How does the “first permitted marketing or use” requirement affect patent term extension eligibility?
The “first permitted marketing or use” requirement is a crucial factor in determining eligibility for patent term extension. According to 35 U.S.C. 156(a)(5) and 37 CFR 1.720(e), the approval for commercial marketing or use must generally be the first permitted under the provision of law under which the regulatory review occurred. For human drug products:…
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