Pimavanserin tartrate

2025年6月，CAFC维持了地区法院的判决，认定Nuplazid的活性成分专利（显而易见型重复专利）有效，该专利将阻止MSN的仿制药至2030年。CAFC维持Acadia的帕金森药物Nuplazid活性成分专利有效byTiPLab 木桃Nuplazid®（活性成分pimavanserin）是首个也是唯一一个用于治疗与帕金森病性精神病相关的幻觉和妄想的药物，选择性靶向5-HT2A受体，2016年获得FDA批准。根据 Acadia 的公开信息，2024年 Nuplazid® 在美国的销售额为 6.094 亿美元。本案中，MSN提交了一份Nuplazid® 仿制药的ANDA。FDA 暂时批准了 MSN 的 ANDA。双方将争议限制在US 7,601,740（’740 专利，活性成分专利）权利要求 26 的有效性上。MSN 根据US 9,566,271（’271 专利，医药用途专利）对 ’740 专利提出质疑。’271 专利的权利要求 5 涉及一种通过使用pimavanserin 酒石酸盐来治疗幻觉的方法。’740 专利的权利要求 26 涉及pimavanserin 酒石酸盐。案件争议焦点主要争议焦点在于，’271 专利是否可以作为 ’740 专利的显而易见型重复授权（obvious-type double patenting，OTDP）的参考专利，而影响 ’740 专利的有效性。其中，’740专利（’561申请）是母案，’271专利是 ’527申请的延续案（CON），而 ’527申请最初是母案 ’561申请的延续案（CON），后来申请人将其更改为分案（DIV）。’740专利后续还获得了PTA和PTE，如下图的时间表所示， ’740专利的递交日和授权日均早于 ’271专利，但其到期日晚于’271专利。根据35 U.S.C. § 121中的安全港条款，在满足一定条件下，对于要求重复专利主题的母案申请及其分案申请（DIV）免受 OTDP 的影响。地区法院观点地区法院认为，专利必须是较早提交的才能作为 OTDP 参考专利，因此 ’271 专利不能作为 ’740 专利的参考专利而使其无效。CAFC观点由三位联邦巡回法院法官组成的小组发布了一份简短意见，维持了地区法院的裁决。CAFC应用了其最近在 Allergan v. MSN (Fed. Cir. 2024) 一案中的裁决，即， “先提交、先授权、后到期的权利要求，不能因具有共同优先权日的后提交、后授权、先到期的参考权利要求而使其无效”。因此，CAFC认同地区法院的判决，即，’271 专利的权利要求 5 不能作为 OTDP 参考专利，用于使 ’740 专利的权利要求 26 无效。该判决明确了在一些情况下，显而易见型重复专利可能免受在后递交专利的影响，从而获得更晚的到期日。* 以上文字仅为促进讨论与交流，不构成法律意见或咨询建议。© 作为一家专业服务公司，TiPLab坚持原创的系统的研究，注重系统性知识积累与专业影响力。欢迎读者个人分享转发，各专业平台媒体如需转载请联系TiPLab获得授权。 TiPLab提供基于研究的核心知识产权服务FTO：技术商业化实施的侵权风险防范TiPLab通过对细分技术领域内核心技术和重要专利的长期研究，结合自身在数据检索和分析方面的专长，致力于帮助客户深入了解、积极应对潜在的专利侵权风险。Due Diligence：商业活动中的知识产权尽职调查在企业许可交易、融资、并购、上市等过程中，TiPLab帮助企业和投资方了解目标技术/产品的专利保护强度及产品商业化过程中潜在的专利侵权风险，从而为商业谈判和决策提供支持依据。Patenting：全球范围内高价值专利资产的创设TiPLab熟知全球主要国家和地区的法律实践和细分领域内的前沿技术进展情况，通过前瞻性的专利布局策略，帮助客户通过创设有价值的专利资产而获取、保持和巩固独特的竞争优势。

Acadia Pharmaceuticals, the brain-focused drug developer, surprised some on Wall Street last week with a pair of predictions.The first: the companys two products, which brought in close to $1 billion in 2024, should eventually generate between $1.5 billion and $2 billion in combined yearly sales. The second: five experimental medicines in Acadias research pipeline could, if they come to market, collectively peak at $12 billion in annual sales.The road to such commercial success will be long and fraught, as neuroscience is a famously difficult, setback-ridden area of development. But Catherine Owen Adams, the industry veteran who took over as Acadias CEO last fall, maintains the company is up to the challenge.I didn't come into this job to putter along at a $3 billion market cap, she said in an interview. I believe this company can get to the next level of mid-cap. That's how I'm leading this business to get there.To reach that goal, Owen Adams said a top priority for her team is further building out Acadias research, through a much more assertive business development strategy. That may include deals for drugs in the later stages of testing the kind of assets that can serve as the value inflection point analysts have sought.The hope, according to the chief executive, is Acadias pipeline will grow at least 25% to 30% from external innovation in the coming years, and that $12 billion figure bumps up to $15 billion or $20 billion as a result.Owen Adams spoke to BioPharma Dive about why Acadia offered up such bold sales forecasts and where the company believes it can play to win in brain research.The following conversation has been edited and condensed for clarity.BIOPHARMA DIVE: Neuroscience is a wide area of research, and your pipeline reflects that. Acadia is going after two rare diseases, Alzheimers psychosis, depression, epilepsy. Why did the company decide to target those indications?CATHERINE OWEN ADAMS: When I came to Acadia nine months ago, part of the attraction was the pipeline. A lot in there was super interesting. I spent the last six to seven months with [research and development head] Liz Thompson trying to understand what we're trying to achieve. What's our focus?The brand we are developing is underserved neurological and rare diseases. Underserved is actually quite an important descriptor of those two areas, because we're not going to move into Alzheimer's degeneration. It's just too big for us.However, the areas around that, where there are maybe less players, less interest sometimes because it might be smaller populations, more niche populations we believe we can play to win.If you look at our pipeline, most of those fit. I would say [ACP-211] probably is on the bubble. Treatment-resistant depression is a fairly large space, but we argue its underserved, and we believe we have the opportunity to really make a difference there with something that has less monitoring.Forecasting Acadia's pipeline potentialDrugStageIndicationPeak sales potentialACP-101Ph. 3Prader-Willi Syndrome~$1-2BACP-204Ph. 2Alzheimers psychosis, Lewy body dementia psychosis>$2BACP-211Ph. 2Major depressive disorder>$2BACP-271Ph. 1-readyHuntingtons disease, tardive dyskinesia~$1-2BACP-711Ph. 2Essential tremor>$2BSOURCE: Table and estimates from research by Mizuho Securities analyst Uy Ear.How do you strike a balance between drugs seen as higher risk-reward, and those with maybe a more straightforward shot at getting through testing and onto the market?OWEN ADAMS: The balance for us comes with the ability to drive precision medicine into neurological diseases. The risks inherent within neuropsych, particularly, are subjective endpoints, large studies, high placebo effects. We all know it's hard. What we're trying to build is a movement into that space that's anchored in a bit more than just symptomatic endpoints.If you look at how we're running the Alzheimer's disease psychosis trial and the Lewy body dementia psychosis trial, what we unveiled at our R&D Day was an additional level of rigor around using biomarkers within those patients to try and understand the science.In each of those trials, while we have the more subjective endpoints of the various scales, we are also looking at augmenting that and making the populations more homogeneous using additional biomarkers.How important is having promising biomarkers when deciding whether or not to pursue a disease or subset of research? Are biomarkers part of go, no-go decisions?OWEN ADAMS: In some areas it's go, no-go. In the areas that we're in, the biomarker science is not necessarily concrete yet.My belief, having spent 25, 30 years in pharma and more recently, in oncology, where biomarker [reliance] goes without saying, is that as a society we need to get more precise about where we use medicines, what patients we use them, how we use them. Biomarkers are our current way of doing that, and we need to advance that within neuropsych. It's been sort of a backwater, in terms of advancing the science as fast as other areas. It's harder.My vision for Acadia becoming a biotech powerhouse in this space is built on precision medicine and data innovation. I'm really looking to push the company to advance the science, as well as, obviously, build a clinical trial we believe is the right one.If we look globally at countries where we want to have our medicines available, I think having biomarker-led patient population identification is going to help, particularly in single-payer systems. We have seen an unwillingness to pay [when] you just use a medicine on everybody and see what happens.Analysts claim that, during turbulent markets, companies will double down in areas they feel most experienced. You have two products: Nuplazid for Parkinsons disease psychosis and Daybue for Rett syndrome. How much have those two products influenced your pipeline decisions?OWEN ADAMS: I think [they do], but it's not necessarily based on the last six months of market volatility.With most pharma companies, you see a tendency to understand an area, have a lot of learning and then build the next product to be better. You can see many examples. In the case of Rett syndrome, Daybue has GI side effects, and we are looking to improve upon that. We look at 2591 with the hope that maybe we can evolve the side effect profile and still have the same efficacy.Similarly, Nuplazid is a great drug. But there are areas where it could do better. We were limited because it had a QT signal, so we've designed ACP- 204 to eliminate the QT signal and to act faster. Those things, for me, make sense, because you're really derisking, even though the analysts haven't given us much credit.If you look at essential tremor with ACP-711, which we just licensed in from Saniona in December, its a very different space; high unmet need, a bit of a graveyard. We think we found some really interesting science.211 is in major depressive disorder, another very different space. But I was at Janssen when we launched Spravato, so I know the space and understand what it takes.I don't want us to be so focused that we miss opportunities. It's about balancing where we know and then new areas where we think we can learn.What were the biggest lessons you learned from the Spravato story?Spravato became a blockbuster product over seven years. It was not a blockbuster product out the door. The efficacy was always really strong, but the infrastructure that the U.S. healthcare system had in place when we launched Spravato was very underdeveloped.Catherine Owen AdamsPermission granted by Acadia PharmaceuticalsJ&J had to spend a lot of time developing that infrastructure and support systems to allow doctors to be able to use it for the right patients. Every six months to a year, we'd learn more, and they'd put different things in place to ensure it continued to evolve. It was a huge investment to get Spravato to where it is now.We are now the beneficiaries of a much more defined system where doctors get paid for monitoring. When we launched Spravato, there wasn't even a code that doctors could use to get paid. There's always a downside to being the first, but it was a long, long road. Longer than they thought anyway.What are Acadias BD priorities right now?OWEN ADAMS: We've defined our focus: underserved neurological and rare diseases. That's where we want to play to win. Within that space, we're fairly open about the science we want. Science that is hopefully first in class or best in class. Everybody says that, but I mean it. I don't want to be the second, third or fourth to market, unless we've got something we believe is truly differentiating, which I think is where 211 fits.Acadia is not afraid to make scientific risk decisions, regulatory risk decisions. Where I won't make a risk decision is financially. We are in a very strong financial position, and I believe for the future of our company, we need to hold true to minimizing financial risk.With that in mind, I'd also like to look at some slightly later-stage products. We've got a lot of earlier-stage products. I would love to see us focusing a bit more on Phase 2 Phase 3 if it's possible but Phase 2-stage products, where we can get something to market in the 2030 timeframe.The upside of this market being a little bit difficult is that there are quite a few earlier-stage companies who maybe are more financially fragile than they were six months ago. So there's opportunity to go in and make a deal.You gave two big sales predictions during the R&D day. One was on Nuplazid and Daybue. Why did you release that figure?OWEN ADAMS: I've come up through the commercial line, and I believe analysts need to understand where I think we can get to. I'm strongly commercial, and I don't put numbers out there that I don't believe we can achieve. Those numbers are based on strong, objective data that I stand behind, and I think the analyst community are underestimating and have been overly cautious about both Daybue and Nuplazid.One of the big things in the last two months is that we got clarity on our patent for Nuplazid, now out to 2038, so that gives us a lot more runway. Nuplazid will, at some point if the Inflation Reduction Act exists as it does today, which is a big caveat run into a pricing situation with the IRA, as every other drug will. But Daybue has the potential to continue to grow and to go global. I think people are underestimating ... our ability to stabilize the current patient population.I'd rather have a conversation about: are we going to hit $1.5 billion to $2 billion or not, than say Im not willing to go there. As a CEO with a commercial background, I should be willing to go there. I can't hide behind, Well, I don't feel comfortable. Okay, then, why am I here?There was also that $12 billion peak annual sales forecast you put on the pipeline programs. Whats the biggest challenge you see getting to that number?OWEN ADAMS: Without wanting to be flippant, the biggest hurdle is the clinical outcome of the trials. The trial designs that we're looking at; the thinking that's gone into them; the additional biomarkers; the additional steps we're putting in place ... I think we're really focused on getting the best Phase 3 trial designs we can.Then, it becomes: can you commercialize with that outcome? Again, I stand behind the numbers. I don't think they're unreasonable. I've not pushed the team. I understand how all parts of a forecast are built.The biggest headwind, ultimately, will be the clinical data and the access environment that exists when we launch. Those two are outside of our control. We can design the clinical trials, we can prepare for the access environment, but that will make a difference. '