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HLS Therapeutics Comments on U.S. Court of Appeals Decision in Amarin Patent Litigation
HLS Therapeutics Comments on U.S. Court of Appeals Decision in Amarin Patent Litigation ...
About this update from Hls Therapeutics, Inc.
[{"type":"text","content":"\n\n\n\nHLS Therapeutics Comments on U.S. Court of Appeals Decision in Amarin Patent Litigation\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\n\nCanada NewsWire\nTORONTO, Sept. 3, 2020\n\n\n\nU.S. decision does not relate to Vascepa in Canada Vascepa was granted 8 years of data exclusivity by Health Canada upon approval Vascepa patent estate could potentially extend protection in Canada to 2039 TORONTO, Sept. 3, 2020 /CNW/ - HLS Therapeutics Inc. (\"HLS\" or the \"Company\") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, comments on the U.S. Court of Appeals for the Federal Circuit ruling in Amarin Corporation plc's (\"Amarin\") ongoing patent litigation. The Court upheld the March ruling by the U.S. District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to Amarin's VASCEPA® (icosapent ethyl) capsule franchise. HLS has in-licensed the exclusive rights to VASCEPA for the Canadian market from Amarin. \nHLS affirms that that this litigation and judgment do not impact VASCEPA in Canada as:\nGeographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to this litigation and judgment; VASCEPA was added to Health Canada's Register of Innovative Drugs in January 2020 and benefits from eight years of data protection until December 2027; VASCEPA is also the subject of numerous Canadian issued patents and pending patents that were not part of the U.S. litigation and that could extend patent protection in Canada to 2039; and No litigation is pending in Canada regarding VASCEPA.\"As with the U.S. district court ruling earlier this year in March, the appeals court ruling in the U.S. does not affect the Canadian business for VASCEPA or our growth outlook for the product, which we believe could achieve a peak-year revenue run-rate of $275-325 million,\" said Gilbert Godin, President and COO of HLS. \"Since our launch earlier this year, we continue to move forward on our pl...