美国已分离DNA分子可专利性之辩及启示

美国Myriad案是引发已分离DNA分子是否具有可专利性论争的重要案件。2011年，美国联邦巡回法院推翻纽约南区法院作出的一审判决，认定已分离DNA分子具有可专利性，这一裁判的根本性逆转更是激起利益各方的广泛关注和持久争辩。争辩中，对立双方往往忽略一个事实，即基因、天然DNA和已分离DNA三者内涵和外延不尽相同，应予以区分。因而，认为所有基因及DNA分子都不具有可专利性是不可取的，但不加区分地一律赋予授权资格同样毫无依据。判断已分离DNA分子的可专利性资格，重点应考量与天然DAN分子的组分差异，并采用多重标准综合判断。同时，应严格将科学发现排除在可专利性资格范围之外。

On Dispute over Patentability of Isolated DNA Molecules in the United States and Its Inspiration

The Myriad case, an important case in the United States, causes a dispute over patentability of isolated DNA molecules. In 2011, the Federal Circuit Court issued a verdict that isolated DNA molecules were patentable, which stirred up bitter and lasting controversy. Both sides of the controversy have neglected differences in the connotation and denotation of genes, natural DNA molecules and isolated DNA molecules. Therefore, it is not desirable to hold that no genes or DNA molecules are patentable and it is totally groundless to believe that all genes and DNA molecules are patentable. Special emphasis should be placed on the compositional differences with natural DNA molecules in the patentability evaluation of isolated DNA molecules. Meanwhile, scientific discoveries should be removed from the evaluation of patentability