PDF(Pubmed)
Abstract：
UNASSIGNED: Brand-name drugs are sold at high prices in the US during market exclusivity periods protected by patents. Multiple overlapping patents protecting a drug are known as patent thickets and can effectively delay the emergence of price-lowering generic competition for many years.
UNASSIGNED: To evaluate the composition of patent thickets of 10 top-selling prescription drugs in the US and compare the characteristics of drug patents filed during development with those filed on these products after US Food and Drug Administration (FDA) approval.
UNASSIGNED: This cross-sectional study examined US patent thickets of the 10 prescription drugs with the highest US net sales revenue in 2021 using information on issued patents and patent applications as of June 30, 2022, obtained from a public database by the Initiative for Medicines, Access, and Knowledge. Data were analyzed from September 2022 to June 2023.
UNASSIGNED: Prevalence of patents filed before and after FDA approval; types of claims present in issued patents (ie, chemical composition, method of use, process or synthesis, formulation, and delivery device); and patent thicket density (number of active patents at a given time).
UNASSIGNED: The 10 top-selling prescription drugs in the US for 2021 included 4 small-molecule drugs and 6 biologics. These 10 drugs were linked to 1429 patents and patent applications: 742 (52%) issued patents, 218 (15%) pending applications, and 469 (33%) abandoned applications. Almost three-quarters of patent applications (1028 [72%]) were filed after FDA approval. The postapproval proportion was higher for biologics (80%) than for small-molecule drugs (58%). Postapproval filing of patent applications peaked in the first 5 years after FDA approval for small-molecule drugs and 12 years after FDA approval for biologics. Of 465 patents issued for applications filed after FDA approval, 189 (41%) had method of use claims, 127 (27%) had formulation claims, and 103 (22%) had process or synthesis claims, while 86 (19%) had chemical composition claims and 46 (10%) had device claims. Patent thicket density peaked 13 years after FDA approval, at which time these 10 drugs were protected by a median (IQR) of 42 (18-83) active patents, 66% of which were filed after FDA approval.
UNASSIGNED: This study found that among the 10 top-selling prescription drugs in the US in 2021, patents filed after FDA approval and containing claims covering aspects other than the active ingredient of the drug contributed to patent thickets. Scrutiny of patent applications and of patents filed after FDA approval is needed to facilitate timely generic or biosimilar competition.
UNASSIGNED: To evaluate the composition of patent thickets of 10 top-selling prescription drugs in the US and compare the characteristics of drug patents filed during development with those filed on these products after US Food and Drug Administration (FDA) approval.
UNASSIGNED: This cross-sectional study examined US patent thickets of the 10 prescription drugs with the highest US net sales revenue in 2021 using information on issued patents and patent applications as of June 30, 2022, obtained from a public database by the Initiative for Medicines, Access, and Knowledge. Data were analyzed from September 2022 to June 2023.
UNASSIGNED: Prevalence of patents filed before and after FDA approval; types of claims present in issued patents (ie, chemical composition, method of use, process or synthesis, formulation, and delivery device); and patent thicket density (number of active patents at a given time).
UNASSIGNED: The 10 top-selling prescription drugs in the US for 2021 included 4 small-molecule drugs and 6 biologics. These 10 drugs were linked to 1429 patents and patent applications: 742 (52%) issued patents, 218 (15%) pending applications, and 469 (33%) abandoned applications. Almost three-quarters of patent applications (1028 [72%]) were filed after FDA approval. The postapproval proportion was higher for biologics (80%) than for small-molecule drugs (58%). Postapproval filing of patent applications peaked in the first 5 years after FDA approval for small-molecule drugs and 12 years after FDA approval for biologics. Of 465 patents issued for applications filed after FDA approval, 189 (41%) had method of use claims, 127 (27%) had formulation claims, and 103 (22%) had process or synthesis claims, while 86 (19%) had chemical composition claims and 46 (10%) had device claims. Patent thicket density peaked 13 years after FDA approval, at which time these 10 drugs were protected by a median (IQR) of 42 (18-83) active patents, 66% of which were filed after FDA approval.
UNASSIGNED: This study found that among the 10 top-selling prescription drugs in the US in 2021, patents filed after FDA approval and containing claims covering aspects other than the active ingredient of the drug contributed to patent thickets. Scrutiny of patent applications and of patents filed after FDA approval is needed to facilitate timely generic or biosimilar competition.
摘要：
品牌药在受专利保护的市场独占期在美国以高价销售。保护药物的多个重叠专利被称为专利灌木丛，可以有效地推迟多年来降低价格的仿制药竞争的出现。
■评估美国最畅销的10种处方药的专利组成，并将开发过程中提交的药物专利的特征与美国食品和药物管理局（FDA）批准后提交的这些产品的专利特征进行比较。
这项横断面研究使用截至2022年6月30日已发布的专利和专利申请的信息，对2021年美国净销售收入最高的10种处方药的美国专利灌丛进行了审查，该信息来自药品倡议的公共数据库。Access,和知识。数据从2022年9月到2023年6月进行了分析。
■在FDA批准之前和之后提交的专利的患病率；已发布专利中存在的权利要求类型（即，化学成分,使用方法,过程或合成，配方，和递送装置)；和专利丛林密度(给定时间的有效专利数量)。
■2021年美国最畅销的10种处方药包括4种小分子药物和6种生物制剂。这10种药物与1429项专利和专利申请相关：742项（52%）已授权专利，218（15%）待决申请，469份(33%)放弃申请。近四分之三的专利申请（1028[72%]）是在FDA批准后提交的。生物制剂的批准后比例（80％）高于小分子药物（58％）。专利申请的批准后提交在FDA批准小分子药物后的前5年和FDA批准生物制剂后的12年达到顶峰。在FDA批准后申请的465项专利中，189人（41%）有使用方法的权利要求，127（27%）有配方索赔，103(22%)有工艺或合成要求，86(19%)有化学成分索赔，46(10%)有装置索赔。专利丛林密度在FDA批准13年后达到顶峰，当时这10种药物受到42(18-83)个活性专利的中位数(IQR)保护，其中66％是在FDA批准后提交的。
■这项研究发现，在2021年美国最畅销的10种处方药中，在FDA批准后提交的专利以及涵盖药物活性成分以外的其他方面的权利要求都促成了专利灌木丛。需要对专利申请和FDA批准后提交的专利进行审查，以促进及时的仿制药或生物仿制药竞争。
■评估美国最畅销的10种处方药的专利组成，并将开发过程中提交的药物专利的特征与美国食品和药物管理局（FDA）批准后提交的这些产品的专利特征进行比较。
这项横断面研究使用截至2022年6月30日已发布的专利和专利申请的信息，对2021年美国净销售收入最高的10种处方药的美国专利灌丛进行了审查，该信息来自药品倡议的公共数据库。Access,和知识。数据从2022年9月到2023年6月进行了分析。
■在FDA批准之前和之后提交的专利的患病率；已发布专利中存在的权利要求类型（即，化学成分,使用方法,过程或合成，配方，和递送装置)；和专利丛林密度(给定时间的有效专利数量)。
■2021年美国最畅销的10种处方药包括4种小分子药物和6种生物制剂。这10种药物与1429项专利和专利申请相关：742项（52%）已授权专利，218（15%）待决申请，469份(33%)放弃申请。近四分之三的专利申请（1028[72%]）是在FDA批准后提交的。生物制剂的批准后比例（80％）高于小分子药物（58％）。专利申请的批准后提交在FDA批准小分子药物后的前5年和FDA批准生物制剂后的12年达到顶峰。在FDA批准后申请的465项专利中，189人（41%）有使用方法的权利要求，127（27%）有配方索赔，103(22%)有工艺或合成要求，86(19%)有化学成分索赔，46(10%)有装置索赔。专利丛林密度在FDA批准13年后达到顶峰，当时这10种药物受到42(18-83)个活性专利的中位数(IQR)保护，其中66％是在FDA批准后提交的。
■这项研究发现，在2021年美国最畅销的10种处方药中，在FDA批准后提交的专利以及涵盖药物活性成分以外的其他方面的权利要求都促成了专利灌木丛。需要对专利申请和FDA批准后提交的专利进行审查，以促进及时的仿制药或生物仿制药竞争。
