SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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Item 8.01. Other Events.
On July 13, 2020, Intercept Pharmaceuticals, Inc. (the “Company”) received a paragraph IV certification notice (the “PIV Notice”) from Apotex Inc. (“Apotex”) indicating that Apotex has submitted to the U.S. Food and Drug Administration an Abbreviated New Drug Application (“ANDA”) seeking approval to manufacture and sell a generic version of the Company’s 5 mg and 10 mg dosage strengths of Ocaliva® (obeticholic acid) for primary biliary cholangitis prior to the expiration of the Company’s U.S. Patents Nos. 9,238,673, 10,047,117, 10,052,337, and 10,174,073 (collectively, the “Challenged Patents”), which are listed for Ocaliva in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (referred to as the “Orange Book”). The PIV Notice alleges that the Challenged Patents, which expire between June 2033 and April 2036, are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic products described in Apotex’s ANDA. Apotex did not make a paragraph IV certification against the Company’s U.S. Patents Nos. 7,138,390, 8,058,267 or 8,377,916, which are also listed for Ocaliva in the Orange Book. The Company may receive additional paragraph IV certification notices in the future from ANDA filers seeking approval of a generic version of Ocaliva.
The Company is currently reviewing the PIV Notice from Apotex and intends to vigorously defend and enforce its intellectual property rights protecting Ocaliva.
This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, statements regarding the Company’s intention to defend and enforce its intellectual property rights as well as Intercept’s understanding of the content of the paragraph IV certification notice. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Current Report on Form 8-K, and the Company undertakes no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by the Company’s management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks. Actual results may differ materially from historical results or those anticipated or predicted by the Company’s forward-looking statements as a result of various important factors, including, but not limited to, the impact of general economic, industry, market or political conditions and the other risks and uncertainties identified in the Company’s periodic filings, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the month ended March 31, 2020.
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.
|INTERCEPT PHARMACEUTICALS, INC.|
|By:||/s/ Sandip Kapadia|
|Title:||Chief Financial Officer and Treasurer|
Date: July 15, 2020