※ 引述《kaikai1112 (骨髓捐赠match也是种缘份)》之铭言： : → skymien07:那麽抽取的技术or检测方法等等...都不具专利性了 03/19 07:35 : → skymien07:引述car所说，药物、抗体的制造的专利性反而比较大 03/19 07:37 : → skymien07:http://xian51020.pixnet.net/blog/post/25663225 03/19 07:39 : → skymien07:上面是我刚刚浏览到的美国医学生物智财判例 : 感谢 S 大大分享的美国判例 这个判例对 Gene Patent 造成了根本性的影响 : 再分享刚找到的 美国专利界对较早的地院判例的一些看法 : (S 大大分享的是 更新的 联邦法院 confirm 地院见解的判决) 刚好路过，看到了这个议题也想野人献曝分享一下资讯。 因为也对Myriad这个案子有兴趣， 我去查了一下联邦巡回上诉法院(CAFC)的网站 http://www.cafc.uscourts.gov/opinions-orders/search/report.html CAFC应"还没有"确认地院的判决才对。 目前全案还正由CAFC审理中。 毕竟地院2010/4判决才出来， 以CAFC龟速的审理，不太可能2010/6/14正式判决就出炉了...@@a Skymien07版友推文中所引用的智财判例， 该篇作者所引用的法院见解其实是"地院"的见解(见第七页)。 AMP v. USPTO地院判决全文可见: http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf (虽是简易判决，但其实一点也不简易，共一百五十二页....0rz...) 另外，不知道版上先进是否已有分享过这个网站： http://www.patentdocs.org/federal_circuit/ 这是一个专利与生物、医药相关议题的部落格，文章都是由美国专利律师撰写整理， 非常详实。 有关AMP v. USPTO也可参考该部落格一连串的整理: http://www.patentdocs.org/2011/02/amp-v-uspto-briefing-update.html (统计了本案法院之友的立场，有趣的是赞成翻案的似乎还是多数说) 第一次造访，若有重复或疏漏还请多多包涵。 : http://tinyurl.com/ydgjuow : Myriad Loses Ruling Over Breast Cancer-Gene Patents (Update3) : March 29, 2010, 8:20 PM EDT : By Susan Decker and Thom Weidlich : March 29 (Bloomberg) -- Myriad Genetics Inc. lost a U.S. court ruling over : its patents for a way to detect inherited breast cancer in a decision that : may lead to other challenges to gene-related patents. : U.S. District Judge Robert Sweet in New York ruled the patents invalid today, : saying they “are directed to a law of nature and were therefore improperly : granted.” The judge sided with the American Civil Liberties Union, which : sued on behalf of groups including the Association for Molecular Pathology : and American College of Medical Genetics. : “This is ground-breaking,” said Barbara Caulfield, a patent lawyer with : Dewey & LeBoeuf in Palo Alto, California, who submitted arguments against the : patents on behalf of the March of Dimes. “Now all naturally occurring gene : patents are invalid by the reasoning of this opinion. This is really a sea : change for patents in life sciences.” : ============================================================================ : 现在所有自然存在的基因都将被无效 此一判决将会对生技专利带来海啸般的改变 : Myriad makes a widely used test for detecting breast cancer. Medical groups : say Myriad’s tight control over use of the genes has discouraged scientists : from exploring other options for breast-cancer screening. The trade group for : biotechnology companies argued that the challenge to the Myriad patents may : hinder investment in research. : Patents aren’t allowed for rules of nature, natural phenomena or abstract : ideas, although the U.S. Patent and Trademark Office has said genes can be : patented if they are “isolated from their natural state and purified.” : ============================================================================ : USPTO 以往认为 由自然界状态纯化分离形式的基因 是可以取得专利的 : Gene Sequencing : Myriad, based in Salt Lake City, said its patents cover how to sequence the : gene to identify its components, and using that sequence to look for : mutations to determine if the woman has a higher risk of developing breast : cancer. The genes are known as BRCA1 and BRCA2. : Sweet said that Myriad simply identified something that occurred in the body, : and that the comparisons of DNA sequences are “abstract mental processes” : and neither are eligible for patent protection. : ============================================================================= : "甜美" 法官认为 Myriad 公司只是辨识出人体中天然存在的事物 : 而 DNA 的比对过程 也仅仅是 "人类心智过程的浓缩" 两者皆不适於以专利保护 : “The identification of the BRCA1 and BRCA2 gene sequences is unquestionably : a valuable scientific achievement for which Myriad deserves recognition, but : that is not the same as concluding that it is something for which they are : entitled to a patent,” Sweet ruled. : Patent Eligibility : The case hinged on the baseline question of whether certain gene-related : inventions were eligible for patent protection and didn’t look further into : the specifics of whether Myriad’s work met other criteria for a patent, such : as that it was novel or non-obvious. : ============================================================================ : 本案仅碰触到 "基因相关专利" 是否适合准予专利 : 而未探讨 Myriad 公司的成果是否符合 新颖性或进步性等等 其它专利要件 : “The principal that an isolated gene is the same as a gene is a broad : principal and may have an impact on other gene patents,” said Christopher : Hansen, a lawyer for the ACLU, who said he was “delighted” with the : decision. Hansen said about 20 percent of human genes are patented. : ======================================================================== : "分离纯化的基因" 与 "天然基因" 地位相同 : 是一个会对其他基因专利造成冲击的 法院见解 : 目前有 20% 的人类基因取得专利保护 : The case is sure to be appealed to a court in Washington that specializes in : patent law, and most likely to the Supreme Court. Officials with Myriad didn’ : t immediately return queries seeking comment. Myriad dropped as much as 12 : percent after the close of regular trading. The shares were down 23 cents to : $24.90 on the Nasdaq Stock Market before Sweet released his opinion. : 本案当然会上诉至华盛顿法庭 而且相当有可能会争讼至最高法院 : Myriad 公司的股价 在例行性会商 後掉了 12% : The patents “consist essentially of looking at genes,” the groups : challenging Myriad said in a filing. The groups contend the patents inhibit : testing and limit women’s options in medical care. The case has been closely : watched by the biotechnology industry and various medical groups. : Alternative Tests : Caulfield, who is former general counsel for Affymetrix Inc., which makes : instruments to analyze genes, said the ruling, if upheld on appeal, would : spur research into alternative tests, such as for new mutations of genes. : ========================================================================== : Caulfield, Affymetrix Inc. (gene chip 领域的着名公司) 的前顾问认为 : 此一判决 会迫使研发人员 采取例如将基因加以突变的其他手段(以回避此一判决) : “If people want to own a gene, they can create them synthetically,” said : Caulfield. “You can own a synthetic creation of a gene, but you can’t : create one that’s naturally occurring or the test for it. If you had a : particular test that did a search for mutations plus genes, you could patent : the test, just not the simple comparison.” : Edward Reines of Weil Gotshal in Silicon Valley, who represents biotechnology : companies, disagreed and said it could hurt investment into genetic research. : “So much of the area of genetic discovery requires people working hard,” he : said. “It’s hard to find a genetic solution to a health problem, but it’s : easy to copy. You can’t rely on academic curiosity. Motivating incubators : around this country is something we want to do.” : ============================================================================= : 生技公司代表 Edward Reines 指出 此一判决 将会伤害基因研发的投资意愿 : "要为医疗疾病寻求解答 是相当艰辛的 但是抄袭沿用却是很简单的" : "我们不能只是依赖学术研究(来发展基因技术)" : "推动培育这个国家的育成厂商是我们的目标" : Years of Litigation : He said today’s decision sets the stage for years of litigation to determine : where the line is between what’s eligible for patents and what is not. : ============================================================================= : 今日的判决 为 "什麽成果可以给专利 什麽不行"之界线 : 这个长达数年的诉讼争论 划下了里程 : In granting the patents, the PTO went beyond what was allowed in a 1980 : Supreme Court decision credited with opening up the biotechnology industry, : ACLU said in court filings. It has the support of the American Medical : Association and the American Society for Human Genetics. : Biotechnology Industry Organization, the trade group of biotech companies : that supported Myriad in the case, is reviewing the decision, Stephanie : Fischer, a spokeswoman for the group, said. : The judge did throw out claims that the patent office acted outside its : authority in granting the patents. The judge said that, were an appeals court : or the Supreme Court affirm his decision, the patent office would “conform : its examination policies” to the court rulings. : 法官指出 一旦此判决经过诉愿法庭或最高法院确认之後 : USPTO 将会更改审查政策以因应此一判决 : The case is Association for Molecular Pathology v. U.S. Patent and Trademark : Office, 09cv4515, U.S. District Court for the District of New York. : ※ 引述《skymien07 (平常心)》之铭言： : : 专利版的各位好~ : : 由於最近正在准备"人类基因的可专利性"议题 : : 我的内容简约如下 : : 蕴藏生命密码的基因如果被申请专利 : : 其优点:可以鼓励基因学术研究，驱策基因科学持续往前 : : 缺点:造成学术研究的垄断，专利申请者有权去影响相关基因研究的进行 : : 而且涉及到商业利益，会造成滥用 : : ex:一家公司针对糖尿病的遗传基因做出许多研究贡献，并且取得研发出有效控制的药物 : : 这间公司虽在糖尿病的遗传基因研究成果丰硕，但也因专利造成其他研究学者，所能 : : 进行的方法与器材有限制、其技术也无法与该公司竞争。 : : 对於病患而言，该公司所生产的药物虽然疗效佳，却因为昂贵的价格而造成许多人的 : : 不满... : : 结论:DNA专利虽然可行，但由於企业之间的竞争，反而间接影响了基因研究的速度 : : 再者，成果应该符合大众期待与需求 : : 对於DNA基因专利的审核，必须较其他专利更加严格以防止基因专利滥用 : : 因为资料很多，我只简短打出我上述的小概念， : : 顺便在这边请教各位前辈我的观念有没有错误的地方(非法律本科系) : : 如果有其他基因专利的例子都可以拿来讨论，让我知道错在哪?或哪里需要补充? : : 谢谢不吝指教^^ -- --

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