The Impacts of Enhanced Drug-Patent Examination

加强药品专利审查的影响

• 批准号: 10587507
• 负责人: MICHAEL D. FRAKES
• 金额: $ 31.66万
• 依托单位: NATIONAL BUREAU OF ECONOMIC RESEARCH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10587507
• 关键词: Acceleration; Anecdotes; Biological Products; Books; Categories; Characteristics; Clinical; Code; Communities; Data; Databases; Disease; Ensure; Equilibrium; Event; Exercise; FDA approved; Institution; Investigation; Legal; Legal patent; Literature; Longevity; Manufacturer; Measures; Methods; Nature; Oranges; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Policies; Polymorph; Process; Proteins; Quasi-experiment; Research; Resources; Route; Running; Source; System; Text; Time; Trademark; age related; cost-effectiveness evaluation; court; design; hatching; improved; innovation; novel; screening; simulation; small molecule

OTHER PROJECT INFORMATION – Project Summary/Abstract THE IMPACTS OF ENHANCED DRUG-PATENT EXAMINATION The legal patentability requirements are designed to respect the balance between patient access to existing longevity-improving drugs and incentivizing their existence in the first place. However, the patent system may fail to achieve this balance if it does not provide patent examiners with the resources—mainly, time—needed to apply these patentability standards. Given the legal presumption of validity of incoming patent applications, insufficient examination time may lead to concerns that the U.S. Patent and Trademark Office (PTO) will issue patents on non-novel or obvious innovations, a result which may unnecessarily inhibit patient access and thereby compromise patient outcomes. Patent quality concerns of this nature have been particularly paramount in the case of “secondary” patents—i.e., patents on subsidiary drug features such as on routes of administration. Given that secondary patent applications are often filed years after the issuance of the active- ingredient patent, they have the potential to meaningfully extend the effective patent lives of given drug products, potentially limiting access on the margin to clinically valuable drugs. In this project, we propose to investigate the full extent to which secondary patenting practices may be extending effective patent lives of FDA-approved drugs. Further, drawing on certain PTO reforms and features, we will investigate the impacts of increasing examination time on drug-patent examination quality. In particular, we will address four aims:  Compiling, reviewing and coding data from both the PTO and the FDA, we will build a database of small-molecule drug patents associated with FDA-approved drug products from the mid-1980s to the present, containing various information associated with each such patent, including information (if any) on claims associated with secondary drug features.  We will similarly build a database of large-molecule drug patents, though this effort will likely require a deeper and more extensive review of raw PTO materials given the lack of a congressionally mandated list of biologics-related patents associated with FDA-approvals.  Using these data and employing various quasi-experimental approaches, we will estimate the relationship between the examination time allotted to examiners and the likelihood that the patents they issue meet the legal patentability requirements.  Drawing on the results from Aim #3, we will run simulation exercises to assess the degree to which an increase in examination time will shorten the effective patent lives of approved FDA drug products and thereafter draw on various estimated moments from the generic-entry literature to estimate the resulting effects on increased/accelerated patient access to approved medications.

其他项目信息-项目概要/摘要 加强药品专利保护的重要性 法律的可专利性要求旨在尊重患者对现有产品的使用权与专利权之间的平衡。 提高寿命的药物，并激励他们的存在摆在首位。但是，专利制度可以 如果不能为专利审查员提供所需的资源，主要是时间， 适用这些专利标准。考虑到专利申请有效性的法律的推定， 审查时间不足可能会导致美国专利商标局（PTO）发出的担忧， 非新颖或明显创新的专利，这可能会不必要地限制患者使用， 从而损害患者的结果。这种性质的专利质量问题尤其受到 在“次要”专利的情况下是最重要的--即，专利的附属药物的特点，如路线， 局鉴于二级专利申请往往是在主动专利发布数年后提交的， 成分专利，它们有可能有意义地延长给定药物的有效专利寿命 产品，潜在地限制了获得有临床价值的药物的机会。在这个项目中，我们建议 调查二级专利实践在多大程度上可以延长有效的专利寿命， FDA批准的药物。此外，借鉴某些PTO改革和特点，我们将调查的影响， 增加了药品专利审查质量的审查时间。具体而言，我们将实现四个目标： 通过对PTO和FDA的数据进行汇编、审查和编码，我们将建立一个数据库， 与FDA批准的药品相关的小分子药物专利，从20世纪80年代中期到 存在，包含与每个此类专利相关的各种信息，包括信息（如果有的话） 与次要药物特征相关的索赔。 我们将类似地建立一个大分子药物专利数据库，尽管这一努力可能需要 由于缺乏国会授权的对PTO原材料进行更深入、更广泛的审查， 与FDA批准相关的生物制品相关专利列表。 使用这些数据并采用各种准实验方法，我们将估计 分配给审查员的审查时间与专利被审查的可能性之间的关系 符合法律的专利性要求。 根据目标3的结果，我们将进行模拟练习，以评估 审查时间的增加将缩短FDA批准的药品的有效专利寿命， 此后利用各种估计的时刻，从一般进入文献，以估计产生的 对增加/加速患者获得获批药物的影响。