AbbVie Inc. v. Kennedy Inst. of Rheumatology Trust, No. 13-1545 (Fed. Cir. 2014)
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The Kennedy patents cover a popular treatment for rheumatoid arthritis: a combination therapy of a disease-modifying antirheumatic drug and an antibody. The 766 patent expired in October 2012; the 422 patent will expire in August 2018. In 2002, AbbVie1 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 more than $100 million in royalties for AbbVie’s U.S. sales of Humira. When the 442 patent issued in 2010, Kennedy demanded that AbbVie secure an additional license for that patent in order to continue sales of Humira. Kennedy conceded that the 766 patent encompasses the same inventive subject matter as the 442 patent, but contended that the 442 patent was nonetheless patentable because 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. AbbVie obtained a declaratory judgment that claims of the 442 patent were invalid over the 766 patent for obviousness-type double patenting. The Federal Circuit affirmed.
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