Question: List one item the applicant must establish under 35 U.S.C. 156(a)(1)-(5). Answer: 35 U.S.C. 156(a)(1)-(5) require that the applicant establish that: (1) the patent has not expired before an application under 35 U.S.C. 156(d) was filed (this may be an application for patent term extension under subsection (d)(1) or an application for interim extension under subsection (d)(5)); (2) the patent has never been extended under 35 U.S.C. 156(e)(1); (3) the application for extension is submitted by the owner of record of the patent or its agent to the Office within 60 days of regulatory agency approval of the commercial marketing…
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