11998 Janice M. Mueller

Assistant Professor of Law, Suffolk University (Boston). David Conlin, Warren Woessner, Anne Craig, and Anita Varma provided helpful criticism. I am grateful for the research assistance of Thomas Johnston.

2. 35 U.S.C. 112 (1994).

3. 379 F.2d 990 (C.C.P.A. 1967).

4. Id. at 995 (characterizing issue on appeal as "not whether [one skilled in the art] would be so enabled but whether the speciûcation discloses the compound to him, speciûcally, as something appellants actually invented").

5. 119 F.3d 1559 (Fed. Cir. 1997); see also A Bitter Battle over Insulin Gene, 277 SCIENCE 1028, 1028 (1997) (describing suit as a "vicious ûght [that] centers on a landmark discovery by [University of California at San Francisco] biologists at the dawn of the biotechnology era: the ûrst successful cloning of the rat insulin gene") [hereinafter Bitter Battle].

6. Deoxyribonucleic acid (DNA) consists of two complementary strands of nucleotides, which include the four basic compounds adenine (A), guanine (G), cytosine (C), and thymine (T), oriented so that bases from one strand non-covalently bond to the bases of the opposite strand. See Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1207 n.4 (Fed. Cir. 1991).

7. Central claiming of an invention refers to the drafting of a narrow claim to a particular embodiment with broad judicial interpretation of that claim as covering all equivalents. Peripheral claiming or deûnition of an invention involves reciting the periphery or boundaries thereof and ûnding only those devices infringing that fall within the periphery. See Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 62 F.3d 1512, 1565 (Fed. Cir. 1995) (Nies, J., dissenting).

8. Patent Act of 1790, 2, 1 Stat. 109, 110 (repealed 1793). For a detailed discussion of the statutory development of the written description requirement from the Patent Act of 1790 through the Patent Act of 1952, see In re Barker, 559 F.2d 588, 592-93 (C.C.P.A. 1977).

9. 20 U.S. (7 Wheat.) 356 (1822).

10. Id. at 358-59.

11. Id. at 364-66.

12. Id. at 434 (quoting Patent Act of 1793, 3, 1 Stat. 318, 321 (repealed 1836)). The "description" language of section 3 of the Patent Act of 1793, interpreted by the Evans Court, substantially tracked the Patent Act of 1790:

[E]very inventor, before he can receive a patent ... shall deliver a written description of his invention, and of the manner of using, or process of compounding the same, in such full, clear, and exact terms, as to distinguish the same from all other things before known, and to enable any person skilled in the art ... to make, compound, and use the same.

Patent Act of 1793, 3, 1 Stat. 318, 321 (repealed 1836).

13. Evans, 20 U.S. (7 Wheat.) at 434.

14. Id. at 435.

15. Id. at 433-34 (stating with respect to the enablement requirement that "[i]t is not pretended that the plaintiff's patent is not in this respect sufûciently exact and minute in the description").

16. Id. at 434.

17. See Markman v. Westview Instruments, Inc. 517 U.S. 370, 375 (1996) (explaining that "[c]laim practice did not achieve statutory recognition until the passage of the Act of 1836 and inclusion of a claim did not become a statutory requirement until 1870 ... '[T]he idea that the claim is just as important if not more important than the description and drawings did not develop until the Act of 1870 or thereabouts.'") (citations omitted)).

18. See Evans, 20 U.S. (7 Wheat.) at 434 (stating that one object of a patent speciûcation is "to put the public in possession" of the claimed invention).

19. 35 U.S.C. 112, 2 (1994).

20. See Markman, 517 U.S. at 379 (explaining that "inclusion of a claim did not become a statutory requirement until 1870 ...").

21. Cf. In re Barker, 559 F.2d 588, 594 (C.C.P.A. 1977) (Rich, J., concurring) (noting "evolutionary history of the language of 112 whose "words are of ancient lineage and, in spite of the fact they are inappropriate to some situations, they were preserved, in writing the Patent Act of 1952, because they were familiar and had many times been construed").

22. 379 F.2d 990 (C.C.P.A. 1967).

23. See Harris A. Pitlick, Looking Beyond Blazemarks on Trees-It's Time to Revisit the Description Requirement in the Wake of Warner-Jenkinson, 79 J. PAT. & TRADEMARK OFF. SOC'Y 625, 628 & n.12 (1997) (characterizing Ruschig as "ûrst identif[ying] in 1967 the written description requirement").

24. Ruschig, 379 F.2d at 991 (noting that the claim at issue was added for purposes of invoking interference on September 25, 1957 in an application ûled on July 31, 1956).

25. Id. at 995.

26. 481 F.2d 910 (C.C.P.A. 1973)

27. Id. at 914.

28. 935 F.2d 1555 (Fed. Cir. 1991).

29. Id. at 1561 (quoting Rengo Co. v. Molins Mach. Co., 657 F.2d 535, 551 (3d Cir. 1981)).

30. See Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443, 449 (Fed. Cir. 1986) (stating that prior art against which claims are analyzed for nonobviousness "must have existed as of the date of invention, presumed to be the ûling date of the application until an earlier date is proved").

31. See 35 U.S.C. 102(a) (1997) (stating that an invention is not patentable if "known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant ..."); id. 102(e) (stating that an invention is not patentable if "described in a patent granted on an application for patent by another ûled in the United States before the invention thereof by the applicant for patent ..."); id. 102(g) (stating that an invention is not patentable if "before the applicant's invention thereof the invention was made in this country by another who had not abandoned, suppressed, or concealed it"); id. 103(a)(1)(A) (stating that an invention is not patentable though novel "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").

32. See In re Smith, 481 F.2d 910, 914 (C.C.P.A. 1973) ("Compliance with the ûrst paragraph of 112 is adjudged from the perspective of the person skilled in the relevant art.").

33. The written description requirement thus shares a mixed "subjective/objective" perspective with the best mode inquiry of section 112 of the Patent Act. Analysis of best mode compliance includes two elements: (1) whether, at the time the inventor ûled his patent application, he knew of a mode of practicing his claimed invention that he considered to be better than any other; and (2) if the inventor in fact contemplated such a preferred mode, whether the disclosure is adequate to enable one skilled in the art to practice the best mode. See Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923, 927-28 (Fed. Cir. 1990).

34. See 35 U.S.C. 112, 1 ("The speciûcation shall contain a written description of the invention, and of the manner and process of making and using it ...."); id. 112, 2 ("The speciûcation shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention."). Drawings must also be furnished "where necessary for the understanding of the subject matter sought to be patented." Id. 113.

35. In re Ruschig, 379 F.2d 990, 996 (C.C.P.A. 1967) (emphasis in original).

36. 481 F.2d 910 (C.C.P.A. 1973).

37. Id. at 914 (citing Ruschig, 379 F.2d at 996).

38. Smith, 481 F.2d at 914.

39. Ruschig, 379 F.2d at 991.

40. Claim 13 of Ruschig's application recited, "13. N-(p-chlorbenzenesulfonyl)-N-propylurea." Id.

41. Id. at 994 (agreeing with appellants and the Board that "naming is not essential ...").

42. The Ruschig court analogized the speciûcation's lack of guidance in identifying the compound of claim 13 to the lack of "blaze marks" on a forest trail:

It is an old custom in the woods to mark trails by making blaze marks on the trees. It is no help in ûnding a trail or in ûnding one's way through the woods where the trails have disappeared-or have not yet been made, which is more like the case here-to be confronted simply by a large number of unmarked trees. Appellants are pointing to trees. We are looking for blaze marks which single out particular trees. We see none.

Ruschig, 379 F.2d at 994-95.

43. Id. at 995.

44. 835 F.2d 1419, 1420 (Fed. Cir. 1987).

45. Id. at 1419.

46. Id. at 1420 (noting that parent application did not mention "equiaxed microstructure" property, nor state the requirements for forming such microstructure).

47. Id.

48. Id. at 1423 (holding that "[t]he disclosure in a subsequent patent application of an inherent property of a product does not deprive that product of the beneût of an earlier ûling date. Nor does the inclusion of a description of that property in later-ûled claims change this reasonable result.").

49. 935 F.2d 1555 (Fed. Cir. 1991).

50. Id. at 1558. The claimed catheter required a return lumen diameter "substantially less than 1.0 but substantially greater than 0.5 times" the diameter of the combined lumens. Id. at 1566.

51. Id. at 1565.

52. Id. at 1566 (pointing to an afûdavit of the plaintiff's physician witness as explaining "why one of skill in the art of catheter design and manufacture, studying the drawings of the '081 application in early 1982, would have understood from them that the return lumen must have a diameter within the range recited by independent claims 1 and 7 of the '329 patent").

53. 982 F.2d 1527 (Fed. Cir. 1992).

54. Firmware code is permanently stored in read-only memory (ROM).

55. Id. at 1533.

56. Id. at 1533-34.

57. Id. at 1534.

58. Id.

59. 480 F.2d 1376 (C.C.P.A. 1973).

60. Id. at 1384.

61. Id. at 1377-78 (describing the invention and reproducing representative claims 34 and 47).

62. Id. at 1377.

63. Id. at 1378.

64. Id. at 1382.

65. Id. at 1383. The court also relied on the fact that prior art patents showed the use of liquids as segmentizing media. Id. (describing disclosure of Kessler patent); id. at 1384 (characterizing Kessler patent as "additional evidence of the knowledge of one skilled in the automatic sample analysis art [that] supports appellants' position that to such persons appellants' description conveys the idea of using inert fluids broadly").

66. Id. at 1384.

67. Id. The Smythe court provided the following oft-cited example to illustrate its point: If the original written description of a patent application directed to the "scales of justice" disclosed only a one-pound "lead weight" as a counterbalance to determine the weight of a pound of flesh, the applicant should not be prevented by the written description requirement from later more broadly claiming the counterbalance as a "metal weight" or even generically as a one-pound "weight." Although a "metal weight" or a one-pound "weight" are both broader than the expressly disclosed one-pound "lead weight," they are "obviously art-recognized equivalent[s]." The broader claims should be permitted because the applicant's disclosure of the "use and function" of the "lead weight" as a counterbalance would immediately convey to others that the applicant had invented a scale with a one-pound counterbalance weight, "regardless of its composition." Id. at 1384.

68. See Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559, 1562 (Fed. Cir. 1997).

69. Bitter Battle, supra note 4, at 1029 (remarks of William Rutter, former University of California, San Francisco scientist and current chair of Chiron Corporation, Emeryville, California). UC's successful isolation of the rat insulin gene represented "the ûrst time the entire genetic sequence for an insulin gene had been spelled out ...." Id.

70. Lilly, 119 F.3d at 1562-63.

71. See Regents of the University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d (BNA) 1225, 1227 (S.D. Ind. 1995). Lilly did not assert written description non-compliance with respect to the second UC patent in suit, U.S. Patent No. 4,431,740. See id. at 1241 (discussing Lilly's anticipation and enablement challenges to the '740 patent).

72. "Complementary" DNA (cDNA) is a complementary copy or "clone" of messenger RNA (mRNA), made in the laboratory by reverse transcription of mRNA. A cDNA contains only the protein-encoding regions of DNA. See In re Deuel, 51 F.3d 1552, 1554 (Fed. Cir. 1995).

73. The claims of UC's '525 patent provided:

1. A recombinant plasmid replicable in procaryotic host containing within its nucleotide sequence a subsequence having the structure of the reverse transcript of an mRNA [cDNA] of a vertebrate, which mRNA encodes insulin.

2. A recombinant procaryotic microorganism modiûed to contain a nucleotide sequence having the structure of the reverse transcript of an mRNA of a vertebrate, which mRNA encodes insulin ....

4. A microorganism according to claim 2 wherein the vertebrate is a mammal.

5. A microorganism according to claim 2 wherein the vertebrate is a human.

6. A plasmid according to claim [1] comprising a plasmid containing at least one genetic determinant of col E1.

7. A microorganism according to claim 2 comprising a strain of Escherichia coli.

Lilly, 39 U.S.P.Q.2d at 1258 nn. 23 & 24.

74. Id. at 1227.

75. Lilly, 119 F.3d at 1562.

76. Lilly, 39 U.S.P.Q.2d at 1240.

77. Lilly, 119 F.3d at 1567. Example 6 was added to the application corresponding to the '525 patent in 1978. See Lilly, 39 U.S.P.Q.2d at 1240 (noting that the application "was expanded on April 19, 1978, to add example six, relating to the potential isolation of human DNA").

78. Lilly, 39 U.S.P.Q.2d at 1240 (stating that "it was not until nearly two years after the original application for the '525 [patent] was ûled that UC inventors actually isolated and characterized human insulin cDNA"); id. at 1243 (stating that "UC contends that the [human proinsulin amino acid] sequence was not known until [the September 12, 1979 ûling date of UC's '740 patent], at which time inventors of the '740 patent actually isolated and characterized the human source DNA that codes for proinsulin").

79. Id. at 1239-41 (identifying the "written description requirement" as the only issue of invalidity raised with respect to '525 patent); see also Federal Circuit Rules it Takes More Than One cDNA Sequence to Claim a Genus, III INTELL. PROP. LAWCAST (Dec. 29, 1997) (audio interview of UC counsel Harold J. McElhinny) (stating that Lilly never raised non-enablement as a defense to UC's '525 patent).

80. Bitter Battle, supra note 4, at 1029.

81. Lilly, 39 U.S.P.Q.2d at 1239.

82. Id. at 1227.

83. Id. at 1241 (holding that "the speciûcation of the '525 patent adequately describes only the rat insulin cDNA; the inventors' claims to the genera of vertebrates and mammals and to the human species are invalid").

84. Id. at 1240.

85. Id. at 1241 (emphasis added).

86. Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559, 1569 (Fed. Cir. 1997).

87. Id. at 1567.

88. Id. (contrasting the lack of human cDNA sequence data with UC's provision of rat cDNA sequence data in example 5 of the '525 patent).

89. Id.

90. Id. at 1566 (citing the "precise deûnition" standard of Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)).

91. 984 F.2d 1164 (Fed. Cir. 1993). For a further discussion of Fiers, see infra part IV.B.1.

92. Fiers, 984 F.2d at 1171.

93. The Fiers decision in turn extended the holding of Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991), into the written description arena. The Amgen court held that conception of a DNA invention "has not been achieved until reduction to practice has occurred, i.e., until after the gene has been isolated." Id. at 1206. Correspondingly, the Fiers court held that "[i]f a conception of a DNA requires a precise deûnition, such as by structure, formula, chemical name, or physical properties, as we have held, then a description also requires that degree of speciûcity." Fiers, 984 F.2d at 1171.

94. Fiers, 984 F.2d at 1172.

95. 51 F.3d 1552 (Fed. Cir. 1995). For a further discussion of Deuel, see infra part IV.B.2.

96. Deuel, 51 F.3d at 1558.

97. Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559, 1567 (Fed. Cir. 1997).

98. Id. at 1569 (rejecting "UC's argument that the district court clearly erred in ûnding claims 1, 2, 4, 6 and 7 invalid for failure to provide an adequate written description").

99. Id. at 1568-69 (citation omitted).

100. Id. at 1568 (citing Fiers v. Revel, 984 F.2d 1164, 1169-71 (Fed. Cir. 1993)).

101. Lilly, 119 F.3d at 1568.

102. Id.

103. 379 F.2d 990 (C.C.P.A. 1967).

104. Id. at 991.

105. Id. at 994.

106. 481 F.2d 910 (C.C.P.A. 1973).

107. Id. at 914 (citations omitted).

108. See, e.g., In re Smythe, 480 F.2d 1376, 1382-85, 1385 n.5 (C.C.P.A. 1973) (addressing whether the written description and original claims adequately supported "inert fluid" limitation added by preliminary amendment).

109. In re Wright, 866 F.2d 422, 424 (Fed. Cir. 1989); see also MANUAL OF PATENT EXAMINING PROCEDURE 2163.03(a) (Rev. 2, July 1996) (citing Wright for the proposition that "[a]n amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as ûled").

110. 436 F.2d 1033 (C.C.P.A. 1971).

111. 475 F.2d 1389 (C.C.P.A. 1973).

112. Id.

113. Id. at 1391 (citation omitted). The CCPA conûrmed the Gardner holding that originally ûled claims constitute part of the disclosure in In re Koller, 613 F.2d 819, 823 (C.C.P.A. 1980) (citing Gardner for the proposition that "original claims constitute their own description"). The Koller court held that method claims reciting the term "liquid medium," presented in a continuing application, were supported in accordance with section 112 of the Patent Act by a grandparent application's claims that used the same terminology. Id. at 823 ("the term 'liquid medium' is found in both places [and] the two sets of claims are similar in wording").

114. Gardner, 480 F.2d at 879.

115. Id.

116. See 35 U.S.C. 112, 2 (1994) (requiring that the "speciûcation shall conclude with one or more claims ...").

117. Id.

118. In re Smith, 481 F.2d 910, 914 (C.C.P.A. 1973) (citing In re Gardner, 475 F.2d 1389 (C.C.P.A.), denying reh'g, 480 F.2d 879 (C.C.P.A. 1973), and In re DiLeone, 436 F.2d 1303 (C.C.P.A. 1971)); see also In re Wertheim, 541 F.2d 257, 264 (C.C.P.A. 1976) (citing Gardner as support for holding that the claim on appeal, "an originally ûled claim, is its own written description in the appealed application").

119. 76 F.3d 1168 (Fed. Cir. 1996).

120. Id. at 1171 (explaining that '451 application on appeal was ûled in 1983 as a continuation-in-part of a parent application ûled in 1982 and later abandoned); id. (describing Board's holding that "the speciûc polypeptide of claim 70 was not described in the original speciûcation of application Serial No. 06/483,451"); id. at 1173 (restating examiner's ûnal rejection that "the speciûcation did not convey that Alton had possession of the subject matter of claim 70 as of April 15, 1983-the ûling date of the '451 application").

121. "Modiûcation (1)" refers to the deletion of the ûrst three amino acids of the natural 146-amino acid chain of IFN-g coupled with the placement of the amino acid methionine at the beginning of the amino acid sequence of the resulting IFN-g . Id. at 1171 (comparing claim 70 with example 5).

122. "Modiûcation (2)" refers to the substitution of an asparagine, the 81st amino acid in the IFN-g chain, with lysine. Id. (comparing claim 70 with example 5).

123. The expert declaration asserted that modiûcations (1) and (2), both possessed by the example 5 analog, were independent of each other, and thus that the description of both modiûcations constituted a description of each separate modiûcation. Id. at 1176.

124. 115 F.3d 942 (Fed. Cir. 1997).

125. Id. at 943-44 (characterizing the invention as relating to a "device for reconstructing the spatial current distribution in a biological object, such as a patient's head or brain, within which object volume elements exhibit current distributions produced by current sources in the object," and reproducing appealed claims 8 and 9 which recited "means for reconstructing the current distributions" and "reconstruction means for determining the current distributions," respectively).

126. Id. at 944.

127. Id.

128. Id. at 946.

129. Id.

130. On the merits, the Dossel court held that section 112 was satisûed. The application's written description in combination with the language of claims 8 and 9 constituted a sufûcient disclosure of structure corresponding to the "reconstructing means."

131. Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559, 1567 (Fed. Cir. 1997).

132. Currently unresolved is the potential for application of Lilly's narrow "description by structure" requirement to biotechnological subject matter other than genes. Claims to antibodies, for example, are typically supported by descriptions of the antibody's binding function rather than its structure. See Kate H. Murashige, Genome Research and Traditional Intellectual Property Protection-A Bad Fit?, 7 RISK: HEALTH, SAFETY AND ENV'T 231, 234 (1996) (stating that PTO practice is to grant protection for antibodies claimed "in entirely functional terms").

133. 427 F.2d 833 (C.C.P.A. 1970).

134. Id. at 839 (explaining that "[i]n cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement .... In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved").

135. Id. at 836.

136. See KENNETH J. BURCHFIEL, BIOTECHNOLOGY AND THE FEDERAL CIRCUIT 7.2(a), at 150 (1995). Burchûel contends that:

[a] written description of such a biotechnology invention [as in Fisher] does not require that the speciûcation recite the nucleic acid sequence of a gene invention, or the amino acid sequence of a polypeptide product .... Since a chemical compound inherently has a structure, claims may be added deûning that structure, and the same disclosure may be added to the speciûcation without introducing 'new matter' prohibited under 35 U.S.C. 132.

Id. (citation omitted).

137. Fisher's method involved extracting ACTH from the frozen pituitary glands of hogs, sheep, cows, or other animals, including whales. Fisher, 427 F.2d at 834.

138. Id.

139. Id. at 835 (reciting claim 4).

140. Id. at 836.

141. Id.

142. Id.

143. Id. The court explained that Fisher's parent application "discloses treatment of hog pituitary extracts," and relied on the intervening Li reference's disclosure of the amino acid sequence for porcine (hog) ACTH to conclude that "[t]he hog-extracted products disclosed in [Fisher's] parent application must therefore have had the recited sequence." Id.

144. The Fisher court ultimately afûrmed the PTO's section 112 rejection on a different rationale: that the parent speciûcation did not enable those skilled in the art to make ACTHs as broadly as recited in CIP claim 4, which was not limited to polypeptides containing the 39 amino acids inherently present in the hog, beef, and lamb ACTH extracts disclosed in Fisher's parent application. Id.

145. The count at issue in Fiers recited: "A DNA which consists essentially of a DNA which codes for a human ûbroblast interferon-beta polypeptide." Fiers v. Revel, 984 F.2d 1164, 1166 (Fed. Cir. 1993).

146. Id. at 1171-72.

147. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991).

148. Fiers, 984 F.2d at 1167-69 (characterizing Amgen as requiring reduction to practice evidenced by isolation of the gene in order to establish date of conception for gene claimed per se, rather than claimed in product-by-process format).

149. Fiers, 984 F.2d at 1167.

150. Id. at 1170.

151. Id.

152. Id. at 1171. Without citation to any authority, the Fiers court asserted that "[a]n 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." Id. at 1170.

153. Id. at 1171 (concluding that "one cannot describe what one has not conceived").

154. Cf. id. at 1169 (noting that "[w]hile one does not need to have carried out one's invention before ûling a patent application, one does need to be able to describe that invention with particularity").

155. See In re Ruschig, 379 F.2d 990, 995 (C.C.P.A. 1967) (analyzing written description compliance by asking whether speciûcation disclosed later-claimed invention "as something appellants actually invented").

156. The statute provides:

A person shall be entitled to a patent unless ...

(g) before the applicant's invention thereof the invention was made in this country by another who had not abandoned, suppressed, or concealed it. In determining priority of invention there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was ûrst to conceive and last to reduce to practice, from a time prior to conception by the other.

35 U.S.C. 102(g) (1994).

157. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991) (quoting Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987)).

158. See Amgen, 927 F.2d at 1206 (agreeing with district court that claimed gene encoding human EPO was not conceived until reduced to practice through isolation of the gene).

159. See id. at 1207 (noting that evidence in the record indicating that "several companies, as well as Amgen and GI, were unsuccessful using Fritsch's approach"). The Amgen court speciûcally based its afûrmance of the trial court's holding that an adequate conception of the DNA sequence was not achieved until reduction to practice on "the uncertainties of the method and lack of information concerning the amino acid sequence of the EPO protein." Id.; see also Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1229 (Fed. Cir. 1994) (citing Amgen for the proposition that "conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the speciûcity of the inventor's idea that it is not yet a deûnite and permanent reflection of the complete invention as it will be used in practice").

160. See Burroughs, 40 F.3d at 1228 (citing Coleman v. Dines, 754 F.2d 353, 359 (Fed. Cir. 1985)); see also Field v. Knowles, 183 F.2d 593, 600-01 (C.C.P.A. 1950) (holding that, to establish priority of invention, "the conception and disclosure to others required is the inventor's completed thought expressed in such clear terms as to enable those skilled in the art ... to make ... the ... compound ... which constitutes the subject matter of the invention").

161. See 35 U.S.C. 282 (1994) ("[a] patent shall be presumed valid"). Moreover, the methods disclosed by UC in the '525 application were those that it later used with success to isolate the human proinsulin cDNA. See Regents of the University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d (BNA) 1225, 1239 (S.D. Ind. 1995).

162. See Stephen A. Bent & Paul M. Booth, Genomics Race Raises Ownership Boundary Issue, NAT'L L.J., Jan. 26, 1998, at C3, C4 n.30 (characterizing Lilly's requirement for "actual" rather than "conceptual" possession of claimed subject matter as "alien" to earlier written description case law).

163. See infra part IV.B.2.

164. Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993) (emphases added).

165. Lilly, 39 U.S.P.Q.2d at 1240. In Amgen, the Federal Circuit held that "when an inventor is unable to envision the detailed constitution of a gene so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e., until after the gene has been isolated." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991).

166. See Fiers, 984 F.2d at 1170 (stating that "the Board concluded that the Israeli application was not enabling since Revel had not yet conceived the DNA of the count and 'logically, one cannot ... enable an invention that has not been conceived'"). It has been suggested that, in view of the enablement rejection of Revel's application, the Federal Circuit's written description discussion in Fiers is entirely dicta, not required for afûrmance of the Board's decision. See BURCHFIEL, supra note 135, 7.2(b), at 150-51.

167. In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976).

168. Id. at 262.

169. Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559, 1567 (Fed. Cir. 1997) (discussing example 6).

170. Id.

171. 51 F.3d 1552 (Fed. Cir. 1995).

172. Lilly, 119 F.3d at 1567.

173. Deuel, 51 F.3d at 1558 (explaining that "[a] prior art disclosure of the amino acid sequence of a protein does not necessarily render particular DNA molecules encoding the protein obvious because the redundancy of the genetic code permits one to hypothesize an enormous number of DNA sequences coding for the protein").

174. Lilly, 119 F.3d at 1567.

175. UC's determination of the rat cDNA sequence made its subsequent isolation of the human insulin gene "relatively easy." See Bitter Battle, supra note 4 , at 1029.

176. Regents of the University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d (BNA) 1225, 1239 (S.D. Ind. 1995) ("UC adds that the isolation method taught in the '525 patent was that method it subsequently used actually to isolate the human proinsulin cDNA.").

177. 568 F.2d 1349 (C.C.P.A. 1978).

178. Id. at 1350-51.

179. Id. at 1352.

180. Id.

181. Id.

182. Regents of the University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d (BNA) 1225, 1239 (S.D. Ind. 1995).

183. The Lilly court blurred the distinction between the enablement and written description requirements when, in invalidating genus claims 1, 2, 4, 6, and 7 of the '525 patent, it required that the written description of these DNA genera be provided by "means of a recitation of a representative number of cDNAs, deûned by nucleotide sequence," Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559, 1569 (Fed. Cir. 1997), and described this requirement as "analogous to enablement of a genus under 112, 1, by showing the enablement of a representative number of species within the genus." Id.

184. See Bitter Battle, supra note 4, at 1029 (reporting that some patent experts view Lilly as having "a broad impact, compelling gene hunters to spell out the exact sequence of all the DNA they hope to claim, rather than just the function of the genes.").

185. 108 F.3d 1361, 1367-68 (Fed. Cir.), cert. denied, 118 S. Ct. 397 (1997) (on appeal from the grant of a preliminary injunction, holding non-enablement with respect to claimed method for production of human growth hormone through cleavable fusion expression, and requiring that "[w]here, as here, the claimed invention is the application of an unpredictable technology in the early stages of development, an enabling description in the speciûcation must provide those skilled in the art with a speciûc and useful teaching").

186. The Lilly court did not hesitate to distinguish earlier written description cases on the ground that they did not involve biotechnological subject matter. See Lilly, 119 F.3d at 1568 (distinguishing Utter v. Hiraga, 845 F.2d 993 (Fed. Cir. 1988), as involving "machinery of limited scope bearing no relation to the complex biochemical claims before us").

187. See BURCHFIEL, supra note 135, 18.5, at 474 (suggesting that "the 'useful arts' of biotechnology are hindered by unique requirements, such as the suggestion that identiûcation of physical structure may be essential for a written description of biotechnological inventions .... ").

188. See In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970).

189. See Lilly, 119 F.3d at 1568 (distinguishing Utter, 845 F.2d 993, as "involv[ing] machinery of limited scope bearing no relation to the complex biochemical claims before us"). The Utter court held that "[a] speciûcation may, within the meaning of 35 U.S.C. 112 1, contain a written description of a broadly claimed invention without describing all species that claim encompasses." Utter, 845 F.2d at 998.

190. See Sean Johnston & Leora Ben-Ami, Unpredictability Factor Narrows Biotech Patents, NAT'L L.J., June 16, 1997, at C2 (cataloguing "various disparate areas" of biotechnology that the Federal Circuit has considered unpredictable).

191. This previously fundamental tenet of patent law is further called into question by the Federal Circuit's decision in Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998). In Gentry, the court concluded that a patent claiming a sectional sofa was invalid for failure to comply with the written description requirement. Because the location on a center console of the controls for the recliner portions of the sofa was "essential" to the invention, in the court's view, the patentee was not entitled to claims reciting the controls as located anywhere else. Gentry thus represents a signiûcant contraction from the rule that an invention may be claimed more broadly than the speciûc embodiments disclosed in the speciûcation, particularly in the mechanical arts.