Lixiana’s NCE Patent Worth $70 Million Broken after First Challenge in 5 Years
기자명 Sodam Park reporter   입력 2023.07.21 12:25  수정 2023.07.21 12:27  댓글 0




Upheld claim in defensive confirmation trial affirms NVP Healthcare's rights, while competitors await product approval.


 


NVP Healthcare ("NVP"; formerly "Navipharm") successfully challenged the new chemical entity (NCE) patent for the anticoagulant drug, 'Lixiana®', worth $70 million, a patent that had previously been a significant obstacle for Korean domestic pharmaceutical companies. Since the patent featuring the "composition" had already been breached, and now the NCE patent barrier has collapsed, the period to launch generic drugs is expted to be significantly shortened, without any appeal from the originator.


According to industry sources on July 11th, the Korean Intellectual Property Trial and Appeal Board (IPTAB) issued a favorable decision to NVP in the scope confirmation trial subject to a 'diamine derivative'-related patent. This patent relates to the new chemical entity covering Lixiana®, an oral anticoagulant (NOAC) developed by Daiichi Sankyo, scheduled to expire on November 10, 2026.


Since the introduction of the NOAC series drugs as a first-line treatment in 2015, Lixiana® entered the market as a latecomer in February 2016, but has showed the fastest growth. The drug's advantages, such as no need for blood tests or dietary adjustments unlike the existing anticoagulant Warfarin, have been key to its success.


In the case of Lixiana®, its sales soared to $70.1 million in 2022, demonstrating a steep increase even after its sales were approximately $30 million in 2018, according to IQVIA. Despite a reduction in the drug's price, the industry views this as a considerable rise.


The noteworthy aspect of this patent dispute is that it marks the first time that the NCE patent has been broken in a lawsuit related to the launch of generic versions of Lixiana®. These lawsuits were filed by Korean domestic pharmaceutical companies over the past five years. Lixiana® is currently protected by formulation- and substance-type patents, set to expire on August 21st, 2028. The formulation patent was challenged by Boryung Pharmecutical in July 2018, while the substance patent was done by Kolmar Korea (now Genuone Sciences) in August 2018.


Other domestic pharmaceutical companies also joined the patent trials, including Hanmi Pharmaceutical, Kolmar Korea, HK Inno.N, Kolmar Pharma, Hutecs Korea Pharma, Chongkundang, Samjin Pharmaceutical, Dong-A ST, and Shin-il Pharmaceuticals. Boryung has first received the favorable decision to the trials against the formulation patent in July 2020, and then the others have also obtained the same favorable results.


The remaining challenge centered around the NCE patent. These companies have all been dismissed or withdrawn their trials since March 2020. This left domestic pharmaceutical companies with no option but to wait until 2026 to launch their products, until NVP successfully challenged the NCE patent.


However, NVP, the first to break the NCE patent, still faces hurdles. Unlike other companies, they have not filed a trial against the patent expiring in 2028. Additionally, Dong-A ST has first obtained approval for their generic product named 'Edoxia,' while the six generic products (from Shin-il Pharm, Korea Prime Pharmaceuticals, Shinpoong Pharmaceuticals, Anguk Pharmaceuticals, NexPharm Korea, and Korea Union Pharm) are also waiting for release after obtaining approval.


An industry insider commented, "The crux of the matter lies in determining who will achieve market dominance: the company that broke the 'Lixiana®' barrier, which domestic pharmaceutical companies have been trying to overcome for five years, but still has a long regulatory approval process ahead, or the other domestic companies who are ready to launch with already obtained product approvals."
[Source : HITNEWS] click to read an original article