Prior User Rights Study Report to Congress - America Invents Act

usiness or enterprise activities of a defendant. 69 Thus, prior use in Germany must be independent of anythird parties and solely in the interest of the party asserting a prior user rights defense. 70 The use of a thirdparty to realize the invention is not considered a prior use activity. 71 However, production for others ispermissible. 72In view of the above, the prior user rights defense of the AIA appears to adopt a use definitionsimilar to most of the studied countries. Under the AIA, prior use activity is defined as commercial use,“either in connection with an internal commercial use or an actual arm’s length sale or other arm’s lengthcommercial transfer of a useful end result of such commercial use.” 73 The statute also affirmatively setsforth several scenarios in which subject matter is explicitly considered as being “commercially used” andthus eligible for the prior user rights defense. 74 For example, one provision states that subject matter forwhich commercial marketing or use is subject to a premarketing regulatory review period during whichsafety or efficacy is established shall be deemed to be commercially used for purposes of the prior userright defense during the regulatory review period. 75 Additionally, a second provision provides that use ofthe subject matter by a “nonprofit research laboratory or other nonprofit entity, such as a university orhospital, for which the public is the intended beneficiary” will be considered a “commercial use” forpurposes of the prior user right defense. 76It is noteworthy to briefly discuss in this study how in some jurisdictions, prior use may havedifferent definitions based on statutory subject matter. These prior use definitions can be divided intothree types: (i) activities related to product-inventions; (ii) activities related to product-by-processinventions; and (iii) activities related to process inventions. Of these, activities (i) and (ii) are usuallycoextensive.For example, in Australia, the prior use standard is exploitation (and taking definitive steptowards exploitation) of “the product, method or process in the patent area.” 77 Exploitation, per theAustralian standard, is defined differently based on the subject matter of the invention. 7869 German Patent Act, at § 12(1); see also German Patent and Trademark Office, Response to WIPO Questionnaireon Exceptions and Limitations to Patent Rights 8, http://www.wipo.int/export/sites/www/scp/en/exceptions/submissions/germany.pdf (last visited Dec. 21, 2011).70 Rojahn, supra note 67, at slide 10.71 Id.72 Id. at slide 17.73 § 5, 125 Stat. at 297 (to be codified at 35 U.S.C. § 273(a)).74 Id. (to be codified at 35 U.S.C. § 273(c)).75 Id. (to be codified at 35 U.S.C. § 273(c)(1)).76 Id. (to be codified at 35 U.S.C. § 273(c)(2)).77 Australian Patent Law, at § 119(5).78 Id.; See also Adam Wright, Assistant Director, International Policy and Cooperation, IP Australia, Response toWIPO Questionnaire on Exceptions and Limitations to Patent Rights 12-15,16