岗位必读建议：

• RA（注册专员）：负责理解专利提交和上市审批流程，确保公司遵守FDA规定。
• R&D（研发部门）：需要明白专利要求，以指导新药研发过程中的专利策略。
• Legal（法务部门）：必须理解文件内容，以处理专利相关的法律事务和策略。
• QA/QC（质量保证/控制部门）：需要了解法规要求，确保产品质量符合FDA标准。

工作建议：

• RA：审查现有和新提交的NDA，确保专利信息符合FDA的最新要求。
• R&D：在药物开发早期就考虑专利要求，规划研发路径避开专利障碍。
• Legal：为公司提供专利策略咨询，处理可能出现的专利纠纷。
• QA/QC：确保产品开发和生产过程中遵循FDA的专利和上市要求。

适用范围：
本文适用于化学药和生物制品的新药申请（NDA）以及简化新药申请（ANDA和505(b)(2)申请），由美国食品药品监督管理局（FDA）发布，适用于Biotech、大型药企、跨国药企以及CRO和CDMO等各类企业。

要点总结：

1. 专利提交和上市审批流程：明确了新药申请时必须提交的专利类型，包括药物成分、药物产品和使用方法，以及不得提交的专利类型，如包装、代谢产物和中间体专利。
2. 专利声明要求：规定了NDA申请者必须提供的专利声明内容，以及如何证明所提交的专利符合要求。
3. 30个月延迟审批的规定：解释了在ANDA或505(b)(2)申请中，如果申请者证明专利无效或不会侵权，FDA不能在30个月内批准该申请的流程。
4. 专利信息提交要求：要求申请者在NDA或补充文件中提交专利信息，并在FDA批准后30天内提交更新的专利信息。
5. 多次30个月延迟的限制：规定了每个ANDA和505(b)(2)申请只能有一次30个月的延迟审批机会。

以上仅为部分要点，请阅读原文，深入理解监管要求。

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:

1. 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.

2. 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.

3. 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.

4. Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.

5. 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.