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Aurinia Announces LUPKYNIS® (voclosporin) Patent Challenge Settlement Reached With Sun Pharmaceuticals

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Aurinia Pharmaceuticals (NASDAQ: AUPH) and Sun Pharmaceuticals have reached a settlement regarding patent infringement claims related to Sun's CEQUA® product. The settlement includes a joint motion to dismiss an Inter Partes Review of Aurinia's U.S. Patent No. 10,286,036. This agreement is contingent on the U.S. Patent Trial and Appeal Board terminating the Inter Partes Review. Both companies will cease further claims against each other under this settlement.

Positive
  • Settlement agreement reduces legal risks for Aurinia.
  • Termination of Inter Partes Review may enhance patent protection.
Negative
  • Settlement could imply potential vulnerabilities in Aurinia's patent claims.

- Sun Pharmaceuticals and Aurinia agreed to file a joint motion to dismiss Inter Parties Review of Patent No. 10,286,036

- Parties have settled the patent infringement claim against Sun’s CEQUA® product

- Settlements are Contingent Upon U.S. Patent Trial and Appeal Board (PTAB) Terminating Inter Partes Review

VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) announces it has entered into a settlement agreement with Sun Pharmaceutical Industries, Inc., Sun Pharmaceuticals Industries, Ltd., and Sun Pharma Global FZE (collectively, Sun Pharmaceuticals) that involves both Aurinia and Sun Pharmaceuticals filing a joint motion to terminate the ongoing Inter Partes Review (IPR) directed at Aurinia’s U.S. Patent No. 10,286,036, as well as settlement of the ongoing patent infringement litigation in the United States (U.S.) related to Sun’s CEQUA® product. Under the settlement agreement, which is contingent upon the U.S. Patent Trial and Appeal Board approving the joint motion to terminate the IPR, both parties agreed to dismiss their claims and counterclaims against each other and cease bringing any future further action against the other.

About LUPKYNIS
LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN). LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is in the United States (U.S.) and across the European Union (E.U).

About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

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.

Investor/Media Contact:

Aurinia@westwicke.com

Source: Aurinia Pharmaceuticals Inc.

FAQ

What is the recent settlement between Aurinia and Sun Pharmaceuticals about?

Aurinia and Sun Pharmaceuticals settled patent infringement claims, agreeing to file a joint motion to dismiss an Inter Partes Review of Aurinia's Patent No. 10,286,036.

How does the settlement affect Aurinia Pharmaceuticals' stock?

The settlement reduces legal risks and uncertainty, which may positively influence investor sentiment regarding Aurinia's stock.

What are the conditions of the settlement between AUPH and Sun Pharmaceuticals?

The settlement is contingent upon the U.S. Patent Trial and Appeal Board approving the joint motion to terminate the Inter Partes Review.

What is U.S. Patent No. 10,286,036 related to?

U.S. Patent No. 10,286,036 is associated with Aurinia's products and was a subject of the patent infringement claims against Sun's CEQUA®.

Aurinia Pharmaceuticals Inc

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