专利和产品:立法改革的挑战和机遇
1Brigham and Women's Hospital and Harvard Medical School.
概括
品牌制药公司使用专利和产品来推迟仿制药的竞争. 需要进行改革来限制这些专利游戏,特别是复杂的药物设备组合,以确保及时获得负担得起的药物.
科学领域:
- 制药行业 制药行业 制药行业
- 知识产权法 知识产权法
- 医疗保健政策 医疗保健政策
背景情况:
- 品牌制药制造商利用专利和产品等策略来扩大市场独家权并限制仿制药的竞争.
- 这些策略特别适用于药物设备组合,如吸入器和特定糖尿病药物,使通用药物进入市场变得复杂.
- 现有的立法努力旨在加快仿制药竞争,但需要进一步改革,以解决普遍的专利"游戏技巧".
研究的目的:
- 分析专利杂和产品杂对仿制药竞争的影响.
- 评估当前立法提案在促进及时通用药物进入方面的有效性.
- 提出进一步的改革,以制制制药行业的反竞争专利做法.
主要方法:
- 分析品牌制药公司采用的专利策略.
- 审查有关制药专利改革的立法行动和提案.
- 检查仿制药批准的挑战,特别是复杂的药物设备组合.
主要成果:
- 专利 (对外设特征的众多专利) 和产品 (新专利的重制) 有效地推迟了通用竞争.
- 药物设备组合特别容易受到这些延迟策略的影响,扩大市场独家权.
- 目前的立法努力是向前迈出的一步,但不足以完全解决这个问题.
结论:
- 进一步的改革至关重要,以限制制药专利的游戏技巧,并促进及时的仿制药竞争.
- 建议包括USPTO对专利进行重新审查,加强FDA监督,限制侵权诉讼,加强对专利挑战的激励,并增加FDA对复杂仿制药的灵活性.
- 实施这些改革可以为患者提供更容易获得和负担得起的药物.
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