Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (“Aurinia” or the “Company”) today received notice regarding the U.S. Patent Office (USPTO) Patent Trial and Appeal Board (PTAB) decision to institute trial on the Inter Partes review (“IPR”) filed by Sun Pharmaceuticals, directed at U.S. Patent No. 10,286,036. This patent is related to the LUPKYNIS® dosing protocol for lupus nephritis.
“While this decision is disappointing, as we have stated from the start of his process, we will vigorously defend this patent,” said Peter Greenleaf, President and CEO, Aurinia Pharmaceuticals. “This patent already had significant review at the USPTO before being approved as being a valid patent by that office and we are fully prepared to continue legal proceedings to protect our intellectual property.”
Patent No. 10,286,036 was issued to Aurinia in support of the unique eGFR pharmacodynamic dosing protocol used within the Company’s clinical trials, and extends patent protection for LUPKYNIS to 2037. Regardless of the final outcomes of the IPR, the Company has filed a standard form patent term extension for its existing composition of matter patent, which, if granted, would extend the term of that patent by 5 years to October 2027. A determination on patentability, relative to the IPR, is expected on or prior to July 26, 2023.
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (LN). The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.
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Investor and Corporate
DeDe Sheel, VP, Investor Relations