By Donald Zuhn --
Last month, in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, the Federal Circuit affirmed a determination by the District Court for the Southern District of New York that U.S. Patent No. 7,846,442, which is owned by the Mathilda & Terence Kennedy Institute of Rheumatology Trust ("Kennedy Trust"), was invalid under the doctrine of obviousness-type double patenting in view of the Kennedy Trust's U.S. Patent No. 6,270,766.
The '766 and '442 patents are directed towards methods of treating rheumatoid arthritis by co-administering a disease-modifying antirheumatic drug (such as methotrexate) and an anti-TNFα antibody. Representative claim 8 of the '766 patent recites (with emphasis added):
8. A method of treating rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and an [anti-TNFα] antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.
and representative claim 1 of the '442 patent recites (with emphasis added):
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 [TNFα] antibody or a human [TNFα] binding fragment thereof to the individual, wherein the anti-human [TNFα] or fragment thereof (a) binds to an epitope on human [TNFα], (b) inhibits binding of human [TNFα] to human [TNFα] 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 relevant differences between the two representative claims are as follows: (1) while the '766 method is directed towards any "individual in need," the '442 method is directed towards individuals with "active disease"; (2) while the '766 method recites "co-administering" methotrexate and an anti-TNFα antibody, the '442 method recites "adjunctively administering" an anti-TNFα antibody with methotrexate.
The '766 patent application, which was filed on August 1, 1996, claimed the benefit of an application that was filed on October 8, 1992. After the '766 patent issued in 2001, the Kennedy Trust filed the '442 patent application. Although the specification of the '442 patent is identical to that of the '766 patent, the '442 patent only claims the benefit of the '766 patent's August 1, 1996 filing date. As a result, while the '766 patent expired on October 8, 2012, the '442 patent does not expire until August 21, 2018.
As the opinion notes, AbbVie, Inc. and AbbVie Biotechnology Ltd. ("AbbVie"), which license the '766 patent but not the '442 patent, paid the Kennedy Trust more than $100 million in royalties in order to sell its anti-TNFα antibody, Humira, in combination with methotrexate for the treatment of rheumatoid arthritis. However, when the '442 patent issued in 2010 and the Kennedy Trust sought an additional license from AbbVie, AbbVie instead filed a declaratory judgment action seeking a determination that the '442 patent was invalid for obviousness-type double patenting.
At trial, the Kennedy Trust contended that the '442 patent was patentable over the '766 patent because the latter claims a broad genus of methods for treating rheumatoid arthritis, and the former claims a narrower species of those treatment methods having unexpected results. The District Court, however, determined that the claims of the '442 patent that were at issue in the declaratory judgment action were invalid over certain claims of the '766 patent. In reaching that decision, the District Court determined that the adjunctive administration of the '442 method was one of three forms of co-administration covered by the '766 patent, and that the term "active disease" as recited in the '442 method covered all patients suffering from rheumatoid arthritis and requiring treatment. Thus, the District Court determined that the '442 patent covered the same invention as the '766 patent, and as a result that the asserted claims of the '442 patent were invalid over the asserted claims of the '766 patent for obviousness-type double patenting.
In an opinion by Judge Dyk, joined by Judges Wallach and Chen, the Federal Circuit affirmed the District Courter's determination, finding the '442 patent invalid for obviousness-type double patenting in light of the '766 patent. As the opinion inicates, the Kennedy Trust argued that:
[T]he statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist and the doctrine should be discarded. More specifically, [the] Kennedy [Trust] contends that the Uruguay Round Agreement Act (URAA), Pub. L. 103-465, 108 Stat. 4809, effective June 8, 1995, and its implementation of a 20-year period of patent protection that runs from a patent's earliest claimed priority date, eliminated the need for the obviousness-type double patenting doctrine. . . . Now that the patent term is measured from the earliest claimed priority date, as opposed to the date of issuance, [the] Kennedy [Trust] contends that the submarine patent problem no longer exists and that the URAA amendment vitiated the policy basis for the doctrine of obviousness-type double patenting.
The Court, however, countered that:
[T]his argument ignores another crucial purpose of the doctrine: It is designed to prevent an inventor from securing a second, later expiring patent for the same invention. . . . That problem still exists. Patents claiming overlapping subject matter that were filed at the same time still can have different patent terms due to examination delays at the PTO.
As a result, the Court determined that "the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates." With respect to the dispute between AbbVie and the Kennedy Trust, the Court stated that the Kennedy Trust was "not entitled to an extra six years of monopoly solely because it filed a separate application unless the two inventions are patentably distinct."
Before reaching a decision on whether the differences between the '766 and '442 patents rendered their claims patentably distinct, the Court addressed the disputed terms of "co-administering" and "active disease." With respect to the first term, the Kennedy Trust argued that the District Court's construction excluded a fourth form of co-administration, namely, administration of the anti-TNFα antibody antibody alone after discontinuing the administration of methotrexate. The Court, however, noted that "[t]he '766 patent's specification confirms the correctness of the district court's claim construction," in that "[t]he specification never uses the term 'co-administering' to refer to patients who only received the antibody after discontinuing treatment with methotrexate."
With respect to the second term, the Kennedy Trust argued that the prosecution history revealed that a more specific definition of "active disease" (i.e., particularly sick patients) was critical to the Examiner's allowance of the '442 patent claims. "[A]ssum[ing], without deciding, that [the Kennedy Trust's] proposed construction of 'active disease' was correct," the Court noted that "[t]he consequence is the genus claimed in the '766 patent (treating all patients in need thereof) is broader than the species claimed in the '442 patent (treating patients with 'active disease,' i.e., particularly sick patients)." As a result, the Court stated that it "must decide 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 patients generally (the '766 patent)."
While noting that "[i]t is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus," the opinion points out that "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." In the instant case, the opinion stated that "it is clear that a reader of the '766 patent could have easily envisioned a species limited to sicker patients," and determined that the District Court was correct in concluding that the species of the '442 patent was not patentably distinct from the genus of the '766 patent.
As for the Kennedy Trust's argument that the species of the '442 patent showed unexpected results, the Court found that argument to be unsupported. Looking to the specification to assess what results were expected at the time the '766 patent application was filed (which the Court stated was permissible), the Court determined that "the '442 patent merely claims the known utility of the '766 patent and does not claim a species with unexpected results." The Court therefore concluded that the '442 patent was invalid for obviousness-type double patenting in light of the '766 patent.
AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014)
Panel: Circuit Judges Dyk, Wallach, and Chen
Opinion by Circuit Judge Dyk