Prior to the AIA, Section 273 provided a defense to business method patents only. Now, Section 273 provides an expanded defense based on earlier commercial use of a process or instrumentality used in a manufacturing or other commercial process. 35 U.S.C. § 273(a). Additional commercial uses include for premarketing regulatory review and for continued, noncommercial use by nonprofit entities. See 35 U.S.C. § 273(c).
Requirements to use defense -
Assertion of the defense is available for patents issued on or after September 16, 2011, and requires showing, by clear and convincing evidence,
(1) good faith, commercial use of the subject matter in the United States, either in connection with an internal commercial use or an actual arm’s length sale or other arm’s length commercial transfer of a useful end result of such commercial use, and...
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