Sarepta Therapeutics Inc. has secured a $115.2 million verdict against Nippon Shinyaku Co. Ltd. for patent infringement related to its Duchenne muscular dystrophy drug, Vyondys 53.
Sarepta Therapeutics Inc. has emerged victorious in a significant patent infringement case against Japanese pharmaceutical company Nippon Shinyaku Co. Ltd. A Delaware federal jury awarded Sarepta $115.2 million in damages, concluding that Nippon Shinyaku's drug Viltepso infringed on a patent held by Sarepta. This verdict marks a substantial win for Sarepta, which has been embroiled in legal battles with Nippon Shinyaku over their respective Duchenne muscular dystrophy (DMD) treatments.
The jury's decision came after a two-phase trial in which Sarepta successfully argued that Nippon Shinyaku's U.S. Patent No. 10,385,092 was invalid due to its coverage of an obvious invention. This ruling effectively nullified Nippon Shinyaku's claims against Sarepta's Vyondys 53, which had been accused of patent infringement by Nippon Shinyaku.
Sarepta's Vyondys 53, which received accelerated approval from the U.S. Food and Drug Administration in 2019, generated over $130 million in sales last year. Meanwhile, Nippon Shinyaku's Viltepso, approved in 2020, brought in more than $84 million from U.S. sales. The legal dispute began in 2021 when Nippon Shinyaku filed a lawsuit against Sarepta, alleging patent infringement and seeking a declaration that Viltepso did not infringe Sarepta's patents. Sarepta countered with its own allegations in 2022.
In addition to the financial damages awarded, the jury rejected Nippon Shinyaku's competing patent claims, further solidifying Sarepta's position in the market for DMD treatments. The verdict underscores the importance of patent rights in the pharmaceutical industry, where companies invest heavily in research and development to bring new therapies to market.
Sarepta expressed gratitude for the jury's decision, while Nippon Shinyaku has yet to comment on the outcome. The case highlights the ongoing challenges and complexities of patent litigation in the biotech sector, where innovation and intellectual property rights are critical to business success.
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