To list a patent in the Orange Book as covering a product that is the subject of an NDA, the patent must claim the active ingredient drug for which the NDA was submitted and approved.
Proving vicarious liability of a system claim requires showing that a first party directed or controlled a second party’s use of the system as a whole, not just a portion of the system.
When a determination of whether there is a motivation to combine references to show obviousness is necessary, the analysis requires specificity and adequate explanation.
The omission of a word that was present in a provisional application may be used to inform claim construction of the claim terms of the nonprovisional patent, even if the provisional application was incorporated by reference in the nonprovisional patent.
Bioequivalence is not sufficient, on its own, to prove infringement by the doctrine of equivalents by the function-way-result test. Bioequivalence may satisfy the result prong, but an accuser still must prove the accused product performs the same function and works in a similar way as the claimed invention.
A district court may impose additional sanctions under its inherent power on top of awarding attorney fees and costs under Section 285.
If a property of a claimed composition is inherent, then there is no requirement to show a reasonable expectation of success of achieving the claimed composition when combining prior art references to prove obviousness.