首页 > 资讯 > FDA橙皮书中每年列出多少专利？

出自识林

2016-08-19 Lachman CONSULTANTS

申办人需要在NDA递交资料中提交的信息包括“申办人提交申请的药品所声明或该药使用方法所声明的任何专利，以及与如果一个人没有被专利所有人许可而参与药品的生产、使用或销售，应合理地主张专利侵权声明相关的任何专利的专利号和过期日期”。如果在NDA提交时没有可列出的专利，但在提交NDA之后或在NDA获批之后或在补充提交给NDA之时颁发了专利，申办人必须符合监管要求列出此类专利。申办人必须就他们的专利列出作出某些声明。FDA需要从管理和预算办公室对于由FDA收集数据获得批准。

8月15日的联邦公报（FR）通告宣布与FDA3542表和3542A表（专利声明表）有关的专利信息收集批准延期，FDA指出在2012年、2013年和2014年提交到FDA列在橙皮书中的专利数量分别为458、509和617，平均528/年。在阅读这篇FR之前，我不得不承认我并不知道有多少专利提交到FDA列入橙皮书。

在FR通告中出现的一些有趣的使人信以为真的事实是：

• FDA承认有许多专利可能包含在多件申请中提交，并估计这个比例占到了14%。
• FDA“在2012、2013和2014日历年分别批准了86、94和107件NDA，我们估计其中71%提交了列入橙皮书的专利信息。”
• FDA在2012、2013和2014财年还批准了大约101、101和110件NDA补充申请，要求提交专利声明。

FR通告进一步解释了填写表格和向FDA报告信息对于企业的负担。读者能够在这些看似简单的信息收集通知中发现些什么肯定会很有趣。

Lachman CONSULTANTS - Bob Pollock先生
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So How Many Patents Are Listed in the Orange Book Each Year?
By Bob Pollock | August 17, 2016 原文地址

Sponsors are required to submit information in their NDA filings to include “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” If no patent was available for listing at the time of NDA submission but a patent subsequently issues after the NDA is filed, after approval of the NDA or or at the time that a supplement is filed to the NDA, the sponsor must comply with the regulatory requirements to list such patents. The sponsors must make certain declarations regarding their patent listings. FDA is required to obtain approval from the Office of Management and Budget (OMB) for the collection of data by the FDA.

In a recent Federal Register (FR) Notice (here) announcing the extension of approval for the collection of patent information dealing with the FDA forms 3542 and 3542A (patent declaration forms), the FDA noted that the numbers of patents submitted to FDA for listing in the Orange Book (OB) in 2012, 2013 and 2014 were 458, 509 and 617, respectively, for an average of 528/year. Before reading this FR, I have to admit that I had no idea how many patents had been submitted to the FDA for inclusion in the Orange Book (OB).

Some interesting factoids that appear in the FR notice are:

• FDA recognizes that multiple patents may be submitted to multiple applications and estimates that occurs in about 14% of the time.
• FDA “approved 86, 94, and 107 NDAs in calendar years 2012, 2013, and 2014, respectively, of which we estimate 71 percent submitted patent information for listing in the Orange Book.”
• FDA also approved approximately 101, 101, and 110 NDA supplements in FYs 2012, 2013, and 2014, respectively, for which submission of a patent declaration would be required.

The FR Notice further explains the burden on the industry for filling out the forms and reporting the information to the Agency. It is certainly interesting what you can find in some of these seemingly simple information collection notices. It is also noteworthy that a significant portion of my life is being absorbed by these FR notices. I find they are also very good for inducing sleep, even though I have not seen any clinical studies that can support the safety or efficacy of FR Notices for this indication.