On January 17, 2024, Daiichi Sankyo announced that,The United States Patent and Trademark Office (USPTO) has issued a final written decision declaring Seagen’s patent “10808039” invalid.This includes the use of auristatin peptides linked to antibody-drug conjugates (ADCs) through specific linker technologies.The patent dispute between Daiichi Sankyo and Seagen dates back to 2008, when the two companies reached a global exclusive agreement to collaborate on the development of DR5-ADC using the latter's ADC platform. The licensing agreement stipulated that during the collaboration period, Daiichi Sankyo should immediately inform Seagen of all improvements made to ADC-related conjugation technologies, and the relevant ownership rights would belong to Seagen.However, the cooperative relationshipEnded in 2015.In 2019, Seagen and Daiichi Sankyo regarding the latter'sADC Drug DS-8201 (Enhertu) Engages in a Patent Dispute Tug-of-WarSeagen believes that Daiichi Sankyo's ADC drugs are improved based on its own patents. According to the cooperation terms at that time, it also has the right to receive a share of Enhertu's sales.Figure 1: Structure of DS-8201 (Source: AstraZeneca official website)
And Daiichi Sankyo, of course, would not agree,Filed a motion for declaratory judgment in response, claiming that SeagenIts ADC product has no required rights, and the company stated that it will "vigorously defend" its proprietary intellectual property.December 2020, Daiichi Sankyo submitted a post-grant review to the PTO, challenging Seagen's 039 patent claims. In April 2022, the PTO granted this request, but in July of the same year, the agency reversed its decision following a complaint filed by Seagen.February 2023, The PTO ordered the original post-authorization review team to re-examine the issue and decide whether to accept the appeal based on "whether Daiichi Sankyo's application provided compelling evidence of unpatentability." Ultimately, the PTO decided to restart the review.October 2023The U.S. District Court for the Eastern District of Texas issued a revised final ruling in the patent litigation between Daiichi Sankyo and Seagen, ordering Daiichi Sankyo to pay Seagen 8% of DS-8201 sales as a patent royalty from April 1, 2022, to November 4, 2024. In response, Daiichi Sankyo is currently appealing the decision.ADC is a relatively hot R&D track in recent years.. In terms of the number of patents,According to Global Data, in just the past three years, the pharmaceutical industry has filed and been granted 633,000 patents related to ADC drugs.Although there is patent protection, the complex structure of ADC inevitably leads to some patent loopholes, especially around blockbuster drugs, which may result in many patent disputes., which is inevitable. Therefore, for related pharmaceutical companies, it is also necessary to take precautions in this regard.
References:
[1]US agency nixes Seagen patent, handing Daiichi Sankyo a win in long-running Enhertu entanglement.Fierce pharma.By Zoey BeckerJan 17, 2024 11:46am.
[2]USPTO Rules Against Seagen in ADC Patent Battle with Daiichi Sankyo.Biospace.Published: Jan 17, 2024 By Tristan Manalac.
[3]The Patent Dispute Between Seagen and Daiichi Sankyo: An Inevitable Risk. Amino Observation. 2023-03-22.
[4] Daiichi Sankyo Official Website.Scan the WeChat QR code, add the editor of the Antibody Circle, and those who meet the requirements can join the Antibody Circle WeChat group!Please indicate: Name + Research Direction!All reproduced articles in this official account are intended to convey more information, with the source and author clearly indicated. Media or individuals who do not wish to be reproduced can contact us (cbplib@163.com), and we will immediately proceed with deletion. All articles represent the views of the author and do not represent the position of this site.
