Moderna起诉辉瑞(Pfizer)及其合作伙伴BioNTech专利侵权,称这两家公司开发新冠疫苗时抄袭了其技术。
Moderna于8月26日在美国和德国提起诉讼,称其相信辉瑞-BioNTech疫苗侵犯了公司的信使核糖核酸(mRNA)专利技术。Moderna早在新冠疫情爆发前几年就已经开始开发该项技术。
Moderna指责辉瑞和BioNTech未经许可抄袭其“突破性技术”,用于开发新冠疫苗。
Moderna在8月26日的一份新闻稿中称:“辉瑞和BioNTech对四种不同候选疫苗进行了临床测试,其中有疫苗方案本可以避开Moderna的创新途径。”
“然而,辉瑞和BioNTech最终决定继续开发的疫苗,采用了与[Moderna疫苗]Spikevax完全相同的mRNA化学改性技术。”
Moderna表示,其科学家早在2010年就开始研究该项技术,并声称其在五年后最早对该技术进行了人体试验。
“同样,尽管有许多不同的选择,辉瑞和BioNTech却复制了Moderna的方法,在冠状病毒脂质纳米颗粒配方中编码全长刺突蛋白。”该公司补充道。“在新冠病毒首次出现的前几年,Moderna的科学家发明了一种导致中东呼吸综合征(MERS)的冠状病毒疫苗,开发了这种方法。”
辉瑞被诉讼“震惊”
辉瑞的一位发言人在8月26日告诉《财富》杂志,Moderna的诉讼出乎意料。
该发言人说:“辉瑞-BioNTech尚未全面审查该投诉,但鉴于我们的新冠疫苗是基于BioNTech的专有mRNA技术,由BioNTech和辉瑞共同开发的,因此我们对诉讼感到惊讶。”
“我们对支持辉瑞- BioNTech疫苗的知识产权仍然具有信心,并将对诉讼指控进行有力辩护。”
Moderna的首席执行官斯特凡内·班塞尔于8月26日表示,该公司正在提起诉讼,“以保护我们在新冠疫情爆发之前的十年中率先开发、投资数十亿美元创建并获得专利的创新mRNA技术平台。”
他补充说,Moderna还利用其mRNA技术开发治疗艾滋病毒等传染病以及癌症等非传染性疾病的药物。
疫苗专利
2020年10月,在临床试验之外使用任何新冠疫苗之前,Moderna承诺,在疫情持续期间,不会强制执行其与新冠肺炎相关的专利。
该公司在今年3月改变了方针,认为疫情已经进入“新阶段”,疫苗供应不再在世界许多地区造成可获得性问题。
当时,Moderna称,它永远不会在92个中低收入国家实施专利,但它希望其他公司在其他市场“尊重其知识产权”。它补充说,如果竞争对手的疫苗生产商提出要求,它愿意授予“商业上合理的”许可证以使用其技术。
Moderna在8月26日对辉瑞和BioNTech提起诉讼时指出,起诉的目的并非迫使它们的疫苗下市,或者寻求司法禁令阻止疫苗的未来销售。
Moderna还表示,公司寻求的损害赔偿与辉瑞疫苗在获得专利承诺豁免的92个国家的销售无关,也不会针对美国政府应该负责的情况寻求任何损害赔偿。
Moderna的主张针对的是在2022年3月8日之后销售的疫苗,该公司当天调整了新冠疫苗专利政策。
Moderna的代表并未立即答复《财富》杂志关于赔偿金额的问题。
竞争激烈的领域
对mRNA疫苗的研究已经持续了数十年,但这项技术随着新冠疫苗的上市才开始被公开使用。
Moderna和辉瑞-BioNTech疫苗都使用mRNA技术激发人体的免疫反应,从而形成对病毒的保护力。
在2020年开展的三期临床试验中,这两款疫苗的有效率均为约95%。然而,这两款疫苗的设计都是针对原始病毒株,对于之后出现的各种变异毒株的防护力较弱。
所有公司都在努力开发特别针对BA.4和BA.5奥密克戎亚变异毒株的疫苗。目前这两种亚变异毒株是美国的主要病毒株。
去年,辉瑞的新冠疫苗销售额达到370亿美元。
Moderna于2021年在全球共交付8.07亿剂疫苗,价值177亿美元。
辉瑞-BioNTech疫苗在2020年12月被美国食品与药品管理局(U.S. FDA)授予紧急使用授权(Emergency Use Authorization)。监管部门在一周后也授予Moderna疫苗紧急使用授权。
据Our World in Data统计,在美国,辉瑞-BioNTech新冠疫苗的应用最广泛,其次是Moderna疫苗。
但《纽约时报》(New York Times)的调查发现,在全球使用最广泛的是牛津-阿斯利康(Oxford-AstraZeneca)疫苗,这款疫苗并未使用mRNA技术。《纽约时报》称,排在第二位的是辉瑞-BioNTech疫苗,其次是Moderna疫苗。(财富中文网)
译者:刘进龙
审校:汪皓
Moderna起诉辉瑞(Pfizer)及其合作伙伴BioNTech专利侵权,称这两家公司开发新冠疫苗时抄袭了其技术。
Moderna于8月26日在美国和德国提起诉讼,称其相信辉瑞-BioNTech疫苗侵犯了公司的信使核糖核酸(mRNA)专利技术。Moderna早在新冠疫情爆发前几年就已经开始开发该项技术。
Moderna指责辉瑞和BioNTech未经许可抄袭其“突破性技术”,用于开发新冠疫苗。
Moderna在8月26日的一份新闻稿中称:“辉瑞和BioNTech对四种不同候选疫苗进行了临床测试,其中有疫苗方案本可以避开Moderna的创新途径。”
“然而,辉瑞和BioNTech最终决定继续开发的疫苗,采用了与[Moderna疫苗]Spikevax完全相同的mRNA化学改性技术。”
Moderna表示,其科学家早在2010年就开始研究该项技术,并声称其在五年后最早对该技术进行了人体试验。
“同样,尽管有许多不同的选择,辉瑞和BioNTech却复制了Moderna的方法,在冠状病毒脂质纳米颗粒配方中编码全长刺突蛋白。”该公司补充道。“在新冠病毒首次出现的前几年,Moderna的科学家发明了一种导致中东呼吸综合征(MERS)的冠状病毒疫苗,开发了这种方法。”
辉瑞被诉讼“震惊”
辉瑞的一位发言人在8月26日告诉《财富》杂志,Moderna的诉讼出乎意料。
该发言人说:“辉瑞-BioNTech尚未全面审查该投诉,但鉴于我们的新冠疫苗是基于BioNTech的专有mRNA技术,由BioNTech和辉瑞共同开发的,因此我们对诉讼感到惊讶。”
“我们对支持辉瑞- BioNTech疫苗的知识产权仍然具有信心,并将对诉讼指控进行有力辩护。”
Moderna的首席执行官斯特凡内·班塞尔于8月26日表示,该公司正在提起诉讼,“以保护我们在新冠疫情爆发之前的十年中率先开发、投资数十亿美元创建并获得专利的创新mRNA技术平台。”
他补充说,Moderna还利用其mRNA技术开发治疗艾滋病毒等传染病以及癌症等非传染性疾病的药物。
疫苗专利
2020年10月,在临床试验之外使用任何新冠疫苗之前,Moderna承诺,在疫情持续期间,不会强制执行其与新冠肺炎相关的专利。
该公司在今年3月改变了方针,认为疫情已经进入“新阶段”,疫苗供应不再在世界许多地区造成可获得性问题。
当时,Moderna称,它永远不会在92个中低收入国家实施专利,但它希望其他公司在其他市场“尊重其知识产权”。它补充说,如果竞争对手的疫苗生产商提出要求,它愿意授予“商业上合理的”许可证以使用其技术。
Moderna在8月26日对辉瑞和BioNTech提起诉讼时指出,起诉的目的并非迫使它们的疫苗下市,或者寻求司法禁令阻止疫苗的未来销售。
Moderna还表示,公司寻求的损害赔偿与辉瑞疫苗在获得专利承诺豁免的92个国家的销售无关,也不会针对美国政府应该负责的情况寻求任何损害赔偿。
Moderna的主张针对的是在2022年3月8日之后销售的疫苗,该公司当天调整了新冠疫苗专利政策。
Moderna的代表并未立即答复《财富》杂志关于赔偿金额的问题。
竞争激烈的领域
对mRNA疫苗的研究已经持续了数十年,但这项技术随着新冠疫苗的上市才开始被公开使用。
Moderna和辉瑞-BioNTech疫苗都使用mRNA技术激发人体的免疫反应,从而形成对病毒的保护力。
在2020年开展的三期临床试验中,这两款疫苗的有效率均为约95%。然而,这两款疫苗的设计都是针对原始病毒株,对于之后出现的各种变异毒株的防护力较弱。
所有公司都在努力开发特别针对BA.4和BA.5奥密克戎亚变异毒株的疫苗。目前这两种亚变异毒株是美国的主要病毒株。
去年,辉瑞的新冠疫苗销售额达到370亿美元。
Moderna于2021年在全球共交付8.07亿剂疫苗,价值177亿美元。
辉瑞-BioNTech疫苗在2020年12月被美国食品与药品管理局(U.S. FDA)授予紧急使用授权(Emergency Use Authorization)。监管部门在一周后也授予Moderna疫苗紧急使用授权。
据Our World in Data统计,在美国,辉瑞-BioNTech新冠疫苗的应用最广泛,其次是Moderna疫苗。
但《纽约时报》(New York Times)的调查发现,在全球使用最广泛的是牛津-阿斯利康(Oxford-AstraZeneca)疫苗,这款疫苗并未使用mRNA技术。《纽约时报》称,排在第二位的是辉瑞-BioNTech疫苗,其次是Moderna疫苗。(财富中文网)
译者:刘进龙
审校:汪皓
Moderna is suing Pfizer and its partner BioNTech for patent infringement, claiming that the companies copied its technology to develop their COVID-19 vaccine.
Filing lawsuits in both the U.S. and Germany on August 26, Moderna said it believed the Pfizer-BioNTech vaccine violated patented mRNA technology that it had begun developing years before the pandemic took hold.
Moderna accused Pfizer and BioNTech of copying its “groundbreaking technology” without permission to develop their own vaccine against the coronavirus.
“Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna’s innovative path,” the company alleged in a press release on August 26.
“Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification as [Moderna vaccine] Spikevax.”
Moderna said its scientists began working on the technology in 2010, and claimed it became the first company to test the tech in human trials five years later.
“Again, despite having many different options, Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus,” the firm added. “Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East respiratory syndrome (MERS) years before COVID-19 first emerged.”
Pfizer “surprised” by lawsuit
A spokesperson for Pfizer told Fortune on August 26 that Moderna’s lawsuit had been unexpected.
“Pfizer-BioNTech has not yet fully reviewed the complaint, but we are surprised by the litigation given the Pfizer-BioNTech COVID-19 vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” the spokesperson said.
“We remain confident in our intellectual property supporting the Pfizer-BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”
Moderna CEO Stéphane Bancel said on August 26 that the company was filing the lawsuits “to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic.”
He added that Moderna was also using its mRNA technology to develop medicines for infectious diseases like HIV as well as noncommunicable diseases like cancer.
Vaccine patents
In October 2020—before any COVID vaccines were being used outside clinical trials—Moderna pledged not to enforce its COVID-19–related patents while the pandemic endured.
The company changed course in March of this year, arguing that the pandemic had entered a “new phase” where vaccine supply was no longer creating accessibility issues in many parts of the world.
At the time, Moderna said it would never enforce patents in 92 low- and middle-income countries, but that it expected other companies to “respect its intellectual property rights” in other markets. It added that it was willing to grant “commercially reasonable” licenses to use its technology if rival vaccine makers requested them.
As it filed its lawsuits against Pfizer and BioNTech on August 26, Moderna said it was neither seeking to remove their COVID vaccine from the market nor seeking an injunction to prevent its future sale.
The company also said the damages it sought were not related to sales to the 92 countries exempt from its patent pledge, and added that it would not seek any damages where the U.S. government would be liable.
All of the damages Moderna sought would be for sales that occurred after March 8, 2022, when the company changed its COVID vaccine patent policy.
Representatives for Moderna were not immediately available to answer Fortune’s questions about how much the company is seeking in damages.
Competitive space
Messenger RNA (mRNA) vaccines have been studied for decades—but the technology was only rolled out for public use with the launch of COVID-19 vaccines.
The Moderna and the Pfizer-BioNTech vaccines use mRNA technology to trigger an immune response that protects recipients against the virus.
Both vaccines had efficacy rates of around 95% in Phase III clinical trials carried out in 2020. However, both were designed to combat the original strain of the virus, and are less effective against variants that have emerged since.
All of the companies are working to develop vaccines specifically targeted at the BA.4 and BA.5 Omicron subvariants, which are the dominant strains of the virus in the United States.
Last year, Pfizer made $37 billion from sales of its COVID-19 vaccine.
Moderna sold $17.7 billion worth of COVID vaccines globally in 2021, delivering 807 million vaccines.
The Pfizer-BioNTech vaccine was granted Emergency Use Authorization by the U.S. FDA in December 2020. Regulators granted Moderna’s vaccine emergency approval a week later.
In the U.S., the Pfizer-BioNTech vaccine is the most widely used COVID-19 shot, according to Our World in Data, with Moderna coming in second place.
Globally, however, the Oxford-AstraZeneca vaccine—which does not use mRNA technology—is the most widely used, according to an investigation by the New York Times. Pfizer-BioNTech is the second most widely used vaccine worldwide, according to the Times, followed by Moderna.