To keep drug prices high, pharma has been piling up the patents
To keep drug prices high, pharma has been piling up the patents
为了维持高药价，制药公司正在疯狂堆积专利
The cost of healthcare in general is a debilitating, pre-existing condition for Americans. But the high prices of prescription drugs usually stand out as a pain point. While there are many insidious reasons why Americans pay more—often far more—for their medicines than people in peer countries, exploitation of the US patent system is an obvious one. 总体而言，医疗保健成本对美国人来说是一种令人衰弱的“既有疾病”。但处方药的高昂价格通常是最突出的痛点。尽管美国人购买药物的费用往往远高于其他同类国家，其背后的原因错综复杂，但对美国专利制度的滥用显然是其中一个主要原因。
A study published Monday in JAMA highlights just how much patent exploitation has grown since 1990. In that time, researchers found that the number of patents on small-molecule drugs has more than tripled, going from an average of 2.1 patents per drug approved in 1990 to 6.9 for those approved in 2019. 周一发表在《美国医学会杂志》（JAMA）上的一项研究强调了自1990年以来，专利滥用现象增长了多少。研究人员发现，在此期间，小分子药物的专利数量增加了两倍多，从1990年获批药物平均每种2.1项专利，增加到2019年获批药物平均每种6.9项专利。
Most of the growth was in “nonprimary” patents—patents that generally aren’t related to a drug’s active ingredient, but are instead for things like minor tweaks to a drug’s nonactive ingredients, updates to the way the drug is used, or the design of specialty delivery devices, such as auto-injectors. Together, those extra patents on an individual drug can create what’s called a “patent thicket,” which delays the release of affordable generics on the market, keeping drug prices higher for longer without actual clinical advancements. 大部分增长来自于“非核心”专利——这些专利通常与药物的活性成分无关，而是针对药物非活性成分的微小调整、药物使用方式的更新，或是自动注射器等特殊给药装置的设计。这些针对单一药物的额外专利共同构成了所谓的“专利丛林”（patent thicket），这延迟了平价仿制药的上市，在没有实际临床进展的情况下，使药价在更长时间内保持高位。
The study—led by S. Sean Tu, an expert in drug and patent law at the University of Alabama—found that the increase in patents per drug extended the time in which a drug was patented from an average of two years in 1990 to an average of 6.1 years in 2019. “Because patent protection typically determines how long brand-name firms can charge monopoly prices, the rapid growth of nonprimary patents may contribute to limited price competition that benefits patients and the health care system by helping avoid unnecessary spending,” Tu and colleagues write. 这项由阿拉巴马大学药物与专利法专家 S. Sean Tu 领导的研究发现，每种药物专利数量的增加，使得药物的专利保护期从1990年的平均2年延长到了2019年的平均6.1年。Tu 及其同事写道：“由于专利保护通常决定了品牌药企能收取垄断价格的时长，非核心专利的快速增长可能会限制价格竞争，而这种竞争本可以通过帮助避免不必要的支出，从而造福患者和医疗体系。”
Patent overgrowth
专利过度增长
For the study, Tu and colleagues used publicly available data to look at small-molecule drugs approved by the Food and Drug Administration and the patents filed on those drugs. (Other types of approved drugs, like biologics, are not systematically listed by the FDA in a publicly available database.) The researchers categorized the types of patents associated with each drug and how they affected the term in which the drug remained under patent. The researchers focused on drugs granted FDA approval between 1990 to 2019, giving a five-year follow-up period for patents. Still, this likely underestimates the current sizes of patent thickets, as patent activity is now extending up to nine years after FDA approval, the authors write. 为了进行这项研究，Tu 及其同事利用公开数据调查了美国食品药品监督管理局（FDA）批准的小分子药物及其相关专利。（其他类型的获批药物，如生物制剂，并未被 FDA 系统地列入公开数据库。）研究人员对每种药物相关的专利类型进行了分类，并分析了它们如何影响药物的专利保护期限。研究重点关注了1990年至2019年间获得 FDA 批准的药物，并对专利进行了五年的跟踪观察。作者指出，这可能仍然低估了当前“专利丛林”的规模，因为专利活动现在已经延伸到 FDA 批准后的九年。
Between 1990 and 2019, Americans saw their spending on prescription drugs soar. According to a Peterson-KFF analysis, the per capita, inflation-adjusted spending on prescription drugs in the US was $291 in 1990. By 2019, spending had risen to $1,084. Earlier this year, an analysis by the Commonwealth Fund found that Americans spent nearly twice as much on prescription drugs as the average spending of other high-income countries. 在1990年至2019年间，美国人的处方药支出大幅飙升。根据 Peterson-KFF 的分析，1990年美国人均处方药支出（经通胀调整后）为291美元。到2019年，这一支出已升至1084美元。今年早些时候，英联邦基金（Commonwealth Fund）的一项分析发现，美国人在处方药上的支出几乎是其他高收入国家平均水平的两倍。
During the study period, “primary patents” on drugs—those usually related to the active ingredient—changed little. But nonprimary patents more than tripled. Overall, the FDA approved 1,981 small-molecule drugs between 1990 and 2019. For those 1,981 drugs, there were 10,940 patents total. Nonprimary patents made up 84 percent of them. 在研究期间，药物的“核心专利”（通常与活性成分相关）变化不大。但非核心专利却增加了两倍多。总体而言，FDA 在1990年至2019年间批准了1981种小分子药物。这1981种药物总共拥有10940项专利，其中非核心专利占了84%。
A key limitation of the study is that it didn’t look directly at delays to the availability of generic drugs, which are likely linked to patent thicket growth. Tu and colleagues note that drug makers often argue that additional patents don’t delay generic drugs. But the examples often used in those arguments are drugs approved before 2010, when patent thicket growth was lower than it is today. 该研究的一个主要局限性在于，它没有直接调查仿制药上市的延迟情况，而这很可能与专利丛林的增长有关。Tu 及其同事指出，制药商经常辩称，额外的专利并不会延迟仿制药的上市。但这些论点中经常引用的例子都是2010年之前获批的药物，当时专利丛林的增长程度远低于今天。
The authors call for various reforms to cut back patent thickets, including more scrutiny by the US Patent and Trademark Office (USPTO), as well as laws that could limit minor add-on patents. They also suggest allowing courts to force disgorgement of drug companies found to have abused patents. Without regulatory reforms soon, this boom in patent thickets “will likely entrench extended exclusivity periods that are disconnected from meaningful therapeutic innovation and continue to complicate and delay generic entry,” Tu and colleagues write. 作者呼吁进行多项改革以削减专利丛林，包括美国专利商标局（USPTO）加强审查，以及制定限制小型附加专利的法律。他们还建议允许法院强制那些被发现滥用专利的制药公司退还非法所得。Tu 及其同事写道，如果监管改革不能尽快落实，这种专利丛林的激增“很可能会固化延长的独占期，而这些独占期与有意义的治疗创新脱节，并将继续使仿制药的进入变得复杂和延迟。”