The Patent Trial and Appeal Board recently denied institution of inter partes review of two Allergan patents directed to a hyaluronic acid-based gel containing lidocaine. Teoxane S.A. v. Allergan, PLC, IPR2017-01906, Paper 15 (P.T.A.B. March 9, 2018); Teoxane S.A. v. Allergan, PLC, IPR2017-02002, Paper 14 (P.T.A.B. March 9, 2018).
The patents at issue, U.S. Patent Nos. 8,357,795 and 8,450,475, claim compositions containing lidocaine and hyaluronic acid (“HA”) crosslinked with an agent such as 1,4-butanediol diglycidyl ether (“BDDE”).
Petitioner argued that certain claims were anticipated by Hunter, a patent application disclosing a composition comprising an HA component in combination with an agent that slows HA breakdown, and, optionally, an anesthetic agent (e.g., lidocaine). Hunter referred to a gel marketed under the name Restylane, but did not disclose that the HA component was crosslinked using BDDE. To establish the BDDE crosslinking component, Petitioner relied on a non-prior art reference (“Beasley”)—published five years after Hunter—that explained that Restylane contains HA crosslinked with BDDE. The panel rejected Petitioner’s reliance on Beasley because Petitioner failed to establish that the Restylane gel described in Beasley was identical to the Restylane gel described in Hunter. The PTAB rejected a similar argument based on another branded gel even though the composition of that gel was described in two separate, non-prior art references.
Thus, while non-prior art references may inform the obvious inquiry, it is imperative to tie those references to products available before the critical date.