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LEGAL PROCEEDINGS
6 Months Ended
Jun. 30, 2013
LEGAL PROCEEDINGS

NOTE 11 – LEGAL PROCEEDINGS

On February 15, 2012, the Company received a Paragraph IV Patent Certification from Par Pharmaceutical, Inc. (“Par”) advising that Par had filed an Abbreviated New Drug Application (“ANDA”) with the FDA for a generic version of DUEXIS, containing 800 mg of ibuprofen and 26.6 mg of famotidine. Par has not advised the Company as to the timing or status of the FDA’s review of its filing, or whether it has complied with FDA requirements for proving bioequivalence. In March 2012, the Company filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Par and Par Pharmaceutical Companies, Inc. for filing an ANDA against DUEXIS and seeking an injunction to prevent the approval of Par’s ANDA and/or preventing Par from selling a generic version of DUEXIS. In January 2013, the Company filed a second suit against Par in the United States District Court for the District of Delaware claiming patent infringement of additional patents that have been issued for DUEXIS and seeking an injunction to prevent the approval of Par’s ANDA and/or preventing Par from selling a generic version of DUEXIS. A patent claim construction hearing is scheduled for August 21, 2013, and a trial date is currently set for the second quarter of 2014. All of the Company’s issued U.S. patents covering DUEXIS are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Under the FDA’s rules and regulations, because the Company initiated a patent infringement suit to defend a patent identified in the Paragraph IV notice within 45 days after the FDA’s receipt of the notice, the FDA is prevented from approving the ANDA until the earlier of 30 months from the date of the first suit or a decision in the infringement case that the patent is not infringed or invalid.

On March 13, 2013, the Company received purported Notice Letters that a Paragraph IV Patent Certification had been filed by Alvogen Pine Brook, Inc. (“Alvogen”), advising that Alvogen had filed an ANDA with the FDA for a generic version of RAYOS, containing up to 5 mg of prednisone. In the Notice Letters, Alvogen noted that as of March 13, 2013, the FDA had not accepted the ANDA for review. Alvogen has agreed that their Notice Letters do not constitute Notice as described in 21 U.S.C. 355(j)(2)(B). On July 15, 2013, the Company received a Paragraph IV Patent Certification from Watson Laboratories, Inc.—Florida (“WLF”), advising that WLF had filed an ANDA with the FDA for a generic version of RAYOS, containing up to 5 mg of prednisone. WLF has not advised the Company as to the timing or status of the FDA’s review of its filing. The Company is evaluating the Paragraph IV Patent Certifications and intends to vigorously enforce its intellectual property rights relating to RAYOS. All of the issued U.S. patents covering RAYOS are listed in the FDA’s Orange Book. Under the FDA’s rules and regulations, if the Company initiates a patent infringement suit to defend the patents identified in a Paragraph IV notice within 45 days after the FDA’s receipt of a proper notice under 21 U.S.C. 355(j)(2)(B), the FDA would be prevented from approving the ANDA until the earlier of 30 months from the date of the suit or a decision in the infringement case that each of the patents is not infringed or invalid.