→ 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) 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^^ --

※ 发信站: 批踢踢实业坊(ptt.cc) ◆ From: 140.118.16.38 ※ 编辑: kaikai1112 来自: 140.118.16.38 (03/19 10:14) ※ kaikai1112:转录至看板 Biotech 03/19 14:51