声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。美国联邦贸易委员会（Federal Trade Commission，简称FTC）日前向制药行业的“垃圾专利（Junk Patents）”开火，火力焦点集中在20种关系民生问题的药物，针对哮喘、慢性阻塞性肺炎、糖尿病和肥胖症等疾病，包括当下大红大紫的Ozempic。美国联邦贸易委员会（Federal Trade Commission，简称FTC）是美国政府的一个独立机构，成立于1914年，其主要任务是维护和促进市场竞争，保护消费者免受不公平或欺诈性商业行为的侵害。FTC负责执行一系列法律，包括《联邦贸易委员会法》和《不公平或欺诈性行为禁止法》等，确保企业遵守公平竞争和消费者权益保护的规定。FTC也负责监督反垄断法律的实施，处理反垄断调查和诉讼。面对专利丛林所导致的药价居高不下的情况，美国联邦贸易委员会此番扩大了针对制药公司提交所谓“垃圾”专利清单的行动。此举是美国政府遏制制药行业涉嫌滥用专利行为的一部分。制药公司花样翻新地设置的专利壁垒阻碍的仿制药的入市，使得受到专利荫护的品牌药物可以恣意享受价格鸿利。FTC向 10 家制药公司发出了警告信，对“橙皮书”登记册的 300 多项专利提出异议。“橙皮书”登记册由FDA维护，对于维护正当的产品竞争意义重大，可以指导仿制药公司查询品牌公司所主张的药品专利。FTC此举是受Hatch-Waxman Act（又称《药品价格竞争与专利期补偿法案》）所支持的，这项法案用于解决专利侵权问题，并最终帮助仿制药公司能够在美国销售其产品。FTC宣称，一些品牌药品公司在橙皮书中列出了专利，但没有正确声明某些关键信息，例如原料药或药物使用方法，而且品牌制药商在橙皮书中“无中生有“地列出了大量额外专利，推迟了仿制药的批准。近年来，品牌药制药公司通过法律杠杆阻碍仿制药入市的情况俯仰皆是。仿制药制造商也可以根据Hatch-Waxman Act挑战橙皮书专利清单。如果挑战成功，该法案将授予仿制药制造商短暂的独占权，从而将其产品先于其他仿制药投放市场。如果遭到了来自于品牌药制造商的起诉，FDA也可以推行“30个月内禁止批准仿制药”的条款。30个月对于某些重磅炸弹级别的药物来说意味着至少25亿美元的销售额（每年10亿美元）。因此品牌商理论上可以有恃无恐地通过“假摔”的方式获利。面对品牌药通过不合理专利诉求打压仿制药入市的现象，FTC已于去年 11 月开始向一些品牌制药公司发出警告，罪状包括他们未能列出哮喘吸入器和肾上腺素自动注射器专利。当时收到警告的公司包括艾伯维、阿斯利康、Mylan Specialty、勃林格殷格翰、葛兰素史克和梯瓦的子公司。葛兰素史克、Kaleo 和 Impax Labs 三家公司遵守了FTC 的警告，从橙皮书中移除了各自涉事产品的无效专利。但也有五家公司拒绝了FTC的指控。阿斯利康今年 2 月对FTC 作出回应，称该机构所质疑的一些所谓的“垃圾专利“有助于仿制药制药制造商更好地“了解他们需要应对的知识产权格局”。AZ称其专利“合法”，并表示至少一种其药物的仿制药竞争对手已进入市场。梯瓦制药也表示，它不会利用专利列表来“抑制竞争、延长垄断或哄抬患者价格”。梯瓦还认为，橙皮书专利清单“本质上是有利于竞争的”，也是“法律和监管环境的一个关键方面”。然而2022年的研究发现，一些公司不仅仅在吸入器内部药物上获得了专利，还在吸入器设备本身上获得了专利。它们将旧的有效成分填充进新的吸入器，或者将有效成分从一个吸入器转移到另一个吸入器，并在获得批准后通过监管机构获得了新的专利和独家权利。极端的案例导致了某些专利被延长了28年。在最新的一波的行动中，FTC再次向勃林格殷格翰、梯瓦、阿斯利康和葛兰素史克子公司签署了警告信。除此之外，诺和诺德、Amphastar Pharmaceuticals、Norton、Covis Pharma 和诺华也位列其中。而最近发表的一项研究发现，超过一半糖尿病注射笔专利隐藏了几个重要特征，本来不应该被列入橙皮书之中。FTC表示，此次罗列的问题专利是“虚假”的，因为它们与所销售的药物无关，例如诺和诺德糖尿病药物 Victoza 的注射“按钮”或 Ozempic 的“带有扭力弹簧和可旋转显示器的注射装置”。制药公司有 30 天的时间删除或修改其专利列表，或证明这些列表符合监管要求，否则将受到伪证处罚。一位FTC官员表态，他们正在讨论那些无视警告信且没有删除其专利的行为，并将采取进一步的行动，“联邦贸易委员会不会发出空洞的威胁”。FTC的2024年最新警告信涉及了当前火热的Ozempic，但分析师认为，此举对于诺和诺德的影响甚小。因为对于Ozempic来说，其有效成分的专利可以支持他们在2032年之前享有市场独占，FTC并未针对semaglutide的有效成分专利进行警告。FTC需要防止的是专利到期后不合理的续血沿寿。因此Ozempic的市场独占目前不会受到挑战和影响。Ref.Silverman, E. Diabetes treatments have improperly listed patents that should be removed, analysis finds. STAT. 05. 02. 2024.Silverman, E. Drugmakers use monopoly tactics to thwart lower-cost generic competition for inhalers, analysis finds. STAT. 17. 05. 2022.Roush, T. FTC Warns ‘Junk Patents’ Could Make Drugs Like Ozempic Pricier—Here’s How. Forbes. 30. 04. 2024.Whyte, L. E. FTC Targets ‘Junk’ Patent Listings on Ozempic and Other Drugs. WSJ. 30. 04. 2024.-END-药事纵横投稿须知：稿费已上调，欢迎投稿各位朋友好，觉得本文对您有帮助，请随手点一下下方的在看，以便让你的朋友也能看到哦。

专利侵权

2024-05-01

·FiercePharma

FTC targets Novo's Ozempic, others in crackdown on 300-plus 'junk' patent listings in FDA database

Federal Trade Commission Chair Lina Khan argued that pharma companies are using "bogus patent listings" in the FDA Orange Book to "block competition and inflate the cost of prescription drugs." The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. After an initial round of challenges launched in November against more than 100 patents by nine drugmakers, the FTC is back targeting another 300-plus patent listings by eight pharma firms in the FDA’s Orange Book. The FTC argues those patents for altogether 20 brand-name products are “junk” listings that could be used by pharma companies to stymie competition and inflate drug prices. AstraZeneca, Boehringer Ingelheim, GSK and Teva once again found themselves in the crosshairs of the U.S. antitrust watchdog. But the most high-profile products involved in this wave of disputes, as spelled out by the FTC, are perhaps Novo Nordisk’s GLP-1 drugs Ozempic, Saxenda and Victoza. In response to a Fierce Pharma request for comment, Novo said it’s reviewing the warning letter received from the FTC. The antitrust agency in a Tuesday release mistakenly identified Ozempic as a weight loss drug when it’s only approved by the FDA to control Type 2 diabetes. Novo’s Wegovy, which contains the same GLP-1 receptor agonist semaglutide as Ozempic, is approved for obesity. The two brands, while both coming in an injectable pen administered weekly, are available in different maintenance dose strengths. The FDA Orange Book records branded drug patents that serve as reference for generic drug developers. The FTC argued that by putting up sham patents, biopharma companies have exploited a policy that blocks the FDA from approving a generic drug for 30 months if an originator timely files an infringement lawsuit against a generic over a patent listed in the Orange Book. The FTC first warned in September that it would scrutinize improperly listed drug patents in the FDA database. Then, in November, it challenged more than 100 patents for several drug products that deploys special delivery devices, such as an inhaler or an injector. In response, GSK, Amneal’s Impax Laboratories and Kaleo have delisted some patents. GSK also voluntarily removed certain patents that were not challenged by the FTC. Earlier this year, Boehringer Ingelheim, AZ and GSK all committed to capping their inhalers’ monthly out-of-pocket costs at $35. This time around, the FTC is once again eyeing some drug-device combos. Besides the Novo drugs, AstraZeneca’s Bydureon pen for diabetes is also part of the FTC’s challenge. Four GSK inhalers using the Ellipta device, such as the chronic obstructive pulmonary disease and asthma therapies Breo and Trelegy, were included. A GSK spokesperson confirmed receipt of the new warning letter and said the company will do its own analysis as the law requires. Previously, GSK retracted four of five patents flagged by the FTC from the Orange Book back in November. “Once complete, we will respond to the FDA and FTC in accordance with the FDA’s process,” the GSK spokesperson said of the latest review. For Novartis, its COPD drugs Seebri and Utibron landed on the FTC’s radar. Boehringer saw patents for its Striverdi and Stiolto inhalations using the Respimat technology under the agency’s microscope. In a statement shared with Fierce Pharma, Boehringer said it has “never wrongfully submitted patents for listing in the Orange Book—not for any of our inhaler products or any other products in our portfolio.” The company believes its patents in the FDA database are “valid, enforceable and properly listed.” “Drug-and-device combination products are complex and costly to develop and manufacture, and we file patents to protect our investment in innovations like these that benefit people and improve their lives.” Teva had the most patents implicated among the drugmakers, with about 60 patents targeted across five brands using the Respiclick, Digihaler or Redihaler platforms between it and its Norton Waterford subsidiary. The company did not immediately reply to a request for comment. Covis Pharma and Amphastar Pharmaceuticals round out the eight companies, The FTC is currently challenging the patents under the FDA’s regulatory dispute process, but the antitrust agency warned that it retains the right to take any further action. The FTC has yet to bring any additional sanctions against companies that have refused to remove patents in the agency’s first round of scrutiny.