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AbbVie, Inc., et al., v. The Mathilda & Terrence Kennedy Institute of Rheumatology Trust

Author: Tu Phan-Kerr

The Federal Circuit affirmed a judgment by the United States District Court for the Southern District of New York invalidating Claims 1-7, 13-14, and 17-20 of U.S. Patent No. 7,86,442 (the '442 patent) under the doctrine of obviousness-type double patenting over Claims 8-14 of U.S. Patent No. 6,270,766 (the '766 patent). Both the '442 patent and the '766 patent are owned by Kennedy, and cover the use of Humira® (adalimumab).

Representative Claim 8 of the '766 patent is directed to a method of treating rheumatoid arthritis by "co-administering" methotrexate and an anti-TNFα antibody to "an individual in need thereof." Representative Claim 1 of the '442 patent is also directed to treating rheumatoid arthritis but recites "adjunctively administering" methotrexate and an anti-TNFα antibody to an individual whose "active disease is incompletely controlled despite already receiving methotrexate. AbbVie licensed the '766 patent from Kennedy on December 23, 2002, and paid over $100 million in royalties for the sale of Humira® in the U.S. Kennedy’s '442 patent issued in 2010. Kennedy then demanded AbbVie obtain an additional license to the '442 patent (which will expire in August 21, 2018). AbbVie responded by bringing an action in the Southern District of New York for declaratory judgment that the claims of the '442 patent were invalid over the '766 patent for obviousness-type double patenting.

As the Federal Circuit noted, an obviousness-type double patenting analysis involves two steps: First, the court construes the claims in the earlier patent and the claims in the later patent and determines the differences. Second, the court determines whether those differences render the claims patentable distinct.

The District Court had construed the term "co-administering" in the '766 patent as covering three possible forms: (1) methotrexate and anti-TNFα antibody are started at approximately the same time ("concomitantly"), (2) methotrexate is started first and anti-TNFα antibody is then added ("adjunctively") to ongoing and continuing methotrexate treatment, or (3) anti-TNFα antibody is started first and then methotrexate is added ("adjunctively") to ongoing and continuing anti-TNFα antibody treatment. The District Court determined that the term "adjunctively" in the '442 patent was encompassed by one of these forms - specifically, to mean a method of administering anti-TNFα antibody (or fragment thereof) to ongoing methotrexate treatment. In addition, the District Court construed the term "active disease" in the '442 patent to cover all patients suffering from rheumatoid arthritis and requiring treatment, as described in the '766 patent. District Court found the '442 patent to be invalid because one of ordinary skill in the art would have envisaged the species of adjunctive administration, and there was no substantial difference between the individuals with "active disease" in the '442 patent and the patient population of the '766 patent.

On appeal, the issue was whether a patent that claims to treat a subset of patients with more severe rheumatoid arthritis ('the 442 patent) is an obvious variant of a patent that claims treatment of rheumatoid arthritis generally (the '766 patent).

The Federal Circuit agreed with the District Court's claim construction, and stated that, while "[i]t is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus," the "species are unpatentable when prior art disclosures describe the genus containing those species such that a person of ordinary skill in the art would be able to envision every member of the class." The Federal Circuit found that the species of the '442 patent was not patentably distinct from the genus of the '766 patent since "it [wa]s clear that a reader of the '766 patent could have easily envisioned a species limited to sicker patients." With respect to Kennedy's contention that the '442 patent claimed a species with unexpected results, it was noted that the '766 patent disclosed "[t]he present invention is based on the discovery that the treatment of patients suffering from [rheumatoid arthritis] with [anti- TNFα antibody]…as adjunctive and/or concomitant therapy to methotrexate therapy produces a rapid and sustained reduction in the clinical signs and symptoms of the disease [emphasis added]." Hence, the '442 patent merely claimed the disclosed utility of the '766 patent and did not claim a species with unexpected results that were patentable over the '766 patent.