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What can Japan learn from various generic promotion programs in other developed countries?

日本可以从其他发达国家的各种通用推广计划中学到什么？

基本信息

批准号：
16K17110
负责人：
ワンジャンユン
金额：
$ 2.5万
依托单位：
Hitotsubashi University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Young Scientists (B)
财政年份：
2016
资助国家：
日本
起止时间：
2016-04-01 至 2018-03-31
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-16K17110/
关键词：
Hatch-Waxman Act pharmaceutical patents reverse payments patent renewal entry competition patent challenge generic entry Hatch-Waxman marketing exclusivity 経済理論

项目摘要

My primary research focus is on the 1984 Hatch-Waxman Act (HW Act) in the US and its related issues. So far, I have two written papers and one on-going paper on this subject. My first written paper is entitled “Pharmaceutical patent and generic entry competition”. In this paper, I set up a theoretical model to examine whether the act can achieve its two seemingly contradicting goals, to promote both brand-name innovation and generic competition. My second written paper is entitled “Pharmaceutical patent and reverse payment settlements”. In the US, reverse payments are made by a brand-name company to generic firms to delay generic entry. Under the HW Act, reverse payments can make a generic firm drop a patent challenge and stay out of the market until the patent expires. In the paper, I set up a theoretical model to study the effects of reverse payment under the HW Act and find that although it delays entry, it can be beneficial to the whole society at the same time. My ongoing research examines how the patent renewal system can interfere with the HW Act. To obtain the full-length patent life, a patent owner must pay a renewal fee to renew the patent every once in a while. With the HW Act, generic firms are more motivated to cut a patent short, which adds to the costs of renewing it. The theoretical setup here allows a brand-name company to choose whether to renew its patents when facing generic challenge. I expect to get some policy implications on how to set up the patent renewal fees to better serve the purposes of the HW Act.

我的主要研究重点是1984年美国的哈奇-韦克斯曼法案（HW Act）及其相关问题。到目前为止，我已经写了两篇论文和一篇正在进行的论文。我的第一篇书面论文的题目是“药品专利和仿制药进入竞争”。在本文中，我建立了一个理论模型来检验该法案是否能够实现其两个看似矛盾的目标，即促进品牌创新和仿制药竞争。我的第二篇书面论文题为“制药专利和反向支付结算”。在美国，名牌公司向仿制药公司支付反向付款，以推迟仿制药上市。根据HW法案，反向支付可以使仿制药公司放弃专利挑战，并在专利到期之前退出市场。在本文中，我建立了一个理论模型来研究HW法案下的反向支付的效果，发现它虽然延迟了进入，但同时也可以使整个社会受益。我正在进行的研究考察了专利续期制度如何干扰HW法案。为了获得完整的专利期限，专利权人必须每隔一段时间支付一笔续期费来更新专利。有了HW法案，非专利公司更有动力缩短专利期限，这增加了更新专利的成本。这里的理论设置允许品牌公司在面临仿制药挑战时选择是否更新其专利。我希望在如何设置专利续期费以更好地服务于HW法案的目的方面得到一些政策启示。