主题：【原创】《Next》与基因研究 -- 淮夷

回看文章同学。

谢谢你的回复。你说的对，因为基因专利而不允许研究大概很少见。今天跟一个前从事生物学研究的同事聊了一下。即便是有专利的基因通常也会给以研究为目的的使用一个free license。但潜在的问题是一旦研究出成果而要付诸商业用途呢？是不是要向基因的专利权人得到新的许可和支付费用呢？支付多少是合理的呢？

下面是google来的关于基因专利的一个描述，不知道是不是还up to date.

USPTO has issued a few patents for gene fragments. Full sequence and function often are not known for gene fragments. On pending applications, their utility has been identified by such vague definitions as providing scientific probes to help find a gene or another EST or to help map a chromosome. Questions have arisen over the issue of when, from discovery to development into useful products, exclusive right to genes could be claimed.

The 300- to 500-base gene fragments, called expressed sequence tags (ESTs), represent only 10 to 30% of the average cDNA, and the genomic genes are often 10 to 20 times larger than the cDNA. A cDNA molecule is a laboratory-made version of a gene that contains only its information-rich (exon) regions; these molecules provide a way for genome researchers to fast-forward through the genome to biologically important areas. The original chromosomal locations and biological functions of the full genes identified by ESTs are unknown in most cases.

Patent applications for such gene fragments have sparked controversy among scientists, many of whom have urged the USPTO not to grant broad patents in this early stage of human genome research to applicants who have neither characterized the genes nor determined their functions and uses.

In December 1999, the USPTO issued stiffer interim guidelines (made final in January 2001) stating that more usefulness—specifically how the product functions in nature—must now be shown before gene fragments are considered patentable. The new rules call for "specific and substantial utility that is credible," but some still feel the rules are too lax.

The patenting of gene fragments is controversial. Some say that patenting such discoveries is inappropriate because the effort to find any given EST is small compared with the work of isolating and characterizing a gene and gene product, finding out what it does, and developing a commercial product. They feel that allowing holders of such "gatekeeper" patents to exercise undue control over the commercial fruits of genome research would be unfair. Similarly, allowing multiple patents on different parts of the same genome sequence --say on a gene fragment, the gene, and the protein-- adds undue costs to the researcher who wants to examine the sequence. Not only does the researcher have to pay each patent holder via licensing for the opportunity to study the sequence, he also has to pay his own staff to research the different patents and determine which are applicable to the area of the genome he wants to study.

source: http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml

最近有一个诉讼 (见 http://www.aclu.org/freespeech/gen/brca.html)，原告要求法院裁定针对两个有关breast and overian cancer的基因专利无效. 诉讼起因是一个叫Myriad Genetics的公司因为拥有对这两个基因的专利，从而是全美唯一有权做breast and overian cancer diagnostic testing的机构。而其他研究机构不能测试这些基因，也无法开发出替代测试方法。Myriad的对这些基因的垄断不但使得患者必须支付巨额费用而且被剥夺了听取second opinion的权利。希望这个case的发展会给基因专利权的法律问题带来突破。话说回来，我们对美国的法院似乎是不应该抱有太大希望的 - 即使这个案子comes out favorable to the plaitiffs, 法官很有可能会narrowlly apply the facts and limits its precedential value.