Boehringer Ingelheim International GMBH and Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) have prevailed in two inter parts review trials against one of AbbVie’s patents related to Humira®.  In two final written decisions issued, the Patent Trial and Appeal Board (the “PTAB” or “Board”) found all claims of U.S. Patent No. 8,889,135 (the ’135 patent”) invalid.

The ’135 patent, entitled “Methods of Administering Anti-TNFα Antibodies,” issued on November 18, 2014.  According to the final written decision, the ’135 patent discloses methods of treating rheumatoid arthritis (“RA”) with a human anti-tumor necrosis factor α (“TNFα”) antibody.  The decision further explains that:

The methods of the claimed invention involve administering an anti-TNFα antibody having the six complementarity determining regions (“CDRs”) and heavy chain constant region of D2E7, a known recombinant human anti-TNFα antibody. The methods further include administering a total body dose of 40 mg of the anti-TNFα antibody subcutaneously every 13–15 days, i.e., biweekly, for a period of time sufficient to treat RA.

See IPR 2016-00408, Final Written Decision at p.4 (internal citations omitted).  After considering the parties arguments and evidence, the Board concluded that the Petitioner had satisfied its burden of demonstrating by a preponderance of the evidence that the subject matter of claims 1-5 of the ’135 patent would have been obvious in view of the prior art, and the claims are unpatentable.  Id. at pp. 45-49.

The proceedings are IPR2016-00408 and IPR2016-00409.  The decision also notes that the parties identified inter partes proceeding IPR2016-00172, in which Coherus BioSciences Inc. petitioned for review of claims 1–5 of the ’135 patent, as a related matter.  Id. at p. 3 citing Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., Case IPR2016-00172 (PTAB) (“the 172 IPR”).  According to the decision, the Board instituted inter partes review of claims 1–5 of the ’135 patent in the 172 IPR, and found claims 1–5 unpatentable in a final written decision issued May 16, 2017.  Id., citing Coherus, Case IPR2016-00172, slip op. at 44 (PTAB May 16, 2017) (Paper 60).

Litigation regarding Humira® is currently ongoing before Judge Robinson in the United States District Court of Delaware. That case involves ten of AbbVie’s patents and Amgen’s proposed biosimilar adalimumab product.  See AbbVie v. Amgen, Civ. No. 1:16-cv-666, (D. Del.)(SLR).  Several additional patents related to Humira® are currently being challenged in post-grant proceedings before the PTAB.  The final written decision in the proceedings discussed above, as well as a summary of the IPR proceedings on other patents related to Humira®, can be found in the RFEM IPR Dashboard.