Legal Reasoning (DYK, Wallach, Chen)

Background

‘766 Patent Claim The ’766 patent […] claims a method of co-administering the anti-TNFα antibody and methotrexate. Independent claim 8 is representative: “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.” […] Claims 9 through 14 depend, either directly or indirectly, on claim 8, adding additional limitations to the method of treating rheumatoid arthritis set forth in claim 8. [...] For example, claim 9 recites “[a] method of claim 8 wherein the [anti-TNFα] antibody or antigen-binding fragment is administered in a series of doses separated by intervals of days or weeks.”

Abbvie Inc. at *4 (internal citations omitted).

‘422 Patent Claim The ’442 patent application was filed on September 12, 2005, and claimed priority to the date the ’766 patent was filed: August 1, 1996. The specification of the ’442 patent is identical to that of the ’766 patent. Independent claim 1 of the ’442 patent is 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 [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 rheu-

matoid arthritis.



Id. at *5.

Legal Standard: Obviousness- Type Double Patenting (ODP), generally While often described as a court-created doctrine, ob- viousness-type double patenting is grounded in the text of the Patent Act. […] Section 101 reads: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, . . . may obtain a patent therefor.” [...] Thus, § 101 forbids an individual from obtaining more than one patent on the same invention, i.e., double patenting. As this court has explained, “a rejection based upon double patenting of the obviousness type” is “grounded in public policy (a policy reflected in the patent statute).” [...]

Id. at *9 (internal citations omitted).

1: ODP and Uruguay Round

ODP Still Relevant Kennedy views the purpose of [ODP] narrowly: “The ODP doctrine developed to curb abuses, made possible by continuation practice” wherein “[n]either the Examiner nor a patent challenger could assert prior art arising between the filing date of the continuation application and an earlier claimed priority date.” […] But this 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. […] So too where, as here, the applicant chooses to file separate applications for overlapping subject matter and to claim different priority dates for the applications, the separate patents will have different expiration dates since the patent term is measured from the claimed priority date.[…] When such situations arise, the doctrine of obviousness-type double patenting ensures that a particular invention (and obvious variants thereof) does not receive an undue patent term extension. […]

Abbvie Inc. at *11-12 (internal citation omitted).

Fallaux and Gilead Precedents Although this court has recognized that the doctrine of obviousness-type double patenting is less significant in post-URAA patent disputes, we have also recognized its continued importance. For example, in In re Fallaux, we recognized “that the unjustified patent term extension justification for obviousness-type double patenting” may have “limited force in . . . many double patenting rejections today, in no small part because of the change in the Patent Act from a patent term of seventeen years from issuance to a term of twenty years from filing.” […] At the same time, the continued importance of the doctrine of obviousness-type double patenting where two patents have different expiration dates was recently reaffirmed by this court in Gilead. In Gilead, we held that a later-issued, but earlier-expiring patent could qualify as a double patenting reference, and thus invalidate an earlier-issued, but later expiring patent.

Id. at *12-13.

[2: ODP and Genus-Species Patent Family]

Steps of ODP Analysis We now turn to the question of whether the doctrine applies here. The obviousness-type double patenting analysis involves two steps: “First, the court ‘construes the claim[s] in the earlier patent and the claim[s] in the later patent and determines the differences.’ Second, the court ‘determines whether those differences render the claims patentably distinct.’” […] “‘A later claim that is not patentably distinct from,’ i.e., ‘is obvious over[ ] or anticipated by,’ an earlier claim is invalid for obviousness-type double patenting.” […]

Abbvie Inc. at *13.

Claim Construction “co-administering” The specification never uses the term “co-administering” to refer to patients who only received the antibody after discontinuing treatment with methotrexate. The specification makes clear that the invention described in the claims is limited to concomitant and adjunctive use. The specification outlines several possible modes of co-administration: “TNF antagonists can be administered prior to, simultaneously with (in the same or different compositions) or sequentially with the administration of methotrexate. For example, TNF antagonists can be administered as adjunctive and/or concomitant therapy to methotrexate therapy.” [...] “Concomitant” therapy involves starting the two drugs at the same time and then continuing their administration together; “adjunctive” therapy involves starting one of the drugs after the other and then continuing their administration together. The specification concludes that “[t]he present invention relates to the discovery that tumor necrosis factor antagonists can be administered to patients suffering from a TNF-mediated disease as adjunctive and/or concomitant therapy to methotrexate therapy, with good to excellent alleviation of the signs and symptoms of the disease.”

Id. at *14-15.

“active disease” We assume, without deciding, that Kennedy’s proposed construction of “active disease” was correct. The 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). Thus, assuming Kennedy’s construction of the term “active disease” is correct, we 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).

Id. at *20-21.

Obviousness Legal Standard [O]bviousness is not demonstrated merely by showing that an earlier expiring patent dominates a later expiring patent. Nor do we think that the district court here relied on any such principle. It is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus. […] But not every species of a patented genus is separately patentable. […] [W]hen a “genus is so limited that a person of ordinary skill in the art can ‘at once envisage each member of this limited class,’ . . . a reference describing the genus anticipates every species within the genus.”

Id. at *23 (internal citations omitted).

[…] Kennedy’s claim of non-obviousness rests on its contention that the species has unexpected results. A species contained in a previously patented genus may be patentable if the species manifests unexpected properties or produces unexpected results. […] To determine whether the ’442 patent is directed to a species that yielded unexpected results, we must necessarily look to the ’766 patent’s disclosures to assess what results were expected at the time the ’766 patent application was filed. The demonstration of utility of the ’766 patent relies on the T-14 study, the very study that Kennedy now relies on to show that the ’442 patent led to unexpected results and merits a separate patent. Indeed, Kennedy’s definition of the term “active disease” is taken from the T-14 study. The ’766 patent relied on the results obtained in the T-14 study to demonstrate that a combination therapy of methotrexate and anti-TNFα antibody improved the health of the very subset of rheumatoid arthritis patients that Kennedy now contends show that the method of the ’442 patent led to unexpected results. Thus, the ’442 patent merely claims the known utility of the ’766 patent and does not claim a species with unexpected results.

Id. at *24, 25-26.

Conclusion