Categories: Double Patenting Date: Aug 25, 2014 Title: Abbvie v. Kennedy Inst. of Rheumatology Trust: Uruguay Round Agreement Did Not Negate Obviousness-Type Double Patenting
|Title||Abbvie Inc. v. Kennedy Inst. of Rheumatology Trust, No. 2013-1545 (Fed. Cir. Aug. 21, 2014).|
|[1: : ODP and Uruguay Round] Kennedy argues that the statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist and the doctrine should be discarded. More specifically, Kennedy 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.|
Abbvie Inc. at *10.
|[2: ODP and Genus-Species Patent Family] [Whether] “[…]the differences in subject matter between the claims” of the ’766 and ’442 patents render their claims “patentably distinct” because the ’442 patent applies to [‘][treating] patients with active disease[,’] [which is a species of the ‘766 patent genus characterization as ‘treating all patients in need thereof’].|
Id. at *21 (internal citations omitted, text added).
|[1: : ODP and Uruguay Round] 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. […] We now make explicit what was implicit in Gilead: the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates. We hold that Kennedy is not entitled to an extra six years of monopoly solely because it filed a separate application unless the two inventions are patentably distinct.|
Id. at *12-13.
|[2: ODP and Genus-Species Patent Family] [S]pecies 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. Here, we think it is clear that a reader of the ’766 patent could have easily envisioned a species limited to sicker patients [because the disclosure of the genus in the ‘766 parent patent relied on a T-14 study that serves as the basis for the species in the ‘422 child patent]. |
Id. at *24 (text added).
|The Mathilda and Terrance Kennedy Institute of Rheumatology Trust (Kennedy) owns U.S. Patent Nos. 7,846,442 (the ’442 patent) and 6,270,766 (the ’766 pa- tent). Both patents are directed towards methods of treating rheumatoid arthritis by co-administering two drugs. AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively, AbbVie) are licensees of the ’766 patent but not the ’442 patent. In 2011, AbbVie sued Kennedy in the Southern District of New York for a declaratory judgment that the ’442 patent was invalid under the doctrine of obviousness-type double patenting because the ’442 patent was not patentably distinct from the ’766 patent. |
Abbvie Inc. at *2.
|[T]he district court found that the ’442 patent covered the exact same invention as the ’766 patent and held that asserted claims of the ’442 patent were invalid over the asserted claims of the ’766 patent for obviousness-type double patenting.|
Id. at *8.
|Legal Reasoning (DYK, Wallach, Chen)|
|‘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-
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.
|“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.
|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.
|In sum, we conclude that the ’442 patent is invalid for obviousness-type double patenting in light of the ’766 patent.|
Abbvie Inc. at *28.