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Legal Proceedings
12 Months Ended
Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]  
Legal Proceedings

NOTE 17 - LEGAL PROCEEDINGS

PENNSAID 2%

On May 6, 2022, Apotex received FDA approval to market a generic diclofenac sodium topical solution 2% (“Apotex ANDA Product”), following the apparent forfeiture by Actavis Laboratories UT, Inc. (“Actavis”) of its first-filer exclusivity. On May 13, 2022, the Company filed a complaint against Apotex asserting that the manufacture, use, offer for sale, or sale of the Apotex ANDA Product would infringe U.S. Patent No. 9,066,913 (the “‘913 patent”) in the United States District Court for the District of Delaware. The Company previously successfully enforced the ‘913 patent against Actavis in the District of New Jersey and the Federal Circuit subsequently affirmed the District Court’s ruling.

The Company purchased PENNSAID 2% from Nuvo Pharmaceuticals Inc. (“Nuvo”) in 2014. Apotex alleges that a settlement agreement entered into in January 2013 with Nuvo (“Nuvo Settlement”) provides it with a license to the ‘913 patent. The Company disputes the scope of Apotex’s settlement and license with Nuvo, contending that it does not provide Apotex with a license to the ‘913 patent, which was issued to the Company after the Company’s purchase of PENNSAID 2% from Nuvo.

On May 17, 2022, the Company moved for a preliminary injunction enjoining Apotex from engaging in the commercial manufacture, use, offer to sell, or sale of the Apotex ANDA Product. On May 27, 2022, the parties filed a stipulated preliminary injunction and a proposed expedited briefing schedule to present the underlying license dispute to the District Court by way of a motion for summary judgment, which the District Court entered on May 31, 2022. On August 23, 2022, the District Court held a hearing on the motion for summary judgment and the parties subsequently provided supplemental briefing on certain legal matters requested by the District Court. On November 7, 2022, the District Court ruled in Apotex’s favor, finding that the Nuvo Settlement provided Apotex a license to the ‘913 patent and that Apotex’s ANDA Product consequently does not infringe the ‘913 patent. Apotex subsequently alleged that the preliminary injunction was wrongfully entered and caused Apotex to suffer monetary losses. Apotex is also seeking an award of its attorney fees. The Company disputes Apotex’s allegations that it incurred monetary losses or that it is entitled to an award of attorney fees. The parties are currently briefing these issues to the District Court.

PROCYSBI

On February 2, 2022 and February 16, 2022, the Company received notice from Teva Pharmaceuticals, Inc. (“Teva”) that it had filed Abbreviated New Drug Applications (“ANDA”) with the FDA seeking approval of generic versions of PROCYSBI granules and capsules, respectively. The ANDAs contained Paragraph IV Patent Certifications alleging that the patents covering PROCYSBI granules and capsules are invalid and/or will not be infringed by Teva’s manufacture, use or sale of the medicines for which the ANDAs were submitted. On March 15, 2022, the Company filed suit against Teva in the United States District Court for the District of New Jersey for patent infringement, seeking to prevent Teva from selling its generic versions of PROCYSBI granules and capsules.

RAVICTI

On June 7, 2022, the Company received notice from Taro Pharmaceuticals Industries, Ltd. (“Taro”) that it had filed an ANDA with the FDA seeking approval of a generic version of RAVICTI. The ANDA contained Paragraph IV Patent Certification alleging that the patents covering RAVICTI are invalid and/or will not be infringed by Taro’s manufacture, use or sale of the medicine for which the ANDA was submitted. On July 20, 2022, the Company filed suit against Taro in the United States District Court for the District of New Jersey for patent infringement, seeking to prevent Taro from selling its generic version of RAVICTI.