Joint adjudication scheme (along with Department of Commerce's Patent and Trademark Office (PTO)) relating to requests for extension of patent terms for veterinary biological products under the Virus-Serum Toxin Act. APHIS's role is to determine length of a product's regulatory review period and, if a due diligence petition is filed by an interested party, to hold an informal hearing on the petition. (9 CFR Part 124). APHIS determinations on regulatory review period are designed to used be in conjunctions with PTO regulations concerning patent term extensions. (PTO rules: 37 CFR 1.1710 - 1.791).
|Level||Name of Office||Sub-Agency/Bureau/Division:||Are administrative appeals permitted from final decisions at this stage?|
Policy, Evaluation, and Licensing (APHIS/PEL)