Kesselheim Aaron S, Avorn Jerry
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass 02120, USA.
JAMA. 2005 Feb 16;293(7):850-4. doi: 10.1001/jama.293.7.850.
The pharmaceutical and biotechnology industries have long relied on patenting as the primary means of allocating ownership and control over new discoveries. Yet, patent protection is a double-edged sword that has major implications for the future of innovation in biomedical science in the United States. Excessive "upstream" patenting of genes and molecular targets could hinder further research by creating a need for expensive and inefficient cross-licensing. However, limiting such basic science patenting could allow private entities to use the results of years of costly publicly funded research to produce and market lucrative products without compensating university- or public sector-based innovators. Academic and other nonprofit research centers would, therefore, be deprived of revenue for pursuing novel therapeutics or other seminal research work that may not be patentable. Recent court cases illustrate the inherent conflicts in allocating ownership and control of basic biomedical discoveries. Several options exist to avoid the complex problems of overlapping basic science patents while still rewarding pivotal discoveries and encouraging further innovation. These include establishing basic science patent pools and mandating arbitration arrangements that would assign credit and royalties for biotechnology innovations that depend on prior research that was performed, financed, or both in the public sector.
长期以来，制药和生物技术行业一直依赖专利作为分配对新发现的所有权和控制权的主要手段。然而，专利保护是一把双刃剑，对美国生物医学科学创新的未来有着重大影响。对基因和分子靶点进行过度的“上游”专利申请可能会因需要进行昂贵且低效的交叉许可而阻碍进一步的研究。然而，限制此类基础科学专利申请可能会使私人实体能够利用多年来由公共资金资助的昂贵研究成果来生产和销售利润丰厚的产品，而无需向基于大学或公共部门的创新者提供补偿。因此，学术机构和其他非营利性研究中心将无法获得收入来开展可能无法获得专利的新型治疗方法或其他开创性研究工作。最近的法庭案件说明了在分配基础生物医学发现的所有权和控制权方面存在的内在冲突。有几种选择可以避免基础科学专利重叠的复杂问题，同时仍然奖励关键发现并鼓励进一步创新。这些选择包括建立基础科学专利池以及强制实施仲裁安排，以便为依赖于在公共部门进行、由公共部门资助或两者兼有的先前研究的生物技术创新分配荣誉和版税。
