由于REMS体系是从2007年FDAAA颁布时才开始出现的，而且设计REMS规定的大品种数量有限，所以到目前为止，在获取参比制剂的问题上打官司的案件只有7起，其中最著名的就是Celgene的沙利度胺（反应停）。由于沙利度胺有可能导致严重的胎儿致畸，1998年FDA批准时就严格限制了该产品的流通渠道（当时还没有REMS体系，之一计划被称为STEPS，System for Thalidomide Education and Prescribing Safety），STEPS也限制了仿制药公司从其他渠道获取参比制剂，2008年Lannet公司尝试从Celgene购买参比制剂失败后将它告上法庭，起诉Celgene滥用安全限制要求来阻碍仿制药厂获取参比制剂，以强迫消费者支付垄断的高昂价格，Celgene反诉被驳回后不久，案子就以双方和解结束。【案例详情内容可查看[pdf] 】
和FDA一样，对于原研药公司利用REMS阻拦仿制药厂获取参比制剂的情况，国会的进展也是“雷声大雨点小”。两党议员都对这个问题表示了关注而且提出了两部建议的法案：FAST法案（Fair Access for Safe and Timely Generics Act of 20157）和CREATS法案（Creating and Restoring Equal Access To Equivalent Samples Act of 20178）。它们分别是由俄亥俄州共和党议员Stiver Steve和佛蒙特州民主党议员Laehy Patrick Joseph在2015年和2017年提出的。但是这两部建议法案自从提交到现在暂时还没有被国会考虑，仍处在法案推介阶段。
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
Mandatory Reading:
Regulatory Affairs (Reg)
Intellectual Property (IP)
Quality Assurance (QA)
Legal Department
Work Suggestions:
Reg: Ensure the company's drug applications comply with the new drug application procedures and bioequivalence standards.
IP: Monitor patent term extensions and the impact on the company's patent strategy.
QA: Verify that manufacturing processes meet the identity, strength, quality, and purity requirements.
Legal Department: Advise on patent infringement issues and the legal implications of abbreviated new drug applications.
Scope of Application: The Drug Price Competition and Patent Term Restoration Act of 1984 applies to chemical drugs, including new molecular entities and generic drugs, in the United States. It is intended for regulatory bodies, pharmaceutical companies, and legal entities involved in drug development and approval processes.
Key Points Summary:
Abbreviated New Drug Applications (ANDAs): The Act allows for the streamlined approval of generic drugs by submitting abbreviated applications showing bioequivalence to the listed drug, without repeating costly and time-consuming clinical trials.
Patent Term Restoration: Offers a mechanism to extend the effective patent life of a drug to partially compensate for the time lost during the regulatory review process, up to a maximum of five years.
Data Exclusivity: Provides a period of data exclusivity, during which the FDA cannot approve ANDAs for other companies that rely on the innovator's safety and efficacy data.
Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.
Regulatory Review Period: Defines the regulatory review period for calculating patent term extensions and sets rules for due diligence during the application process.
Conclusion: The Drug Price Competition and Patent Term Restoration Act of 1984 is a landmark legislation that balances the need for accessible, affordable medications with the incentive for innovation. It has significantly impacted the pharmaceutical industry by fostering competition and ensuring that both innovator and generic drug companies have clear pathways to market. The above points are not exhaustive; for comprehensive understanding, the full text of the Act should be consulted.
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