Abstract
Synopsis
During inter partes review (IPR) proceedings, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) denied patentee's motion to enter an amendment replacing claims found to be unpatentable with new, substitute claims 18–29. The PTAB found that claim 18 lacked written description support, and that “proposed claims 19–29 depend from independent claim 18” and, thus, “are also unsupported for at least the same reasons.” On appeal, the Federal Circuit found that the PTAB had erred in its analysis, because in fact the proposed claims 26–29 did not depend from claim 18, as both parties acknowledged. The challenger argued that the court should affirm the PTAB's decision nonetheless, because claims 26–29 were invalid on other grounds, but the court declined to do so, finding that the PTAB had not addressed any of these alternative grounds for affirmance, and therefore did not make factual findings necessary for this court to conducting meaningful review. “Vacating and remanding is appropriate here, where the PTAB provided only an erroneous basis to reject [claims 26–29] and did not make factual findings relevant to alternate grounds for rejection.”
Appellee Array Biopharma Inc. (“Array”) sought inter partes review of certain claims of Appellant Takeda Pharmaceutical Company Limited's (“Takeda”) U.S. Patent No. 8,592,454 (“the '454 patent”). During the proceedings, Takeda filed a contingent motion to amend, seeking to replace any challenged claims found to be unpatentable with certain substitute and new claims. The U.S. Patent and Trademark Office's Patent Trial and Appeal Board (“PTAB”) issued a final written decision finding claims 1–7 and 12–16 of the '454 patent unpatentable, inter alia, as anticipated. The PTAB also denied Takeda's Contingent Motion to Amend, finding that, inter alia, proposed substitute claims 26–29 (“the Asserted Claims”) lacked written description support.
Takeda appeals. We vacate and remand for further proceedings.
Background
The '454 patent “relates to a novel nitrogen-containing heterocyclic compound having excellent antagonistic action for a tachykinin receptor and use thereof.” The claimed invention asserts to be “useful” as “an agent for the prophylaxis or treatment of various diseases such as a lower urinary tract disease, a digestive tract disease[,] or a central nervous system disease.”
The Asserted Claims were offered by Takeda during the inter partes review as proposed substitute claims in the event the PTAB found the original claims unpatentable. The Asserted Claims include independent claims 26 and 28, from which claims 27 and 29 depend, respectively. The Asserted Claims recite:
26. A method of antagonizing an NK1 receptor in a mammal, comprising administering an effective amount of a pharmaceutical composition comprising a compound represented by the formula [in original claim 1] to the mammal.
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27. The method according to claim 26, wherein the method further comprises administering an effective amount of the composition to antagonize an NK2 receptor and/or an NK3 receptor. 28. A method of antagonizing an NK2 receptor in a mammal, comprising administering an effective amount of a pharmaceutical composition comprising a compound represented by the formula [in original claim 1] to the mammal. 29. The method according to claim 28, wherein the method further comprises administering an effective amount of the composition to antagonize an NK1 receptor and/or an NK3 receptor.
Discussion
Takeda argues PTAB's rejection of the Asserted Claims for lack of written description support was based on “an erroneous premise” that “mandates reversal or remand.”
I. Standard of Review and Legal Standard
Pursuant to the Administrative Procedure Act, 5 U.S.C. §§ 551–559 (2012), we will only set aside the PTAB's denial of a motion to amend if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, and set aside factual findings that are unsupported by substantial evidence,” Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1306 (Fed. Cir. 2015).
II. The PTAB Erred in Denying Takeda's Contingent Motion to Amend with Respect to the Asserted Claims
The PTAB, after finding that proposed substitute claim 18 lacked written description support pursuant to 37 C.F.R. § 42.121(b), explained that “proposed claims 19–29 depend from independent claim 18” and, thus, “are also unsupported for at least the same reasons.” This was error, as both parties acknowledge. Although the PTAB is correct that proposed claims 19–25 depend from proposed claim 18, the Asserted Claims do not. Instead, proposed claims 26 and 28 are independent claims, from which proposed claims 27 and 29 depend, respectively. Accordingly, the PTAB's determination that the Asserted Claims lack written description support is based on an error and is not supported by substantial evidence.
Despite this error, Array argues this court should affirm the PTAB on the basis that: (1) Takeda failed to comply with the requirements of 37 C.F.R. § 42.121 for other reasons; (2) the Asserted Claims are anticipated by two prior art references; and (3) the Asserted Claims are unpatentable for lack of written description and enablement pursuant to 35 U.S.C. § 112. Typically, “[t]he agency tribunal must make findings of relevant facts, and present its reasoning in sufficient detail that the court may conduct meaningful review of the agency action.” Here, the PTAB did not provide an opinion as to any of Array's alternative grounds for affirmance, and therefore did not make factual findings necessary for this court to conducting meaningful review. In such a situation, where the PTAB's “action is potentially lawful but insufficiently or inappropriately explained, we have consistently vacated and remanded for further proceedings.” Vacating and remanding is appropriate here, where the PTAB provided only an erroneous basis to reject the Asserted Claims and did not make factual findings relevant to alternate grounds for rejection.