United States: Species Are Unpatentable When Prior Art Disclosures Describe The Genus Such That A Person Of Ordinary Skill In The Art Would Be Able To Envision Every Member Of The Class

In AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, No. 13-1545 (Fed. Cir. Aug. 21, 2014), the Federal Circuit affirmed the district court's finding of obviousness-type double patenting. 

The Mathilda and Terence Kennedy Institute of Rheumatology Trust ("Kennedy") is the owner of U.S. Patent Nos. 6,270,766 ("the '766 patent") and 7,846,442 ("the '442 patent"), directed to methods of treating rheumatoid arthritis by co-administering a disease-modifying antirheumatic drug and an antibody.  The '766 patent claims a method of co-administering the Tumor Necrosis Factor Alpha ("TNFα") antibody and methotrexate.  After the '766 patent issued, Kennedy obtained the '442 patent, which contains "method of treatment" claims.  While Kennedy admits that the claims of the '442 patent are encompassed by the '766 patent, the claims of the '442 patent are directed towards a more specific patient group.  The '766 patent previously expired on October 8, 2012, and the '442 patent, which claimed a later priority date than the '766 patent, expires on August 21, 2018.

In 2002, AbbVie Inc. and AbbVie Biotechnology Limited (collectively "AbbVie") licensed the '766 patent and obtained FDA approval to sell Humira, an anti-TNFα antibody, for use either alone or in combination with methotrexate, for the treatment of rheumatoid arthritis.  After the '442 patent issued in 2010, Kennedy demanded that AbbVie pay royalties under the '442 patent in order to continue sales of Humira.  In response, AbbVie sued Kennedy for DJ that the claims of the '442 patent were invalid over the '766 patent under the doctrine of obviousness-type double patenting.  After conducting a bench trial, the district court found that the '442 patent covered the same invention as the '766 patent and was invalid over the claims of the '766 patent for obviousness-type double patenting.  The district court entered a partial final judgment, under Fed. R. Civ. P. 54(b), in favor of AbbVie, and Kennedy appealed.

"Thus, 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."  Slip op. at 24.

The Federal Circuit first turned to Kennedy's argument that the statutory and policy rationales for the doctrine of obviousness-type double patenting no longer exist and, thus, the doctrine should be discarded.  Specifically, "[n]ow that the patent term is measured from the earliest claimed priority date, as opposed to the date of issuance, Kennedy contends that the submarine patent problem no longer exists and that the [Uruguay Round Agreements Act] amendment vitiated the policy basis for the doctrine of obviousness-type double patenting."  Slip op. at 11.  The Court, however, disagreed, explaining that Kennedy ignored that the doctrine is also designed to prevent inventors from obtaining a second, later expiring patent on the same invention, which is another "crucial purpose of the doctrine."  Id.  Noting its recent decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), the Court stated, "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."  Slip op. at 13.  Indeed, the Court explained, "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.

The Court next addressed whether the doctrine of obviousness-type double patenting applied in the instant case.  Noting that obviousness-type double patenting is a two-step inquiry, the Court first turned to the claim construction of the terms "co-administration" and "active disease" as used in both the '766 and '442 patents. 

As to the term "co-administration," the Court found that, by way of claim construction, Kennedy was attempting to enlarge the scope of the '766 patent while simultaneously narrowing the scope of the '442 patent.  Kennedy took the position that the district court's claim construction of the term "co-administration" erroneously excluded a fourth form of co-administration.  The Court, noting that the specification confirmed the correctness of the district court, found that "[t]he specification never uses the term 'co-administering' to refer to patients who only received the antibody after discontinuing treatment with methotrexate."  Id. at 14.  Indeed, the Court explained, the '766 patent's specification "makes clear that the invention described in the claims is limited to concomitant and adjunctive use."  Id.  Kennedy also argued that the principle of claim differentiation favored its interpretation that claim 8 encompassed embodiments where "single doses of either the antibody or methotrexate are delivered to patients," whereas claim 9 demonstrated that "the only additional limitation is that the anti-TNFα antibody must be administered in a series of doses separated by intervals of days or weeks."  Id. at 18 (citation and internal quotation marks omitted).  The Court did not find Kennedy's argument persuasive because it found that claim 9 does not disclose discontinuation of methotrexate and that the administration of methotrexate is assumed to be ongoing with the single or multiple antibody doses.  Thus, the Federal Circuit found that the specification and claims of the '766 patent supported the district court's correct interpretation of the term "co-administration."

The Court then assessed the district court's claim construction of the term "active disease."  Kennedy contended that the '442 patent provided an explicit definition for the term "active disease."  In support of this contention, Kennedy relied on the prosecution history and the examiner's indefiniteness rejection of the '442 patent for failing to define the term "active disease."  Kennedy provided an explanation that after it pointed to a particular portion of the specification as providing a more specific definition of the term "active disease" during prosecution, the examiner allowed the '442 patent's claims.  AbbVie argued that the particular quoted portion of the specification set forth two definitions and, thus, the inventors could not be viewed as having acted as their own lexicographers.  The Court, however, assumed, without deciding, that Kennedy's proposed construction for "active disease" was correct.  Accordingly, the Court stated that, in the second step of the obviousness-type double patenting inquiry, 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)."  Id. at 21.

Turning to the obviousness inquiry in the second step of its analysis, the Federal Circuit provided a discussion of the law of obviousness-type double patenting and found that "it is clear that a reader of the '766 patent could have easily envisioned a species limited to sicker patients.  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."  Id. at 24.  The Court also addressed Kennedy's claim that the species had unexpected results, but found that such a claim was unsupported.  The Court explained that to assess whether the '442 patent yielded unexpected results, the Court had to assess what results were expected at the time the '766 patent application was filed.  The Court concluded that the '442 patent merely claimed the known utility of the '766 patent and did not claim a species with unexpected results.  The Court also acknowledged Kennedy's argument that the '766 patent's disclosures could not be used to determine whether the results of the '442 patent were unexpected because doing so would be tantamount to treating the disclosures of the '766 patent as prior art.  The Court explained that while "a reference patent's specification cannot be used as prior art in an obviousness-type double patenting analysis," "it is also well settled that we may look to a reference patent's disclosures of utility to determine the question of obviousness."  Id. at 26 (citations omitted).  Because the Court determined that the '442 patent did not claim a species manifesting unexpected results, the Court concluded that the '442 patent would have been obvious over the '766 patent.

Accordingly, the Federal Circuit affirmed the district court's finding that the '442 patent was invalid for obviousness-type double patenting in light of the '766 patent and awarded costs to AbbVie.

Judges:  Dyk (author), Wallach, Chen

[Appealed from S.D.N.Y., Judge Crotty]

This article previously appeared in Last Month at the Federal Circuit, September 2014.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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