Item 8.01 Other Events.
On June 21, 2017, Omeros filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware and a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Sandoz Inc., or Sandoz, and on June 22, 2017, Omeros filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware and a patent infringement lawsuit in the U.S.
District Court for the District of New Jersey against Lupin Ltd. and Lupin Pharmaceuticals, Inc
., which we refer to collectively as Lupin. The lawsuits were filed under the Hatch-Waxman Act for Sandoz’s and Lupin’s respective infringement of six Omeros patents: U.S. Patent Nos. 8,173,707, 8,586,633, 9,066,856, 9,278,101, 9,399,040 and 9,486,406, whi
ch relate to Omeros’ drug OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3% and which are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, published by the U.S. Food and Drug Administration, or
FDA. The lawsuits were filed in response to Notice Letters Omeros received from Sandoz and Lupin that each company had filed an Abbreviated New Drug Application, or ANDA, containing a Paragraph IV Certification under the Hatch-Waxman Act and seeking appro
val from the FDA to market a generic version of OMIDRIA prior to the expiration of the six Orange Book-listed patents for OMIDRIA. These patents were granted following review by the U.S. Patent and Trademark Office, are presumed to be valid under governing
law, and can only be invalidated in federal court with clear and convincing evidence.
Under the Hatch-Waxman Act, Omeros was permitted to file suit within 45 days from its receipt of each Notice Letter and thereby trigger a 30-month stay of the FDA’s approval of the respective ANDAs. Each stay is expected to remain in effect until November 2019. The assertions raised in Sandoz’s and Lupin’s Paragraph IV Notice Letters are substantially similar to those raised by Par Pharmaceutical, Inc. and its subsidiary Par Sterile Products, LLC, which we refer to collectively as Par, in Omeros’ current patent litigation against Par. Omeros believes the assertions in the Sandoz and Lupin Paragraph IV Notice Letters do not have merit, and Omeros intends to vigorously prosecute its infringement claims against Sandoz and Lupin.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. These statements include, but are not limited to, Omeros’ expectations regarding the lawsuits. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this Current Report on Form 8-K. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading “Risk Factors” in Omeros’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and Omeros assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.