by Dennis Crouch
Baxalta Inc. v. Genentech, Inc., 2020 WL 5048435 (Fed. Cir. Aug. 27, 2020)
Although not en banc, this case was picked-up by five different Federal Circuit judges with two separate opinions and one recusal.
Sitting by designation as a D.Del. district court, Judge Dyk sided with the accused infringer Genentech by narrowly construing Baxalta’s US7033590. Although perhaps most jury members would need some help with definitions, the disputed terms are incredibly basic and fundamental to anyone involved with biotech. Disputed terms:
- Antibody; and
- Antibody fragment.
Following claim construction, the parties stipulated to non-infringement.
On appeal, the Judges Moore, Wallach, and Stoll took up the claim construction question. However, after oral arguments Judge Stoll recused herself and Judge Plager stepped-in. The new panel rejected Judge Dyk’s claim construction and consequently vacated the non-infringement judgment.
The patent is directed to a treatment for hemophilia and claims “an isolated antibody or antibody fragment” that binds to FactorIXa and increased its procoagulant activity.
Judge Dyk explained that the term antibody might have various potential meanings. But here, the patentee expressed a narrower definition within its specification with the following statement:
Antibodies are immunoglobulin molecules having a specific amino acid sequence which only bind to antigens that induce their synthesis. . . . Each immunoglobulin molecule consists of two types of polypeptide chains. Each molecule consists of large, identical heavy chains (H chains) and two light, also identical chains (L chains).
‘590 at Col. 5. Applying this portion of the patent, the district court limited the scope of antibody to molecules having one set of identical H-chains and a set of identical L-chains.
Genentech’s product uses an antibody organized with a variety of H- and L- chains (not all the H-chains are identical to one another). Thus, Judge Dyk’s requirement of identical chains led to the admission of non-infringement.
On appeal, the Federal Circuit took Judge Dyk to task — finding that the patent did not suggest such a narrow definition of the term. Dependent claim 4, for instance, identifies the antibody as being selected from “the group consisting of … a chimeric antibody, a humanized antibody, … [and] a bispecific antibody.” The court explains that none of these antibody types in the dependent claim conform with the narrow definition of the term as used in claim 1.
The district court’s construction which excludes these explicitly claimed embodiments is inconsistent with the plain language of the claims. . . . The plain language of these dependent claims weighs heavily in favor of adopting Baxalta’s broader claim construction.
Slip Op. The court then looked at the definition discussed by Judge Dyk and concluded that it was a “generalized introduction” rather than a “definitional statement.” In this process, the court noted the lack of patent-profanity such as “the present invention is … ” The court’s conclusion is supported by other aspects of the specification that refers to the bispecific and other forms of antibodies that do not conform to Judge Dyk’s definition. The result: “The claim construction excluding these disclosed and claimed embodiments is therefore incorrect.”
The case also included some prosecution history. In particular, the patentee amended its claims from “antibody derivative” to “antibody fragment.” On appeal, the court found no clear statement from the prosecution history regarding how that amendment modified the scope. Without a ‘clear statement’ there is no prosecution disclaimer leading to disavowal of scope.