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美国药品专利声明相关规定修订

首页 > 资讯 > 资讯公开 > 美国药品专利声明相关规定修订

页面比对

出自识林

美国药品专利声明相关规定修订
505(b)(2)
页面比对
笔记

2015-02-09 识林

跳转到: 导航, 搜索

译者按:2015年2月6日联邦公报(FR)发布题为“简化新药申请和505(b)(2)申请”拟议规定的通告,有90天的评议期,公众可以通过regulation.gov在评议期内提交意见和建议。这一重要的拟议规定是业界长久期待的,且各方持有各种不同观点,识林将在今后这段时期密切跟进。联邦公报是美国联邦政府的官方公报,内容包含政府机构规定、拟议规定和公共通告等。除联邦假日外,每日公布。

《食品、药品和化妆品法(FD&C)》最主要的更新每5年发生一次,往往此时使用者付费立法需要更新以使FDA能够继续收取使用者付费。这些5年一次的更新之一是在2003年。关注FD&C法的读者会知道,国会喜欢给那些往往是乏味的立法安上动人的标题。这次的修订案被称为“医疗现代化法案”或简称为MMA。这一立法的实际标题是“2003年医疗处方药、改善和现代化法案”。

在所有5年一次的使用者付费更新议案中,2003年的MMA在更新使用者付费之外,对FD&C法案有大量修订。其中之一是第XI项,有关专利声明以及ANDA和505(b)(2)(文献NDA,即"paper NDA", 是按新药申请的仿制药,通常不必做临床试验,但可同新药一样获得专有的品牌名)相关问题。专利在橙皮书(Orange Book)中加以列示的基本框架,以及专利声明、挑战、相关通知程序、以及30个月保留期系统都已经在1984年原始Hatch-Waxman法中确立。但是随着时间的推移,已发展出了几乎是无尽的漏洞使得品牌药公司可以延长市场专营期,甚至与首个提交的仿制药商达成某些协议。所有问题当中最大的一个是,当首个仿制药提交者的市场专营期开始后没有时间限制,且在市场专营期结束之前无法批准第二个和后续仿制药提交者的ANDA。这几乎无限推迟了仿制药上市。另一个大问题是,Hatch-Waxman法案实际措辞表示,ANDA批准和市场专营期由“法院判决”触发,这意味着,关于专利侵权案件的联邦法院判决将作为IV段提交的结果。显而易见,Hatch-Waxman的意思是最终法院判决,指的是上诉法院的判决,而不是原联邦地区审判法院的判决,但多年来许多联邦法官告诉FDA,法案说的不是最终法院判决。因为法案中没有说明是“最终”,就不意味着是“最终”,这就是为什么法律被认为是“耳聋、口哑、眼盲”,只按照字面意思理解法律,而未能把握法律的内涵。除了这些问题外,还有许多其它问题导致ANDA批准延迟,坦率地讲,是一些对Hatch-Waxman目的的公然滥用。MMA修正案着手“修正”所有这些问题,从而理应使得专利声明系统按照原本Hatch-Waxman的目的运转。

MMA于2003年通过,现在已经是2015年,自FDA被指示修订管理专利声明系统的法规,已经过去了大约11年半。那么在这11年半里发生了什么?FDA一直喜欢说自己在没有立法时行政,换一种说法就是在前进中立法。秉持对各方公平性的原则,要求FDA在法规中明确说明法律是什么,从而让花费大量资金和时间参与的各方准确地知道各种情况下会遇到什么。FDA一直认为整个专利声明系统难以法典化,原始的CFR法规花超过10年的时间才形成,而现在我们再次遇到了这个难题。

因此,这则联邦公报(FR)通告(请见此处)简单地冠以“ANDA和505(b)(2)申请”也许过于宽泛,其目的是解决MMA指导下FDA编撰这一新规定,以“修正”1984 Hatch-Waxman法案的滥用(和一些错误)。显然,需要花费一些时间来阅读、消化和提炼这则FR通告的内容,所以如果你们对第IV段提交,ANDA或505(b)(2)感兴趣,请留意一些知名食药律师事务所对这则拟议的总结。

最后,MMA是否能“修正”所有问题?可以预料,集合成千律师数十亿美元可能利润的情况下,绝无可能。就像税法,当修补完一个漏洞,另一个就随之而来!

北京大学药物信息与工程研究中心 - Garth Boehm博士 2015-02-08
校译:识林-椒 2015-02-09
识林TMwww.shilinx.com版权所有,未经许可不得转载。如需使用请联系admin@shilinx.com

Implementation of Title XI of the MMA
Written by Garth Boehm February 08, 2015

As we have seen before, most major changes to the Food, Drug, & Cosmetics Act (FD&C) occur every 5 years when the User Fee legislation has to be renewed to enable continued collection of User Fees by FDA. One of those 5 yearly renewals was in 2003. Those of you who have followed amendments to the FD&C Act will be aware that Congress loves to give catchy titles to what is often rather boring legislation. This particular set of amendments is called the “Medicare Modernization Act” or MMA for short. The actual title of the legislation is “Medicare Prescription Drug, Improvement, and Modernization Act of 2003”.

As with all these 5 yearly User Fee renewal bills, this one had a large number of amendments to the FD&C Act in addition to those renewing User Fees. One of these was Title XI which addressed patent certification and related matters for ANDAs and 505(b)(2)s (Paper NDAs). Although the basic framework of patent listing in the Orange Book and the system of certification, challenge, associated notification procedures, and the 30-month stay had all been established in the original Hatch-Waxman Act of 1984, over time there had developed almost endless loopholes that enabled brand companies to extend exclusive marketing and even to make deals with generic first filers. One of the biggest problems of all was that there was no time limit on when the first generic filer’s market exclusivity began and no way to approve second and subsequent generic filers ANDAs until the market exclusivity was over. This allowed for the hold up of generic marketing almost indefinitely. Another big problem was that the actual wording of the Hatch-Waxman Act stated that ANDA approval and marketing exclusivity was triggered by “a court decision” meaning a federal court decision on a patent infringement case brought as a result of the para IV filing. It was crystal clear that Hatch-Waxman meant to say a final court decision, meaning the decision of the appeal court, not the original federal district trial court, but as many federal judges told FDA over the years, the Act does not say Final court decision. Because the Act doesn't say “final” it cannot mean “final”, that is why the law is said to be “deaf, dumb, and blind”, it means what it says, not what it intended to say. In addition to these problems, there were a myriad of other issues that led to ANDA approval delays, and quite frankly some very blatant abuses of the intention of Hatch-Waxman. The MMA amendments set out to “fix” all these problems and so supposedly make the patent certification systems function as originally intended by Hatch-Waxman.

Well MMA was passed in 2003 and for those of you without a calendar handy, it is now 2015, about 11.5 years since FDA was directed to amend the regulations governing that patent certification system. So what has been happening in the 11.5 year interim? FDA has been, as they like to say, governing off the legislation, which is another way of saying we are making it up as we go. Fairness to all parties requires that FDA clearly state in the regulation what the law is so that all parties involved in spending very substantial amounts of money and time know exactly what to expect for each situation. However FDA has always found the whole patent certification system hard to codify, the original CFR regulations took well over a decade to produce, and here we are again.

So the Federal Register Notice (see here) simply titled “Abbreviated New Drug Applications and 505(b)(2) Applications” perhaps an overly broad title, is intended to address the MMA's direction to FDA to codify the new rules aimed at “fixing” the abuses (and some errors) of the Hatch-Waxman Act of 1984. Obviously it will take some time to read, digest, and distill what this FR Notice is saying, so for those of you with an interest in para IV filings, either ANDAs or 505(b)(2)s, keep an eye out for summaries of this proposal which I am sure will be forthcoming form prominent Food & Drug Law firms.

Finally, did the MMA “fix” all the problems? Well, as you might expect when you mix thousands of lawyers with billions of dollars in possible profits, no it didn't. It's like tax law, when you close one loophole, another opens!

识林TMwww.shilinx.com版权所有,未经许可不得转载。如需使用请联系admin@shilinx.com

Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)

Mandatory Reading:

  • Regulatory Affairs (Reg)
  • Intellectual Property (IP)
  • Quality Assurance (QA)
  • Legal Department

Work Suggestions:

  • Reg: Ensure the company's drug applications comply with the new drug application procedures and bioequivalence standards.
  • IP: Monitor patent term extensions and the impact on the company's patent strategy.
  • QA: Verify that manufacturing processes meet the identity, strength, quality, and purity requirements.
  • Legal Department: Advise on patent infringement issues and the legal implications of abbreviated new drug applications.

Scope of Application:
The Drug Price Competition and Patent Term Restoration Act of 1984 applies to chemical drugs, including new molecular entities and generic drugs, in the United States. It is intended for regulatory bodies, pharmaceutical companies, and legal entities involved in drug development and approval processes.

Key Points Summary:

  1. Abbreviated New Drug Applications (ANDAs): The Act allows for the streamlined approval of generic drugs by submitting abbreviated applications showing bioequivalence to the listed drug, without repeating costly and time-consuming clinical trials.

  2. Patent Term Restoration: Offers a mechanism to extend the effective patent life of a drug to partially compensate for the time lost during the regulatory review process, up to a maximum of five years.

  3. Data Exclusivity: Provides a period of data exclusivity, during which the FDA cannot approve ANDAs for other companies that rely on the innovator's safety and efficacy data.

  4. Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.

  5. Regulatory Review Period: Defines the regulatory review period for calculating patent term extensions and sets rules for due diligence during the application process.

Conclusion:
The Drug Price Competition and Patent Term Restoration Act of 1984 is a landmark legislation that balances the need for accessible, affordable medications with the incentive for innovation. It has significantly impacted the pharmaceutical industry by fostering competition and ensuring that both innovator and generic drug companies have clear pathways to market. The above points are not exhaustive; for comprehensive understanding, the full text of the Act should be consulted.

解读法规指南

适用岗位:

  • “注册”岗位:负责提交专利信息,处理专利认证和声明。
  • “QA”岗位:确保提交的文件符合法规要求。
  • “研发”岗位:了解专利信息对药物开发的影响。

工作建议:

  • 注册岗位:确保所有专利信息及时准确地提交给FDA,并在需要时提供必要的专利认证或声明。
  • QA岗位:审核提交给FDA的所有文件,确保它们符合21 CFR 314和320的要求。
  • 研发岗位:监控专利信息,评估其对药物研发项目的影响。

文件适用范围:
本文适用于化学药和生物制品的505(b)(2)申请和ANDAs。它涵盖了创新药和仿制药的注册分类,适用于美国市场的药物,由Biotech、大型药企、跨国药企等各类企业遵守。

要点总结:

  1. 专利信息提交:明确了提交专利信息的要求,包括药物成分、药物产品以及使用方法专利。
  2. 专利认证:规定了申请人在提交505(b)(2)申请或ANDA时的专利认证要求,特别是针对方法专利。
  3. 专利信息修正:提出了在专利信息变更时的修正流程,包括专利重新发布或专利期限延长。
  4. 专利认证的修订:在法院发现专利侵权后,要求申请人修订其专利认证。
  5. 生物等效性数据:更新了支持505(b)(2)申请和ANDAs的生物等效性数据类型。

结论:
以上要点是对法规指南的简要解读。为了深入理解监管要求,建议阅读原文。

详细解读:

  • 专利信息提交:申请人必须在提交505(b)(2)申请或ANDA时,提供涉及药物成分、药物产品或使用方法的专利信息。这包括在专利重新发布或专利期限延长时提交更新的专利信息。
  • 专利认证要求:申请人需要对每个及时提交的专利进行认证,包括声明专利无效、不可执行或不会因制造、使用或销售而侵权。
  • 专利信息修正:如果专利信息发生变化,如专利重新发布或根据法院命令修改,申请人必须提交修正的专利信息。
  • 专利认证的修订:在法院作出专利侵权的最终裁决后,申请人需要将专利IV认证更改为专利III认证,或在适用的情况下,提供有关使用方法专利的声明。
  • 生物等效性数据:FDA将接受科学有效的测量方法来评估不打算被吸收到血液中的药物的生物等效性。

请求评论:
FDA邀请有关方面对上述提案提出评论,包括对法规的清晰度、实施的可行性以及对行业的影响等。评论可以涉及对提案的具体建议,或者对FDA在实施过程中可能需要考虑的其他问题。

法律依据:
本提案的法律依据包括《医疗保险处方药改善和现代化法案》(MMA)和《联邦食品、药品和化妆品法案》(FD&C Act)的相关条款。

影响分析:
FDA已经评估了该提案的潜在影响,包括对小型企业的可能影响。该提案旨在平衡鼓励仿制药的可用性和将创新新药引入市场的需求。

公众意见征询:
FDA鼓励所有利益相关者,包括NDA持有者、NDA申请人(包括505(b)(2)申请人)和ANDA申请人,对本提案提出意见。意见可以涉及对提案的具体建议,或者FDA在实施过程中可能需要考虑的其他问题。

总结:
本提案旨在通过明确和更新505(b)(2)申请和ANDAs的法规要求,提高行业对法规的理解和遵守,同时减少不必要的诉讼和延误,为品牌药和仿制药制造商提供商业确定性。

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