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United States Court of Appeals for the Federal Circuit
August 21, 2014, Decided
[*1368] [***1002] Dyk, Circuit Judge.
The Mathilda and Terrance Kennedy Institute of Rheumatology Trust (Kennedy) owns U.S. Patent Nos. 7,846,442 (the '442 patent) and 6,270,766 (the '766 patent). Both patents are directed towards methods of treating rheumatoid arthritis by co-administering two drugs. AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively, AbbVie) are licensees of the '766 patent but not the '442 patent. In 2011, AbbVie sued Kennedy in the Southern District of New York for a declaratory judgment that the '442 patent was invalid under the doctrine of obviousness-type double patenting because the '442 patent was not [**2] patentably distinct from the '766 patent. We agree with AbbVie that the '442 patent would have been obvious in light of the '766 patent. Accordingly, we affirm the district court's finding of invalidity.
Rheumatoid arthritis is an autoimmune disease that causes painful joint inflammation. If left untreated, this disease can result in bone destruction and lead to potentially [*1369] life-threatening complications. Although there is no cure for rheumatoid arthritis, scientists have developed a number of treatments that help abate this disease. The patents at issue in this appeal cover a very popular and effective treatment for rheumatoid arthritis: combination therapy of a disease-modifying antirheumatic drug and an antibody.
Kennedy secured two patents on this combination therapy—the '766 and '442 patents. The first (the '766 patent) expired on October 8, 2012, while the second (the '422 patent) [***1003] does not expire until August 21, 2018. The question here is whether the '442 patent is invalid for obviousness-type double patenting. Some background of the two patents is essential to understanding the double patenting issue.
Prior to the advent of this combination therapy, patients were treated with disease-modifying antirheumatic drugs, such as methotrexate. However, in [**3] the 1980s, researchers began to study the use of antibodies in the treatment of rheumatoid arthritis. Antibodies are the proteins that the immune system uses to identify and neutralize foreign bodies such as viruses and bacteria. During this period, the named inventors of the '766 and '422 patents discovered that a protein called Tumor Necrosis Factor Alpha (TNFα) is partially responsible for the inflammation rheumatoid arthritis causes. This discovery led the inventors to research antibodies that block the TNFα protein. In September 1994, the inventors began a study of rheumatoid arthritis patients whose disease had not responded completely to treatment with methotrexate. The inventors gave those patients an anti-TNFα antibody, either alone or in combination with methotrexate treatment. This study, known as the T-14 study, formed the basis of the '766 and '442 patents and demonstrated the utility of the method claimed in the patents. The T-14 study revealed that rheumatoid arthritis patients better responded to anti-TNFα antibodies when they were administered in conjunction with methotrexate as compared to the response observed when either of the drugs was administered alone.
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
764 F.3d 1366 *; 2014 U.S. App. LEXIS 16090 **; 112 U.S.P.Q.2D (BNA) 1001 ***
ABBVIE INC. AND ABBVIE BIOTECHNOLOGY LIMITED, Plaintiffs-Appellees, v. THE MATHILDA AND TERENCE KENNEDY INSTITUTE OF RHEUMATOLOGY TRUST, Defendant-Appellant.
Prior History: [**1] Appeal from the United States District Court for the Southern District of New York in No. 11-CV-2541, Judge Paul A. Crotty.
Abbvie Inc. v. Mathilda & Terence Kennedy Inst., 956 F. Supp. 2d 429, 2013 U.S. Dist. LEXIS 106463 (S.D.N.Y., 2013)
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Civil Procedure, Appeals, Standards of Review, Clearly Erroneous Review, Patent Law, Defenses, Patent Invalidity, General Overview, Evidence, Burdens of Proof, Clear & Convincing Proof, De Novo Review, Infringement Actions, Claim Interpretation, Double Patenting