基因DNA專利的問題想請教討論 - 專利

※ 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^^

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