"Know your invention." It is a simple statement, and one that I often repeat in introductory seminars on patenting. For a Patent Applicant (and her Patent Attorney), a clear understanding of the invention to be claimed is essential both for determining what features of the invention must be recited in one or more claims, and also what and how those features must be described in the claim-supporting specification. For some inventions however, the patentable technological advance lies not so much in those features that are present in the claimed invention, but rather in those that are excluded from it. Recently, in
The '405 Patent describes treatments for relapsing-remitting multiple sclerosis (RRMS) by administration of the immunosuppressant fingolimod. The claimed treatments require administration of a specific daily dose of the immunosuppressant "absent an immediately preceding loading dose regimen." A "loading dose" is understood in the art to be a large initial dose of a therapeutic agent that is typically given to a patient prior to a more defined treatment regimen. The '405 does not expressly describe methods of administering fingolimod in the absence of a "loading dose," but simply describes its use in regimens of various periodic administrations. In this aspect the '405 Patent resembles myriad other patents in describing its therapeutic method by what it is, without concretely defining what it is not. However, despite not expressly describing the absence of the recited "loading dose," a district court held the patent to be valid and infringed. The CAFC disagreed.
In supporting its holding, the court helpfully defined the boundaries of what constitutes descriptive support for a negative limitation by reference to past precedent of such exclusions (e.g., describing reasons to exclude or drawbacks to the limitation, alternatives, or even express exclusions). Most significantly, the court stated that "disclosure of the element" is crucial in establishing support: "Silence is generally not disclosure." This may sound as self-evident as a weather report here in
Taken to its logical conclusion, the flexibility of the US standard results in the following maddening statement from the court: "While a written description's silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclosing the negative limitation" (emphasis added). Under these equivocations, the court is expressing a clear standard: silence is not enough, but could be used in conjunction with the knowledge of the art to demonstrate inherency. Later in the opinion, the court emphasizes that the burden of demonstrating such inherent description and knowledge of the art is squarely on the shoulders of the Applicant. In this case, the court found that
The holding in
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