Harvard University; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
West Virginia University College of Law.
Chest. 2023 Aug;164(2):450-460. doi: 10.1016/j.chest.2023.02.031. Epub 2023 Feb 25.
Patients with asthma and COPD rely on inhalers to control symptoms. Yet, these products remain expensive, in part because brand-name manufacturers have obtained numerous patents on inhalers, including on their delivery devices. Recent antitrust litigation has raised questions about the boundaries of listing device patents with the US Food and Drug Administration (FDA), particularly when patents do not claim any active ingredients.
How have manufacturers relied on device patents to preserve market exclusivity on brand-name inhalers?
We identified patents on brand-name inhalers approved for asthma and COPD between 1986 and 2020 using the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). We extracted information about patents from LexisNexis TotalPatent One and Google Patents and searched device patents for mention of active ingredients or other prespecified features linking the patent to the relevant drug. For each inhaler, we determined the duration of protection added by device patents.
The FDA approved 53 brand-name inhalers for asthma and COPD from 1986 through 2020, 39 of which had at least one device patent. One hundred thirty-seven distinct device patents were in the final cohort, representing 49% of all patents listed on inhalers. Seventy-seven percent of device patents made no mention of active ingredients or their molecular structures, and 72% made no mention of any relevant prespecified feature connecting the device patent to the drug product. For the 39 brand-name inhalers with one or more device patents listed in the Orange Book, device patents extended the duration of market protection by a median of 5.5 years (interquartile range, 0.0-10.5 years) beyond the last-to-expire nondevice patent.
Patent and regulatory reform is needed to promote generic competition and to ensure that patients with asthma and COPD have access to affordable medications.
哮喘和 COPD 患者依赖吸入器来控制症状。然而，这些产品仍然很昂贵，部分原因是名牌制造商对吸入器及其给药装置获得了多项专利。最近的反垄断诉讼引发了人们对将装置专利与美国食品和药物管理局 (FDA) 一起列出的界限的质疑，尤其是当专利不主张任何活性成分时。
制造商如何依赖装置专利来维持名牌吸入器的市场独占性？
我们使用 FDA 的《批准药物产品治疗等效性评估》（橙色书），确定了 1986 年至 2020 年期间批准用于哮喘和 COPD 的名牌吸入器的专利。我们从 LexisNexis TotalPatent One 和 Google Patents 中提取专利信息，并搜索装置专利中是否提到了将专利与相关药物联系起来的活性成分或其他预定特征。对于每个吸入器，我们确定装置专利增加的保护期限。
FDA 从 1986 年至 2020 年批准了 53 种用于哮喘和 COPD 的名牌吸入器，其中 39 种至少有一种装置专利。最终队列中有 137 项不同的装置专利，占吸入器上列出的所有专利的 49%。77%的装置专利未提及活性成分或其分子结构，72%的装置专利未提及将装置专利与药物产品联系起来的任何预定特征。在橙色书中列出了一种或多种装置专利的 39 种名牌吸入器中，装置专利将市场保护期延长了中位数 5.5 年（四分位距，0.0-10.5 年），超过了最后失效的非装置专利。
需要进行专利和监管改革，以促进仿制药竞争，并确保哮喘和 COPD 患者能够获得负担得起的药物。
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