Form 8-K

Date: February 19, 2015

SALIX PHARMACEUTICALS, LTD.

/S/ WILLIAM BERTRAND, JR.

William Bertrand, Jr.

Acting Chief Operating Officer,

Executive Vice President and General Counsel

8-K 1 d878822d8k.htm FORM 8-K Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): February 19, 2015

SALIX PHARMACEUTICALS, LTD.

(Exact name of registrant as specified in its charter)

Delaware

000-23265

94-3267443

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

8510 Colonnade Center Drive

Raleigh, North Carolina

27615

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (919) 862-1000

Not Applicable

(Former name or former address, if changed since last report)

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:

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

On February 17, 2015, Santarus, Inc., a wholly owned subsidiary of Salix Pharmaceuticals, Ltd. (the “Company”), and Cosmo Technologies Limited (“Cosmo”), the Company’s licensor, commenced a lawsuit against generic drug maker Actavis Laboratories FL, Inc. (“Actavis”) for Actavis’s infringement of six patents listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) as covering Uceris^® and its use. This lawsuit was filed within the 45-day response period provided by the Hatch-Waxman Act. The lawsuit was filed in the United States District Court for the District of Delaware. On February 19, 2015, the Company and Cosmo filed a second complaint against Actavis for infringement of the same six Orange Book patents in the District of New Jersey, also within the 45-day response period provided by the Hatch-Waxman Act.

The Company and Cosmo filed these lawsuits in response to a notice letter, dated January 5, 2015, sent by Actavis regarding its filing with the FDA of Abbreviated New Drug Application No. 205457 seeking approval for Actavis to manufacture and sell budesonide extended release tablets. This notice letter also stated that ANDA No. 205457 contained Paragraph IV certifications, under 21 U.S.C. Section 355(j) of the Federal Food, Drug, and Cosmetic Act, with respect to the six patents listed in the Orange Book on that date as covering Uceris^®: U.S. Patent Nos. 7,410,651; 7,431,943; 8,293,273; 8,784,888; 8,895,064 (“the ‘064 patent”); and RE43799. These six patents are all expected to expire on June 9, 2020, with the exception of the ‘064 patent, which is expected to expire on September 7, 2031. The Company remains committed to protecting its intellectual property rights, including its patent protection for Uceris^®.

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.