Nanotechnology and biotechnology patents

International Journal of Law and Information Technology

Volumn 14, Issue 3, 2006, Pages 310-369

  Zekos, Georgios I ^a  

^a Riga Graduate School of Law   (Latvia)

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EID: 33845190960     PISSN: 09670769     EISSN: 14643693     Source Type: Journal    
DOI: 10.1093/ijlit/eal011     Document Type: Article

References (477)

1. U.S. CONTS. art. 1, §8, cl. 8. Congress has die power'to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective writings and Discoveriers.' DONALD CHISUM ET AL, PRINCIPLES OF PATENT LAW 3 (2d ed. 2001).A patent gives an inventor the right to exclude. A patent does not give the inventor the positive right to make, use, or sell the invention. This is a common misunderstanding of the modern patent grazu....' If a competitor desires to use the patented invention, the competitor must obtain permission or a license from the patent holder to do so. At ch.2. Several reasons exist for requiring full. disclosure, including preventing duplication of work and effort, advancing technology by allowing others to see the invention so that they may make improvements, and making the inventor clarify the limits of his rights so that others know exactly what they can practice without risk of infringement. By making the boundaries of die invention clear, full disclosure serves society by allowing unhindered development in fields related, but not identical, to the patented invention and by allowing improvements to be made on the invention.
2. U.S. 303 (1980).
3. DNA is a double-stranded chain of chemical subunits called micleotides. Proteins are composed of chains of chemical subunits called amino acids. Amino acids are organic compounds containing both an amino group and a carboxylic acid. Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1206 (Fed. Cir. 1991). 'A gene is a chemical compound, albeit a complex one...'
4. Daniel Kevles & Ari Berkowitz, The Gene Patenting Controversy: A Convergence of Law, Economic Interests, and Ethics, 67 BROOK L. REV. 233,248 (Fall 2001).
5. 'Given that the human genome is widely regarded as a common birthright of people everywhere, governments may feel increasing pressure to limit the property rights sought in DNA sequences.' In re O'Farrell, 853 F.2d 894 (Fed. Cir. 1988).
6. David B. Resnik, DNA Patents and Human Dignity, 29 J.L. MED. & ETHICS 152 (2001) (arguing that DNA patents do not violate human dignity because they do not constitute complete commodification of human beings).
7. Moore v. Regents of the University of California, 793 P.2d 479,506-23 (Cal. 1990) (Mosk,J., dissenting) (objecting to denial of patient's demand for recovery of proceeds from sale of cell line developed from patient's tissues)
8. Melissa E. Horn, Note, DNA Patenting and Access to Healthcare: Achieving the Balance Among Competing Interests, 50 CLEV. ST. L. REV. 253, 268-69 (2002) (stating that'[t]the granting of patents creates legalized monopolies designed to encourage innovation' but that this 'is having an undesirable and contradictory effect')
9. Universal Declaration on the Human Genome and Human Rights, U.N. Educational, Scientific and Cultural Organization, 29th Sess., 29C/ Resolution 19, art. 12(a).(Nov. 11, 1997) ('Benefits from advances in biology, genetics and medicine, concerning the human genome, shall be made available to all, with due regard to the dignity and human rights of each individual.').
10. Rebecca S. Eisenberg, Re-Examining the Role of Patents in Approprating the Value of DNA Squences, 49 EMORY LJ. 783, 787-88 (2000) (noting that patent claims on DNA molecules 'do not prevent anyone from perceiving, using, and analyzing information about what the DNA sequence is')
11. Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258,1267-68 (Fed. Cir.' 2001); Biotechnology business method patents issued to Incyte Genomics, Inc., while not claiming sequence information itself, may have the practical effect of foreclosing access to sequence information.
12. See U.S. Patent No. 6,023,659 (issued Feb. 8, 2000) (claiming a database system for searching biomolecular sequences)
13. U.S. Patent No. 5,966,712 (issued Oct. 12, 1999) (claiming a database system for searching genomic sequence libraries).
14. Herman T. Blumenthal, Milestone or Genomanial 56A J. GERONTOLOGY SERIES A 529 (2001) (explaining that even after die sequencing of the human genome, identifying the genes associated with human aging will likely require several decades of research).
15. In re Alappat, 33 F.3d 1526 (Fed. Cir. 1994) (en banc) (holding that a claim directed to a computer programmed to execute a mathematical algorithm satisfies §101 subject matter requirement),
16. with Diamond v. Diehr, 450 U.S. 175, 186 (1981) (holding mathematical algorithms unpatentable)
17. State Street Bank & Trust v. Signature Financial Group, 149 F.3d 1368 (Fed. Cir. 1998),
18. cert. denied, 525 U.S. 1093 (1999) (holding that business methods are patentable subject matter)
19. with Hotel Security Checking Co. v. Lorraine Co., 160 F. 467, 469 (2nd Cir. 1908) (holding that a system of transacting business, even if novel, is not a patentable 'art')
20. and cf. J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001) (holding that seeds are patentable subject matter)
21. J.E.M. AG Supply, 534 U.S. 124, (2001) (attributing broad interpretation of §101 to 'the forward-looking perspective of the utility patent statute').
22. In re Bergstrom, 427 F.2d 1394, 1401-02 (C.C.P.A. 1970) ('By definition, pure materials necessarily differ from less pure or impure materials and, if the latter are the only ones existing and available as a standard of reference... perforce the 'pure' materials are 'new' with respect to them.')
23. John M. Golden, Biotechnology, Technology Policy, and Patentability: Natural Products and Invention in the American System, 50 EMORY L.J. 112, 127 (2001) (describing the product of nature doctrine as 'effectively toothless' because the "purification exception' tends to swallow the rule').
24. Jon F. Merz & Mildred K. Cho, Disease Genes Are Not Patentable. A Rebuttal of McGee, 7 CAMBRIDGE QUARTERLY OF HEALTHCARE ETHICS 425 (1998).
25. Burton T. Ong, Patenting the Biological Bounty of Nature. Re-Examining the Status of Organic Inventions as Patentable Subject Matter, 8 MARQ. INTELL. PROP. L. REV. 1, 19-20 (2004).
26. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948).
27. ENCYCLOPEDIA BRITANNICA, available at http://www.britannica.com/ search?query=Biotechnology&ct=&fuzzy=N
28. Diamond v Chakrabarty 447 US 303,
29. Biogen Inc v Medeva Pic 36 IPR 438 (Deciding that an isolate DNA sequence encoding the hepatitis B Virus could support a patent)
30. Deoxyribonucleic acid ('DNA') comprises die genetic information of most living organisms. A related molecule, ribonucleic add ('RNA') is involved in the translating of the genetic information contained in DNA. The sequence of the RNA or DNA molecule specifies the amino add sequence of the proteins and polypeptides found in living organisms. Recombinant DNA technology is an umbrella term for procedures that result in the predetermined alteration of DNA. The ability to manipulate and alter DNA depends on the activity of purified enzymes that cut and rejoin DNA molecules in very precise and predictable ways. Charis Eng & Jan Vijg, Genetic Testing. The Problems and the Promise, 115 NATURE BIOTECHNOLOGY 422, 425-26 (1997) (explaining that there is a technological gap between gene identification and large-scale genetic testing. However, the author predicts. that once the DNA template preparation limitation is overcome, genetic testing will likely revolutionize our basic concepts of what medicine is and how we should go about developing drugs for the treatment of human disease.).
31. David Stipp, Gene Chip Breakthrough FORTUNE, Mar. 31, 1997, at 56,
32. Utility Examination Guidelines, 66 Fed. Reg. 1092-02 (Jan. 5, 2001).
33. U.S.C. §§ 1201-05 (2000).
34. Legal Protection of Databases, Council Directive 96/9, 1996 O.J. (L77) 2.
35. Digital Millennium Copyright Act 17 U.S.C. §1201 (2000).
36. Feist Publ'ns Inc. v. Rural Tel. Serv., 499 U.S. 340 (1991) (holding that a telephone directory lacked the basic degree of creativity needed for copyright protection).
37. Tina Masciangioli & Wei-Xian Zhang, Environmental Technologies at the Nanoscale, ENVTL. SCI. & TECH., Mar. 1, 2003, at 103A ('Nanotechnology refers broadly to using materials and structures with nanoscale dimensions, usually ranging from 1 to 100 nanometers (nm).')
38. Barry Newberger, Intellectual Property and Nanotechnology, 11 TEX. INTELL. PROP. L.J. 649, 650 (2003) ('In my opinion, a more practical definition is the application of science at the nanoscale.').
39. Fullerine Patent Database,' http://www.godunov.com/Bucky/Patents.html.
40. John R. Allison et al., Valuable Patents, 92 Geo. L.J. 435, 465-70 (2004)
41. Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 151 (1989) ('The federal patent system thus embodies a carefully crafted bargain for encouraging the creation and disclosure of new, useful, and nonobvious advances in technology and design in return for the exclusive right to practice the invention for a period of years.')
42. Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480-81 (1974) (describing patent laws as fostering productive efforts by inventors and insuring adequate and full disclosures of inventions)
43. Grant v. Raymond, 31 U.S. 218, 241-42 (1832) ('The patent grant is the reward stipulated for the advantages derived by the public for the exertions of the individual, and is intended as a stimulus to those exertions.')
44. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 330-31 (1945) ('The primary purpose of our patent system is not reward of the individual but die advancement of the arts and sciences.')
45. United States v. Masonite Corp., 316 U.S. 258, 278 (1942) (citation omitted) ('The promotion of the progress of science and the useful arts is the 'main object'; reward of inventors is secondary and merely a means to that end.')
46. Motion Picture Patents Co. v. Universal Film Mfg. Co., 243 U.S. 502, 511 (1917) ('This court has consistently held that the primary purpose of our patent laws is not the creation of private fortunes for the owners of patents but is 'to promote the progress of science and useful arts.")
47. AT&T Corp. v. Excel Communications, Inc., 172 F.3d 1352, 1356 (Fed. Cir. 1999) ('As this brief review suggests, this court (and its predecessor) has struggled to make our understanding of the scope of [35 U.S.C.] § 101 responsive to the needs of the modern world.').
48. Wilson Sporting Goods Co. v. David Geoffrey & Assocs., 904 F.2d 677, 684 (Fed. Cir. 1990) ('Since prior art always limits what an inventor could have claimed, it limits the range of permissible equivalents of a claim.').
49. Sage Prods., Inc. v. Devon Indus., 126 F.3d 1420, 1424-26 (Fed. Cir. 1997) (limiting equivalents due to clarity of the patent's disclosure).
50. Fonar Corp. v. Gen. Elec. Co., 107 F.3d 1543 (Fed. Cir. 1997)
51. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)
52. Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002)
53. Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999)
54. Eli Lilly, 119 F.3d at 1559
55. In re Deuel 51 F.3d 1552, 1559 (Fed. Cir. 1995)
56. In re Goodman, 11 F.3d 1046, 1052 (Fed. Cir. 1993)
57. In re Bell, 991 F.2d 781 (Fed. Cir.1993)
58. Fiers v. Rivel, 984 F.2d 1164 (Fed. Cir. 1993)
59. Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200 (Fed. Cir. 1991).
60. An inventor is one who makes 'some contribution to the inventive thought and to the final result' of an invention. Monsanto Co. v. Kamp, 269 F. supp. 818, 824 (D.D.C. 1967).
61. One who merely suggests an idea without the means of reducing the idea to practice is not an iriventor. Regents of the Univ. of Cal. v. Symbiotics Corp., 849 F. Supp. 740, 742 (S.D. Cal. 1994).
62. Some describe the process of innovation as 'the search for, and the discovery, development, improvement and adoption of new processes, new products, and new organizational structures and procedures.' Thomas M. Jorde & David J. Teece, Innovation, Cooperation and Anti-trust, 4 High Tech. L.J. 1, 5 (1989).
63. Invention, on the other hand, can be defined as that part of innovation that represents the 'discovery' aspect. Steven Cherensky, A Penny for Their Thoughts: Employee-Inventors, Pre-invention Assignment Agreements, Property, and Personhood, 81 Cal. L. Rev. 597, 609 (1993).
64. U.S.C. §101 (1988).
65. U.S.C.1§03 reads in part: A patent may not be obtained... if the differences between the subject matter to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.
66. U.S.C.1§03(a) (2000).
67. In www.Wipo.int referred that an invention 'must be of practical use; it must show an element of novelty, that is, some new characteristic which is not known in the body of existing knowledge in its technical field. This body of existing knowledge is called 'prior art'. The invention must show an inventive step, which could not be deduced by a person with average knowledge of the technical field...scientific theories, mathematical methods, plant or animal varieties, discoveries of natural substances, commercial methods, or methods for medical treatment (as opposed to medical products) are generally not patentable.'
68. John Barton, 'Reforming the Patent System' (2000) 287 Science 1933.
69. Patent Reform Act of 2005, H.R. 2795, 109th Cong. §3 (2005).
70. Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000) ('Invalidity by anticipation requires that the four corners of a single, prior art document describe every element of the claimed invention, either expressly or inherently, such that a person of ordinary skill in the art could practice the invention without undue experimentation.').
71. Graham v. John Deere Co., 383 U.S. 1, 34-37 (1966) (combining elements from prior art patents to conclude that claimed invention was obvious).
72. U.S.C. §101, §103(a). (1994).
73. Section 18(1) and Section 40 Patents Act 1990 (Cth). See Sam Ricketson & Megan Richardson, Intellectual Property: Cases Materials and Commentary (2 nd ed, 1998) at 577-674. s18 (2) Patents Act 1990 (Cth) excludes human beings and the biological processes for their generation.
74. In re Walter, 618 F.2d 758, 764 (C.C.P.A. 1980).
75. Parker v. Flook, 437 U.S. 584 (1978).
76. In re Bergy, 596 F.2d 952, 959-61 'the questions of whether a particular invention is novel or useful are questions wholly apart from whether the invention falls into a category of statutory subject matter.'
77. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) 'Patents cannot issue for the discovery of the phenomena of nature. The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of the laws of nature, free to all men and reserved exclusively to none.'
78. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
79. Ex parte Latimer, 1889 Dec. Com. Pat. 123.
80. Cochrane v. Deiner, 94 U.S. 780 (1877).
81. Tilghman v. Proctor, 102 U.S. 707 (1880).
82. Diamond v. Diehr, 450 U.S. 175 (1981).
83. Gottschalk v. Benson, 409 U.S. 63 (1972).
84. Perkin-Elmer Corp. v. Westinghouse Elec. Corp., 822 F.2d 1528, 1532 (Fed. Cir. 1987) (stating that pioneer patent claims are entitled to broad construction under doctrine of equivalents)
85. Phanesh Koneru, To Promote the Progress of Useful Articles?: An Analysis of the Current Utility Standards of Pharmaceutical Products and Biotechnological Research Tools, 38 IDEA: J.L. & TECH. 625, 644 (1998) (suggesting that competitors of the patentee 'might erroneously assume that the patentee would normally disclose (and thus has disclosed the best use and would not invest further in the invention to find other uses').
86. Convention on the Grant of European Patents, Oct. 5, 1973, 1065 U.N.T.S. 199.
87. Council Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, 1998 O.J. (L 213) 13.
88. Convention for the European Patent for the Common Market, 1976 O.J. (L 17), 15 I.L.M. 5 (1976).
89. U.S.C.A. § 101-103 (West 1984 & Supp. 2000). Section 101 sets forth which inventions are patentable, Section 102 enumerates novelty as a condition for patentability, and Section 103 requires the subject matter of a patent to be 'non-obvious.' EPC Article 53, entitled 'Exceptions to Patentabilty,' asserts that patents shall not be granted for: Inventions the publication or exploitation of which would be contrary to ordre public or morality, provided that the exploitation shall not be deemed so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.
90. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (holding that a mixture of bacteria was not patentable because the qualities of the bacteria were manifestations of natural phenomena).
91. Decision T356/93, Plant Genetic Systems/Glutamine Synthetase Inhibitors (Opposition by Greenpeace), 1995 E.O.P.R.357, 366.
92. Decision T320/87, Lubrizol/Hybrid Plants, 1988 E.P.O.R. 173, 178.
93. Howard Florey/Relaxin (Opposition by Fraktion der Grunen Im Europaischen Parlament; Lannoye), 1995 E.P.O.R. 541, 543-46. Article 53 ECP
94. Decision on the Common Position Adopted by the Council with a View to Adopting a European Parliament and Council Directive on the Legal Protection of Biotechnological Inventions, 1998 O.J. (C 167) 26, 26-27.
95. Article 6(1) is very similar to EPC Article 53(a). It states that [i]nventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. Biotech Directive excludes from patentabilty human/animal chimeras, human germ cells, processes for modifying the germ line genetic identity of humans, processes for human cloning, and uses of human embryos for industrial and commercial purposes.
96. Robert P. Merges, The Economic Impact of Intellectual Property Rights: An Overview and Guide, 19 J. CULTURAL ECON. 103 (1995).
97. Cochrane v. Deener, 94 U.S. 780, 788 (1877),
98. See Hotel Security Checking Co. v. Lorraine Co., 160 F. 467, 469 (2d Cir.1908).
99. Kenneth W. Dam, Some Economic Considerations In The Intellectual Property Protection Of Software, 24 J. LEGAL STUD. 321, 369-71 (1995) (stating many of the problems with patent quality that had been identified with respect to software patents, and voicing optimism that problems can be addressed).
100. Andrew M. Riddles & Brenda Pomerance, Software Patentee Must Conduct Own Search: Prior-Art Searches Made By The Patent Office Often Are Not Thorough Enough To Be Trusted, NAT'L L. J., Jan. 26, 1998, at C19. (referring PTO of being little better than a 'registration process' for some kinds of software patents).
101. Quantel, Ltd. v. Adobe Systems, Inc., 1997 U.S. Dist. LEXIS 16779 at 14-23 (D. Del. Sept. 22, 1997) (jury verdict invalidating software patents; special verdict form shows numerous 'prior public use' references).
102. Gold, R. (2002), 'Gene Patents and Medical Access', Intellectual Property Forum, Vol. 40, pp. 20-27.
103. GENETIC INVENTIONS, ENTELLECTUAL PROPERTY RIGHTS AND LICENSING PRACTICES, OECD 2002. Claims in gene patent applications pertain, among other things, to: Genes or partial DNA sequences such as cDNAs, ESTs, SNPs, promoters and enhancers. Proteins encoded by these genes and their functions in the organism. Vectors used for the transfer of genes from one organism to another. Genetically modified micro-organism, cells, plants and animals. Processes used for the making of a genetically modified product. Uses of genetic sequences or proteins which include: genetic tests for specific genetic diseases or pre-disposition to such diseases; drugs developed on the basis of the knowledge of proteins and their biological activity; industrial applications of protein functions.
104. U.S. Patent No. 6,329,184 (issued Dec. 11, 2001) (claiming 'I. A crystalline form of mammalian TRAP (tartrate-resistant and purple acid phosphatase), activated by cleavage prior to crystallization with a protease, wherein the crystalline form of the mammalian TRAP is capable of being used for X-ray studies, and wherein the crystalline form of the mammalian TRAP has a crystal structure with atomic structural coordinates as given in Table 2, or with coordinates having a root mean square deviation therefrom, with respect to conserved backbone atoms of the listed amino acid sequence, of not more than 1.5 ... [Angstrom].') U.S. Patent No. 6,490,588 (issued Dec. 3, 2002) (claiming 'A Method of searching one or more ligand compound to a target biopolymer from a three-dimensional structure database'); U.S. Patent No. 5,856,116 (issued Jan. 5, 1999) (claiming '1. A method for identifying a potential inhibitor for an interleukin-1.beta, converting enzyme, comprising the steps of:: a. using a three-dimensional structure of said enzyme as defined by atomic coordinates of interleukin-1.beta. converting enzyme according to FIG. 5; b. employing said three-dimensional structure to design or select said potential inhibitor; c. synthesizing said potential inhibitor; and d. contacting said potential inhibitor with said enzyme in the presence of a substrate to determine the ability of said potential inhibitor to inhibit said enzyme.')
105. Donald Voet & Judith G. Voet, Biochemistry 141, 165 (2d ed.1995).
106. Merck & Co., Inc. v. Olin Mathieson Chem. Corp., (1958) 253 F.2d 156, 161, 163.
107. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
108. U.S. 584 (1978) (holding that 'the laws of nature, physical phenomena, and abstract ideas' are not patentable).
109. Commission of die European Communities, Proposal for a Council Directive on the Legal Protection of Databases, COM (92) 24 Final (May 1992).
110. David R. Syrowik, International Software Protection, 70 Mich. B.J. 656, 657-58 (1991)
111. IBM, Decision of the Technical Board of Appeal 3.5.1 dated 14 February 1989 T38/86, 1989 Official J. EPO, no. 10.
112. Koch & Sterzel GmbH v. Siemens AG, Decision of the Technical Board of Appeal 3.4.1 dated 21 May 1987 T26/86, 1988 Official J. EPO, nos. 1-2.
113. VICOM Systems Inc., Decision of the Technical Board of Appeal 3.5.1 dated 15 July 1986 T208/84, 1987 Official J. EPO, no. 1.
114. Marshall A. Leaffer, Protecting United States Intellectual Property Abroad: Toward a New Multilateralism, 76 IOWA L. REV. 273, 287 (1991).
115. U.S.C. §101 (2002).
116. 8) 156 ALR 30.
117. Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232
118. International Business Machines Corporation v Commissioner of Patents (1991) 22 IPR 417.
119. Exclusions from patentability for living phenomena has been justified by reference to the unpatentability of natural phenomena. Funk Bros. Seed Co v Kalo Inoculant Co 333 US 127.
120. Parker v Bergy 438 US 902, 444 US 924. The exclusion of natural phenomena derives form the distinction between patentable technical objects and unpatentable abstract principles.
121. Boulton v Bull 126 ER 651 (distinguishing between manufactures and abstract notions or elementary truths of the arts and since).
122. Le Roy v Tatham 55 US 15 (a principle is not patentable because it is a fundamental truth and no one can an exclusive right).
123. The Supreme Court in US has confirmed that utility patent claims to plants and seeds satisfy the 35 U.S.C. §101 subject matter eligibility requirement. J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 127 (2001).
124. USC §161.
125. USC § 2321-2583. Plant Variety and Seeds Act, 1964, Ch 14 (amended 1997).
126. In Rank Hovis McDougall Ltd's Application (1976) 46 AOJP 3915, a patent was allowed for a new strain of micro-organism that could be used to produce an edible protein.
127. 0] FCA 316 (2000) 46 IPR 553.
128. Dianne Nicol, 'Should Human Genes be Patentable Inventions under Australian Patent Law?' (1996) 3 (3) JLM 231
129. City of Milwaukee v Activated Sludge Inc 69 F2d 577 (a method of using bacteria in the treatment of waste was patentable because it involved physical methods and apparatus for handling).
130. Funck Bross Seed 333 US 127 (refusing a patent for bacterial strains on the ground of want of invention).
131. Bergstrom 427 F2d 1394 (prostaglandins). American Fruit Growers Inc v Brogdex Co 283 US 1 (an orange rendered decay-resistant by injection with borax was not patentable because the injection did not produce a new orange which was a product of nature and thus unpatentable).
132. Merck & Co v Olin Mathieson Chem Corp 253 F2d 156 (Vitamin B12).
133. Dennis v. Pitner, 106 F.2d 142, 145 (7th Cir. 1939) "The laws of nature,' 'the principles of nature,' 'the fundamental truths,' etc., are not patentable, have been oft repeated but seldom understandingly used.'
134. Treibacher Chemische Werke GmbH v. Roessler & Hasslacher Chem. Co., 214 F. 410 (S.D.N.Y. 1914).
135. In General Electric Co. v. De Forest Radio Co., 28 F.2d 641, 643 (3rd Cir. 1928). A patent for elemental tungsten was held invalid as covering a product of nature because the tungsten that the inventor uncovered was the 'tungsten of nature'
136. CERN-European Organization for Nuclear Research, Why is Antihydrogen Interesting?., at http://athena. web.cern.ch/athena/ Anette Pahl et al.,
137. Antihydrogen at the MPQ: Introduction, http://www.mpq. mpg.de/~haensch/ antihydrogen/introduction.html.
138. Decision T356/93, Plant Genetic Systems/Glutamine Synthetase Inhibitors, supra note 97, at 363 (describing how Greenpeace, the opponent of the patent for a herbicide-resistant plant, insisted, as grounds for revocation, that the exploitation of the invention had resulted in 'serious, irreversible environmental risks')
139. Howard Florey/Relaxin (Opposition by Fraktion der Grunen Im Europaischen Parlament; Lannoye), 1995 E.P.O.R. 541, 543-46.
140. The inventor filed a patent application with the EPO on December 12, 1983. Id. at 543. He obtained the patent (EP-B-112 149) some nine years later and a mention of the patent grant was published on April 10, 1991.at 548 (explaining that, although a previously unknown substance may occur in nature, if that substance is isolated and a process for obtaining it is developed, the substance and the process may be patentable). An example of a naturally occurring patentable substance is blood clotting factors.
141. European Patent Convention, supra note 13, art. 54(2) (stating that the state of the art includes everything available to the public prior to the date of the filing of die patent application).
142. Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (finding a human-made micro-organism patentable, because it was a product of human ingenuity)
143. Parker v. Flook, 437 U.S. 584, 593 & n. 15 (1978) (noting that naturally occurring substances are not patentable, because they are mere discoveries of an existing phenomenon)
144. Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (disallowing a patent for conversion of numerals due to the abstractness of the claim and the traditional notion that an idea itself is not patentable)
145. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (invalidating a patent for product claims involving mixed culture bacteria because the qualities of the bacteria were 'the work of nature')
146. Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1853) (distinguishing an unpatentable scientific principle or natural law from the patentable application of such to a 'special purpose').
147. Rebecca S. Eisenberg, Re-examining the Role of Patents in Appropriating the Value of DNA Sequences, 49 EMORY L.J. 783, 786 (2000).
148. American Wood-Paper Co. v. Fibre Disintegrating Co. 90 U.S. (23 Wall.) 566 (1874). (mere purification of a preexisting substance does not create a new, patentable product without a significant alteration to the preexisting product.)
149. Int'l Patents Dev. Go. v. Penick & Ford, Ltd., 15 F. Supp. 1038 (D. Del. 1936). The patentee's invention was the novel process for creating dextrose artificially-the product itself was no different from that found in nature except that it was crystallized and purified.
150. Sterling Drug, Inc. v. Watson, 135 F. Supp. 173 (D.D.C. 1955).
151. Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156 (4th Cir. 1958).
152. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 135 (1948) (Frankfurter, J., concurring) (Everything that happens may be deemed, the work of nature, and any patentable composite exemplifies in its properties, the laws of nature).
153. Ex parte Reed, 135 U.S.P.Q. (BNA) 105 (Pat. Off. Bd. App. 1961). (because the appellants had developed a means by which to gather large amounts of products of nature, they merited patents on those products due to the resulting increased therapeutic value.)
154. In r e Bergstrom, 427 F.2d 1394 (C.C.P.A. 1970).
155. Parker v. Flook, 437 U.S. 584 (1978).
156. In re Sarkar, 588 F.2d 1330, 1333 n.10 (C.C.P.A. 1978) (observing that novelty and nonobviousness are irrelevant to section 101 analysis).
157. EU Commission, Legal Protection of Biotechnical Inventions: Frequently Asked Questions on Scope and Objectives of the EU Directive (98/44) (July 3, 2000), at http://europea.eu.int/comm/internal_market/en/ intprop/indprop/2k-39.htm.
158. Michael J. Malinowski & Maureen A. O'Rourke, A False Start? The Impact of Federal Policy on the Genotechnology Industry, 13 YALE J. REG. 163, 231 (1996). at 231 (Preexisting DNA molecules, proteins, and other biochemicals are not patentable subject matter because they are not 'inventions' as required by the Patent Act.).
159. Abbott v. Coe, 109 F.2d 449, 450 (D.C. Cir. 1939) (observing that useful innovation is not patentable without invention, and innovation does not amount to invention unless it requires rare talent to create it).
160. Parke-Davis & Co. v. H. K. Mulford & Co., 189 F. 95 (C.C.S.D.N.Y. 1911).
161. Kuehmsted v. Farbenfabriken of Elberfeld Co., 179 F. 701 (7th Cir. 1910).
162. Union Carbide Co. v. American Carbide Co., 181 F. 104 (2d Cir. 1910).
163. John Richards, International Aspects of Patent Protection for Biotechnology, 4 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 433, 450 (1993).
164. European Parliament and Council Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, recital 23, 1998 O.J. (L 213), 13
165. See EU Commission, Legal Protection of Biotechnical Inventions: Frequently Asked Questions on Scope and Objectives of the EU Directive (98/44) (July 3, 2000), at http://europea.eu.int/comm/internal_market/ intprop/indprop/2k-39.htm.
166. David E. Huizenga, Protein Variants: A Study on the Differing Standards for Biotechnology Patents in the United States and Europe, 13 EMORY INt'L 1. REv. 629, 662 (1999) (noting that much of the work in DNA sequencing is automated)
167. Precision Specialty Metals, Inc. v. United States, 116 F. Supp. 2d 1350, 1364 n.13 (Ct. Int'l Trade 2000) (noting that change of name does not, by itself, usually prove a substantial transformation).
168. Hartranft v. Wiegmann. 121 U.S. 609 (1887).
169. Graham v. John Deere Co. 383 U.S. 1, 14 (1966), '[a]n invention which has been made, and which is new in the sense that the same thing has not been made before, may still not be patentable if the difference between the new thing and what was known before is not considered sufficiently great to warrant a patent.'
170. Reynolds-S.W. Corp. v. Dresser Indus., 372 F.2d 592, 595 (5th Cir. 1967) (finding that patent infringement occurs where allegedly infringing product 'perform[s] substantially the same function or accomplish[es] a substantially identical result by substantially identical means and the principle or mode of operation must be the same')
171. Merrill v. Builders Ornamental Iron Co., 197 F.2d 16, 20 (10th Cir. 1952) (holding that a patent is not infringed unless the allegedly infringing product 'produces substantially the same effect in substantially the same way as that taught in the patent')
172. Mesinger v. W. Auto Supply Co., 375 F. Supp. 1143, 1147 (S.D. Fla. 1974) (noting that 'infringement exists only where the accused device and the teachings of the patent in suit are substantially identical in structure, mode of operation, and results accomplished').
173. In American Fruit Growers, Inc. v. Brogdex Co. 283 U.S. 1 (1931), the Court rejected a patent on citrus fruit treated with borax to resist mold.
174. In re Davis, 164 F.2d 626, 632 (C.C.P.A. 1947) (holding that an improvement in the degree of stability of the applicant's chemical 'would not be sufficient to lend patentability to the product claims, since it is a difference in degree only')
175. In re Michalek, 161 F.2d 253, 255 (C.C.P.A. 1947) (holding that merely producing a more purified version of a preexisting chemical does not merit a patent because the resulting product does not 'differ in kind from that disclosed by the prior art').
176. Dewey & Almy Chem. Co. v. Mimex Co., 37 F. Supp. 36, 38 (E.D.N.Y. 1941),
177. red in part, 124 F.2d 986 (2d Cir. 1942) ('It is a well recognized principle that the substitution of materials does not constitute invention unless indeed a wholly different effect results from the substitution. It is true that certain advantages are claimed but the mere difference in degree is not such as to warrant the finding of invention').
178. Animal Legal Defense Fund v. Quigg, 932 F.2d 920, 923 (Fed. Cir. 1991) ('An article of manufacture or composition of matter occurring in nature will not be considered patentable unless given a new form, quality, properties or combination not present in the original article existing in nature in accordance with existing law').
179. In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995)
180. Michael S. Greenfield, Recombinant DNA Technology: A Science Struggling with the Patent Law, 44 STAN. L. REV. 1051, 1079 (1992).
181. Annulment proceedings by the Netherlands against Directive 98/44/EC -Decision of the Court of Justice of the European Communities of 9 October 2001 http://curia.eu.int/jurisp/cgi-bin/form.pl?lang=en& Submit=Submit&docrequire=alldocs&numaff=C-377%2F98&datefs= &datefe=&nomusuel=&domaine=&mots=&resmax=l00
182. European Group on Ethics in Science and Technologies (EGE), Opinion no. 16, 'Ethical Aspects of Patenting Inventions involving Human Stem Cells', 7 May 2002, http://europa.eu.int/comm/ european_group_ethics/docs/avis16_en_complet.pdf, s. 1.12.
183. National Research Development Corporation v Commissioner of Taxation (1959) 102 CLR 252.
184. Rescare Ltd v Anaesthetic Supplies Pty Ltd (1993) 25 IPR 119.
185. Kirin-Amgen Inc v Board of Regents of University of Washington & Anor (1995) 33 IPR 557.
186. American National Standards Institute, Guidelines for Implementation of the ANSI Patent Policy, available at http://web.ansi.org/public/library/ guides/-ppguide.html
187. Biogen/Hepatitis b T296/93 1995 EPOR 1
188. Enzo Biochem Inc v Gen-Probe Inc 296 F3d 1316.
189. Genetics Inst Inc v Amgen Inc 502 US 856. The patenting of informational products has been permitted in Europe. Philips/Record Carrier T 1194/97 2001 EPOR 193. IBM/Computer Programs T 1173/97/2000 EPOR 219. (construing EPC art 52 narrowly to permit the patenting of computer programs)
190. Supply Inc v Pioneer Inc 534 US 124 (Denying protection under 1§01 would be inconsistent with forward looking perspective of the utility patent statute).
191. Biogen inc v Medeva Plc 36 IPR 438 (support for an expansive view of patent eligibility in the context of modern biotechnology)
192. AT&T Corp v Excel Communications Inc 127 F3d 1352 (permitting patents for mathematical algorithms contrary to the historical principles).
193. In State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998), cert. denied, 119 S.Ct. 851 (1999).
194. The Federal Circuit decision recognized business method patents involving a patent entitled 'Data Processing System for Hub and Spoke Financial Services Configuration.' keeping track of individual mutual fund investments ('spokes') which have been pooled into a single portfolio (a 'hub'). Leo I. Raskind, The Bad Business of Business Method Patents, 10 Ford. Intell'l Prop'y Media & Entertainment L.J. 57 (1999). Mathematical algorithms are patentable so long as they produce a 'useful' result, including something as non-physical as a final share value which means that methods of doing business were patentable subject matter.
195. In Merrill Lynch Inc.'s Application [1988] R.P.C. 1, aff 'd, [1989] R.P.C. 561. the court came to a unquestionably different result than the State Street court, ruling that a computer program that causes a computer to calculate numbers to provide pricing information did not involve a technical step and was therefore unpatentable.
196. Supply 534 US 135. Lubrizo/Hybrid Plant T320/87 1990 EPOR 173 (construing EPC art 53b narrowly to exclude recombinant plants). Harvard/ Onco-Mouse 1991 EPOR 525.
197. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, 1998 OFFICIAL J. EUR. COMMUNITIES O.J. (L 213) 13-21, available at http://europa.eu.int/eur-lex/pri/en/oj/dat/1998/1_213/ 1_21319980730en00130021.pdf.
198. ibid
199. In re Bell, 991 F.2d 781, 785 (Fed. Cir. 1993).
200. USPTO argued that the entire nucleotide sequence of the gene would be prima facie obvious when the amino acid sequence for that gene could be found in the prior art. In Re Deuel 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995).
201. G. Kenneth Smith & Denise M. Kettelberger, Patents and the Human Genome Project, 22 AIPLA Q.J. 27 (1994).
202. 'There is little dispute that defined, functional DNA sequences obtained through research in the human genome project will be, and should be, patented.' Paul J. Heald & Suzanna Sherry, Implied Limits on the Legislative Power: The Intellectual Property Clause as an Absolute Constraint on Congress, 2000 U. ILL. L. REV. 1119, 1164-65 (2000).
203. Karen I. Boyd, Nonobviousness and the Biotechnology Industry: A Proposal for a Doctrine of Economic Nonobviousness, 12 BERKELEY TECH. L.J. 311, 312 (1997).
204. 'Virtually cost-free to the public fisc, making patents slightly easier to get will satisfy the policy needs of the biotechnology industry and will be logically defensible.' Daniel L. McKay, Patent Law and Human Genome Research at the Crossroads: The Need for Conggressional Action, 10 SANTA CLARA COMPUTER & HIGH TECH. L.J. 465, 495 (1994)
205. (quoting Thomas D. Kiley, Patents on Random Complementary DNA Fragments?, 257 SCIENCE 915, 918 (1992)). 'lest we eliminate patent incentives for the development of important medicines.'
206. U.S. Patent No. 5,169,941 (issued Dec. 8, 1992) (regarding multiple sclerosis)
207. U.S. Patent No. 5,220,013 (issued June 15, 1993) (concerning Alzheimer's disease)
208. U.S. Patent No. 5,324,641 (issued June 28, 1994) (pertaining to insulin precursors for diabetes treatment)
209. U.S. Patent No. 5,362,623 (issued Nov. 8, 1994) (targeting malignant tumors)
210. U.S. Patent No. 5,370,998 (issued Dec. 6, 1994) (concerning tuberculosis).
211. U.S. Patent No. 4,766,075 (issued Aug. 23, 1988) (regarding human tissue plasminogen activator).
212. Geron Gets Patent Tied to Human Embryonic Stem Cells, REUTERS NEWSWIRE, Mar. 13, 2001.
213. U.S. Patent No. 6,057,434 (issued May 2, 2000) (involving mammary transforming protein)
214. U.S. Patent No. 5,880,263 (issued Mar. 9, 1999) (concerning human chemotactic protein)
215. U.S. Patent No. 5,597,709 (issued Jan. 28, 1997) (involving human growth hormone variants)
216. U.S. Patent No. RE 32,011 (issued Oct. 22, 1985) (reissuing U.S. Patent No. 4,361,509 (issued Nov. 30, 1982)) (pertaining to human Factor VIII:C, used to treat hemophilia).
217. Rebecca Eisenberg, 'Genomic Patents and Product Incentives' in Bartha Maria Knoppers, Claude Laberge & Marie Hirtle (eds), Human DNA: Law and Policy (1997) at 374. 'Patents on DNA sequences are likely to have different impacts on firms that occupy different market niches in the biotech industry .... One firm's research tool is another firm's end product.'
218. Thomas Caskey & Alan Williamson, 'Merck, SmithKline and Patents' (1996) 381 Nature 360.
219. Craig Venter, 'The Sequence of the Human Genome' (2001) 291 Science 1304.
220. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
221. Amgen Inc. v. Chugai Pharm. Co. Ltd., 927 F.2d 1200 (Fed. Cir. 1991).
222. F.2d 781 (Fed. Cir. 1993).
223. F.3d 1552 (Fed. Cir. 1995).
224. Ex parte Movva, 31 U.S.P.Q.2d 1027 (1993).
225. EX parte Goldgaber, 41 U.S.P.Q.2d 1172 (Bd. Pat. App. & Int. 1995).
226. Bd. of Regents v. Eli Lilly & Co., 2002 Pat. App. LEXIS 176 (Bd. Pat. App. & Int. 2002).
227. Eli Lilly & Co. v. Bd. of Regents, 334 F.3d 1264 (Fed. Cir. 2003).
228. Trilateral project B3b: Comparative study on biotechnology patent practices (Theme: Nucleic acid molecule related inventions whose functions are inferred based an homology search), at http://www.european-patent-office.org/tws/sr-3-b3b_bio_search.htm
229. Leslie G. Restaino, Steven E. Halpern and Dr. Eric L. Tang, Patenting DNA-Related Inventions in the European Union, United States and Japan: A Trilateral Approach or a Study in Contrast?, 2003 UCLA J.L. & Tech. 2
230. In re Baird, 16 F.3d 380 (Fed. Cir. 1994)).
231. See In re Mayne, 104 F.3d 1339 (Fed. Cir. 1997).
232. Rhone-Poulenc Ago v Dekalb Genetics Corp. 272 F3d 1335.
233. Deuel 51 F3d 1558
234. Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994).
235. Schendel v. Curtis 83 F.3d 1399.
236. In re Dillon 919 F.2d 688, 692 (Fed. Cir. 1990).
237. See 35 U.S.C.A. §301
238. Robert Blackburn, Evolving Patent Law in the New Age of Biomedical Science, 4 TEX. REV. L. & POL. 87, 88 (1999) (noting that in traditional pharmaceutical chemistry, the chemist makes many derivatives of a given 'lead compound' that has a desirable activity in the hope of finding a derivative that has similar activity but can be manufactured more efficiently).
239. In re Deuel, 51 F.3d 1552.
240. Rebecca S. Eisenberg & Robert P. Merges, Opinion Letter as to the Patentability of Certain Inventions Associated with the Identification of Partial cDNA sequences, 23 AIPLA Q.J. 1, 32 (1996) (noting that the CAFC's approach 'would seem to make all novel DNA sequences patentable, however trivial the scientific advance that led to their identification').
241. In re Donaldson, 16 F.3d 1189, 1192 (1994) ('Obviousness under section 103 is a question of law that this court reviews de novo.').
242. In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995)
243. In re Bell, 991 F.2d 781 (Fed. Cir. 1993).
244. Donna M. Gitter, International Conflicts Over Patenting Human DNA Sequences in the United States and the European Union: An Argument for Compulsory Licensing and a Fair-Use Exemption, 76 N.Y.U. L. REV. 1623, 1651 (2001) (concluding that 'arguments against the patentability of human DNA sequences, per se, are a dead letter under U.S. law')
245. Bonito Boats Inc. v. Thunder Craft Boats Inc., 489 U.S. 141, 150-51 (1989) ('The federal patent system thus embodies a carefully crafted bargain for encouraging the creation and disclosure of new, useful, and nonobvious advances in technology and design in return for the exclusive right to practice the invention for a period of years.')
246. Brenner v. Manson, 383 U.S. 519, 534-35 (1966) ('The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly [to an inventor] is the benefit derived by the public from an invention with substantial utility.').
247. Ian Ayres & Paul Klemperer, Limiting Patentees' Market Power Without Reducing Innovation Incentives: The Perverse Benefits of Uncertainty and Non-Injunctive Remedies, 97 MICH. L. REV. 985, 1008 (1999) ('[T]he current patent system ... allows the patentee to capture a rough and limited proxy of consumer value and then lets the potential innovator decide whether the benefits of innovation justify the costs.')
248. William F. Baxter, Legal Restrictions on Exploitation of the Patent Monopoly: An Economic Analysis, 76 YALE L.J. 267, 268-71 (1966) (noting that an optimum innovation policy would equalize social and private valuations of innovative outputs, but arguing that subsidies and patent monopolies are incapable of achieving an exact balance)
249. Howard F. Chang, Patent Scope, Antitrust Policy, and Cumulative Innovation, 26 RAND J. ECON. 34, 49 (1995) (arguing that research will be underproduced if its social value exceeds its appropriable private value)
250. Mark F. Grady & Jay I. Alexander, Paient Law and Rent Dissipation, 78 VA. L. REV. 305, 308 (1992) (describing optimal patent grant as an award to the inventor of rent equal to '[t]he difference between what society would pay for an innovation and its actual cost of development')
251. Edmund W. Kitch, The Nature and Function of the Patent System, 20 J.L. & ECON. 265, 266 (1977) (noting that insofar as a patent functions as a reward, it 'tends to make the amount of private investment in invention closer to the value of its social product').
252. 'An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. 'VOLKER VOSSIUS ET AL., EUROPEAN MATERIALS AND INDEX 27 (1995), available at http://www.european-patentoffice.org/legl/epc/e/ contents.html.
253. The Japanese Patent Office interprets Japan Patent Law section 29 (2) to mean that a patent should only be granted for an improved invention showing remarkable progress over the prior art in terms of its purpose, constitution or effect. Sekizo Hayashi, Main Changes of Japanese Patent System and Important Decisions: In Chronological Order from 1960, 27 A.I.P.P.I. 299, 300 (2002).
254. Yusuke Hiraki, Patentability Requirements and Scope of Protection of Expressed Sequence Tags (ESTs), Single Nucleotide Polymorphisms (SNPs) and Entire Genomes, 25 A.I.P.P.I. J. 10, 13 (2000).
255. The basic rule that is applied in an obviousness analysis in Australian law is set forth in Welcome Foundation Ltd. v. VR Lab.: [T]he question of obviousness involves asking the question whether the invention would have been obvious to a non-inventive worker in the field, equipped with the common general knowledge in that particular field as at the priority date, without regard to documents in existence but not prior art of such common general knowledge.
256. Wellcome Found. Ltd. v. VR Lab. (Aust.) Pty. Ltd. (1984) 34 A.L.R. 213, 216 (Austl.), http://www.austlii.edu.au/au/cases/cth/high_ct/ 148clr262.html.
257. Genentech Inc.'s Patent [1989] R.P.C. 147 (Eng. C. A. 1988).
258. Dainippon Pharm. Co. Ltd. v. Otsuka Pharm. Co. Ltd., Eur. Pat. Off., T 236/96 (1999), available at http://legal.european-patentoffice.org/dg3/ biblio/t960236eul.htm
259. Genentech, Inc. v. Celtrix Pharm., Inc., Eur. Pat. Off., T 637/97 (2000), available at http://legal.european_patent_office.org/dg3/ biblio/t970637eul.htm
260. Unilever N. V. v. Celltech Ltd. Chr. Hansens Lab. A/S, Eur. Pat. Off., T 386/94 (1996).
261. Chiron Corp. v. US Surgical Corp., Eur. Pat. Off., T 475/93 (1997), available at http://legal.european-patent-office.org/dg3/biblio/ t930475eul.htm Claims directed to a DNA molecule comprising the Bt gene from Bt Berliner lacked an inventive step because the isolation and sequencing of the Bt Berliner gene was done by a well-established method, and there was no evidence that any difficulties were encountered.
262. Aventis Crop Sci. v. Agrigenetics LP Novartis AG, Eur. Pat. Off., T 1054/ 97 (2000), available at http://legal.european-patentoffice.org/dg3/ biblio/t971054eul.htm
263. In re Farber, Eur. Pat. Off., T 111/00 (2002), http://legal.european-patent-office.org/dg3/biblio/t000111eu1.htm isolation of the human cytokine cDNA was carried out in a straightforward manner using the prior art DNA as a probe, and the skilled person would have considered cloning of the human cDNA as a matter of routine experimentation since the probe was available.
264. Novartis v. DSM Gist Holding B.V., Eur. Pat. Off., T 479/97 (2001), http://legal.european-patent-office.org/dg3/biblio/t970479eu1.htm screening for a gene encoding a protein using a homologous DNA probe was a matter of common knowledge, and hence, it would not have required inventive skills to isolate the pelD gene using the peID DNA as a probe.
265. In re Farber, Eur. Pat. Off., T 111/00 (2002), http://legal.european-patent-office.org/dg3/biblio/t000111eu1.htm There is no inventive step when methods of isolation were routine and the isolated gene did not have any unexpected features.
266. Aventis Crop Sci. v. Agrigenetics LP Novartis AG, Eur. Pat. Off., T 1054/ 97 (2000), http://legal.european-patentoffice.org/dg3/biblio/ t971054eu1.htm
267. 87, BIOGEN/Recombinant DNA, [1990] E.P.O.R. 190 (Eur. Pat. Off. (Technical Bd. App.) 1989).
268. person skilled in the art would not have been able to isolate the specific DNA molecules by application of the common general knowledge. T 500/91, BIOGEN/Alpha-interferon II, [1995] E.P.O.R. 69, 72 (Eur. Pat. Off. (Technical Bd. App.) 1992).
269. 98, THE SALK INSTITUTE FOR BIOLOGICAL STUDIES/Fibroblast Growth Factor (Eur. Pat. Off. (Technical Bd. App.) 2001), http://legal.european-patent-office.org/dg3/pdf/t98O343eu1.pdf sequencing the bovine bFGF polypeptide and isolating the DNA that encodes it must involve an inventive step. The isolation and characterization ] of the full length sequence involved an inventive step.
270. 96, ELI LILLY/Protein C (Eur. Pat. Off. (Technical Bd. App.) 1999), http://legal.european-patent-office.org/dg3/pdf/t960223eu1.pdf
271. TRILATERAL PROJECT B3B: COMPARATIVE STUDY ON BIOTECHNOLOGY PATENT PRACTICES (THEME: PATENTABILITY OF DNA FRAGMENTS), at http://www.european-patent-office.org/tws/sr-3-b3b-ad.htm According to the Directive that: [The] subject matter of an invention shall not be considered unpatentable for thereason only that it is composed of living matter.'
272. COM (88) 496 (17 October 1988)
273. CJ 1989 C 10, p. 3 at Article 2.
274. Pay-Bas v. Parliament and Council. ECR 2000 1-06229 (25 July 2000).
275. Pay-Bas v. Parliament and Council, Case C-377/98, ECR 2001 I-7079 (Judgment').
276. Pay-Bas v. Parliament and Council, Case C-377/98, ECR 2001 I-07079 Opinion of Advocate General Jacobs ('Opinion'), para. 97.
277. ROBERT N. WEEKES, Challenging The Biotechnology Directive A Letter from America [2003] EBLR 325
278. European Patent Office, Guidelines for Examination in die EPO; Part C, Chapter IV: Patentability, Article 52 (4), at http://www.european-patent-office.org/legal/gui_lines/e/c_iv_4.htm
279. Robin Teskin, Human Gene Patenting - An Overview of Legal and Ethical Considerations, FOOD AND DRUG LAW INSTITUTE UPDATE Issue 3 May/June, 2001, available at http://www.fdli.org/pubs/Update/toc/2001/issue3.html
280. AIPPI Report, Question Q 150: Patentability Requirements and Scope of Protection of Expressed Sequence Tags (ESTs), single Nucleotide Polymorphisms (SNPs) and Entire Genome, available at http://www.aippi.org/reports/q150/gr-q150-e-questions.htm
281. Fed. Reg. 1092-99 (2001).
282. According to the USPTO guidelines for the examination of applications for compliance with the utility requirement, the utility requirement is satisfied if a utility is 'credible', assessed from the perspective of a person of ordinary skill in the art. Department of Commerce, United States Patent and Trademark Office, 'Revised Utility Examination Guidelines: Request for Comment', Federal Register, Vol. 64, No. 244, 21 December 1999, pp. 71440-71442.
283. Courtney J. Miller, Patent Law and Human Genomics, 26 CAP. U. L. REV. 893, 911 (1997).
284. The British Group of AIPPI, Patentability Requirements and Scope of Protection of Expressed Sequence Tags (ESTs), Single Nucleotide Polymorphisms (SNPs) and Entire Genomes, 1 EUR. INTELL. PROP. REV. 39-42 (2000).
285. JAPAN PATENT OFFICE, TRILATERAL PROJECT 24.1 - BIOTECHNOLOGY, COMPARATIVE STUDY ON BIOTECHNOLOGY PATENT PRACTICES COMPARATIVE STUDY REPORT, art. 2.1, at http://www.jpo.go.jp/torikumi_e/kokusai_e/tws/ sr-3-bio.htm
286. Brenner v. Manson, 383 U.S. 519, 534 (1966) ('The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility.')
287. Cross v. Iizuka, 753 F.2d 1040, 1044 (Fed. Cir. 1985).
288. Raytheon Co. v. Roper Corp., 724 F.2d 951, 956 (Fed. Cir. 1983).
289. Rey-Bellet v. Engelhardt, 493 F.2d 1380, 1385 (C.C.P.A. 1974) (stating that 'conception of [an] ... invention is not complete absent a conception of its utility.
290. Kridl v. McCormick 105 F.3d 1446, 1447 (Fed. Cir. 1997).
291. Monarch Knitting Mach. Corp. v. Sulzer Morat GMBH, 139 F.3d 877, 881 (Fed. Cir. 1998).
292. Gummow v Snap on tools 58 USPQ 2d 1414.
293. Fanar Corp v Gen Elec Co 107 F3d 1543.
294. Regents O Univ of Calif v Eli Llilly Co 109 F3d 1559.
295. Panduit Corp v Dennison Co 810 F2d 1561.
296. Exxon v United States 265 F3d 1371.
297. Cyber Corp v Fas Tech Inc 138 F3d 1448.
298. Bauch v Barnes Inc 796 F2d 443.
299. Helifix Ltd v Blok Ltd 208 F3d 1339.
300. Dayco Prod v Total 258 F3d 1317.
301. Endress v Hawk 122 F3d 1040.
302. In re Vaeck 947 F2d 488.
303. Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1379 (Fed. Cir. 1999) (referring to separate enablement, written description, and best mode requirements).
304. Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323, 56 U.S.P.Q.2d (BNA) 1481, 1483 (Fed. Cir. 2000) (explaining that the test for whether the written description requirement has been met must be assessed on a case-by-case basis).
305. Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998).
306. In re Vaeck, 947 F.2d 488, 496 (Fed. Cir. 1991) ('Where, as here, a claimed genus represents a diverse and relatively poorly understood group of microorganisms, the required level of disclosure will be greater than, for example, the disclosure of an invention involving a 'predictable' factor such as a mechanical or electrical element.').
307. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
308. In re Wilder, 736 F.2d 1516, 1521, 222 U.S.P.Q. (BNA) 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description where the specification merely outlined the goals the inventors sought to achieve).
309. But Fonar Corp. v. Gen. Elec., Co., 107 F.3d 1543, 1549, 41 U.S.P.Q.2d (BNA) 1801, 1805 (Fed. Cir. 1997) (finding, in the context of software, that disclosure of the function was adequate in that art).
310. U.S.C. §112 ¶1 contains three requirements that must be satisfied in order to obtain a patent: Written description, enablement, and best mode. 'The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.'.
311. Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997) 'In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass.
312. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus.' In re Smythe, 480 F.2d 1376, 1383 (C.C.P.A. 1973).
313. 'In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus....'. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
314. Fiers v. Revel, 984 F.2d 1164, 1168 (Fed. Cir. 1993) 'Conception does not occur unless one has a mental picture of the structure of the chemical, or is able to define it by its method of preparation, its physical or chemical properties, or whatever characteristics sufficiently distinguish it.' 'Conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it.'
315. Oka v. Youssefyeh, 849 F.2d 581, 583 (Fed. Cir. 1988). 'Conception requires (1) the idea of the structure of the chemical compound and (2) possession of an operative method of making it.' The PTO rejects patent applications for lack of written description when 'the claim or claims have encompassed more elements, compositions, utilities, and the like than those recited in the specification.'
316. In re DiLeone, 436 F.2d 1404, 1405 n.1 (C.C.P.A. 1971).
317. 'For greater clarity on this point, consider the case where the specification discusses only compound A and contains no broadening language of any kind. This might very well enable one skilled in the art to make and use compounds B and C; yet the class consisting of A, B and C has not been described.' Id.;
318. In re Ahlbrecht, 435 F.2d 908, 911 (C.C.P.A. 1971) ('In the present case, there are no negative statements that esters with two methylenes are not within what is regarded as the invention, but rather here esters wherein n is 2 were never described in explicit terms at all.').
319. Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993).
320. Fiers v. Revel, 984 F.2d 1164, 1169 (Fed. Cir. 1993). 'We thus determined that, irrespective of the complexity or simplicity of the method of isolation employed, conception of a DNA, like conception of any chemical substance, requires a definition of that substance other than by its functional utility.' 'An adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself... [A] bare reference to a DNA with a statement that it can be obtained by reverse transcription [a technique] is not a description; it does not indicate that Revel [appellant] was in possession of the DNA.'
321. Lilly, 119 F.3d at 1566. 'The name cDNA is not itself a written description of that DNA; it conveys no distinguishing information concerning its identity... it thus does not describe human insulin [protein of interest] DNA. Describing a method of preparing a cDNA or even describing the protein that the cDNA encodes...does not necessarily describe the cDNA itself.'
322. Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316 (Fed. Cir. 2002).
323. The technique of depositing biological materials originally arose as a way to satisfy the enablement requirement. By letting the public have the material, they were enabled to use it. 'We hold that reference in the specification to a deposit in a public depository, which makes its contents accessible to the public when it is not otherwise available in written form, constitutes an adequate description of the deposited material sufficient to comply with the written description requirement of §112 ¶1.' at 1326 'Although the structures of those sequences, i.e., the exact nucleotide base pairs, are not expressly set forth in the specification, those structures may not have been reasonably obtainable and in any event were not known to Enzo when it filed its application....'. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003).
324. 'In Enzo-Biochem, we clarified that Eli Lilly did not hold that all functional descriptions of genetic material necessarily fail as a matter of law to meet the written description requirement; rather, the requirement may be satisfied if in the knowledge of the art the disclosed function is sufficiently correlated to a particular, known structure.' The paradox of this court's affirmance of the holding of Enzo is that the Enzo court required no disclosure of the structure of the DNA. See supra note 133. Thus, the Amgen court failed to acknowledge what the court actually did in Enzo. The Federal Circuit has yet to apply the Enzo precedent.'
325. Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112 ¶1, 'Written Description' Requirement, 66 Fed. Reg. 1099 (January 5, 2001) at 1106.
326. The written description requirement is codified in 35 U.S.C. §112, which states that in a patent: 'the specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same...'
327. According to the United States Patent and Trademark Office (the 'PTO'), the requirement 'promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.' Janice M. Mueller, The Evolving Application of the Written Description Requirement to Biotechnological Inventions, 13 BERKELEY TECH. L.J. 615, 620-21 (1998) 'Today, the written description, rather than notifying the public at the time of patent issuance of the asserted scope of the patentee's property right, serves as a manifestation of what was within the scope of the patentee's inventive contribution 'as of his filing date. Thus, the written description requirement takes a 'snapshot' view of the inventor's contribution based on the disclosure in her specification as originally filed, and asks whether that 'snapshot' reasonably conveys to persons of ordinary skill that any subsequently-claimed subject matter was truly and fairly part of that contribution.'
328. In re Ruschig, 379 F.2d 990 (C.C.P.A 1967).
329. In re Barker, 559 F.2d 588, 591-93 (C.C.P.A. 1977), 'A specification may contain a disclosure that is sufficient to enable one skilled in the art to make and use the invention and yet fail to comply with the description of the invention requirement.'
330. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). 'This court in Wilder (and the CCPA before it) clearly recognized, and we hereby reaffirm, that 35 U.S.C. §112, first paragraph, requires a 'written description of the invention' which is separate and distinct from the enablement requirement.'
331. Lockwood, 107 F.3d 1565 (Fed. Cir. 1997).
332. In re Marzocchi 439 F.2d 220, 223 (C.C.P.A. 1971), the CCPA stated, 'In the field of chemistry generally, there may be times when the well-known unpredictability of chemical reactions will alone be enough to create a reasonable doubt as to the accuracy of a particular broad statement put forward as enabling support for a claim.'
333. F.3d 989 (Fed. Cir. 2000), reh'g en banc denied, No. 99-1066, 2000 U.S. App. 12720 (Fed. Cir. May 18, 2000) cert. denied, 531 U.S. 1183 (2001). ('The inquiry for adequate written description simply does not depend on a particular claim format, but rather on whether the patent's description would show those of ordinary skill in the petroleum refining art that the inventors possessed the claimed invention at the time of filing.')
334. Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1209-10.
335. N. Telecom Ltd. v. Samsung Elecs. Co., 215 F.3d 1281, 1288, 55 U.S.P.Q.2d (BNA) 1065, 1070 (Fed. Cir. 2000) (holding that the best mode requirement was satisfied even though thin-line etching, an unclaimed, preferred method for the process for gaseous etching of aluminum and aluminum oxides, was not disclosed in the specification because the claim sufficiently described a general process of plasma etching and the best mode for carrying out that process).
336. Bayer Corp. v. Schein Pharm. Co., Inc., 301 F.3d 1306, 1306-28 (Fed. Cir. 1991). In the invention set forth in the Bayer '444 patent, several precursor molecules were synthesizes, that were then combined together to form the chemical intermediate 6-fluoroquinolinic add ('6-FQA') that is the subject matter of the dispute in the Bayer case.
337. Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923, 928 (Fed. Cir. 1990).
338. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570, 39 U.S.P.Q.2d (BNA) 1895, 1904 (Fed. Cir. 1996) (requiring only that the disclosure in the application 'reasonably convey' to those skilled in the art that the inventor possessed the disputed subject matter).
339. This process of 'chemical synthesis' is a combination of several steps, using a reaction vessel into which the various reactants are introduced. The synthesis mix is then subjected to conditions, such as temperature, pressure change, contact with catalysts, etc. A chemist may choose to make one or more sequential 'chemical intermediates' to be used for further steps in the synthesis, or alternatively, the 'intermediates' may come from another source. Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316, 1360-30, (Fed. Cir. 2002).
340. Brenner v. Manson, 383 U.S. 519 (1966)
341. Eli Lilly & Co. v. Barr Labs., 251 F.3d 955 (Fed. Cir. 2001)
342. Chem Indus. v. U.S., 170 F. Supp. 2d 1335 (2d Cir. 2001)
343. Baoding Yude; Murphy Oil U.S. v. U.S., 81 F. Supp. 2d 942 (Ark. 1999)
344. Eli Lilly & Co. v. Am. Cyanamid Co., 82 F.3d 1568 (Fed. Cir. 1996).
345. William D. Marsillo, How Chemical Nomenclature Confused the Courts, 6 U. Balt. Intell. Prop. J. 29 (1997).
346. W.L. Gore & Associates, Inc. v. Gaarlock Inc., 721 F.2d 1540, 1557 (Fed. Cir. 1990)
347. U.S. 851 (1984)
348. In re Angstad, 537 F.2d 498 (C.C.P.A. 1976).
349. Atlas Powder, 750 F.2d 1576.
350. Fonar Corp. v. General Elec. Co., 107 F.3d 1543, 1548 (Fed. Cir. 1997)
351. U.S. Gypsum Go. v. Natl. Gypsum Co., 74 F.3d 1209, 1212 (Fed. Cir. 1996).
352. Engel Indus. v. Lockformer Co., 946 F.2d 1528, 1531 (Fed. Cir. 1991).
353. Applied Med. Res. Corp. v. United States Surgical Corp., 147 F.3d 1374, 1377 (Fed. Cir. 1998)
354. Transco Prods. Inc. v. Performance Contracting, Inc Transco Prods., 38 F.3d 553.
355. Zygo Corp. v. Wyko Corp., 79 F.3d 1563, 1567 (Fed. Cir. 1996)
356. Wahl Instruments, Inc. v. Acvious Inc., 950 F.2d 1575, 1579 (Fed. Cir. 1991).
357. Dana Corp. v. IPC Ltd. Partn., 860 F.2d 415 (Fed. Cir. 1988)
358. Spectra-Physics v. Coherent Inc., 827 F.2d 1524 (Fed. Cir. 1997)
359. Applied Med. Res. Co. v. U.S. Surgical Corp., 147 Fed. 1374, 1377 (Fed. Cir. 1998),
360. N. Telecom, Ltd. v. Samsung Elec. Co., Ltd., 215 F.3d 1281, 1288 (Fed. Cir. 2000).
361. F.3d 955 (Fed. Cir. 2001)
362. U.S.C. §103 states: Conditions for patentability; non-obvious subject matter (a)A patent may not be obtained, though the invention is not identically disclosed, or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
363. Nobelpharma AB v. Implant Innovations, 141 F.3d 1059 (Fed. Cir. 1998).
364. U.S. Const. Amend. V, 1§. The United States Constitution, Amendment XIV §1 holds; [N]o person shall be held to answer for a capital, or otherwise infamous crime, unless on a presentment or indictment of a grand jury, except in cases arising in the land or naval forces, or in the militia, when in actual service in time of war or public danger; nor shall any person be subject for the same offense to be twice put in jeopardy of life or limb; nor shall be compelled in any criminal case to be a witness against himself, nor be deprived of life, liberty, or property, without due process of law; nor shall private property be taken for public use, without just compensation.
365. Kaluzynski v. Armstrong, 2001 U.S. Dist. LEXIS 11040 (D. Me. 2001)
366. Ostergren v. Village of Oak Lawn, 125 F. Supp. 2d 312 (N.E.2d 2000)
367. Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (specifying that no amount of experimentation is preclusive if merely routine in nature). (stating that the enablement requirement is still satisfied with the necessity of experimentation, so long as the experimentation is not unduly extensive).
368. Genentech, Inc. v. Novo Nordisk, 108 F.3d 1361, 1366, 42 U.S.P.Q.2d (BNA) 1001, 1005 (Fed. Cir. 1997) (clarifying that the patent monopoly is given in exchange for enabling disclosure, 'not for vague intimations of general ideas that may or may not be workable')
369. Brenner v. Manson, 383 U.S. 519, 536, 148 U.S.P.Q. (BNA) 689, 696 (1966) ('[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.').
370. PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37 U.S.P.Q.2d (BNA) 1618, 1623 (Fed. Cir. 1996) ('In unpredictable art areas, this court has refused to find broad generic claims enabled by specifications that demonstrate the enablement of only one or a few embodiments and do not demonstrated with reasonable specificity how to make and use other potential embodiments across the full scope of the claim.').
371. 299 F.3d 1313, 1330 (Fed. Cir. 2002).
372. Wahl Instruments, Inc. v. Acvious Inc 950 F.2d 1575, 1579 (Fed. Cir. 1991).
373. Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544,1563 (Fed. Cir. 1987.)
374. F.3d 1563.
375. F.2d 510.
376. Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923, 928 (Fed. Cir. 1990).
377. Randomex, Inc. v. Scopus Corp., 849 F.2d 585-600 (Fed. Cir. 1998).
378. Dana Corp. v. IPC Ltd. Partn., 860 F.2d 415 (Fed. Cir. 1988)
379. F.2d 772
380. F.2d 1527.
381. N. Telecom, Ltd. v. Samsung Elec. Co., Ltd., 215 F.3d 1281, 1288 (Fed. Cir. 2000).
382. Bayer, 301 F.3d at 1315.
383. K. Eric Drexler, Nanotechnology: From Feynman to Funding, BULL. OF SCI., TECH. & SOC'Y, Vol. 24, No. 1, at 21-27 (Feb. 2004), available at http://www.metamodern.com/d/04/00/FeynmanToFunding.pdf.
384. Los Alamos National Laboratory, Nanoscience and Nanotechnology (Feb. 2004), at http://www.lanl.gov/news/pdf/NanoscienceFact.pdf.
385. Steve Jurvetson, Transcending Moore's Law with Molecular Electronics and Nanotechnology, 1 Nanotechnology L. & Bus. J. 70, 77 (2004).
386. Mark Ratner & Daniel Ratner, Nanotechnology: A Gentle Introduction to the Next Big Idea 7 (2003) (nanoscale circuit components don't necessarily obey Ohm's law)
387. Fantastic Voyage (1966), available at http://us.imdb.com/Title?0060397.
388. According to Richard Siegel (The Next Big Thing, MX, Sept. 28, 2001) nanotechnology could 'cause social and industrial rearrangements not unlike the industrial revolution.'
389. Mihail Roco, A Frontier For Engineering: The Aim of Nanotechnology is To Build the Future, Molecule By Molecule, 123 Mechanical Engineering 52, 54 (Jan. 2001), available at http://www.memagazine.org/backissues/jan01/ features/frontier/frontier.html. at 53 ('This technology will spawn a new kind of industrial revolution in the coming decades. Nanotechnology holds the promise of scientific breakthroughs in a wide range of fields, has an immense potential for industry and the overall economy, for better health care, and for a sustainable environment.').
390. John Falciono, Changing the Way We Live, 123 Mechanical Engineering 4, 4 (Jan. 2001). The new technology 'will change the way we live, the way we combat disease, the way we manufacture products, and even the way we explore the universe.'
391. K. Eric Drexler, Engines of Creation (1986)
392. K. Eric Drexler, et. al., Unbounding the Future (1991). National Nanotechnology Initiative: Research and Development FY 2002, available at http://www.nano.gov/2002budget.html.
393. Robert F. Service, Atom-Scale Research Gets Real; Outlook For Nanotechnology, 290 Sci. 1523, 1526 (2000).
394. Robert Freitas, Nanomedicine 2, (1999), available at http://www.foresight.org/Nanomedicine.
395. Andrew Lawler, Plans For Mars Unite Cancer, Space Agencies, 288 Sci. 415, 415 (2000)
396. M. Reza Ghadiri et. al., Antibacterial Agents Based on the Cyclic D, Lpeptide Architecture, 412 Nature 451, 452-455 (July 26, 2001).
397. David A Scheinberg et. al., Tumor Therapy With Targeted Atomic Nanogenerators, 294 Sci. 1537, 1537 (2001).
398. Elan Pharmaceutical Technologies claims that by using 'Nanocrystals', they can enhance the solubility and speed the delivery time of a drug. See Nanocrystals: Nanoparticulate Drug Delivery Technology, available at http://atlas.pharmalicensing.com/licensing/displicopp/65.
399. David Voss, Nanomedicine Nears The Clinic, 103 Tech. Rev. 60, 62 (2000).
400. Daithi O' hAnluain, Cancer Fight Dips Into Microchips, Wired News, Oct. 15, 2001, available at http://www.wired.com/news/medtech/ 0,1286,47500,00.html
401. The Smaller the Better, The Econ., June 23, 2001.
402. Gene Therapy, at http://www.fda.gov/cber/gene.htm.
403. Patrick McGee, Sizing Up Nanotechnology, Wired News, June 26, 2000, at http://www.wired.com/news/technology/0,1282,37217,00.html.
404. Kristen Philipkoski, Tiny Capsules Float Downstream, Wired News, Oct. 29, 2001, at http://www.wired.com/news/technology/0,1282,47934,00.html.
405. Bai, Q., K.D. Wise, and D.J. Anderson, A High-Yield Microassembly Structure For Three-Dimensional Microelectrode Arrays, 47 IEEE Trans. Biomed. Eng. 281, 281-89 (2000).
406. Robert Freitas, Nanomedicine 2, (1999), available at http://www.foresight.org/Nanomedicine.
407. Robert Freitas, What Would Be The Biggest Benefit To Be Gained For Human Society From Nanomedicine?, at http://www.foresight.org/Nanomedicine/ NanoMedFAQ.html#FAQ19.
408. Robert Freitas, Nanomedicine Art Gallery, at http://www.foresight.org/ Nanomedicine/Gallery/Species/Microbivores.html.
409. Paul Sharke, hybrid NEMS, 123 Mechanical Engineering 42, Feb. 2001, at 42, available at http://www.memagazine.org/backissues/feb01/features/ nems/nems.html.
410. State St. Bank & Trust Co. v. Signature Fin. Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998) (holding that the concrete transformation of data made a mathematical algorithm patentable).
411. Compare Brenner v. Manson, 383 U.S. 519, 534-5 (1966) (holding that a process patent may only be granted 'where specific benefit exists in currently available form'),
412. with In re Brana, 51 F.3d 1560, 1568 (Fed. Cir. 1995) (noting that 'usefulness in patent law ... in the context of pharmaceutical inventions, necessarily includes the expectation of future R&D').
413. Compare Graham v. John Deere Co., 383 U.S. 1 (1966) (holding that an inquiry into the obviousness of an invention is a prerequisite to patentability),
414. with In re Deuel, 51 F.3d 1552, 1559 (Fed. Cir. 1995) ('A general incentive [to try] does not make obvious a particular result.').
415. O'Reilly v. Morse, 56 U.S. (15 How.) 62, 112 (1853)
416. Gottschalk v. Benson, 409 U.S. 63 (1972)
417. Parker v. Flook, 437 U.S. 584 (1978).
418. Bayh-Dole Act of 1980, 35 U.S.C. §200-212.
419. Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 Va. L. Rev. 1575 (2003) (making the argument for strong patent protection of pharmaceuticals).
420. Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1479 (Fed. Cir. 1998)
421. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997 ('Claims may be no broader than the supporting disclosure, and therefore ... a narrow disclosure will limit claim breadth.') at 1480 (deciding that narrowness of the specification limited the plaintiff's claims so as to preclude a finding of infringement outside the scope of the specification).
422. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc) ('Claims must be read in view of the specification, of which they are a part.').
423. John C. Miller et al., The Handbook of Nanotechnology: Business, Policy, and Intellectual Property Law 224 (2005) ('In many different areas of nanotechnology, the intellectual property landscapes are fragmented. A large number of patents held by different entities cover similar inventions and improvements to the same invention.')
424. Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 9 (1966) ('The patent monopoly was not designed to secure to the inventor his natural right in his discoveries. Rather, it was a reward, an inducement, to bring forth new knowledge.')
425. Mazer v. Stein, 347 U.S. 201, 219 (1954) ('The economic philosophy behind the clause empowering Congress to grant patents and copyrights is the conviction that encouragement of individual effort by personal gain is the best way to advance public welfare)
426. Fogerty v. Fantasy, Inc., 510 U.S. 517, 524 (1994) ('The primary objective of the Copyright Act is to encourage the production of original literary, artistic, and musical expression for the good of the public.')
427. Feist Publ'ns, Inc. v. Rural Tel. Serv. Co., 499 U.S. 340, 349-50 (1991) (stating that the 'primary objective of copyright' is to promote public welfare)
428. Stewart v. Abend, 495 U.S. 207, 224-25 (1990) (noting the Copyright Act's 'balance between the artist's right to control the work ... and the public's need for access')
429. Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 167 (1989) (noting the 'careful balance between public right and private monopoly to promote certain creative activity')
430. Sony Corp. of Am. v. Universal City Studios, Inc., 464 U.S. 417, 429 (1984) (stating that the limited monopoly conferred by the Copyright Act 'is intended to motivate creative activity of authors and inventors... and to allow the public access to the products of their genius after the limited period of exclusive control has expired')
431. Twentieth Century Music Corp. v. Aiken, 422 U.S. 151, 156 (1975) (noting that 'private motivation must ultimately serve the cause of promoting broad public availability of literature, music, and other arts')
432. Goldstein v. California, 412 U.S. 546, 559 (1973) (discussing Congress's ability to provide for the 'free and unrestricted distribution of a writing' if required by the national interest)
433. Fox Film Corp. v. Doyal, 286 U.S. 123, 127 (1932) ('The sole interest of the United States and the primary object in conferring the monopoly lie in the general benefits derived by the public from the labors of the authors.')
434. Robert P. Merges & Richard R. Nelson, On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 893 (1990).
435. Rebecca S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. CHI. L. REV. 1017, 1072-73 (1989) ('The risk that the parties will be unable to agree on terms for a license is greatest when subsequent researchers want to use prior inventions to make further progress in the same field in competition with the patent holder, especially if the research threatens to render the patented invention technologically obsolete.').
436. Kenneth W. Dam, The Economic Underpinnings of Patent Law, 23 J. LEGAL STUD. 247, 252 (1994) (noting that in the computer industry, for example, companies coordinate improvements by broad cross-licensing because of 'the pace of research and development and the market interdependencies between inventions').
437. Tate Access Floors v. Architectural Resources, 279 F.3d 1357 (Fed. Cir. 2002) purported to abolish the doctrine, or at least to say it was coextensive with the reach of 35 U.S.C. 1§12, 6.
438. But the Federal Circuit reaffirmed the validity of the doctrine not long after in Amgen, Inc. v. Hoechst Marion Roussel, 314 F.3d 1313 (Fed. Cir. 2003).
439. Lowell v. Lewis, 15 F. Cas. 1018, 1019 (C.C.D. Mass. 1817) ('All that the law requires is, that the invention should not be frivolous or injurious to the well-being, good policy, or sound morals of society.').
440. Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 VA. L. REV. 1575, 1576-77 (2003) ('In theory, then, we have a uniform patent system that provides technology-neutral protection to all kinds of innovation.').
441. Rebecca S. Eisenberg, Analyze This: A Law and Economics Agenda for the Patent System, 53 VAND. L. REV. 2081, 2086 (2000) ('The courts treat the utility requirement as a hybrid subject matter limitation and disclosure requirement.'). at 2085-86 ('Although the utility requirement has played little role in evaluating the patentability of mechanical inventions, it has been more prominent in the chemical and biotechnology fields, in which new compounds are often discovered before their functions are well understood.')
442. R. CARL MOY, MOY'S WALKER ON PATENTS §6:6 (4th ed. 2003) ('As this statement of the trend indicates, the effort is closely related to the concepts of adequate disclosure that are applied under the first paragraph of section 112, and there are considerable arguments in favor of classifying the rules there.').
443. Teresa M. Summers, Note, The Scope of Utility in the Twenty-First Century: New Guidance for Gene-Related Patents, 91 GEO. L.J. 475, 475 (2003) ('To a significant extent, the specific industry sought to be promoted through the patent system influences the boundaries of the law.').
444. Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1206 (Fed. Cir. 1991).
445. Arti K. Rai, The Information Revolution Reaches Pharmaceuticals: Balancing Innovation Incentives, Cost, and Access in the Post-Genomics Era, 2001 U. ILL. L. REV. 173, 195 n.100 (2001) (arguing that 'the Federal Circuit[] views biotechnology as a subset of chemistry and is thus unlikely to decide biotechnology cases by drawing upon analogies from mechanical cases').
446. F.3d 1559 (Fed. Cir. 1996).
447. Stiftung v. Renishaw PLC, 945 F.2d 1173, 1180 (Fed. Cir. 1991) ('An invention need not be the best or the only way to accomplish a certain result, and it need only be useful to some extent and in certain applications.').
448. In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995).
449. CFMT, Inc. v. Yieldup Int'l Corp., 349 F.3d 1333, 1339 (Fed. Cir. 2003) ('The inoperability standard for utility applies primarily to claims with impossible limitations.')
450. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1359 (Fed. Cir. 1999) (When an impossible limitation, such as a nonsensical method of operation, is clearly embodied within the claim, the claimed invention must be held invalid.').
451. In re Cortright, 165 F.3d 1353, 1357 (Fed. Cir. 1999) (requiring the PTO to presume an invention's utility 'unless it has reason to doubt the objective truth of the statements contained in the written description').
452. Newman v. Quigg, 877 F.2d 1575, 1581-82 (Fed. Cir. 1989) (holding that a perpetual motion machine was not patentable).
453. BlackLight Power, Inc. v. Rogan, 295 F.3d 1269, 1271 (Fed. Cir. 2002) (upholding the PTO's withdrawal of an application even after the issue fee had been paid because 'the applicant was claiming the electron going to a lower orbital in a fashion that [the Group Director] knew was contrary to the known laws of physics and chemistry').
454. In re Cortright 165 F.3d 1353 (Fed. Cir. 1999).
455. Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1366 (Fed. Cir. 1999) (An invention is 'useful' under section 101 if it is capable of providing some identifiable benefit.')
456. Utility Examination Guidelines, 66 Fed. Reg. 1092, 1094 (Jan. 5, 2001) ('The utility requirement, as explained by the courts, only requires that the inventor disclose a practical or real world benefit available from the invention....)
457. Matthew J. Vlissides, Jr., Are Second-Generation DNA Sequence Useful?: A Defense of Theorized Protein Patents, 11 FED. CIR. B.J. 901, 917 (2002) ('Thus, in order to prove substantial utility, the new guidelines force applicants to explain the utility of targeted genes, or their expressed proteins, in terms of a real world use, rather than a research use alone.').
458. F.2d 1197 (Fed. Cir. 1993).
459. Richard E. Smalley, Of Chemistry, Love, and Nanobots, SCI. AM., Sept. 2001, at 77 (arguing further that problems with assemblers 'are fundamental, and [cannot] be avoided')
460. see also Robert F. Service, Is Nanotechnology Dangerous?, 290 SCI. 1526, 1527 (2000) (arguing that analogizing assemblers to biological systems represents 'a flawed extrapolation').
461. Brenner v. Manson. 383 U.S. 519 (1966).
462. Natalie M. Derzko, In Search of a Compromised Solution to the Problem Arising from Patenting Biomedical Research Tools, 20 SANTA CLARA COMPUTER & HIGH TECH. L.J. 347, 348 (2004) (noting, in the context of biotechnology, that '[t]here [is] a broad range of materials that might be termed 'research tools' because they can be used in the course of biomedical or biotechnological research').
463. Arti K. Rai, Engaging Facts and Policy: A Multi-Institutional Approach to Patent System Reform, 103 COLUM. L. REV. 1035, 1070-71 (2003) ('If the PTO were to have granted patents - particularly broad patents - on large numbers of these relatively trivial upstream inventions, there is reason to fear that downstream research might have been delayed or perhaps even blocked.').
464. Lance D. Reich, Protecting Tiny Gizmos: The Patent and Trademark Office Is Preparing for Nanotech Applications, NAT'L L.J., Jan. 26, 2004, at S1 ('A potential problem with the lack of a unique classification for nanotechnology-specific prior art is that the examiner may have a difficult time locating the best available prior art to a nanotech patent application.')
465. see also Stephen B. Maebius, Key Considerations in Protecting Your Intellectual Property in Nanotechnology, 4 J. NANOPARTICLE RES. 373, 373 (2002) ('In addition, patents in this area may be broad in scope if there is no known previous work that would give the Patent Office a basis for limiting the scope of the claims.').
466. Beth Quinlivan, Bio's Star Turn, BUS. REV. W KLY., Sept. 25, 2003, at 54.
467. Linda J. Demaine & Aaron Xavier Fellmeth, Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent, 55 STAN. L. REV. 303, 307 (2002) ('Sequencing has also become far less laborious. The ability of scientists to rapidly sequence DNA has resulted in an explosion of discoveries of DNA sequences - both meaningful and meaningless scientifically - that, in turn, has caused a deluge of patent applications claiming DNA sequences and the proteins and other biochemicals for which these sequences code.')
468. Rebecca S. Eisenberg, Re-Examining the Role of Patents in Appropriating the Value of DNA Sequences, 49 EMORY L.J. 783, 785 (2000) ('As DNA sequence discovery has moved beyond targeted efforts to clone particular genes to large-scale, high-throughput sequencing of entire genomes, new questions have emerged.').
469. MICHAEL PYCRAFT HUGHES, NANOELECTROMECHANICS IN ENGINEERING AND BIOLOGY 4 (2003) ('For example, at a fundamental level, chemistry is the original nanotechnology, where custom molecules are delivered to order.').
470. Nathan Machin, Comment, Prospective Utility: A New Interpretation of the Utility Requirement of Section 101 of the Patent Act 87 CAL. L. REV. 421, 434 (1999) (noting that one type of biotechnology called Express Sequence Tags (ESTs) has a 'method of isolation [that] provides very little clue as to the processes in which they are involved, much less their precise roles within that process').
471. J.K. Gimzewski et al., Rotation of a Single Molecule Within a Supramolecular Bearing, 281 SCI. 531, 531 (1998) (describing 'the real-space realization of single-molecule rotors surrounded by like molecules that form a supramolecular bearing').
472. Fiers v. Revel, 984 F.2d 1164, 1169 (Fed. Cir. 1993).
473. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)
474. Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1208-09 (Fed. Cir. 1991).
475. Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir. 2004).
476. In re Kirk, 376 F.2d 936, 961 (C.C.P.A. 1967) (Rich. J., dissenting) (Brenner's utility requirement would never be 'indulged in with respect to other scientific 'tools' or a mechanical or optical or electronic sort.')
477. Ted Sabety, Nanotech Innovation and the Patent Thicket: Which IP Policies Promote Growth?, 1 Nanotechnology L. & Bus. J. 262 (2004).