Aquestive fails to show why EX1013—a document that is cited only in support of a non-instituted ground—(and Dr. Peppas’ discussion thereof, EX1041, ¶¶171-191, 264-362, Appendix A (pp. 197-224), and EX1050) is relevant to the instituted grounds.
Aquestive’s reliance on Genzyme Therapeutic and/or Ariosa Diagnostics is disingenuous given that neither of those decisions involved the lack of notice, and resultant prejudice, that is present here.
The declaration does not provide any “personal knowledge” as required by FRE 901(b)(1), or any other evidence that EX1069 is what Aquestive purports it to be—a manual available to, and followed by, medical technicians in Florida prior to the priority date.
Separately, Dr. Wermeling’s experience in drug development does not qualify him to provide expert opinions on economics and/or regulatory procedures.
Aquestive block cites portions of Dr. Wermeling’s testimony in support of the alleged “expertise”—but, a closer look at the testimony reveals that he (1) is merely “familiar with economic principles” (EX2031, 8:19-22) and otherwise collaborated with trained economists for his written work (id., 10:2-14); (2) has never worked at, or received any formal certifications related to, FDA practice and procedure (id., 10:22-11:7); (3) has limited experience with pricing (id., 77:2-7) and could not make any pricing decisions on his own (id., 79:24-80:81:5), and; (4) is only “pretty familiar” with the 505(b)(2) pathway and would need to consult the “regulatory person at the company” for the answer to a complex question on the same (id., 85:6-86:13).