumatoid arthritis is estimated to affect approximately 0.6 to 1% of the U.S. population. (Tr.⁴ at 136:23–137:13, 137:16–18, 138:18–19; Ex. 1408.1, Mark J. Borigini & Harold E. Paulus, “Rheumatoid Arthritis,” in Treatment of the Rheumatic Diseases (Michael Weismann & Michael Weinblatt eds., 1995), at ABTKEN00444893–94.⁵)

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4. Physicians identify rheumatoid arthritis and measure its severity based on the presence of a variety of signs and symptoms, including morning stiffness, fatigue, pain, and tenderness and swelling of the joints. (Tr. at 138:2–7, 140:17–22, 456:22–457:20.)

B. Treatment of Rheumatoid Arthritis

5. Historically, the treatment of rheumatoid arthritis would begin with nonsteroidal anti-inflammatory drugs (“NSAIDs”), such as ibuprofen and aspirin, to reduce the pain and swelling caused by the disease. While treating symptoms, these medications do not stop or impede the progression of the disease or the damage it causes to the body. (Tr. at 138:20–23, 164:7–13, 164:20–165:1; Ex. 1408.1 at ABTKEN00444895–98.)

6. For patients for whom NSAID treatment did not work, rheumatologists would frequently prescribe cortisone or corticosteroids to reduce pain and swelling. These medications serve as anti-inflammatories, but can have negative side effects. (Tr. at 164:14–16, 165:5–14; Ex. 1408.1 at ABTKEN00444903–06.)

7. Beyond these treatments are disease-modifying antirheumatic drugs, or “DMARDS.” DMARDs are more effective than NSAIDs in reducing the inflammation associated with rheumatoid arthritis, but can produce more serious side effects than the above treatments. Drugs classified as DMARDs include methotrexate, gold compounds, azathioprine, hydroxychloroquine, and sulfasalazine. (Tr. at 165:15–166:18; Ex. 1408.1 at ABTKEN00444898–03.)

C. Methotrexate

8. Methotrexate is a drug that inhibits folic acid metabolism and was originally developed in the late 1940s for the treatment of childhood leukemia. Reports of methotrexate's positive effects in rheumatoid arthritis patients were published in the 1950s, but methotrexate was not adopted as a common treatment for this disease until much later. (Tr. at 166:23–167:14.)

9. By 1985, Dr. Michael Weinblatt and others were studying the use of methotrexate to treat rheumatoid arthritis. A 1985 Weinblatt study reported on the first randomized, placebo-controlled trials of short-term methotrexate treatment for this purpose and provided evidence of the short-term efficacy of methotrexate in the treatment of rheumatoid arthritis. ( Id. at 169:2–170:12; Ex. FD, Michael Weinblatt et al., “Efficacy of Low–Dose Methotrexate in Rheumatoid Arthritis,” New Eng. J. Med. 312:818 (1985).)

10. In 1988, the Food and Drug Administration (“FDA”) approved methotrexate for the treatment of rheumatoid arthritis. (Tr. at 170:24–25.)

11. Subsequent long-term, controlled trials established that methotrexate remained effective for treating rheumatoid arthritis over many years of therapy with acceptable toxicity levels. ( Id. at 171:12–172:11; Ex. 1497, Michael Weinblatt et al., “Methotrexate in Rheumatoid Arthritis,” Arth. & Rheum. 37:1492 (1994).)

12. By 1994, studies and trials “ha[d] documented the efficacy of methotrexate and ha[d] indicated that its onset of action is more rapid than other DMARDs, and patients tend[ed] to remain on therapy

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with methotrexate longer than they remain[ed] on other DMARDs because of better clinical responses and less toxicity.” Additionally...