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The U.S. Department of Justice (DOJ) is reviewing a government patent for HIV, according to a retired Centers for Disease Control and Prevention (CDC) scientist. The scientist, Thomas Folks, indicated that an attorney with the DOJ visited the CDC in Atlanta on April 16 in order to question government researchers who were involved in the use of the HIV drug Truvada for the prevention of HIV infection. Folks retired from the CDC in 2007 and participated in one of the meetings via telephone to help explain the research his team made 15 years ago.
Truvada is manufactured by Gilead Sciences. Gilead argues that the government’s 2015 patent for Truvada is invalid.
The entire case revolves around Truvada for PrEP, which is what the use of the drug for HIV prevention is called.
Folks ran a CDC monkey research laboratory before retirement. Gilead’s Truvada received approval in 2004 for HIV for individuals who had already contracted the virus. The CDC wanted to conduct research into whether the drug could be used as a preventive measure, and Gilead supplied the drugs to the research team. The team’s research focused on repeatedly infecting monkeys with small amounts of HIV, about the level found in semen, to prove that the drug would work as prevention. In 2012, Gilead received approval with the U.S. Food and Drug Administration (FDA) for that use.
It's not clear if the DOJ review is a prelude to a lawsuit against Gilead or if it plans to use the information as part of negotiations with the company over Truvada for PrEP.
The Trump administration proposed a plan on February 5 to eradicate HIV in the U.S. by 2030. Truvada for PrEP would likely be a part of the plan. However, it’s been noted that the Trump administration’s previous policies generally threatened to cut funding to HIV research and programs, including the President’s Plan for Emergency AIDS Relief (PEPFAR).
Admiral Brett P. Giroir, assistant secretary of Health and Human Services (HHS), speaking at an event this week sponsored by the Kaiser Family Foundation, said, “The royalties that would be owed to the department would take years in the making to get to the department” if there were a patent infringement lawsuit. “It wouldn’t really make a difference on the pricing. We’re really going down different avenues to make sure the pricing is lower moving forward. Those negotiations are ongoing.”
HHS Secretary Alex Azar, in an NPR interview earlier this month mentioned ongoing pricing negotiations with Gilead. Gilead told The Washington Post that there were, however, no current negotiations with HHS over the patents owned by the government. “We are in discussions with the government to determine the best ways to broaden access to Truvada for PrEP to vulnerable populations in the United States and support the federal plan to end the HIV epidemic,” Gilead stated.
Meanwhile, seven U.S. Senators led by Sen. Debbie Stabenow (D-MI) sent a letter to HHS asking the agency to outline steps that have been taken to ensure government-held patents are properly licensed, infringements are acted upon, and “to document how they take the affordability of drugs into consideration when licensing patents.”
The six other Senators were Bernie Sanders (I-VT), Ben Cardin (D-MD), Richard Blumenthal (D-CT), Tammy Baldwin (D-WI), Chris Van Hollen (D-MD), and Tammy Duckworth (D-IL).
The letter stated, in part, “Although Secretary Azar has stated that negotiations are ongoing, Gilead has reportedly reached no agreement with the government that would allow them to make use of these patented methods. The government should also be willing to enforce its patents and take legal action against companies that appear to be infringing on their patents, in order to prevent multinational companies from reaping billions of dollars in profits without properly compensating the government for its investments.”
It is unusual for the government to sue for drug patent infringement. According to a Washington Post article last month, HHS has patented more than 2,500 products since 1976. Although the discoveries are publicly financed, the government typically licenses them to private drug companies who then commercialize them. However, there are typically years and millions of dollars that go into taking an idea from patent to commercial drug launch.
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一位退休的疾病控制和预防中心（疾病预防控制中心（CDC））科学家说，美国司法部正在审查一项政府的 HIV 专利。科学家 Thomas Folks 表示，美国司法部的一名律师于4月16日访问了亚特兰大的疾病预防控制中心（CDC）预防控制中心，询问参与使用 Truvada 预防艾滋病毒感染的政府研究人员。2007年，他们从疾病预防控制中心退休，并通过电话参加了其中一次会议，以帮助解释他的团队15年前所做的研究。
Truvada 由吉利德科学（Gilead Sciences）公司生产。吉利德（Gilead）认为政府2015年针对 Truvada 的专利无效。
整个病例围绕 Truvada 治疗 PrEP ，这就是艾滋病预防药物的使用。
退休前，人们在疾病预防控制中心（CDC）猴子研究实验室工作。吉利德（Gilead）的 Truvada 在2004年就已经感染了 HIV 病毒的个人获得了批准。疾病预防控制中心（CDC）希望对这种药物是否可以作为预防措施进行研究，吉利德（Gilead）向研究小组提供了这种药物。该研究小组的研究重点是反复感染少量艾滋病病毒的猴子，这与精液中发现的水平有关，以证明这种药物能够起到预防作用。2012年，吉利德（Gilead）获得了美国食品药品监督管理局（Food and Drug Administration）（ FDA ）的批准。
目前还不清楚司法部的审查是否是针对吉利德（Gilead）的诉讼的前奏，或者是否计划将这些信息作为与 Truvada 公司就 PrEP 进行谈判的一部分。
特朗普政府在2月5日提出了一项计划，到2030年在美国消灭艾滋病。特鲁瓦达的 PrEP 很可能是计划的一部分。然而，有人指出，特朗普政府以前的政策普遍威胁要削减对艾滋病研究和项目的资助，包括总统的紧急艾滋病救援计划（ PEPFAR ）。
卫生与公众服务部( HHS )助理部长布雷特· P · Giroir 海军上将在本周由凯撒家庭基金会( Kaiser Family Foundation )赞助的一次活动上发表讲话时说，“如果出现专利侵权诉讼，该部将需要多年时间才能获得专利使用费”。“这不会真正影响定价。我们真的在走不同的道路，以确保价格更低的前进。这些谈判正在进行中。”
HHS 部长 Alex Azar 在本月早些时候接受 NPR 采访时提到了与吉利德（Gilead）正在进行的定价谈判。不过，吉利德（Gilead）告诉《华盛顿邮报》，目前还没有与 HHS 就政府拥有的专利进行谈判。“我们正在与政府进行讨论，以确定最好的方式，扩大接触 Truvada 的机会，使 PrEP 接触到美国脆弱人群，并支持联邦计划，以结束艾滋病毒疫情，”吉利德（Gilead）说。
与此同时，由参议员领导的七名美国参议员。Debbie Stabenow ( D-MI )给 HHS 发了一封信，要求该机构概述为确保政府拥有的专利得到适当许可、侵权行为得到处理而采取的步骤，并“记录他们在许可专利时如何考虑药品的负担能力”。
其他六名参议员是 Bernie Sanders ( I-VT )、 Ben Cardin ( D-MD )、 Richard Blumenthal ( D-CT )、 Tammy Baldwin ( D-WI )、 Chris Van Hollen ( D-MD )和 Tammy Duckworth ( D-IL )。
政府起诉药品专利侵权是不寻常的。根据《华盛顿邮报》上个月的一篇文章， HHS 自1976年以来已拥有超过2500种产品的专利。尽管这些发现是由政府资助的，但政府通常会将它们授权给私人制药公司，然后将它们商业化。然而，从专利到商业药品上市，通常需要花费数年和数百万美元。