ABBVIE INC. AND ABBVIE BIOTECHNOLOGY LIMITED, Plaintiffs-Appellees,
THE MATHILDA AND TERENCE KENNEDY INSTITUTE OF RHEUMATOLOGY TRUST, Defendant-Appellant
Appeal from the United States District Court for the Southern District of New York in No. 11-CV-2541, Judge Paul A. Crotty.
MARK A. PERRY, Gibson, Dunn & Crutcher LLP, of Washington, DC, argued for defendant-appellant. With him on the brief were WAYNE M. BARSKY and TIMOTHY P. BEST, of Los Angeles, California. Of counsel on the brief were JOHN P. WHITE, NORMAN H. ZIVIN and ROBERT T. MALDONADO, Cooper & Dunham LLP, of New York, New York.
MICHAEL A. MORIN, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Washington, DC, argued for plaintiffs-appellees. With him on the brief were DAVID P. FRAZIER, CASEY L. DWYER and CORA R. HOLT.
Before DYK, WALLACH, and CHEN, Circuit Judges.
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 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
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) 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 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.
Titled " Anti-TNF Antibodies and Methotrexate in the Treatment of Arthritis and Crohn's Disease," the '766 patent application was filed on August 1, 1996, and claimed priority to a date of October 8, 1992. The specification clarifies that the invention
is also based on the unexpected and dramatic discovery that a multiple dose regimen of . . . an [anti-TNF] antibody, when administered adjunctively with methotrexate to an individual suffering from a TNF-mediated disease[,] produces a highly beneficial or synergistic clinical response for a significantly longer duration compared to that obtained with a single or multiple dose regimen of the antagonist administered alone or that obtained with methotrexate administered alone.
'766 Patent col. 2 ll. 39-48 (emphases added).
The '766 patent then claims a method of co-administering the anti-TNFα antibody and methotrexate. Independent claim 8 is representative: " A method of treating rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and an [anti-TNFα ] antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts." '766 Patent col. 35 ll. 59-63.
Claims 9 through 14 depend, either directly or indirectly, on claim 8, adding additional limitations to the method of treating rheumatoid arthritis set forth in claim 8. '766 Patent col. 35 l. 64 to col. 36 l. 51. For example, claim 9 recites " [a]
method of claim 8 wherein the [anti-TNFα ] antibody or antigen-binding fragment is administered in a series of doses separated by intervals of days or weeks." '766 Patent col. 35 ll. 64-67. The '766 patent issued on August 7, 2001, and expired on October 8, 2012.
After the issuance of the '766 patent, the inventors obtained a second patent, the '442 patent, on the method of treatment described therein. Although Kennedy admits that the claims of the '442 patent are encompassed by those of the '766 patent, Kennedy argued that the claims of the '442 patent were separately patentable.
The '442 patent application was filed on September 12, 2005, and claimed priority to the date the '766 patent was filed: August 1, 1996. The specification of the '442 patent is identical to that of the '766 patent. Independent claim 1 of the '442 patent is representative:
1. A method of treating an individual suffering from rheumatoid arthritis whose active disease is incompletely controlled despite already receiving methotrexate comprising adjunctively administering with methotrexate therapy a different composition comprising an anti-human [TNFα ] antibody or a human [TNFα ] binding fragment thereof to the individual, wherein the anti-human [TNFα ] or fragment thereof (a) binds to an epitope on human [TNFα ], (b) inhibits binding of human [TNFα ] to human [TNFα ] cell surface receptors and (c) is administered at a dosage of 0.01-100 mg/kg, and wherein such administration reduces or eliminates signs and symptoms associated with rheumatoid arthritis.
'442 Patent col. 35 ll. 2-15. The remaining claims are similar. Unlike the '766 patent, which is directed towards all " individual[s] in need" of rheumatoid arthritis treatment, '766 Patent col. 35 ll. 35-36, the '442 patent claims treatment of a more specific patient group: individuals with " active disease." '442 Patent col. 35 l. 3. The claim language is also different in that the '442 patent references " adjunctively administering" the two drugs, '442 Patent col. 35 l. 5, whereas the '766 patent refers to " co-administering" the two drugs. '766 Patent col. 35 l. 36. The '442 patent issued on December 7, 2010, and expires on August 21, 2018--six years after the expiration of the '766 patent. Both the '766 and '442 patents were assigned to Kennedy.
On December 23, 2002, AbbVie sought and obtained a license to the '766 patent. Thereafter, AbbVie obtained FDA approval to sell Humira, an anti-TNFα antibody, for use either alone or in combination with methotrexate to treat rheumatoid arthritis. AbbVie paid Kennedy over $100 million in royalties for AbbVie's sale of Humira in the United States. Once the '442 patent issued in 2010, Kennedy demanded that AbbVie secure an additional license for that patent in order to continue sales of Humira.
Unwilling to pay further royalties for the right to sell the same product, AbbVie filed this action in the district court on April 13, 2011. AbbVie sought a declaratory judgment that claims of the '442 patent were invalid over the '766 patent for obviousness-type double patenting. After a bench trial, the district court ruled that claims 1-7, 13, 14, and 17-20 of the '442 patent (all of the claims that are the subject of the declaratory judgment action) were invalid over claims 8-14 of the '766 patent. While Kennedy conceded that the '766 patent encompasses the same inventive subject matter as the '442 patent ( i.e.,
that the '766 patent is a dominant patent), Kennedy contended that the '442 patent was nonetheless patentable over the '766 patent. Kennedy argued that the '766 patent claims a " broad genus" of methods for treating rheumatoid arthritis, whereas the '442 patent claims a " narrower species" of those treatment methods with unexpected results. Appellant's Br. 4.
As the first step of the obviousness-type double patenting inquiry, the district court construed the claims of the patents and rejected Kennedy's proposed construc-tions of the terms " co-administering," as it is used in the '766 patent, and " active disease," as it is used in the '442 patent. Kennedy argued that the word " co-administering" should be construed to cover not only the administration of methotrexate and the antibody together, but also a scenario in which a patient receives methotrexate alone, is taken off methotrexate, and then receives the antibody alone. The district ...