September 20, 2019
Aquestive Therapeutics, Inc. v. Neurelis, Inc., a case decided last month, highlights the risk that the Patent Trial and Appeal Board (PTAB) may decide against instituting an inter partes review (IPR) when the petitioner relies on prior art extensively considered during the original patent prosecution.
Aquestive Therapeutics petitioned for IPR against claims 1–36 in U.S. Patent No. 9,763,876 on the basis the claims would have been obvious over a combination of a U.S. patent (Sonne) and a U.S. patent publication (Meezan). Aquestive also separately filed two other petitions for IPR asserting other grounds of invalidity against the ’876 patent. The ’876 patent relates to nasally administered pharmaceutical solutions.
Neurelis responded by arguing the PTAB should deny institution under 35 U.S.C. 325(d) because Aquestive failed to present new grounds of invalidity substantively different from those already considered during the original patent prosecution. Neurelis argued that both Sonne and Meezan were considered at length during the original patent prosecution and that the Becton Dickinson factors favored denying institution of IPR.
In deciding whether to exercise its discretion under section 325(d), the PTAB considers the non-exhaustive Becton Dickinson factors (a)–(f):
(a) the similarities and material differences between the asserted art and the prior art involved during examination;
(b) the cumulative nature of the asserted art and the prior art evaluated during examination;
(c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection;
(d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art;
(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and
(f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments.
According to the PTAB’s analysis of the extensive original patent prosecution, Sonne and Meezan were evaluated in depth and were the basis of prior art rejections. The PTAB did acknowledge that an aspect of Sonne was mistakenly characterized by Neurelis during original patent prosecution and that Aquestive provided some new evidence (an evidentiary declaration) and hypothetical compounds based on an example in Sonne. However, the PTAB pointed out that the example in Sonne was identified and relied upon by the examiner during the original prosecution, which prompted the PTAB to conclude it “does not warrant the Board retreading the same worn path the Examiner and Applicant travelled during the extensive prosecution history in this patent family.”
Accordingly, the PTAB exercised its discretion and denied institution of trial.
Petitioners should be aware a petition for IPR may well be denied institution when it revisits the same prior art considered in detail by the examiner during original patent prosecution. When faced with such a petition, patent owners are well advised to demonstrate to the PTAB in a preliminary response the similarity of the petition’s challenge to the art and arguments considered during prosecution.
If you have questions regarding this decision, please contact Fitch Even partner Kendrew H. Colton, author of this alert.
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