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Prometheus and Bilski: Pushing the Bounds of Patentable Subject Matter in Medical Diagnostic Techniques with the Machine-or-Transformation Test

Published online by Cambridge University Press:  06 January 2021

Stephen Pessagno
Stephen Pessagno*
Affiliation:
Boston University School of Law, 2011; Santa Clara University
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Abstract

If nature has made any one thing less susceptible than all others of exclusive property, it is the action of the thinking power called an idea, which an individual may exclusively possess as long as he keeps it to himself; but the moment it is divulged, it forces itself into the possession of every one, and the receiver cannot dispossess himself of it.

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Article
Information
American Journal of Law & Medicine , Volume 36 , Issue 4 , December 2010 , pp. 619 - 651
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2010

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References

1 Letter from Thomas Jefferson to Isaac McPherson (1813), in The Jeffersonian Cyclopedia, at 433 (John P. Foley ed. 1900).

2 In re Abrams, 188 F.2d 165, 168 (C.C.P.A. 1951); see also Rubber-Tip Pencil Co. v. Howard, 87 U.S. (20 Wall.) 498, 507 (1874) (“an idea of itself is not patentable … .”).

3 Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336, 1348-50 (Fed. Cir. 2009) (holding that a “mental step does not, by itself, negate the transformative nature of” the entire process), vacated, 130 S. Ct. 3543 (2010) (mem.); see also Metabolite Labs., Inc., v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1368 (Fed. Cir. 2004).

4 35 U.S.C. § 154(a)(1)-(2) (2006).

5 For example, Opinion 9.08 (“New Medical Procedures”) of the American Medical Association's Code of Ethics provides the following:

The intentional withholding of new medical knowledge, skills, and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and to society and is to be condemned.

Prompt presentation before scientific organizations and timely publication of clinical and laboratory research in scientific journals are essential elements in the foundation of good medical care.

Am. Med. Ass’n, Code of Medical Ethics 139-40 (2010), available at http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion908.shtml.

6 35 U.S.C. § 112 (2006).

7 Corrected Brief for Amici Curaie The American College of Medical Genetics et al., at 25- 26, Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336 (Fed. Cir. 2009) (No. 04-CV-1200), vacated, 130 S. Ct. 3543 (2010) (mem.).

8 Prometheus, 581 F.3d at 1339.

9 Corrected Brief for Amici Curaie The American College of Medical Genetics et al., supra note 7, at 10.

10 For a discussion of personalized medicine and the important role intellectual property serves in the field, see Herder, Matthew, Patents & the Progress of Personalized Medicine: Biomarkers Research as a Lens, 18 Annals Health L. 187 (2009).Google Scholar

11 Corrected Brief for Amici Curaie The American College of Medical Genetics et al., supra note 7, at 28 (quoting Personalized Medicine 101, Personalized Medicine Coalition, http://www.personalizedmedicinecoalition.org/about/about-personalizedmedicine/personalized-medicine-101 (last visited Oct. 12, 2010)).

12 See Christopher M. Holman et al., Bilski: Assessing the Impact of a Newly Invigorated Patent-Eligibility Doctrine on the Pharmaceutical Industry and the Future of Personalized Medicine, Current Topics in Medicinal Chemistry (forthcoming) (manuscript at 17), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1424493.

13 Id. at 12 (“It is widely believed that personalized medicine will play an increasingly important role in future drug treatment regimens, so [Prometheus] could be of particular significance for the biotechnology and pharmaceutical industries.”).

14 See, e.g., Murphy, Brian P. & Murphy, Daniel P., Bilski's, “Machine-or-Transformation” Test: Uncertain Prognosis for Diagnostic Methods and Personalized Medicine Patents, 20 Fordham Intell. Prop. Media & Ent. L.J. 755, 760-61 & n.23 (2010)Google Scholar. But see Rochelle C. Dreyfuss, The Patentability of Genetic Diagnostics in U.S. Law and Policy 14-15 (Public Law & Legal Theory Research Paper Series, Working Paper No. 10-68, 2010), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1678123 (distinguishing the high cost of developing therapies with the low cost of developing diagnostics, and noting case studies suggesting that the patent incentive is not needed to encourage the development of diagnostics).

15 Bilski v. Kappos, 130 S. Ct. 3218, 3226 (2010).

16 35 U.S.C. § 154(a)(1) (2006).

17 Kohlhepp, Peter M., Note, When the Invention is an Inventor, 93 Minn. L. Rev. 779, 782 (2008).Google Scholar This tension has been presented in the medical context as a balance between dynamic innovation on the one hand and static access or deadweight loss on the other. See Outterson, Kevin, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 Yale J. Health Pol’y, L. & Ethics 193, 201-02, 219 (2005).Google ScholarPubMed

18 U.S. Const. art. I, § 8, cl. 8 (entrusting Congress 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 Discoveries”).

19 35 U.S.C. §§ 101, 112 (2006).

20 § 102.

21 § 103.

22 § 112.

23 § 101.

24 An Act to Promote the Progress of Useful Arts; and to Repeal the Act Heretofore Made for that Purpose, ch. 11, 1 Stat. 318, 319 (1793) (current version at 35 U.S.C. § 101 (2006)).

25 35 U.S.C. § 101 (1952).

26 35 U.S.C. § 100(b) (2006).

27 Cochrane v. Deener, 94 U.S. 780, 788 (1876). The Supreme Court has recently referred to this judicial definition as “dictum.” Bilski, 130 S. Ct. at 3226.

28 Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

29 35 U.S.C. § 101 (2006).

30 See Schuster, William Michael, Predictability and Patentable Processes: The Federal Circuit's In re Bilski Decision and Its Effect on the Incentive to Invent, 11 Colum. Sci. & Tech. L. Rev. 1, 5 (2010).Google Scholar

31 Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852).

32 Chakrabarty, 447 U.S. at 309.

33 Id. (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)).

34 See Gottschalk v. Benson, 409 U.S. 63, 67 (1972).

35 U.S. Const. art. I, § 8, cl. 8.

36 Funk Bros., 333 U.S. at 130.

37 See Schuster, supra note 30, at 6.

38 Ex parte Lundgren, No. 2003-2088, 76 U.S.P.Q.2d 1385, 1403 (B.P.A.I. Sept. 28, 2005).

39 In re Alappat, 33 F.3d 1526, 1542 n.18 (Fed. Cir. 1994) (citation omitted).

40 O’Reilly v. Morse, 56 U.S. (15 How.) 62, 62 (1853).

41 Id. at 112.

42 Id.

43 Id. at 113.

44 Id. at 112.

45 See Kohlhepp, supra note 17, at 788-89.

46 Id.

47 See Diamond v. Diehr, 450 U.S. 175, 195 (1981). Other secondary rules include the “function of a machine” doctrine, id. at 196, and the “printed matter” doctrine. In re Montgomery, 214 F.2d 136, 139 (C.C.P.A. 1954).

48 See Ambrose, Katharine P., Comment, The Mental Steps Doctrine, 48 Tenn. L. Rev. 903, 903 (1980).Google Scholar

49 Diehr, 450 U.S. at 195.

50 Torrance, Andrew W., Physiological Steps Doctrine, 23 Berkeley Tech. L.J. 1471, 1503 (2008).Google Scholar Professor Torrance suggests that the mental steps doctrine can be viewed as a subset of an implicit, broader rule of patent law that he terms the “Physiological Steps Doctrine,” which “precludes patentability of claims covering products of human physiological processes.” Id.

51 Diehr, 450 U.S. at 195.

52 Collins, Kevin Emerson, Propertizing Thought, 60 SMU L. Rev. 317, 355 (2007).Google Scholar

53 For example, Judge Rich referred to the mental steps doctrine as “something of a morass,” and noted that the statutory language “contains nothing whatever which would either include or exclude claims containing ‘mental steps’ and whatever law there may be on the subject cannot be attributed to Congress.” In re Musgrave, 431 F.2d 882, 890 (C.C.P.A. 1970). See also Risch, Michael, Everything is Patentable, 75 Tenn. L. Rev. 591, 630 (2008)Google Scholar (“[I]t is difficult to square any definition of ‘thought’ with any statutory intention discernable in the categories in § 101.”).

54 Collins, supra note 52, at 355.

55 Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (emphasis added).

56 See In re Comiskey, 554 F.3d 967, 980 (Fed. Cir. 2009) (“[T]his court and our predecessor court have refused to find processes patentable when they merely claimed a mental process standing alone … .”).

57 Interim Guidelines for Examination of Patentable Applications for Patent Subject Matter Eligibility, Off. Gaz. Pat. & Trademark Office, Annex III (Nov. 22, 2005), http://www.uspto.gov/web/offices/com/sol/og/2005/week47/patgupa.htm.

58 See Alco Standard Corp. v. Tenn. Valley Auth., 808 F.2d 1490, 1496 (Fed. Cir. 1986) (“The inclusion in a patent of a [mental] process that may be performed by a person, but that also is capable of being performed by a machine, is not fatal to patentability.”).

59 See Benson, 409 U.S. at 71.

60 Id.

61 Id.

62 Id. at 70 (quoting Tilghman v. Proctor, 102 U.S. 707, 721 (1881)).

63 Id. at 71.

64 See Schuster, supra note 30, at 11 (describing how courts began using a “preemption” analysis in the wake of Diehr).

65 State St. Bank & Trust Co. v. Signature Fin. Group., Inc., 149 F.3d 1368 (Fed. Cir. 1998).

66 Id. at 1370.

67 Id. at 1373.

68 See Schuster, supra note 30, at 12 (“Since its inception, the Useful, Concrete, and Tangible test has been the subject of widespread criticism”).

69 Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006) (mem.) (per curiam).

70 Id. at 136 (Breyer, J., dissenting).

71 Id.

72 See Schuster, supra note 30, at 15.

73 In re Bilski, 545 F.3d 943, 952 (Fed. Cir. 2008), aff’d sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010).

74 Id. at 949.

75 Id.

76 Id. at 950.

77 Id. at 954.

78 Id.

79 Id.

80 Id. at 961.

81 Id. at 962.

82 Id.

83 Id. at 964.

84 Id. at 956.

85 Id. at 963.

86 Id.

87 Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336, 1345 (Fed. Cir. 2009), vacated, 130 S. Ct. 3543 (2010) (mem.).

88 Id. at 1339. Prometheus's two patents were U.S. Patents Nos. 6,355,623 (filed Apr. 8, 1999) and 6,680,302 (filed Dec. 27, 2001). Claim 1 of the ‘623 is representative of the claims asserted by Prometheus:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

89 Prometheus, 581 F.3d at 1340.

90 Id.

91 Id.

92 Id.

93 Id.

94 Id. at 1343.

95 Id.

96 Id.

97 Id. at 1345 (quoting Bilski, 545 F.3d at 962).

98 Id. at 1346.

99 Id. at 1347.

100 Id. at 1346.

101 Id. at 1348.

102 Id. at 1347.

103 Id. at 1348.

104 Id. at 1343.

105 Professor Torrance notes a stark lack of infringement judgments for cases involving “whether transformation of a drug via in vivo conversion into a metabolite can trigger infringement of patent claims covering the metabolite or methods of using the metabolite.” Torrance, supra note 50, at 1500. He suggests that the “unanimity of findings of noninfringement [reflects] a discomfort with the very idea that a product arising naturally within the body, or the activity of the body itself, can infringe, let alone be the subject matter of, a valid and enforceable patent claim.” Id. at 1500-01.

106 Brief for Appellant at 22-23, Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336 (Fed. Cir. 2009), vacated, 130 S. Ct. 3543 (2010) (mem.). See also Timo Minssen & Robert M. Schwartz, US Patent Eligibility in the wake of Bilski v. Kappos: “Business as Usual” in an Age of new Technologies?, 29 Biotechnology L. Rep. (forthcoming 2010) (manuscript at 64-66) (noting that Prometheus’ claims, because they involve metabolites that are man-made, more easily satisfy a “human intervention requirement” than those in LabCorp, where the metabolites were naturally occurring).

107 Bilski, 545 F.3d at 962.

108 Diehr, 450 U.S. at 184.

109 Merck & Co. v. Teva Pharms. U.S.A., Inc., 347 F.3d 1367, 1369 (Fed. Cir. 2003).

110 Id. at 1368-69.

111 Impax Labs., Inc. v. Aventis Pharm., Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008).

112 Note, however, that the Federal Circuit has raised § 101 sua sponte, see In re Comiskey, 499 F.3d 1365, 1371 (Fed. Cir. 2007), so the fact that Merck and Impax did not address subject matter directly cannot be construed to indicate that this statutory requirement was lacking in either case.

113 Brief for Appellees at 32, Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336 (Fed. Cir. 2009), vacated, 130 S. Ct. 3543 (2010) (mem.) (quoting Bilski, 545 F.3d at 962).

114 Id. at 33.

115 Parker v. Flook, 437 U.S. 584, 590 (1978).

116 Brief for Appellees, supra note 113, at 32-33.

117 See In re Meyer, 688 F.2d 789, 794 (C.C.P.A. 1982).

118 Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 129 (1948).

119 Id. at 132.

120 See Brief for Appellees, supra note 113, at 35.

121 Id. (citing In re Nuitjen, 500 F.3d 1346, 1357 (Fed. Cir. 2007)).

122 Nuitjen, 500 F.3d at 1356-57.

123 Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006) (per curiam).

124 Id. at 125.

125 Id. (Breyer, J., dissenting).

126 Id. at 136.

127 Id. at 125.

128 Id. at 136.

129 Id.

130 In re Bilski, 545 F.3d 943, 965 & n.27 (Fed. Cir. 2008).

131 Id. (citing In re Grams, 888 F.2d 835, 839-40 (Fed. Cir. 1989)).

132 Grams, 888 F.2d at 839-40.

133 Id. at 837.

134 Id. at 840.

135 Classen Immunotherapies, Inc. v. Biogen IDEC, 304 Fed. Appx. 866 (Fed. Cir. 2008), vacated 130 S. Ct. 3541 (2010) (mem.).

136 More fully, Claim 1 of the patent at issue stated:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

U.S. Patent No. 5,723,283 col.51 1.50 (filed May 31, 1995).

137 Classen, 304 Fed. Appx. at 867. Although the Federal Circuit did not provide an explanation for its holding, several scholars have argued that (1) the “immunizing” step is transformational because it “is directed to altering subject mammals from an initial state (i.e., susceptible to a pathogen) into a different state (i.e., immune to a pathogen),” and, consequently, (2) the Classen Court must have determined that this step “was not central to the claimed process or constituted mere data-gathering.” Murphy & Murphy, supra note 14, at 770-71. See also Holman et al., supra note 12, at 18-19 (the immunization step “clearly results in a transformation of the individual that was immunized,” so the Federal Circuit “must have concluded that the immunization step is merely a ‘data-gathering step,’ … and thus not central to the claim—in other words, mere ‘insubstantial extra-solution activity.’”).

138 Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336, 1345 n.2 (Fed. Cir. 2009).

139 Id. at 1346 n.3.

140 Id. at 1348.

141 Id.

142 Compare Brief for Appellees, supra note 113, at 39-42, with Brief for Appellant, supra note 106, at 27-29.

143 In re Abele, 684 F.2d 902, 908-09 (C.C.P.A. 1982).

144 Id. at 910.

145 Bilski, 545 F.3d at 962-63.

146 Arrhythmia Research Tech., Inc. v. Corazonix Corp., 958 F.2d 1053, 1055 (Fed. Cir. 1992).

147 Id.

148 Brief for Appellant, supra note 106, at 29.

149 Id. at 29-30.

150 Id. at 28 (quoting Bilski, 545 F.3d at 963-64).

151 Brief for Appellees, supra note 113, at 40.

152 Id. at 40 & n.8.

153 Id. at 40-41.

154 Prometheus, 581 F.3d at 1348.

155 Id.

156 See, e.g., Alco Standard Corp., 808 F.2d at 1496.

157 Brief for Appellees, supra note 113, at 21.

158 Id. Some scholars have suggested that the patentability of an application involving a mental step should turn in part on the level of cognitive control required to perform that step. The more deliberate, and thus the more controllable, mental steps would receive greater protection. See Collins, Kevin Emerson, Constructive Nonvolition in Patent Law and the Problem of Insufficient Thought Control, 2007 Wis. L. Rev. 759, 763 (2007)Google Scholar (proposing “a constructive-nonvolition exemption from patent infringement.”); Torrance, Andrew W., Neurobiology and Patenting Thought, 50 IDEA: The Intell. Prop. L. Rev. 27, 28 (2009)Google Scholar (“[T]houghts subject to ‘executive control’ should be situated more towards the patentable end of the spectrum, whereas ‘default thoughts’ should be situated closer to the unpatentable end of the spectrum.”).

159 Brief for Appellees, supra note 113, at 39. Despite some scholars’ apparent agreement that volitional or deliberate thought processes should receive protection (as discussed in note 158, supra), these scholars have disagreed as to what types of mental steps fall within this protected area. For example, Professor Collins argues that the correlation step in LabCorp is “involuntary,” as it requires “insufficient thought control.” Collins, supra note 158, at 763, 814-24. However, Professor Torrance responds that “neurobiology of executive control suggests otherwise. The fact that this correlation mental step [in LabCorp] is subject to executive control vitiates arguments regarding involuntary patent infringement.” Torrance, supra note 158, at 47.

160 Prometheus, 581 F.3d at 1346.

161 Brief for Appellant, supra note 106, at 30.

162 Id. at 31.

163 Id.

164 Brief for Appellees, supra note 113, at 29.

165 Brief for Appellant, supra note 106, at 33.

166 In re Comiskey, 499 F.3d 1365, 1379 (Fed. Cir. 2007), superseded by, In re Comiskey, 554 F.3d 967 (Fed. Cir. 2009).

167 In re Grams, 888 F.2d 835, 839 (Fed. Cir. 1989).

168 Diamond v. Diehr, 450 U.S. 175, 191-92 (1981).

169 Brief for Appellees, supra note 113, at 27-28.

170 Id.

171 In re Alappat, 33 F.3d 1526, 1545 (Fed. Cir. 1994).

172 WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349 (Fed. Cir. 1999) (citing Alappat at 1558).

173 See Brief for Appellees, supra note 113, at 27.

174 Parker v. Flook, 437 U.S. 584, 590 (1978).

175 See Brief for Appellant, supra note 106, at 36.

176 Id.

177 In re Bilski, 545 F.3d 943, 962 (Fed. Cir. 2008), aff’d sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010).

178 See Gottschalk v. Benson, 409 U.S. 63, 71 (1972) (“It is argued that a process patent must either be tied to a particular machine or apparatus or must operate to change articles or materials to a ‘different state or thing.’ We do not hold that no process patent could ever qualify if it did not meet the requirements of our prior precedents.”).

179 Brief for the Respondent in Opposition at 28-29, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 130 S. Ct. 3543 (2010) (mem.) (No. 09-490).

180 Bilski v. Doll, 129 S. Ct. 2735 (2009) (mem.).

181 See Parker v. Flook, 437 U.S. 584 (1978); Diamond v. Chakrabarty, 447 U.S. 303 (1980); Diamond v. Diehr, 450 U.S. 175 (1981). As will be discussed in Part VI.C., infra, the Court's recent Bilski opinion and two GVRs took a much more minimalistic approach. See Bilski v. Kappos, 130 S. Ct. 3218 (2010); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 130 S. Ct. 3543 (2010) (mem.); Classen Immunotherapies, Inc. v. Biogen IDEC, 130 S. Ct. 3541 (2010) (mem.).

182 See, e.g., Murphy, Brian P. & Murphy, Daniel P., Bilski's, “Machine-or-Transformation” Test: Uncertain Prognosis for Diagnostics Methods and Personalized Medicine Patents, 20 Fordham Intell. Prop. Media & Ent. L.J. 755, 759 n.14 (2010)Google Scholar (noting that the Court has always favored a “flexible standard” over a “more limited, rigid test”); Follett, Angela D., Note, The Problem with Bilski: Medical Diagnostic Patent Claims Reveal Weaknesses in a Narrow Subject Matter Test, 7 U. St. Thomas L.J. 229, 231 (2009)Google Scholar (Federal Circuit's “rigid bar to patentability” is inappropriate); Petition for a Writ of Certiorari, Bilski v. Doll, 129 S. Ct. 2735 (2009) (mem.) (No. 08-964) at 16-20 (presenting the need to reject the Federal Circuit's “rigid” test as the first argument for the Supreme Court to grant certiorari).

183 See, e.g., KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007) (replacing the Federal Circuit's “rigid” approach to § 103 with a more “expansive and flexible approach” gleaned from precedent); eBay Inc. v. MercExchange, 547 U.S. 388, 393-94 (2006) (finding that the Federal Circuit's “categorical” rule regarding injunctive relief improperly departed from the equitable four-factor test traditionally used); Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co, 535 U.S. 722, 739 (2002) (rejecting the Federal Circuit's “more robust” prosecution history estoppel formula for claim construction).

184 In re Bilski, 545 F.3d 943, 956 (Fed. Cir. 2008), aff’d sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010).

185 See Gottschalk v. Benson, 409 U.S. 63, 71 (1972).

186 Bilski v. Kappos, 130 S. Ct. 3218 (2010).

187 Id. at 3231.

188 Id. at 3227, 3231. The second holding was in response to the issue of whether the Court should recognize a categorical exclusion for business method patents. Id. at 3225.

189 Id. at 3226, 3229-30.

190 Id. at 3226 (quoting Diehr, 450 U.S. at 182).

191 Id. (quoting Diehr, 450 U.S. at 182).

192 Id.

193 Id. (quoting Diehr, 450 U.S. at 182).

194 Id.

195 Id.

196 Cochrane v. Deener, 94 U.S. 780 (1877).

197 Bilski, 130 S. Ct. at 3226.

198 Id. at 3227.

199 Id. at 3237 (Stevens, J., concurring in the judgment).

200 Id.

201 Id. at 3225 (quoting Chakrabarty, 447 U.S. at 309) (the three restrictions being the familiar “laws of nature, physical phenomena, and abstract ideas”).

202 Id. at 3239.

203 Id. at 3231.

204 Id.

205 Id.

206 Id. at 3235 (Stevens, J., concurring in the judgment).

207 Id.

208 By issuing a GVR order, the Court summarily grants certiorari, vacates the lower court's judgment without finding error, and remands the case to the lower court for further consideration. See Bruhl, Aaron-Andrew P., The Supreme Court's Controversial GVRs—And an Alternative, 107 Mich. L. Rev. 711, 712 (2009).Google Scholar

209 Mayo Collaborative Servs. v. Prometheus Labs., Inc., 130 S. Ct. 3543 (2010) (mem.).

210 Bruhl, supra note 208, at 712.

211 Id. at 712-13 (stating further that Court's GVR practice represents “a species of mere error correction” with the purpose of giving “the lower court the initial opportunity to consider the possible impact of intervening developments and, if necessary, to revise its decision accordingly”); see also Lawrence v. Chater, 516 U.S. 163, 167 (1996) (explaining that the standard for issuing a GVR is when the Court determines there is “a reasonable probability that the decision below rests upon a premise that the lower court would reject if given the opportunity”). In Tyler v. Cain, 533 U.S. 656, 666 n.6 (2001), the Court rejected an interpretation of a GVR as a ruling on the merits.

212 Classen Immunotherapies, Inc. v. Biogen IDEC, 130 S. Ct. 3541 (2010).

213 Bilski v. Kappos, 130 S. Ct. 3218, 3230 (2010).

214 Id. at 3230-31.

215 Id. at 3231.

216 For the representative claims of Prometheus and Classen, respectively, see supra notes 88, 136.

217 The three dissenting Justices in LabCorp were Justice Breyer, Justice Stevens, and Justice Souter. Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 125 (2006).

218 Of course, the Federal Circuit's discretion does not give it “carte blanche to impose other limitations that are inconsistent with the text and the statute's purpose and design.” Bilski, 130 S. Ct. at 3226.

219 Id. at 3226-27.

220 Id. at 3226, 3231.

221 Brief for the Respondent in Opposition, supra note 179, at 31.

222 Id.

223 Bilski, 130 S. Ct. at 3227 (emphasis added).

224 The Bilski Court emphasized that it was “not commenting on the patentability of any particular invention, let alone holding that any of the above-mentioned technologies [including diagnostics] from the Information Age should or should not receive patent protection.” Id. at 3228. Indeed, “[n]othing in [the Bilski] opinion should be read to take a position on where [the subject matter] balance ought to be struck” for emerging technologies. Id.

225 See id. at 3259 (Breyer, J., concurring in the judgment). A district court, which acknowledged Justice Breyer's concluding words, also noted that “four of the Justices, listed on Justice Stevens's concurring [in the judgment] opinion, would have taken the machine or transformation test to its logical limit to hold that business methods are categorically unpatentable.” Ultramercial, LLC v. Hulu, LLC, No. CV 09-06918, 2010 WL 3360098, at *3 (C.D. Cal. Aug. 13, 2010) (citing Bilski, 130 S. Ct. at 3257 (Stevens, J., concurring in the judgment)). The district judge concluded, “In sum, at least five (and maybe all) Justices seem to agree that the machine or transformation test should retain much of its utility after the Supreme Court's decision in Bilski.” Id.

226 King Pharms., Inc. v. Eon Labs., Inc., Nos. 2009-1437, 2009 1438, 2010 WL 3001333, at *9 (Fed. Cir. Aug. 2, 2010).

227 Many have similarly argued that using the machine-or-transformation test as the sole standard would create uncertainty for diagnostics. See, e.g., Brief of Biotechnology Indus. Organization et al., as Amici Curiae Supporting Neither Party at 14-27, Bilski v. Doll, 129 S. Ct. 2735 (2009) (No. 08-964) (arguing that applying the Federal Circuit's Bilski opinion to biotechnology and medical technology inventions creates uncertainty for issued process patent claims, yet “[b]iotechnology and medical technology processes are not abstract ideas, laws of nature or natural phenomena”); Murphy & Murphy, supra note 14, at 764-81 (stating that while the test “is not particularly well-suited to assessing … diagnostic and genetic screening methods,” the ultimate outcomes of LabCorp, Prometheus, and Classen by the Federal Circuit nonetheless were correct under the fundamental principles limitation); Follett, supra note 182, at 231, 249 (arguing for a removal of the Federal Circuit's rigid test to alleviate “the broad sweeping effect” the court's rule would have on biotechnology processes and diagnostics, and noting that the court's “inconsistent interpretation of a patentable transformation between [Classen and Prometheus] afforded little clarity for future applications of Bilski to” diagnostics).

228 In re Bilski, 545 F.3d 943, 951-52 (alterations in original) (quoting Webster's New International Dictionary of the English Language 1972 (2d ed. 1952)).

229 Id. at 952 (alterations in original) (quoting Diamond v. Diehr, 450 U.S. 175, 185 (1981)). Professor Samuelson notes a constitutional restraint on the definition of “process”:

One major constraint on the meaning of the term “process”’ in the patent statute can be traced to the U.S. Constitution and its provision empowering the Congress to enact legislation to promote the “useful arts”’ by granting exclusive rights to inventors for limited times. “Useful arts” is understood to be the realm of technological and industrial improvements.

Samuelson, Pamela, Benson, Revisited: The Case Against Patent Protection for Algorithms and Other Computer Program-Related Inventions, 39 Emory L.J. 1025, 1033 n.24 (1990).Google Scholar

230 See Bilski, 545 F.3d at 955-56. See also Schuster, supra note 30, at 23 (positing that both the majority and the dissent in the Federal Circuit Bilski decision, despite their differing approaches, “seek the same thing: the exclusion of fundamental principles from § 101”).

231 Bilski, 130 S. Ct. at 3227 (quoting J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124, 135 (2001)).

232 Id. at 3225 (emphasis added) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)).

233 See Prometheus Labs., v. Mayo Collaborative Servs., 581 F.3d 1336, 1349 (Fed. Cir. 2009).

234 Id.

235 Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403 (Fed. Cir. Sept. 1, 2010) (mem.) (order requesting additional briefing from both parties regarding the effect of Bilski on the case).

236 For a discussion of whether patent law should vary according to the type of industry at issue in a particular case, see Burk, Dan L. & Lemley, Mark A., Policy Levers in Patent Law, 89 Va. L. Rev. 1575 (2003).CrossRefGoogle Scholar

237 Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 138 (Breyer, J., dissenting).

238 See Brief for Appellees, supra note 113, at 22.

239 Petition for Writ of Certiorari at 28, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 130 S. Ct. 3543 (2010) (mem.) (No. 09-490).

240 See Brief for Appellees, supra note 113, at 25.

241 See, e.g., William M. Landes & Richard A. Posner, The Economic Structure of Intellectual Property Law 303-306 (2003) (patent monopolies on “scientific principles” pose “enormous transaction costs that would be imposed on would-be users”); Dreyfuss, supra note 14, at 10-14 (arguing that patents impose high social costs, and noting “a stark contrast between the availability of genetic tests that are controlled by a sole source provider and genetic tests that are unpatented or licensed nonexclusively”).

242 For a further discussion of the ethical issues raised by the patenting of medical procedures, see Am. Med. Ass’n, Council on Ethical and Judicial Affairs, Ethical Issues in the Patenting of Medical Procedures, 53 Food & Drug L.J. 341 (1998).Google Scholar

243 Petition for Writ of Certiorari, supra note 239, at 25.

244 Corrected Brief for Amici Curaie The American College of Medical Genetics, supra note 7, at 9.

245 Merges, Robert P. & Nelson, Richard R., On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 839, 915 (1990).CrossRefGoogle Scholar

246 Brief for the Respondent in Opposition, supra note 179, at 32.

247 Friedman, Marc S. et al., Biotech's Biggest Fear Might Come True: Pure Method Patents Might Become Extinct, 196 N.J. L.J. 65, 65 (2009).Google Scholar See also James Bessen & Michael J. Meurer, Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk 175-76, 283 n.15 (2008) (comparing the percentage of new firms with patent applications in various industries and noting the importance of patents to biotech startups).

248 Burk & Lemley, supra note 236, at 1581 (although the precise statistics are uncertain, “[i]n the pharmaceutical industry, for example, the R&D, drug design, and testing of a new drug can take a decade or more and cost, on average, hundreds of millions of dollars”).

249 U.S. Const. art. I, § 8, cl. 8.

250 Brief for the Respondent in Opposition, supra note 179, at 33-34.

251 35 U.S.C. § 287(c)(2)(A) (2006) defines “medical activity” as:

the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

See Dreyfuss, supra note 14, at 4 (arguing that “access problems are best resolved by creating new defenses against infringement liability for those engaged in research and patient care in the diagnostic context.”); Kesselheim, Aaron S. & Mello, Michelle M., Medical Process Patents—Monopolizing the Delivery of Health Care, 355 New Eng. J. Med. 2036 (2006)CrossRefGoogle ScholarPubMed (discussing the incomplete protection afforded by § 287(c) for infringement of process claims and the resulting difficulty in policing patent law in this area).

252 See Robert Green Sterne & Bugaisky, Lawrence B., The Expansion of Statutory Subject Matter Under the 1952 Patent Act, 37 Akron L. Rev. 217, 226 (2004).Google Scholar

253 For a discussion of § 287 and whether medical and surgical procedures should no longer be patentable, see Peschel, Leisa Talbert, Revisiting the Compromise of 35 U.S.C. § 287(C), 16 Tex. Intell. Prop. L.J. 299 (2008).Google Scholar

254 Diamond v. Chakrabarty, 447 U.S. 303, 316-17 (1980). Some scholars have noted that Federal Circuit patent decisions appear to be lacking in policy-based rationales. For example, one commentator noted that the Federal Circuit in Bilski “did not attempt any policy-based analysis, seemingly on the belief that policy issues lie within the domain of the legislature and are already enshrined in the legislation as interpreted by that Supreme Court precedent.” McEniery, Benjamin J., The Federal Circuit in Bilski: The Machine-or-Transformation Test, 91 J. Pat. & Trademark Off. Soc’y 253, 255 (2009).Google Scholar Professors Burk and Lemley took this observation one step further, arguing that “[a]t least in the industries of biotechnology and software … the Federal Circuit has gotten the policy precisely backwards, perhaps because it is not making industry-specific patent policy intentionally.” Burk & Lemley, supra note 236, at 1578.

255 Another closely watched subject matter dispute now making its was through the courts involves isolated DNA indicating a predisposition to breast cancer and a related method of analyzing gene sequences. A New York District Court recently held the claims to be invalid under § 101. Ass’n for Molecular Pathology v. U.S. PTO, 702 F. Supp. 2d 181, 220-37 (S.D.N.Y. 2010). The case is currently being briefed in the Federal Circuit. See Ass’n for Molecular Pathology v. U. S. PTO, No. 2010-1406 (order granting Myriad Genetics, Inc., an extension of time to file its brief).

256 Chakrabarty, 447 U.S. at 316.

257 Id. at 317.