Re: [問題] 基因DNA專利的問題想請教討論

看板Patent (專利)作者villalobos (做好徹底死去的覺悟)時間15年前 (2011/03/28 00:48)推噓1(1推 0噓 2→)

留言3則, 2人參與討論串3/3 (看更多)

※ 引述《kaikai1112 (骨髓捐贈match也是種緣份)》之銘言： : → skymien07:那麼抽取的技術or檢測方法等等...都不具專利性了 03/19 07:35 : → skymien07:引述car所說，藥物、抗體的製造的專利性反而比較大 03/19 07:37 : → skymien07:http://xian51020.pixnet.net/blog/post/25663225 03/19 07:39 : → skymien07:上面是我剛剛瀏覽到的美國醫學生物智財判例 : 感謝 S 大大分享的美國判例這個判例對 Gene Patent 造成了根本性的影響 : 再分享剛找到的美國專利界對較早的地院判例的一些看法 : (S 大大分享的是更新的聯邦法院 confirm 地院見解的判決) 剛好路過，看到了這個議題也想野人獻曝分享一下資訊。因為也對Myriad這個案子有興趣，我去查了一下聯邦巡迴上訴法院(CAFC)的網站 http://www.cafc.uscourts.gov/opinions-orders/search/report.html CAFC應"還沒有"確認地院的判決才對。目前全案還正由CAFC審理中。畢竟地院2010/4判決才出來，以CAFC龜速的審理，不太可能2010/6/14正式判決就出爐了...@@a Skymien07版友推文中所引用的智財判例，該篇作者所引用的法院見解其實是"地院"的見解(見第七頁)。 AMP v. USPTO地院判決全文可見: http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf (雖是簡易判決，但其實一點也不簡易，共一百五十二頁....0rz...) 另外，不知道版上先進是否已有分享過這個網站： http://www.patentdocs.org/federal_circuit/ 這是一個專利與生物、醫藥相關議題的部落格，文章都是由美國專利律師撰寫整理，非常詳實。有關AMP v. USPTO也可參考該部落格一連串的整理: http://www.patentdocs.org/2011/02/amp-v-uspto-briefing-update.html (統計了本案法院之友的立場，有趣的是贊成翻案的似乎還是多數說) 第一次造訪，若有重複或疏漏還請多多包涵。 : 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.” : ============================================================================ : 現在所有自然存在的基因都將被無效此一判決將會對生技專利帶來海嘯般的改變 : 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 以往認為由自然界狀態純化分離形式的基因是可以取得專利的 : 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" 法官認為 Myriad 公司只是辨識出人體中天然存在的事物 : 而 DNA 的比對過程也僅僅是 "人類心智過程的濃縮" 兩者皆不適於以專利保護 : “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. : ============================================================================ : 本案僅碰觸到 "基因相關專利" 是否適合准予專利 : 而未探討 Myriad 公司的成果是否符合新穎性或進步性等等其它專利要件 : “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. : ======================================================================== : "分離純化的基因" 與 "天然基因" 地位相同 : 是一個會對其他基因專利造成衝擊的法院見解 : 目前有 20% 的人類基因取得專利保護 : 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. : 本案當然會上訴至華盛頓法庭而且相當有可能會爭訟至最高法院 : Myriad 公司的股價在例行性會商後掉了 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 領域的著名公司) 的前顧問認為 : 此一判決會迫使研發人員採取例如將基因加以突變的其他手段(以迴避此一判決) : “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 指出此一判決將會傷害基因研發的投資意願 : "要為醫療疾病尋求解答是相當艱辛的但是抄襲沿用卻是很簡單的" : "我們不能只是依賴學術研究(來發展基因技術)" : "推動培育這個國家的育成廠商是我們的目標" : 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. : ============================================================================= : 今日的判決為 "什麼成果可以給專利什麼不行"之界線 : 這個長達數年的訴訟爭論劃下了里程 : 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. : 法官指出一旦此判決經過訴願法庭或最高法院確認之後 : USPTO 將會更改審查政策以因應此一判決 : 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)》之銘言： : : 專利版的各位好~ : : 由於最近正在準備"人類基因的可專利性"議題 : : 我的內容簡約如下 : : 蘊藏生命密碼的基因如果被申請專利 : : 其優點:可以鼓勵基因學術研究，驅策基因科學持續往前 : : 缺點:造成學術研究的壟斷，專利申請者有權去影響相關基因研究的進行 : : 而且涉及到商業利益，會造成濫用 : : ex:一家公司針對糖尿病的遺傳基因做出許多研究貢獻，並且取得研發出有效控制的藥物 : : 這間公司雖在糖尿病的遺傳基因研究成果豐碩，但也因專利造成其他研究學者，所能 : : 進行的方法與器材有限制、其技術也無法與該公司競爭。 : : 對於病患而言，該公司所生產的藥物雖然療效佳，卻因為昂貴的價格而造成許多人的 : : 不滿... : : 結論:DNA專利雖然可行，但由於企業之間的競爭，反而間接影響了基因研究的速度 : : 再者，成果應該符合大眾期待與需求 : : 對於DNA基因專利的審核，必須較其他專利更加嚴格以防止基因專利濫用 : : 因為資料很多，我只簡短打出我上述的小概念， : : 順便在這邊請教各位前輩我的觀念有沒有錯誤的地方(非法律本科系) : : 如果有其他基因專利的例子都可以拿來討論，讓我知道錯在哪?或哪裡需要補充? : : 謝謝不吝指教^^ -- -- ※ 發信站: 批踢踢實業坊(ptt.cc) ◆ From: 216.165.4.60