Written Description Support Requires Working Examples or “Constructive Possession”
Centocor Ortho v. Abbott (decided 2/28/11)By: Erik Spek
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What This Means to You
- When drafting an application, support the claimed invention by working examples or by describing in explicit detail in the specification how the claimed invention can be implemented. Do not rely on references outside of the specification for written description support.
- Prior to asserting a patent claim, scrutinize the specification for written description support.
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Overview
In Centocor Ortho Biotech, Inc. v. Abbott Laboratories, the US Court of Appeals for the Federal Circuit (Federal Circuit) confirmed that to satisfy the written description requirement, an applicant has to show possession of the invention through disclosure in the specification. While actual working examples or a showing of reduction to practice are not an absolute requirement, one of skill in the art has to be able to “visualize or recognize” (or have “constructive possession” of) the claimed invention based on the disclosure.
Case Background
Centocor sued Abbott in the Eastern District of Texas claiming that Abbott’s therapeutic antibody Humira® infringed claims to an anti-TNF-alpha antibody. The district court found for Centocor, along with a damage award of $1.67 billion.
Abbott appealed to the Federal Circuit which reversed the lower court’s decision, finding that the asserted claims, which relate to an anti-TNF-alpha antibody comprising both a human constant region and a human variable region, did not have written description support.
Decision Analysis
The Federal Circuit reviewed the asserted claims for written description support and emphasized that written description requires possession of the invention as shown in the disclosure.
In an objective inquiry into the specification, the court did not find disclosure of an antibody with a human variable region. While the specification disclosed an antibody with a mouse variable region, such a mouse variable region was not a stepping stone for a human variable region. In fact, the human variable region of Abbott’s Humira® was very different from the mouse sequence disclosed in the specification.
The specification provided references on the making of human variable region, but these references were not found to be sufficient to support a showing of possession of the invention. As stated by the court, “The fact that an antibody with a human variable region could be made does not suffice to show that the inventors…possessed such an antibody”.
The Federal Circuit concluded that Centocor did not show possession of the invention because not a single antibody was disclosed that satisfied the claim language, and there was neither a disclosure of characteristics of human variable regions, nor a disclosed relationship between human and mouse regions.
Takeaways
Written description support requires the showing of possession within the four corners of the application. When drafting an application, provide working examples or detailed disclosure for the claimed invention. Do not rely on references outside the specification to fill in any gaps.
When devising a litigation strategy, carefully scrutinize the specification for description support for claims to be asserted. Consider asserting broader claims that do not recite a specific element that may not have been described in detail in the specification.
In this context, it is interesting to note that Centocor did not assert independent claims that would have also covered Abbott’s antibody but that did not recite a human variable region.
