AbbVie Inc. v. The Mathilda & Terence Kennedy Inst. of Rheumatology Trust, ___ F.3d ___ (Fed. Cir. Aug. 21, 2014) (DYK, Wallach, Chen) (S.D.N.Y.: Crotty) (2 of 5 stars)
Fed Cir affirms invalidity based on obviousness-type double patenting. Kennedy obtained two related patents covering treatment methods for rheumatoid arthritis by co-administering two drugs. The later patent claimed a species of the genus covered by the first, earlier-expiring patent.
Viability of obviousness-type double-patenting doctrine: The Fed Cir confirmed the “continued vitality” of obviousness-type double patenting, even after the switch to a patent term of 20 years from filing rather than 17 years from issuance, “where two patents that claim the same invention have different expiration dates.” Slip op. at 13. Here, the later-expiring patent was invalid because the patentee lost its attempt to broadly construe the first patent, which thereby prevented it from showing the later claims were patentably distinct.
Claim construction (first step of this double-patenting doctrine): The term “co-administration” in the first patent’s claims was limited to three treatment modes and did not include a fourth in which use of a second drug begins only after the first is discontinued. The specification outlined only those three modes of treatment, and the patient study that formed the basis for the invention described the “poorer results” for non-overlapping administration. Id. at 17. A dependent claim did not suggest the independent claims covered non-overlapping administration because it “says nothing about the discontinuation” of the first drug. Id. at 18. The term “adjunctively” in the later patent referred to one of the three modes of “co-administration” in the first patent. Moreover, the Fed Cir assumed, without deciding, that the patentee’s construction of “active disease,” as used in the second patent, was correct, such that the first patent covers the treatment of all patients in need, while the narrower second patent only covers the treatment of particularly sick patients.
Not Patentably Distinct (second step of double-patenting doctrine): Because the Fed Cir rejected the broader construction of “co-administration,” the only basis for avoiding invalidity was the “active disease” limitation. This limitation does not make the second patent patentably distinct: “it is clear that a reader of the [first] patent could have easily envisioned a species limited to sicker patients.” Id. at 24. Although “[i]t is well-settled that a narrow species can be non-obvious . . . despite a patent on its genus,” a “species [is] 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.” Id. at 23-24. Nothing suggested the result for sicker patients was unexpected—the patentee’s definition of “active disease” was taken from the patient study that was disclosed in the first patent. “[A] later expiring patent is not patentably distinct from an earlier expiring patent if it merely claims a disclosed utility of the earlier claimed invention.” Id. at 27. And although the disclosure of the earlier expiring patent cannot be used as prior art, the disclosure may be used to decide whether the claims merely define an obvious variations of earlier claims.