|
|
|
| Analysis of the Justification for Gene Patent and Its Substantial Requirements in Patent Examination of America with the Myriad Case as Exemple |
| CAO Li-rong |
| School of Intellectual Property, East China University of Politics and Law, Shanghai 201620, China |
|
|
|
Abstract In regard to the nature of the patent law, the aim of gene patent is to promote the gene research and its related technological innovation as well. However, the issue of gene patent has been controversial since its advent. Especially,The Myriad patents have prompted strong reaction in the jurisdiction of America, Europe as well as Australia. It is not uncommon that the 2011 Myriad case in America then brought about different points of view concerning the isolated DNA sequence. The district court held that Myriad’s composition claims to "isolated" DNA molecules cover patent-ineligible products of nature under §101 since the molecules as claimed do not exist in nature. However United States Court of Appeals Federal Circuit reversed the district court’s decision and held that isolated DNA molecules qualified as patentable subject matter because the claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or compositon of matter——a product of human ingenuity "having a distinctive name, character and use". But it still reflects a state of uncertainty on patentability of isolated DNA. This paper then justifies gene patent and analyzes substantial requirements of gene patent in patent examination of America.
|
|
Received: 08 October 2012
Published: 25 January 2013
|
|
|
|
|
[1] 张靖,张平.基因测试机构的垄断:BRCA1与BRCA2基因专利的命运.科技与法律,2010,88(6):10-14. Zhang J, Zhang P.Science Technology and Law.2010,88(6):10-14.
[2] 耿卓.知识产权发展新趋势:对研发投资保护的加强——以生物技术研究中投资的专利法保护为例.电子知识产权,2009,7:42-45. GengZh.Electronics Intellectual Property,2009,7:42-45.
[3] Adriane S. Uncommon genes unpatentable subject matter. Seattle University Law Review. 2011, 34: 909-934.
[4] 赵雷.美国2011年专利法第一案Myriad案评——人类基因可专利性的再思考.知识产权, 2012, 6: 89-95. Zhao L. A Review of the Top1 U.S.Patent Case in 2011:Rethinking the Patentability of Human Gene.Intellectual Property,2012, 6: 89-95.
[5] Gregory C. Ellis emerging biotechnologies demand defeat of proposed legislation that attempts to ban gene patents. Richmond Journal of Law & Technology, 2008, XV (1), available at: http://jolt.richmond.edu/v15i1/article1.pdf
[6] Kali M, Esther van zimmeren Dynamic patent governance in Europe and The United States: The Myriad example. Cardozo Journal of International and Comparative Law, 2011, 19: 287-341.
[7] Stephen H. Schilling DNA as patentable subject matter and a narrow framework for addressing the perceived problems caused by gene patent. Duke Law Jaurnal. 2011, 12(61): 731-773.
[8] 郑胜利,刘江彬译著.Martin J A, Randall R R, Gordon P.Klancnik, 译者.美国专利法. 知识产权出版社, 2011.
[9] 祁志.打开基因技术专利之门的案例——对Diamond v. Chakrabarty案的剖析. 《医学与哲学(人文社会医学版)》,2006,6:51-55. Qi Zh.The Case of Opening the Door for Gene-related Technologies: analysis of the case "Diamond v. Chakrabarty".Medicine and Philosophy( Humanistic & Social Medicine Edition),2006,6:51-55.
[10] Eighth Edition.Manual of Patent Examining Procedure (MPEP). http://www.uspto.gov/web/offices/pac/mpep/index.htm.
[11] Utility Examination Guidelines,http://law.shu.edu/Students/academics/journals/law-review/Issues/archives/upload/Esoy.pdf
[12] Carolina R R. Promoters Used to Regulate Gene Expression http://www.cambia.org/daisy/promoters/3141/version/default/part/AttachmentData/data/patentlens_techlandscape_promoters.pdf
[13] 张向东,张晨.在华制药领域专利技术资源竞争——美国制药企业专利资源竞争比较及其启示.中国软科学, 2006, 5:63-72. Zhang Q D, Zhang Ch.Patent Technology Resource Competition between US Drug Companies’ in China:An Empirical Comparison and Its Implications.China Soft Science,2006, 5:63-72.
[14] Steven M P, Daniel S M, Christopher T,et al. How to improve R&D productivity: The pharmaceutical Industry's grand challenge. Nature Reviews Drug Discovery, 2010, 9:203-214.
[15] Larry A R, Myriad: How Did Public Policy Weigh In?, Intell. Prop. Strategist, 2010, 5: 1-5.
[16] SACGHS Statement to the Secretary’s Advisory Committee on Genetics, Health and Society. http://www.cap.org/apps/docs/advocacy/comments/SACGHS_comments_gene_patents.pdf.
[17] Mich. T,Tech. L R.Wolrad Prinz zu Waldeck und Pyrmont, Research Tool Patents After Integra v. Merck - Have They Reached a Safe Harbor. 2008, 14: 367- 372.
[18] Christopher M. Holman, Gene Patents Under Fire: Weighing the Costs and Benefits. http://papers.ssrn.com/sol3/papers.cfm.abstract_id=1710150.
[19] Martin L. Katz, Lisa V. Mueller, Mark Polyakov & Steven F. Weinstock, Where Have All the Antibiotic Patents Gone?, Nature Biotechnology. 2006, 24:1529.
[20] Arti K R, Jerome H R, Paul F. Uhlir & Colin Crossman, Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery, Yale J. Health Policy L. & Ethics, 2008, 8(1): 53-89.
[21] Subhashini C, Sapna K, Cory M. Valley & Arti Rai. Proprietary science, open science, and the role of patent disclosure: the case of Zinc-Finger proteins, 27 Nature Biotechnology, 2009, 27:140-144.
[22] Dov G. New rules, different risk: The changing freedom to operate analysis for Biotechnology. North Carolina Journal of Law & Technology, 2010, 11:139-160.
[23] Yusuke H. Problems regarding the patentability of genomics and scope of protection of ESTs in Japan, CASRIP Newsletter, Winter 2000 at 17. |
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
| |
Shared |
|
|
|
|
| |
Discussed |
|
|
|
|
