| Item 8.01. | Other Information. |
On March 1, 2019, BDSI filed a complaint for patent infringement in Delaware against Chemo Research, S.L., Insud Pharma S.L., IntelGenx Corp., and IntelGenx Technologies Corp. (collectively, “Defendants”), asserting that the Defendants infringe BDSI’s Orange Book listed patents for Belbuca®, including U.S. Patent Nos. 8,147,866 and 9,655,843, both expiring in July of 2027, and U.S. Patent No. 9,901,539 expiring December of 2032. This complaint follows a receipt by BDSI on January 31, 2019, of a Notice Letter from Chemo Research S.L. stating that it has filed with the U.S. Food and Drug Administration (“FDA) an Abbreviated New Drug Application (“ANDA”), containing a Paragraph IV Patent Certification, for a generic version of Belbuca® (buprenorphine) Buccal Film in strengths 75 mcg, 150 mcg, 300 mcg, 450 mcg, and 900 mcg. Because BDSI initiated a patent infringement suit to defend the patents identified in the Notice Letter within 45 days after receipt, the FDA is prevented from approving the ANDA until the earlier of 30 months or a decision in the case that each of the patents is not infringed or invalid. Chemo Research S.L.’s Notice Letter also does not provide any information on the timing or approval status of its ANDA.
BDSI believes that it will be able to prevail in this lawsuit. As it has done in the past, BDSI intends to vigorously defend its intellectual property against assertions of invalidity. Each of the three patents carry a presumption of validity, which can only be overcome by clear and convincing evidence. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (“Teva”) had previously sought to litigate the validity of the ‘866 patent, one of the patents in suit, and ultimately settled, acknowledging the validity of this patent.
