GLP-1 受体激动剂的专利和监管专有权。
Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists.
机构信息
School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
出版信息
JAMA. 2023 Aug 15;330(7):650-657. doi: 10.1001/jama.2023.13872.
IMPORTANCE
Glucagon-like peptide 1 (GLP-1) receptor agonists were first approved for the treatment of type 2 diabetes in 2005. Demand for these drugs has increased rapidly in recent years, as indications have expanded, but they remain expensive.
OBJECTIVE
To analyze how manufacturers of brand-name GLP-1 receptor agonists have used the patent and regulatory systems to extend periods of market exclusivity.
EVIDENCE REVIEW
The annual US Food and Drug Administration's (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations was used to identify GLP-1 receptor agonists approved from 2005 to 2021 and to record patents and nonpatent statutory exclusivities listed for each product. Google Patents was used to extract additional data on patents, including whether each was obtained on the delivery device or another aspect of the product. The primary outcome was the duration of expected protection from generic competition, defined as the time elapsed from FDA approval until expiration of the last-to-expire patent or regulatory exclusivity.
FINDINGS
On the 10 GLP-1 receptor agonists included in the cohort, drug manufacturers listed with the FDA a median of 19.5 patents (IQR, 9.0-25.8) per product, including a median of 17 patents (IQR, 8.3-22.8) filed before FDA approval and 1.5 (IQR, 0-2.8) filed after FDA approval. Fifty-four percent of all patents listed on GLP-1 receptor agonists were on the delivery devices rather than active ingredients. Manufacturers augmented patent protection with a median of 2 regulatory exclusivities (IQR, 0-3) obtained at approval and 1 (IQR, 0.3-4.3) added after approval. The median total duration of expected protection after FDA approval, when accounting for both preapproval and postapproval patents and regulatory exclusivities, was 18.3 years (IQR, 16.0-19.4). No generic firm has successfully challenged patents on GLP-1 receptor agonists to gain FDA approval.
CONCLUSIONS AND RELEVANCE
Patent and regulatory reform is needed to ensure timely generic entry of GLP-1 receptor agonists to the market.
重要性
胰高血糖素样肽 1（GLP-1）受体激动剂于 2005 年首次被批准用于治疗 2 型糖尿病。近年来，随着适应症的扩大，这些药物的需求迅速增加，但它们仍然很昂贵。
目的
分析品牌 GLP-1 受体激动剂的制造商如何利用专利和监管系统来延长市场独占期。
证据回顾
使用年度美国食品和药物管理局（FDA）批准的具有治疗等效性评估的药物产品，以确定 2005 年至 2021 年批准的 GLP-1 受体激动剂，并记录每个产品列出的专利和非专利法定独占权。使用 Google Patents 提取有关专利的其他数据，包括每个专利是否是在交付装置或产品的其他方面获得的。主要结果是从 FDA 批准到最后一个专利或监管独占权到期之间预期的来自仿制药竞争的保护时间。
发现
在队列中的 10 种 GLP-1 受体激动剂中，药物制造商向 FDA 列出了每一种产品中位数为 19.5 项专利（IQR，9.0-25.8），包括 FDA 批准前中位数为 17 项专利（IQR，8.3-22.8）和 FDA 批准后中位数为 1.5 项专利（IQR，0-2.8）。GLP-1 受体激动剂列出的所有专利中，有 54%是在输送装置上，而不是在活性成分上。制造商通过在批准时获得中位数为 2 项监管独占权（IQR，0-3）和批准后获得 1 项（IQR，0.3-4.3）来增加专利保护。在考虑到批准前和批准后的专利和监管独占权后，FDA 批准后的预期保护总持续时间中位数为 18.3 年（IQR，16.0-19.4）。没有仿制药公司成功地对 GLP-1 受体激动剂的专利提出质疑，以获得 FDA 的批准。
结论和相关性
需要进行专利和监管改革，以确保 GLP-1 受体激动剂及时获得仿制药进入市场。
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