The Leahy-Smith America Invents Act of 2011 (AIA) provides a
"prior use defense" to patent infringement. Specifically,
a party may defend a patent infringement suit by establishing it
commercially used, in good faith, a process, machine, manufacture,
or composition of matter that is asserted to infringe the patent at
least 1 year before the effective filing date of the claimed
invention, or the date on which the claimed invention was disclosed
to the public (whichever is earlier). This substantially broadens
the prior use defense, which formerly applied only to business
method patents. The new prior use defense provision applies to any
patent issued after September 16, 2011.
The defense applies to commercial uses and certain other uses,
specifically (1) uses by nonprofit entities, such as universities
and hospitals, so long as the public is the intended beneficiary of
the use and any continuing use of the claimed invention is for
noncommercial use, and (2) use of a