Big Molecule Watch
June 14, 2016

PTAB Institutes IPRs on Two More Humira Patents

Yesterday, the PTAB instituted IPRs on two of Abbvie’s Humira patents, U.S. Patent Nos. 9,017,680 and 9,073,987, which are drawn to dosing regimens for AbbVie’s Humira (adalimumab) for the treatment of rheumatoid arthritis. As previously reported here, the PTAB previously instituted an IPR on related U.S. Patent 8,889,135 based on a petition filed by Coherus.

In both the ‘680 and ‘987 IPR institution decisions, the PTAB concluded that the Petitioner had shown “a reasonable likelihood of prevailing in its assertion that the selection of a 40 mg total body dose administered subcutaneously biweekly would have been obvious and no more than routine optimization” in view of the prior art and in view of the state of the art.

With respect to claim construction, the PTAB considered the claim term “method of reducing signs and symptoms in a patient with moderately to severely active rheumatoid arthritis,” which only appears in the preamble of claim 1. The PTAB determined that this preamble is not limiting “beyond specifying the patient to whom the anti-TNFα antibody is administered.”

The Board also considered the claim term “40 mg dosage unit form” and agreed with the Petitioner that the broadest reasonable interpretation encompasses “a syringe filled with 40 mg of D2E7.”

The Board further agreed with the Petitioner that, for the purposes of instituting the IPRs, the subject matter of claims 1-4 would have been obvious over the prior art teachings that D2E7 is a fully human anti-TNFα monoclonal antibody that has been used in clinical studies to treat RA patients and that doses of 40 mg were successfully administered for this indication. The PTAB further stated that the prior art would have motivated a person of ordinary skill to administer 40 mg of D2E7 biweekly, i.e. “once every 13-15 days,” as explicitly listed in the claims.

The Board was not persuaded by the Patent Owner’s arguments regarding a preference of weight-based dosing administered intravenously over a subcutaneous route, stating that collective teachings of the prior art references disclose administering fixed doses of D2E7 to RA patients by subcutaneous injection.

The PTAB rejected the Patent Owner’s secondary considerations argument, finding that the record did not establish that the commercial success of HUMIRA® is commensurate in scope with the claimed invention.

Keep reading Big Molecule Watch for updates on this IPR.