{"id":1306,"date":"2024-12-23T13:21:15","date_gmt":"2024-12-23T13:21:15","guid":{"rendered":"https:\/\/ipfray.com\/?p=1306"},"modified":"2024-12-23T13:21:15","modified_gmt":"2024-12-23T13:21:15","slug":"japans-nippon-shinyaku-vows-to-fight-on-in-u-s-drug-dispute-against-sarepta-therapeutics-despite-heavy-115-million-blow","status":"publish","type":"post","link":"https:\/\/ipfray.com\/staging1\/japans-nippon-shinyaku-vows-to-fight-on-in-u-s-drug-dispute-against-sarepta-therapeutics-despite-heavy-115-million-blow\/","title":{"rendered":"Japan\u2019s Nippon Shinyaku vows to fight on in U.S. drug dispute against Sarepta Therapeutics, despite heavy $115 million blow"},"content":{"rendered":"\n
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Context: <\/strong>In July 2021, Kyoto-based drugmaker Nippon Shinyaku Co., Ltd. sued Sarepta Therapeutics, Inc., a U.S. biotechnology company, in the United States District Court for the District of Delaware, alleging it had breached an ongoing contract by filing petitions for Inter Partes Review with the Patent Trial and Appeal Board at the USPTO. The petitions sought to invalidate seven patents related to a drug used to treat Duchenne Muscular Dystrophy (DMD) \u2013 a genetic disorder that causes people to progressively lose muscle function \u2013 it alleged. The plaintiff also filed invalidation claims against three DMD-related patents and alleged that Sarepta’s own DMD drug infringed seven of Nippon Shinyaku\u2019s patents. In January 2022, Sarepta filed counterclaims against Nippon Shinyaku, enforcing three patents it was licensing from the University of Western Australia. The District of Delaware in May entered summary judgment, finding Nippon Shinyaku had infringed two of those patents. A bifurcated jury trial was then held from December 16 to 20, 2024 to decide on the remainder of the dispute. In two jury verdicts handed down last week, the remaining Sarepta patent was found valid and Nippon Shinyaku was ordered to pay $115.2 million in damages. The jury also held that all seven of the patents Nippon Shinyaku had enforced are invalid.<\/p>\n\n\n\n

What\u2019s new: <\/strong>In a statement today, Nippon Shinyaku has said it \u201cdoes not agree\u201d with the jury verdict and will consider \u201call options\u201d. The company has said it will even consider post-jury motions and appeals (December 23, 2024 Nippon Shinyaku press release<\/a>).<\/p>\n\n\n\n

Direct impact and wider ramifications: <\/strong>Nippon Shinyaku is evidently not going to give up without a fight. The case could get interesting if it asks the judge to overrule the jury or ask for a retrial – and this is granted. While judges often accept the jury verdict, this doesn\u2019t always happen \u2013 and the Japanese drugmaker still has the option to lodge an appeal with the Federal Circuit.<\/p>\n<\/div>\n\n\n\n

Nippon Shinyaku and Sarepta both manufacture drugs for the treatment of DMD \u2013 a severe X chromosome-linked genetic disorder that predominantly affects young boys and causes progressive muscle function loss. Sarepta earned more than $130 million from sales of its DMD drug Vyondys 53 in 2023, while Nippon Shinyaku raked in more than $84 million from its U.S. Viltepso sales. In 2013 and 2015, the University of Western Australia obtained two patents directed towards antisense oligonucleotide-based therapies for the treatment of DMD \u2013 US Patents No. 8,455,636 and 9,024,007. Each of these patents\u2019 claims encompasses Sarepta\u2019s Vyondys 53 but fails to encompass Nippon Shinyaku\u2019s Viltepso.<\/p>\n\n\n\n

These are the patents Nippon Shinyaku asserted (all bear the same title, “antisense nucleic acids”):<\/p>\n\n\n\n