PATENT CASE OF THE WEEK
Baxalta Inc. v. Genentech, Inc., Appeal No. 2019-1527 (Fed. Cir. Aug. 27, 2020)
In this week’s Case of the Week, an appeal from the United States District Court for the District of Delaware, the Federal Circuit deals with issues relating to claim construction.
Baxalta sued Genentech, asserting that Genentech’s Hemlibra product for the treatment of hemophilia infringes claims of U.S. Patent No. 7,033,590 (“the ’590 patent”). The ’590 patent relates to antibody or antibody fragment preparations used to treat patients with Hemophilia A who have developed antibodies that prevent standard treatments from working as they should. Hemophilia A is a form of hemophilia where the activity of a certain enzyme, “clotting factor VIII,” is functionally absent, thereby preventing coagulation (blood clotting) from occurring. These patients are typically treated with factor VIII preparations, but often develop antibodies that hinder the effectiveness of those treatments. The antibodies and antibody fragments claimed by the ’590 patent remedy this by binding to other clotting factors—factor IX or IXa—to compensate for the decreased factor VIII activity, thus allowing clotting to occur.
At the district court, the parties disputed the construction of the terms “antibody” and “antibody fragment.” As to the term “antibody,” Baxalta argued that the term should be construed as “[a] molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains).” Genentech countered that the term should instead be construed as “[a]n immunoglobulin molecule, having a specific amino acid sequence that only binds to the antigen that induced its synthesis or very similar antigens, consisting of two identical heavy chains (H chains) and two identical light chains (L chains).” The district court found that both parties’ proposed constructions were acceptable definitions, but decided to adopt Genentech’s narrower definition because it conformed to an express definition of the term provided in the ’590 patent specification. In so construing the term, the district court recognized that the ’590 patent claims and discloses “bispecific antibodies,” which “can have more than two heavy chains and more than two light chains,” but it determined that these claimed embodiments were “antibody derivatives” rather than “antibodies.” To support this position, the district court cited an amendment Baxalta made to the patent claims during prosecution, wherein an original dependent claim, which recited a list of “antibod[ies] or antibody derivative[s] according to claim 1,” including “chimeric antibodies, humanized antibodies, single chain antibodies, bispecific antibodies, diabodies, and di-, oligo- or multimers thereof.” During prosecution, the patent examiner had rejected the term “antibody derivative” as not enabled for any one of the enumerated list in that dependent claim, and Baxalta amended the claim to recite “antibody fragment” in place of “antibody derivative.” With that change, the examiner removed the enablement rejection. The district court determined that this amendment amounted to a disclaimer of antibody derivatives “including bispecific antibodies, except antibody fragments.”
As to the term “antibody fragment,” Baxalta argued that the term should be construed as “[a] portion of a molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains),” and Genentech argued it should be construed as “[a] fragment of an antibody which partially or completely lacks the constant region; the term ‘antibody fragment’ excludes all other forms of antibody derivatives.” The district court rejected both proposed constructions, relying on a portion of the ’590 patent specification that explained that “factor IX/IXa activating antibodies and antibody derivatives may also include … e.g., ‘technically modified antibodies’ such as synthetic antibodies, chimeric or humanized antibodies, or mixtures thereof, or antibody fragments which partially or completely lack the constant region.” Based on this disclosure, the Court instead construed the term to mean “a fragment of an antibody which partially or completely lacks the constant region; the term ‘antibody fragment’ excludes bispecific antibodies.”
Based on these two claim constructions, the parties stipulated to non-infringement and the district court entered a final judgment. Baxalta appealed, arguing that the district court erroneously construed the terms.
The Federal Circuit first disagreed with the district court’s construction of the “antibody” term, holding that since claim 1 recites “an isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa,” nothing in the plain language limits the term “antibody” to a specific antibody consisting of two identical heavy chains and two identical light chains or an antibody that only binds the antigen that induced its synthesis or very similar antigens. Further, the dependent claims, which claim various types of antibodies, confirm that the term is not so limited because the antibodies recited in the dependent claims do not fall within the narrow definition chosen by the district court. Such construction would render the dependent claims meaningless and therefore invalid.
Moreover, the Court found that the “express definition” relied upon by the district court is merely a generalized introduction of antibodies as opposed to a definitional statement, and does not include terms the Court has held to be limiting in other contexts, such as “the present invention includes,” or “all embodiments of the present invention are.” In construing claims, the Court held that the specification as a whole must be considered and all portions of it must be read in a manner that renders the patent internally consistent. Since the specification as a whole includes specific disclosures regarding the species of antibodies claimed by the dependent claims, all of which fail to comport with the district court’s construction, a construction that excludes those disclosed and claimed embodiments is incorrect.
Finally, the Court explained that the portions of the prosecution history relied upon by the district court—where the patentee replaced the term “antibody derivative” with “antibody fragment”—do not clearly state what scope, if any, was given up with that amendment. A disavowal must be both clear and unmistakable, and because the term “antibody derivative” is not a term commonly used in the art, there is ambiguity in the term and disclaimer could not be established. As such, the Court found that the district court erred in selecting Genentech’s narrower construction of the term and construed “antibody” to mean “an immunoglobulin molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains).”
As to the term “antibody fragment,” the Court similarly disagreed with the district court’s construction because the portion of the specification relied upon by the district court as being definitional does not define antibody fragments as necessarily “partially or completely lack[ing] the constant region,” and as such does not clearly express an intent to redefine a term. Rather, the specification’s use of phrases such as “may also include,” “e.g.,” and “such as,” make clear that the patentee did not intend the specific excerpt cited by the district court to define “antibody fragment.” The Court thus rejected the district court’s construction and defined “antibody fragment” according to its plain and ordinary meaning in light of the specification as a whole; that is, “[a] portion of an immunoglobulin molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains).”
The Court thus vacated and remanded the case for further proceedings consistent with its construction of the two claim terms.
The opinion can be found here.
By Erin M. Forbes
ALSO THIS WEEK
Egenera, Inc. v. Cisco Systems, Inc., Appeal Nos. 2019-2015, -2387 (Fed. Cir. Aug. 28, 2020)
In this case, the Federal Circuit reversed a district court’s finding of judicial estoppel where a patentee sought to re-add an inventor to its patent after petitioning to have him removed during concurrent inter partes review proceedings. The Court also affirmed the district court’s claim construction finding a limitation reciting “logic” to perform functions in a computing patent to be a means-plus-function term under 35 U.S.C. § 112(f).
During the IPR proceedings, appellant Egenera had petitioned the Patent Office to remove one of the listed inventors, Peter Schulter, apparently to support an IPR argument that the invention was conceived before the publication of a prior art reference around the time of Mr. Schulter’s contributions. While the inventorship petition was pending, however, the PTAB declined to institute the IPR, assuming the reference to be prior art but nonetheless rejecting the unpatentability arguments on the merits. Meanwhile, in the infringement case, the district court construed a term reciting “logic” to perform computer functions to be a “means-plus-function” term, and found in a bench trial that the structure recited in the specification for the function had been invented by Mr. Schulter. When Egenera then sought to have the court correct inventorship to re-add Mr. Schulter under 35 U.S.C. 256(b), the district court found that Egenera was barred by judicial estoppel in light of its earlier petition to the PTO, and held the patent to be invalid for failing to list all inventors.
The Federal Circuit affirmed the district court’s claim construction, but vacated its finding of judicial estoppel and invalidity judgment. Cisco first argued that there were no grounds for Egenera to re-correct inventorship at all, asserting that “error” in § 256 meant only inadvertent mistakes and precluded considered, tactical changes like Egenera’s. The Federal Circuit disagreed, holding that “‘error’ is simply the incorrect listing of inventors.” On judicial estoppel, the Federal Circuit also found that Egenera’s positions were not clearly inconsistent, since its later position was necessitated by the district court’s intervening claim construction, which Egenera opposed in district court. The Court also found that because the ministerial PTO petition was not examined and did not contain argument based on underlying fact, Egenera had not “persuaded” a “tribunal” to accept its position, as required for judicial estoppel. However, the Court characterized its holding on this point as narrow, noting that it did not hold that judicial estoppel could not apply to statements made to the PTO during prosecution, or that other forms of estoppel could not apply to ministerial submissions. Finally, the Court found that Egenera would gain no unfair advantage from the re-correction, noting that the PTAB did not rely on Egenera’s prior invention arguments in declining to institute the IPR, which might otherwise have resulted in inconsistent decisions based on different inventorships.
The opinion can be found here
Neville v. Foundation Constructors, Inc., Appeal No. 2020-1132 (Fed. Cir. Aug. 27, 2020)
In this appeal, the Court affirmed the District Court for the Central District of California’s grant of summary judgment of non-infringement. The patents at issue, a divisional patent and its parent, were related to screw-type foundation piles—structures placed underground to add stability to a building’s foundation. Appellants argued that the district court erred in its construction of the claim term “end plate” as requiring an exterior-facing flat surface and that the claim terms “protrusion” and “end plate” referred to two distinct objects. The Court disagreed, finding that the plain language of the patent claims and prosecution history supported the district court’s holding. Because plaintiff failed to show that an “end plate” and “protrusion,” as construed, were present in the accused product, the Court affirmed the district court’s claim construction and grant of summary judgment of non-infringement.
The opinion can be found here.
By Bazsi Takacs