On August 21, 2017, Sandoz filed two IPR petitions against Humira patents claiming a method for treating ulcerative colitis or Crohn's disease with a total body dose of 40 mg of Humira. Sandoz argues that these patents are invalid based on the PTAB’s decision that invalidated a similar Humira method patent claiming the same dose for treating rheumatoid arthritis.
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IPR2017-01988
8,974,790
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1. A method for treating ulcerative colitis in a human subject, comprising administering subcutaneously to a human subject having ulcerative colitis a total body dose of 40 mg of a human anti-TNFα antibody once every 13-15 days for a time period sufficient to treat the ulcerative colitis, wherein the anti- TNFα antibody comprises [Humira].
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IPR2017-01987
8,911,737
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1. A method for treating Crohn's disease in a human subject, comprising administering subcutaneously to a human subject having Crohn's disease a total body dose of 40 mg of a human anti-TNF.alpha. antibody once every 13-15 days for a time period sufficient to treat Crohn's disease, wherein the anti- TNFα antibody comprises [Humira].
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IPR2016-00172
8,889,135
Invalidated by the PTAB
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1. A method for treating rheumatoid arthritis in a human subject, comprising administering subcutaneously to a human subject having rheumatoid arthritis a total body dose of 40 mg of a human anti- TNFα antibody once every 13 -15 days for a time period sufficient to treat the rheumatoid arthritis, wherein the anti- TNFα antibody comprises [Humira].
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Sandoz argues that the only difference between claim 1 of these patents and claim 1 of the ’135 patent invalidated by the Board is the substitution of “ulcerative colitis” or “Crohn's disease” for “rheumatoid arthritis.” According to Sandoz, the prior art (Salfeld) taught that Humira was useful to treat UC, Crohn’s disease, and RA with a dosage range applicable to all three indications. In fact, the only disclosure in the patents that relates to UC or Crohn's disease was lifted directly from Salfeld.
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