Humira Patent Invalid for Obviousness Type Double Patenting

In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, the Federal Circuit affirmed the district court's finding that a second patent covering AbbVie's Humira product is invalid under the doctrine of obviousness-type double patenting. The decision reaffirms the court's stance in Gilead that the doctrine remains valid under the 20-year patent term system, and serves an important public policy goal of ensuring that once a patent protecting an invention has expired, the public is free to practice that invention and its obvious variants. The court may have gone too far, however, in relying on the disclosure of the reference patent to support its obviousness determination.

The Patent at Issue

The patent at issue was Kennedy's U.S. 7,846,422, directed to "Methods of treating rheumatoid arthritis with ... anti-TNF-alpha antibodies and methotrexate." The Federal Circuit cited claim 1 as 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 tumor necrosis factor-α antibody or a human tumor necrosis factor-α binding fragment thereof to the individual, wherein the anti-human tumor necrosis factor-α antibody or fragment thereof (a) binds to an epitope on human tumor necrosis factor-α, (b) inhibits binding of human tumor necrosis factor-α to human tumor necrosis factor-α 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.

The '442 patent was filed September 12, 2005, with a priority claim to August 1, 1996. It was granted in 2010, and was awarded 750 days of Patent Term Adjustment, leading to an expiration date of August 21, 2018.

The earlier patent was the grandparent of the '442 patent, Kennedy's U.S. 7,846,422, directed to "Anti-TNF antibodies and methotrexate in the treatment of arthritis and Crohn's disease." The Federal Circuit cited claim 8 as representative:

8. A method of treating rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and an anti-tumor necrosis factor alpha antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.

The '442 patent is a continuation of the '766 patent (filed...