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2015-02-09 识林

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
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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!

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