Amgen Inc. v. Sanofi
Functional limitations in a claim to a composition of matter may result in claim breadth that is not fully enabled if undue experimentation is required to determine the scope of the functional limitations.
Functional limitations in a claim to a composition of matter may result in claim breadth that is not fully enabled if undue experimentation is required to determine the scope of the functional limitations.
When a patent specification only enables one of ordinary skill in the art to achieve a small subset of a claimed range without undue experimentation, the patentee is not entitled to claim an open-ended range.
The enablement requirement may be met by animal tests or in vitro data. Title 35 does not demand that human testing occur within the confines of Patent and Trademark Office proceedings.
No principle requires that a witness testify as to legal conclusion of undue experimentation, provided factual showing is sufficient to justify jury’s conclusion on factual issue of whether, under all circumstances, more than routine experimentation is needed to make the invention work as claimed. Multiple prior art references offered to prove anticipation do not constitute multiple separate legal theories, each of which must to be proven to show anticipation. If any single reference shows anticipation, the legal theory of anticipation is met. Findings as to invalidity of claims apply only to asserted claims at an infringement trial.
There is no per se requirement for examples to meet the enablement requirement. However, the need for examples to prevent undue experimentation will be assessed by weighing a variety of factors.