Juno Release: Court Decides It Lacks Jurisdiction Before FDA Approval Occurs
SEATTLE--(BUSINESS WIRE)--Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, announced today that the U.S. District Court for the District of Delaware decided it lacked jurisdiction at this time over a lawsuit filed against Kite Pharma, Inc., citing the absence of evidence that an FDA approval decision of Kite’s lead product candidate axicabtagene ciloleucel “is expected on Defendant’s BLA in the immediate future.”
“a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality.”
In December 2016, Juno sued Kite seeking a declaratory judgment that axicabtagene ciloleucel will infringe U.S. Patent No. 7,446,190, when commercially produced. Juno is the exclusive licensee of the patent, titled “Nucleic Acids Encoding Chimeric T Cell Receptors,” which covers, among other things, a construct for a CD-19 targeted CAR T cell treatment that employs a CD28 costimulatory domain.
The Court noted that to issue a declaratory judgment there must exist "a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality." Notwithstanding Kite’s BLA filings and statements of its intent to market the product once FDA approval is obtained, the Court did not find “that FDA approval of Defendant's BLA is imminent or even certain” at this time, and therefore dismissed the lawsuit. The dismissal does not preclude a resolution of the parties’ dispute on the merits at a later time.
The U.S. Patent & Trademark Office issued a final written decision upholding all the claims of the ‘190 Patent in December 2016, defeating Kite’s attempt to invalidate the patent by challenging all of its claims via an inter partes review. Kite has appealed that decision.
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital.
ABOUT THE JUNO-CELGENE COLLABORATION
Celgene Corporation and Juno Therapeutics formed a collaboration in June 2015 under which the two companies will leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on chimeric antigen receptor (CAR) and T cell receptor (TCR) technologies. In April 2016, Celgene exercised its option to develop and commercialize the Juno CD19 program outside North America and China.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including statements regarding Juno’s mission, progress, and business plans, and Juno’s litigation against Kite Pharma, Inc. and allegations made in that litigation. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno's product development activities and clinical trials; Juno's ability to obtain regulatory approval for and to commercialize its product candidates; Juno's ability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno's competitors with respect to competing treatments and technologies; Juno's dependence on third-party collaborators and other contractors in Juno's research and development activities, including for the conduct of clinical trials and the manufacture of Juno's product candidates; Juno's dependence on Celgene for the development and commercialization outside of North America and China of Juno’s CD19 product candidates and any other product candidates for which Celgene exercises an option; Juno’s dependence on JW Therapeutics (Shanghai) Co., Ltd, over which Juno does not exercise complete control, for the development and commercialization of product candidates in China; Juno's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno's business in general, see Juno's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 4, 2017 and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.