Aurinia Pharmaceuticals Notification Regarding Inter Partes Patent Review

Rhea-AI Summary

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced that the U.S. Patent Trial and Appeal Board (PTAB) has decided to institute an Inter Partes review of Patent No. 10,286,036, related to the dosing protocol of LUPKYNIS^® for lupus nephritis. CEO Peter Greenleaf expressed disappointment but affirmed the Company's commitment to defend the patent. This patent provides protection until 2037. Aurinia also filed for a patent term extension for its existing composition patent, potentially extending its term to October 2027. A patentability determination is expected by July 26, 2023.

Positive

• Patent No. 10,286,036 extends protection for LUPKYNIS to 2037.
• The company has filed for a patent term extension that, if granted, would extend a key patent to October 2027.

Negative

• The initiation of the Inter Partes review indicates potential challenges to the patent's validity.

VICTORIA, British Columbia and ROCKVILLE, Md.--(BUSINESS WIRE)-- 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.

About Aurinia

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220726006036/en/

Investor and Corporate

DeDe Sheel, VP, Investor Relations

aurinia@westwicke.com

Source: Aurinia Pharmaceuticals Inc.

FAQ

What does the PTAB's decision mean for AUPH's patent?

The PTAB's decision to institute an Inter Partes review could challenge the validity of AUPH's Patent No. 10,286,036, related to LUPKYNIS.

When will a determination on the patentability be made?

A determination on patentability related to the IPR is expected on or before July 26, 2023.

What is the significance of Patent No. 10,286,036 for AUPH?

This patent protects the unique dosing protocol for LUPKYNIS and extends its market exclusivity until 2037.

How long could the patent term extension last for AUPH?

If granted, the patent term extension could extend AUPH's existing composition patent to October 2027.