Source: http://etheses.lib.ntust.edu.tw/cgi-bin/gs32/gsweb.cgi?o=dstdcdr&s=id=%22G0M10424010%22.&searchmode=basic
Timestamp: 2019-04-25 06:14:26+00:00

Document:
Biotechnology industry is a technology-intensive industry and R & D investment is high in this field. If the R & D results were copied, the fund would go down the drain. Therefore, the patent protection can be described as the lifeblood of the biotechnology industry. In Taiwan, many biotechnology patents were rejected due to the lack of full, clear and sufficient disclosure. The development process of Taiwanese paten law is shorter than the U.S., the accumulated relevant judgments are not as many as the U.S. This thesis studies the development history of the U.S. biotechnology disclosure requirements, comparing Taiwanese Patent Act and judgments with the U.S. Patent Act and judgments, and gives some advices. The biotechnological patents categories of the research include technologies derived from molecular biology such as recombinant DNA, antisense RNA technology, gene regulation technology, analogues of proteins, and antibodies, etc. This thesis aims to sort out the information of rejection reasons for the application of patent and the reasons for the patent invalidity decision made by the court.
In the study of the U.S. Patent Act and American judgment research, the U.S. Patent Act is a statutory law, the United States judgments is case law. This thesis sorts out the U.S. important judgments in respect of biotechnology Patent disclosure requirements, to understand evolution of the first paragraph of the U.S. Patent Act Article 112, which regulates disclosure requirements, and how the disclosure requirements impact of biotechnology patent. This thesis focuses on both "written description requirement" and "enablement requirement." In the study of Taiwanese Patent Act and judgments, the thesis focuses on actual situation field. This thesis sorts out Taiwanese important judgments in respect of biotechnology patent disclosure requirements, Patent Act Article 26 and Taiwanese Examination Guidelines.
According to this thesis, the developments of the U.S. and Taiwanese Patent Act are different. The provisions of Taiwanese Patent Act in respect to disclosure requirements describe in the Patent Act Article 26 first and second paragraph. In the early days, The U.S. patent specifications only had a description without claims. The functions of description not only made inventions “enablement” but also defined the scope of application, thus led to the development of “written description.” The provisions of Taiwanese and U.S. Patent Act in respect to “enablement” are similar. But Taiwanese scholars have many different views about whether Taiwanese Patent Act has connotation about “written description.” After the study on the Taiwanese Patent Act, Examination Guidelines on patent, and the verdicts, the viewpoint of this thesis is that Taiwanese Patent Act article 26 Article first and second paragraph both have connotation about “written description”.
Some Taiwanese and U.S. provisions in respect to disclosure requirements are similar and some are various. There are many differences between the judgments of the Taiwanese and U.S. courts, in some cases, this thesis considers certain judgments of Taiwanese courts are more stringent than judgments of U.S. courts. For example, because the criteria for requirements of excessive experimentation is more stringent in Taiwan, it is suggested that detailed experimental parameters should be provided, and it is better to provide storage when the invention relates to biological materials.
經濟部生技醫藥產業發展推動小組. 生物技術產業單一窗口. 2017 6/3 2017 [cited 2017 6/3].
世界衛生組織. [4/30] 2017; Available from: http://www.who.int/en/.
2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, para. 1, “Written Description” Requirement [R-07.2015].
Biotechnology Patent & Business Strategies, 718 PLI/PAT. 155, 164 (2002).
Cantor, A.E., Using the Written Description and Enablement Requirements to Limit Biotechnology Patents. Harv. JL & Tech., 2000. 14: p. 267.
Donner, I.H., Patent prosecution: law, practice, and procedure. 2007: BNA Books.
Grubb Philip, W., Patents for Chemicals, Pharmaceuticals and Biotechnology. Oxford. DECISIÓN DIAMOND V. CHAKRABARTY, 1999. 447: p. 79-136.
Infectious clones of RNA viruses and vaccines and diagnostic assays derived thereof.
Lodish, H., Molecular cell biology. 2008: Macmillan.
Sampson, M., The evolution of the enablement and written description requirements under 35 USC § 112 in the area of biotechnology. Berkeley Technology Law Journal, 2000: p. 1233-1274.
Stolpa, J.C., Toward Aligning the Law with Biology-The Federal Circuit's about Face in Enzo Biochem, Inc. v. Gen-Probe, Inc. Minn. Intell. Prop. Rev., 2002. 4: p. i.
Upadhaya, S.A., The Postmodern Written Description Requirement: An Analysis of the Application of the Heightened Written Description Requirement to Original Claims. Minn. Intell. Prop. Rev., 2002. 4: p. i.
AbbVie Deutschland GmbH v. Janssen Biotech, Inc. . 759 F.3d 1285 (Fed. Cir. 2014).
Centocor Ortho Biotech, Inc. v. Abbott Laboratories. 636 F.3d 1341 ,(Fed Cir.2011).
Enzo Biochem Inc.v. GenProbe Inc. 323 F.3d 956, 960 (Fed. Cir. 2002).
ENZO BIOCHEM, INC., Plaintiff-Appellant, v. CALGENE, INC., Defendant-Cross Appellant. 188 F.3d 1362 (Fed. Cir. 1999).
Fiers v. Revel. 984 F.2d 1164, 25 U.S.P.Q.2d (BNA) 1601(Fed. Cir. 1993).
In re Argoudelis. 434 F 2d.(CCPA. 1970).
In re Bell. 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993).
In re Deuel. 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995).
In re Gay. 309 F.2d 769, 772 (C.C.P.A. 1962).
In re Lukach. 442 F.2d 967, 169 USPQ 795 (CCPA 1971).
In re Oda. 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).
In Re Robert Goodman, Vic C. Knauf, Catherine M. Houch and Luca Comai. 11 F.3d 1046 (Fed. Cir. 1993).
In re Ruschig. 379 F.2d at 996.
In re Vaeck. 947 F.2d 488 (Fed. Cir. 1911).
In re Wands. 858 F.2d 731 (Fed. Cir. 1988).
In re Wright. 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989).
Pitney Bowers Inc. v. Hewlett-Packard Co. 182 F.3d 1298, 1305 (Fed. Cir 1999).
Regents of the University of California v. Eli Lilly. 119 F.3d 1559, 43 USPQ2d 1398 (Fed Cir 1997).
Tronzo v. Biomet, Inc. 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998).
Univ. of Rochester v. G.D. Searle & Co. 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004).

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