UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01. Other Item.
On July 25, 2022, Rigel Pharmaceuticals, Inc. (“Rigel”) filed a lawsuit in the U.S. District Court for the District of New Jersey against Annora Pharma Private Ltd., Hetero Labs Ltd., and Hetero USA, Inc. (collectively, “Annora”) for infringement of Rigel’s United States Patent Nos. 7,449,458, 8,263,122, 8,652,492, 8,771,648, and 8,951,504. These patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the “Orange Book”) and cover TAVALISSE® fostamatinib disodium tablets, Eq. 100mg base and Eq. 150mg base, (“TAVALISSE”).
Rigel’s lawsuit is in response to an Abbreviated New Drug Application (“ANDA”) filed by Annora seeking approval from the U.S. Food and Drug Administration (“FDA”) to market and sell a generic version of TAVALISSE. In June 2022, Rigel received a Paragraph IV Certification Notice Letter (the “Notice Letter”) from Annora identifying the five asserted patents and alleging that the patents will not be infringed by Annora’s proposed product, are invalid and/or are unenforceable. The Notice Letter did not provide a Paragraph IV certification against any other of Rigel’s patents listed in the Orange Book.
Rigel’s complaint alleges that Annora has infringed the five asserted patents by filing its ANDA and seeks, among other relief, equitable relief enjoining Annora from infringing these patents.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: July 25, 2022 | RIGEL PHARMACEUTICALS, INC. | |
By: | /s/ Dolly A. Vance | |
Dolly A. Vance | ||
Executive Vice President, General Counsel and Corporate Secretary |
Cover |
Jul. 25, 2022 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Jul. 25, 2022 |
Entity File Number | 0-29889 |
Entity Registrant Name | RIGEL PHARMACEUTICALS, INC. |
Entity Central Index Key | 0001034842 |
Entity Tax Identification Number | 94-3248524 |
Entity Incorporation, State or Country Code | DE |
Entity Address, Address Line One | 1180 Veterans Boulevard |
Entity Address, City or Town | South San Francisco |
Entity Address, State or Province | CA |
Entity Address, Postal Zip Code | 94080 |
City Area Code | 650 |
Local Phone Number | 624-1100 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, par value $0.001 per share |
Trading Symbol | RIGL |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
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