Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) granted the Company’s motion to vacate and remand the Patent Trial and Appeal Board (PTAB) decision to invalidate U.S. Patent No. 9,249,149 (’149 patent). Concert’s motion was made in light of the recent CAFC ruling on the Constitution’s Appointments Clause (Arthrex, Inc. v. Smith & Nephew, Inc., No. 18-2140). The case will now be remanded for reconsideration by a new panel of PTAB judges.
The ’149 patent covers CTP-543, Concert’s investigational drug candidate for the treatment of alopecia areata. The inter partes review (IPR) proceeding does not prohibit Concert from developing CTP-543 and does not affect other intellectual property protection that the Company is pursuing, including a new Notice of Allowance from the U.S. Patent and Trademark Office (PTO) covering pharmaceutical compositions of CTP-543 and methods of treating alopecia areata with CTP-543.
"We are pleased that the Federal Circuit granted our motion and look forward to reconsideration by a new panel of PTAB judges. We continue to believe that we have strong arguments for the validity of the ’149 patent," stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "Importantly, we are very pleased we received a Notice of Allowance for a separate patent that will provide independent protection for CTP-543 that is not related to the patent that is subject to the ongoing PTAB proceeding, and is expected to expire in 2037."
The CAFC’s grant of the Company’s motion will take effect on March 16, 2020 unless Incyte Corporation, which filed the petition for the IPR, or the PTO Director, who intervened in the case, seeks rehearing of the CAFC’s decision. If a request for rehearing was denied, the CAFC’s decision would ordinarily take effect seven days after the denial.
Documents relating to the IPR can be accessed on Concert’s website at: https://www.concertpharma.com/platform/intellectual-property/.
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to treat serious diseases and address unmet patient needs. The Company’s approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert’s pipeline of innovative medicines currently targets autoimmune diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com or follow us on Twitter at @ConcertPharma or on LinkedIn.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including, among others, statements about anticipated IPR proceedings, and any other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and timing of future clinical trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations regarding the CAFC’s grant of our motion to vacate and remand the PTAB’s decision to invalidate the ’149 patent and any related proceedings, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
Justine Koenigsberg (investors)
Concert Pharmaceuticals, Inc.
Kathryn Morris (media)
The Yates Network