File: 7- Manolis Created on: 6/11/ :35:00 PM Last Printed: 7/9/2013 8:49:00 PM

Transcription

1 A STRUGGLE FOR CLAIRVOYANCE SECTION 101 OF THE PATENT ACT AS A GATEKEEPER TO PATENT ELIGIBILITY: MAYO COLLABORATIVE SERV. v. PROMETHEUS LABORATORIES, INC. William J. Manolis* PATENT LAW THE PATENT ACT SECTION 101 The United States Supreme Court reaffirms that laws of nature, natural phenomena, and abstract ideas are non-patentable subject-matter. Mayo Collaborative Serv., v. Prometheus Laboratories, Inc., 132 S. Ct (2012). INTRODUCTION I. Mayo Collaborative Serv., v. Prometheus Laboratories, Inc A. Facts & Procedural History B. District Court C. United States Court of Appeals: First Blush D. United States Court of Appeals: Alter Vultus E. United States Supreme Court II. History A. The Patent Acts B. The Patent-Eligibility Trilogy C. In Light of Bilski v. Kappos III. Analysis CONCLUSION INTRODUCTION In Mayo Collaborative Serv., v. Prometheus Laboratories, Inc. (hereinafter referred to as Mayo ), 1 the United States Supreme Court *J.D. Candidate 2013, Duquesne University School of Law; B.A. English Writing and Political Science, University of Pittsburgh,

2 116 Duquesne Business Law Journal Vol affirmed the implicit prohibition against patentability contained in 101 of the Patent Act of ( the Patent Act ). Specifically, the Supreme Court held that laws of nature, natural phenomena, and abstract ideas are not patentable. 3 In arriving at its decision, the Court noted that 101 of the Patent Act must be applied as the threshold test for determining subject-matter patentability. 4 In reaching its holding, the Court examined prior precedent, as well as the history and statutory interpretation afforded to 101. This Case Note examines the level of inquiry to which process patents are subjected. Part I of this Case Note discusses the facts, and procedural history of the case, as well as the basic judicial tenets upon which the Court relied in making its decision. Part II covers the line of authorities upon which the decision is founded, as well as a cursory review of the history of the Patent Act. Finally, this Case Note discusses the implications of subjecting process patents to 101 scrutiny, and whether public policy considerations should serve as an additional bar to process patents invoking laws of nature. I. Mayo Collaborative Serv., v. Prometheus Laboratories, Inc. A. Facts & Procedural History Prometheus Laboratories, Inc. (hereinafter referred to as Prometheus ) was the exclusive licensee of two patents designed to calibrate the levels of metabolites present in the blood of patients administered thiopurine drugs in connection with treatment of immune-related gastrointestinal diseases. 5 The U.S. Patent Nos. 6,355,623 ( the 623 patent ) and 6,680,302 ( the 302 patent ) (collectively, the patents-insuit ), provided a method of measuring the level of two metabolites: 6-thioguinine ( 6-TG ) and 6-methylmercaptopurine ( 6-MMP ), which at levels greater than about 400 and greater than about 7000, respectively, required a potential change in drug dosage, as to avoid toxic side effects. 6 Alternatively, concentrations of the metabolite S. Ct (2012). 2. The Patent Act of 1952, 35 U.S.C. 101 (2006). 3. Mayo, 132 S. Ct. at Id. at Id. at Prometheus Laboratories, Inc. v. Mayo Collaborative Serv., 2008 WL at *1 (S.D. Cal. March 28, 2008), rev'd, 581 F.3d 1336 (Fed. Cir.

3 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 117 TG less than about 230 likely indicated a dosage too low to be effective. 7 Due to the fact that patients metabolized the drugs differently, doctors encountered difficulty in determining whether a particular patient s dose was too high (and causing toxicity), or too low (and likely ineffective); thus, leveling the dosage was paramount in administering proper treatment. 8 In short, the patent claims established a method whereby a diagnostician could correlate the thiopurine drug metabolite levels with their relative therapeutic efficacy or toxicity thresholds, and with some precision, alter the dosage accordingly. 9 Mayo Collaborative Services d/b/a Mayo Medical Laboratories and Mayo Clinic Rochester ( Mayo ) had procured and used diagnostic tests based upon Prometheus s patents for some time; however, in 2004, Mayo announced it would begin using and selling its own test. 10 In June 2004, Mayo rescinded its offer to sell the test, but Prometheus filed a patent infringement complaint against Mayo on June 15, B. District Court After a tortured period of pleadings, the parties dispute culminated in Prometheus and Mayo filing three separate motions for summary judgment. 12 Prometheus filed a motion for summary judgment of no patent exhaustion, with Mayo filing an opposition thereto. 13 Mayo countered with a motion for summary judgment of patent invalidity under 35 U.S.C and Prometheus opposed the motion. 15 Thereafter, Prometheus filed a motion for summary judgment of de- 2009), cert. granted, judgment vacated, 130 S. Ct (U.S. 2010), and rev'd, 628 F.3d 1347 (Fed. Cir. 2010), rev'd, 132 S. Ct (U.S. 2012). 7. Mayo, 132 S. Ct. at Id. 9. Id. 10. Id. The Mayo test utilized somewhat higher metabolite levels to determine toxicity (450 pmol per 8x108 for 6[-]TG and 5700 pmol per 8x108 for 6[-]MMP). Id WL at * Id. at * Id. 14. The Patent Act states: [w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 35 U.S.C WL at *2.

4 118 Duquesne Business Law Journal Vol claratory judgment of infringement, with Mayo opposing it. 16 On May 10, 2007, after briefing all the motions 17, the court held oral argument and took the four motions under submission. 18 In the interim, the parties filed a joint application to request permission to submit additional briefs in light of two recently decided Federal Circuit cases: In re Comiskey 19 and In re Nuijten. 20 Mayo s argument was premised on the supposition that the patentsin-suit are invalid, due to the fact that they claim natural phenomena, and wholly preempt use of said phenomena. 21 Prometheus urged that the correlations between therapeutic or toxic qualities and the level of metabolites present in the blood were not a recitation of the correlations themselves, but rather a statement of the treatment methods, and therefore rested within the ambit of In its most distilled form, the Court reduced Prometheus s method to three steps: (1) administration of the drug to the subject; (2) determine the level of metabolites present in the blood; and (3) be warned of the potential need for a dosage adjustment. 23 The threshold inquiry hinged on a determination 16. Id. 17. Id. Motions included a fourth filed by Prometheus seeking to strike the declaration of Mayo s expert Dr. Bruce Bostrom. Id. 18. Id F.3d 1365 (Fed. Cir. 2007), 554 F.3d 967 (Fed. Cir. 2009) (opinion revised and superseded). Comiskey involved a method and system to compel binding arbitration of any dispute arising from unilateral legal documents, such as a will or contract. Id. at The court held that the system, whether utilizing a computer or other electronic means, was still an unpatentable subject matter pursuant to 101. Id F.3d 1346 (Fed. Cir. 2007). Nuijten concerned a patent application for a signaling technique to reduce distortion caused by the inclusion of watermarks designed to protect against unauthorized copying of audio and video media. Id. at The U.S. Court of Appeals ultimately concluded that the signal was not categorically a patentable subject matter (i.e., either a (i) process; (ii) machine; (iii) manufacture; or (iv) composition of matter). Id. at The fact that the signal was man-made did not make the claim patentable, as artificiality is insufficient by itself to render something a manufacture. Id. at WL at *2. Specifically, the natural phenomena are the correlations between metabolite levels of thiopurine drugs and the resultant efficacy or toxicity thereof, while wholly preempting is premised on the notion that the patents do not claim any man-made composition, but rather the correlations themselves. Id. at * Id. at * Id.

5 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 119 of what (if anything) Prometheus invented, 24 and whether the patent sought to recite a natural phenomenon. 25 The Court ultimately decided that the two active steps in Prometheus s method, administration and determination, were merely datagathering steps for any use of the correlations. 26 Thus, whether the claimed process could be considered a patentable subject matter became contingent upon the final warning step. 27 This proposition was handily assuaged as the step did not require a practitioner to adjust the dosage or take any other action it was the metabolites that provided an indication that the dosage may need adjustment. 28 Now, upon consideration of the fact that the patents-in-suit claimed correlations, the inquiry became whether the correlations were natural phenomena. 29 Though, Prometheus argued that the correlations would not exist without the introduction of man-made drugs, its own expert testified as to the natural metabolization of the drugs when present in the human body. 30 Prometheus urged that the claimed correlations could not be characterized as natural phenomena, because the metabolites do not naturally exist in humans, and only after the body processes the drug does it activate to treat the disease. 31 In support of its contention, Prometheus referenced two cases, one of which involved patentable claims con- 24. Id. Indeed, one can reduce any process to a series of steps. The question is what those steps embody. Id. (citing Lab. Corp. of Am. Holdings v. Metabolite, Inc., 126 S. Ct (2006) (Breyer, J., dissenting from dismissal of certiorari) (emphasis in original)); see also In re Grams, 888 F.2d 835, 839 (Fed. Cir. 1989) (indicating that the relevant query was [w]hat did the applicant[] invent? ) (quoting In re Abele, 684 F.2d 902, 907 (C.C.P.A. 1982)). 25. Prometheus Laboratories, Inc., 2008 WL at * Id. at * Id. at * Id. at * Id. at *6. See Gottschalk v. Benson, 93 S. Ct. 253, 255 (1972) ( [p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work ). 30. Prometheus Laboratories, Inc., at *6-7. Prometheus s expert, Dr. Bloomfield, opined that the key therapeutic aspect of such thiopurine drugs is that they are converted naturally by enzymes within the patient s body to form an agent that is therapeutically active. Id. at *7 (emphasis in original). Moreover, one of the patents inventors conceded that the method derived for observing the correlations was based upon study of a database of patient s information, including those administered 6-MP drugs. Id. 31. Id. at *8.

6 120 Duquesne Business Law Journal Vol cerning the effectiveness of man-made compositions, 32 and another involving a portion of genes and proteins that did not exist in nature. 33 The Court drew distinctions upon Prometheus s supporting authorities, and instead analogized the present issue of patent eligibility with an instance wherein an inventor discovered a previously unknown feature of bacteria, and manipulated its qualities to produce an inoculant for crops. 34 In so stating, the Court held that the Prometheus did not create the correlation between the 6-TG and 6-MMP metabolites levels, rather the inventor discovered the relationship of naturally produced metabolites and their respective therapeutic efficacy and toxicity. 35 Because the Court held that the correlations were natural phenomena, they next endeavored the question of whether the patents-in-suit wholly preempt the use of the phenomena, insofar as the practical effect would be a patent on the natural phenomena itself. 36 In comparing Benson to the case at bar, the Court found that the correlations had no practical application beyond that of treatment for immune-related gastrointestinal diseases, and thus, the fact that application of the patents principles outside of this context are permissible is of no consequence. 37 Prometheus s next argument championed the notion that 32. Id. Merek & Co. v. Teva Pharm., Inc. 347 F.3d 1367, 1369, 1372 (Fed. Cir. 2003) involved a targeted method of treating osteoporosis through use of the manmade composition bisphosphonic acid. 33. Prometheus Laboratories, Inc., at *8. See e.g. Fiers v. Revel, 984 F.2d 1164, 1166, 1172 (Fed. Cir. 1993). 34. Prometheus Laboratories, Inc., 2008 WL at *9. In Funk Bros. Seed Co. v. Kalo Inoculant Co., 33 U.S. 127 (1948), an inventor deduced that particular qualities of certain types of bacteria could be isolated without affecting the properties of another.. The Court held that the inventor did not necessarily create the state of inhibition or non-inhibition in bacteria, but instead appropriated a quality of nature. Id. at Prometheus Laboratories, Inc., 2008 WL at * Id. at *10 (citing Benson, 93 S. Ct. at 257). In Benson, an applicant attempted to patent an algorithm to program a general purpose computer to convert binarycoded decimal form into pure binary form. Id. at 254. The claimed patent was not limited to any particular art or technology, apparatus or machinery, or for any definitive use. Id. As such, the Court held that patenting the process, in connection with a computer, would wholly preempt the mathematical formula and in practical effect would be a patent on the algorithm itself. Id. at Prometheus Laboratories, Inc., 2008 WL at *11. The six possible uses not foreclosed by the patents are: (1) use in research; (2) for diseases other than autoimmune or gastrointestinal diseases; (3) use when results are given in units other than red blood cells; (4)

7 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 121 even though the Court determined that the correlations were natural phenomena, the holding In re Comiskey demonstrates that inclusion of a patent-eligible subject matter, such as a machine, garners a patentable claim under The Court advised that Prometheus s reading of In re Comiskey was too broad, and that the use of a machine or composition of matter in their claim was merely incidental, rather than tied to a specific machine or apparatus. 39 On that premise, the Court reasoned that even if Prometheus s claim was tied to a particular machine or apparatus, it was still invalid under 101 as it sought to patent natural phenomena, and wholly preempted use thereof. 40 Resultantly, Mayo s motion for summary judgment on patent invalidity pursuant to 101 was granted, with all other motions ordered moot. 41 C. United States Court of Appeals: First Blush In Prometheus Laboratories, Inc. v. Mayo Collaborative (hereinafter referred to as Prometheus I ), Prometheus proceeded to appeal the lower court judgment which rendered the patents-in-suit invalid to the Federal Circuit of the United States Court of Appeals. 42 As a preliminary matter, the Court indicated that the key issue to patentability was whether a claim is a replication of a fundamental principle or else building upon the correlations; (5) publishing articles in scientific journals concerning the correlations; and (6) testing and determining metabolite levels so long as no warning is given. Id. at * Id. at *13. Relying on Comiskey, Plaintiff argues that the patents-in-suit meet the requirements of section 101 because the claims involve specific machines. According to Plaintiff, the asserted claims of the patents-in-suit inherently require the use of specific machines to detect the levels of metabolites. These machines include a detector, a pump and an injector. Moreover, Plaintiff asserts, dependent claims 6, 14, 24, 30 and 53 of the 623 Patent expressly require the use of a machine capable of performing high pressure liquid chromatography (HPLC). Thus, according to Plaintiff, the claims are patentable. Id. (internal citations omitted). 39. Id. at * See Parker v. Flook, 98 S. Ct. 2522, 2528 (1978) (holding patents for a composition of matter produced by catalytic chemical conversion of hydrocarbons invalid under 101); See also Grams, 888 F.2d at 840 (holding claims covering a method of diagnosing an abnormal condition in an individual through the use of a standard chemical analyzer which measured levels of chemical biological components as unpatentable). 40. Prometheus Laboratories, Inc., 2008 WL at * Id. at * F.3d at 1339.

8 122 Duquesne Business Law Journal Vol an application of it. 43 The Court referenced their prior decision In re Bilski, articulating the previously established test for determining whether a process was patentable under This test, known as the machine-or-transformation test, is a two-step inquiry, but also imparted the requirement that (1) usage of a specific machine or article transformation must levy limitations on the scope of the patent claim, and (2) the involvement of a machine or transformation must be essential to its purpose and not some superfluous extra step. 45 Thus, if additional steps or methods are included as a matter of gathering data, and not central to the claim s purpose, than a patentee may not rely on those steps to prove the occurrence of a patentable transformation. 46 In their appeal, Prometheus argued that the patents-in-suit satisfy both prongs of the machine-or-transformation test as articulated in Bilski. 47 Prometheus s contention is two-fold: (1) the use of a high pressure liquid chromatography necessarily implicates the use of a machine, and (2) that the synthetic drugs are compositions of matter, and reliance thereon is enough to pass muster under the machine-ortransformation test. 48 In the alternative, Prometheus explains that Bilski is inapplicable, as the methods indicate use of synthetic drugs, and do not recite or wholly preempt natural phenomena. 49 Of the three previously enunciated steps of the patents claims, 50 Prometheus proffers each as a transformation. 51 Furthermore, they state that the machines and transformations coupled in the process are central to its purpose as a whole, and the district court s reasoning would effective- 43. Id. at Id. The test in Bilski stated that [a] claimed process is surely patent-eligible under 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article unto a different state or thing (citing In re Bilski, 545 F.3d 943, 953 (Fed. Cir. 2008)). See generally Benson, 93 S. Ct. at 255, Prometheus I, at (quoting In re Bilski, at ). 46. Id. at Id. 48. Id. 49. Id. 50. Prometheus Laboratories, Inc., 2008 WL at * Prometheus I, at The administration step involves a physical transformation of the human body s metabolic reaction to synthetic thiopurine drugs. Any methods involved in the determining step require a transformation of blood or human tissue in order to extract and determine the metabolic concentration. While the warning step is the transformation of the metabolite levels, which then indicate the possible need for dosage adjustment. Id.

9 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 123 ly eliminate all medical treatment and diagnostic patents based on optimization testing. 52 Mayo countered with the proposition that any involvement of a machine is an insignificant extra-step solution, as the use of a nonspecific machine is only to gather data, and its dependence on the use of high-pressure liquid chromatography is not enough to allow patentability of otherwise natural phenomena. 53 Similarly, the second step may not be considered a transformation, as it is only data acquisition, while the third step in the process does not require any action, as it undergoes no transformation at all. 54 Again, Mayo urged adoption of the district court s rationale, as the claims impart the correlations themselves and preempted all other practical use. 55 The Court s analysis commenced by stating that Prometheus s patents-in-suit were patentable under 101 because they transformed something, and said transformation was central to the purpose of the process. 56 Administration of 6-TG and 6-MMP necessarily involves a transformation in the human body, as the drugs do not pass through without interaction, and the fact that the administration and change in dosage requires natural processes does not preclude it from patentability. 57 Additionally, the Court noted that the critical error in the district court s analysis was labeling the first two steps of the process as mere data gathering, rather than a transformative component of the treatment regime. 58 Moreover, the fact that the last component of the process requires a mental step does not diminish the patentability of the claims as a whole; for the steps combined create a series of transformations that optimize therapeutic efficacy, while reducing toxicity for treatment of a specific disease using specific drugs. 59 Lastly, the Court held that the patents-in-suit do not wholly preempt their use, as the claims are transformative methods, and not correlations. 60 Even still, the claims satisfy the machine-or-transformation test in Bilski, thus they do not foreclose use of a fundamental principle and are pa- 52. Id. 53. Id. 54. Id. 55. Id. at Promethueus I, at Id. at Id. at Id. at Most interestingly, the Court posed the same question from Grams, as did the District Court in its decision. Grams, 888 F.2d at Prometheus I, at 1349.

10 124 Duquesne Business Law Journal Vol tentable under Accordingly, the judgment of the district court was reversed with instruction to deny Mayo s motion for summary judgment for patent invalidity. 62 D. United States Court of Appeals: Alter Vultus Following the U.S. Court of Appeals decision, 63 the U.S. Supreme Court granted Mayo s petition for certiorari, vacating the appeals court judgment and remanding the case for further consideration in light of their intervening opinion in Bilski v. Kappos. 64 Steadfast in its prior judgment, the Court reaffirmed that Prometheus had claimed patentable methods under In its analysis, the Court essentially parroted its previous analysis, only peppering in the factual dissimilarities it had drawn from Bilski. 66 Mayo stressed that Bilski was directive, in that it held that the machine-or-transformation test, while informative, is not outcome determinative. 67 The appeals court interpreted the Supreme Court s opinion in Bilski as not to disavow the machine-or-transformation test, but rather as providing a useful tool in deciding that Prometheus s patents-in-suit still satisfied the requirements of Again, the judgment of the district court was reversed and remanded with the instruction to deny Mayo s claim of patent invalidity Id. at Id. at Prometheus I, 581 F.3d Mayo Collaborative Services v. Prometheus Laboratories, Inc., 130 S. Ct (2010) (mem.). In Bilski v. Kappos, 130 S. Ct. 3218, (2010) the Supreme Court expressly denied the machine-or-transformation test as being the sole determinate of whether a claimed process was patentable under 101. Declining to adopt any bright line rule, the Court based its decision on the previously decided patent trilogy: Benson, 93 S. Ct. 253; Flook, 98 S. Ct. 2522; and Diamond v. Diehr, 101 S. Ct (1981). Prometheus Laboratories, Inc., v. Mayo Collaborative Services, 628 F.3d 1347, 1352 (2010) (hereinafter referred to as Prometheus II ). 65. Prometheus II, 628 F.3d at Id. at Id. at In Bilski, the Supreme Court stated that [t]he Court of Appeals incorrectly concluded that this Court has endorsed the machine-or-transformation test as the exclusive test. Prometheus II, 628 F.3d at 1354 (citing Bilski, 130 S. Ct. at 3226). 68. Id. 69. Id. at 1359.

11 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 125 E. United States Supreme Court The Supreme Court tactfully began its assailment of the appeals court s analysis by opining that Prometheus s claims do not add enough to the correlations to allow the described processes to be considered patentable under The Court theorized that if a natural phenomena is not patentable, than neither is a process reciting a natural phenomena, unless the claimed process involves a practical application, so as to ensure that it is more than a creative patent drafting designed to exploit the law of nature. 71 The Court embarked on its analysis by parsing the steps delineated in Prometheus s claimed processes. 72 Firstly, the administering step only refers to the likely audience of practitioners treating patients for certain diseases with therapeutic drugs, and this relationship existed well before the claims were asserted. 73 Secondly, the wherein clause dictating a potential need for adjusting the drug dosage does nothing more than suggest that the doctor should take relevant natural law into consideration when treating their patient. 74 The determining step states that the doctor, or whomever, may use whatever means to determine the level of metabolites in the blood, something routinely done in investigating the correlations between effective and toxic levels of thiopurine compounds. 75 Summarily, the Court held that neither the individual step, nor the combined sequence of steps when considered as a whole, added anything new to existing laws of nature. 76 In supporting its conclusions, the Court cited to several of its previous decisions, namely, Diehl, Flook, Bilski, Benson, and O Reilly v. Morse. 77 In Diehl, the Court held patentable a technique employing a known mathematical equation in its overall process to determine the appropriate time to open a rubber mold, as the patentee did not seek to foreclose use of the equation, but instead included the formula as only one part of an otherwise inventive transformation. 78 On the other hand, the process at issue in Flook was deemed unpatentable, as the 70. Mayo, 132 S. Ct. at Id. 72. Id. 73. Id. 74. Id. 75. Mayo, 132 S. Ct. at Id. 77. Id. at Id. at (citing Diamond, 101 S. Ct. at 1048).

12 126 Duquesne Business Law Journal Vol practice of monitoring the catalytic conversion of hydrocarbons, and the implementation of establishing alarm limits at certain levels was a well-known convention, and removing the mathematical formula left no invention. 79 In Bilski, a patentee attempted to patent a mathematical formula to hedge risk of price changes in commodities trading, but it was denied as it was considered an abstract idea. 80 Finally, in Benson, the Court determined that the process of converting binary-coded decimals to pure binary numbers on a computer through the implementation of mathematical equation was not patentable, as the equation had no practical application unless paired with a computer, and thus it was overly broad. 81 The Court s main objective in deciding these cases was to prevent the inhibition of future discovery by improperly removing natural laws from the public realm. 82 This concern is most notable in Morse, as the Court held unpatentable the general claim of a transmission of letters and other intelligible characters over a distance through use of electric or galvanic current. 83 Allowing such a general and non-specific mode of writing or printing from a distance would effectively stalwart future innovation without first acquiring permission from the patentee. 84 Public policy considerations are evoked when determining whether to allow a patent without a limited application, as generalities bordering on claims to natural phenomena could potentially foreclose future discovery, or else make it too expensive to pursue. 85 While exclusive rights provide monetary incentives propagating innovation, exclusivity could also potentially thwart invention due to the price of using existing patents, or require inventors and companies to undertake the 79. Id. at 1299 (citing Flook, 98 S. Ct. at 2522). 80. Mayo, 132 S. Ct. at 1300 (citing Bilski, 130 S. Ct. 3218). 81. Id. at Hence the claim (like the claims before us) was overly broad; it did not differ significantly from a claim that just said apply the algorithm. Id. (citing Benson, 93 S. Ct. at 253). 82. Id. 83. Id. 84. Id. 85. Mayo, 132 S. Ct. at Of particular concern is the more abstract a process patent is recited, the greater a potential that it will apply to situations not anticipated by the patentee. Id. (citing C. Bohannan & H. Hovenkamp, Creation without Restraint: Promoting Liberty and Rivalry in Innovation 112 (2012)). Moreover, if truths of nature could be patented, thus creating property rights for the patent holder, rent seeking and enormous licensure fees could create economic impasses. Id. (citing W. Landes & R. Posner, The Economic Structure of Intellectual Property Law (2003)).

13 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 127 cost and time-consuming task of searching patent pending applications, as well as necessitating overly complicated licensing agreements for those seeking use. 86 Ultimately, the Court, in arriving upon its conclusion, sought to reinforce existing case law precedent, protect the anticipated public policy considerations in patentability of claims, whilst exercising judicial restraint before establishing a new protective rule to suit the needs of a particular field, only to produce unknown results in another. 87 And thus, the Supreme Court deemed the patents-in-suit as claiming the laws of nature, and thus invalid under II. History A. The Patent Acts Thomas Jefferson authored The Patent Act of 1793, which recognized a patent eligible subject matter as a new object, manufacture, device, combination thereof, or an improvement upon existing invention. 89 This language derived its authority from the Intellectual Property Clause of the U.S. Constitution. 90 The pronouncement of this Act embodied Jefferson s polymathic nature, to wit, that creation by enterprising and innovative thinkers should be encouraged. 91 During the period after the 1793 Patent Act (hereinafter referred to as The Patent Act of 1793 ), 92 the test for patent eligibility contemplated two dimensions: (1) novelty and (2) utility. 93 Subsequent patent statutes enacted in 1836, 1870, and 1874 preserved the generality of Jefferson s language, however, in 1952 Congress revised existing patent 86. Id. at Id. 88. Id. 89. Diamond v. Chakrabarty, 100 S. Ct. 2204, 2207 (1980) (quoting Act of Feb. 21, 1793, 1, 1 Stat. 319, which dictates any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement [thereof] is eligible for patent protection). 90. U.S. Const. art. I, 8, cl. 8 ( 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 ). 91. Diamond, 100 S. Ct. at 2207 (quoting 5 Writings of Thomas Jefferson (Washington ed. 1871) ( ingenuity should receive a liberal encouragement )). 92. ch. 11, 1, 1 Stat. 318, 319 (repealed 1836) 93. Graham v. John Deere Co. of Kansas City, 86 S. Ct. 684, 686 (1966). See 35 U.S.C. 101, 102.

14 128 Duquesne Business Law Journal Vol laws, and the term art was replaced with process. 94 The intent, as proffered by the congressional Committee Reports accompanying the 1952 Act, indicated that patent eligibility should include anything under the sun that is made by man. 95 Though, for the first time since the inception of the 1793 Patent Act, Congress expressed a third statutory condition for evaluating patentability non-obviousness. 96 B. The Patent-Eligibility Trilogy Following the decision in Great A. & P. Tea Co. v. Supermarket Equipment Corp., 97 and later the recodification of the Patent Act in 1952 by Congress, the Supreme Court would not revisit the question of invention patentability for more than 15 years. 98 In Graham v. John Deere Co. of Kansas City, 99 the Court endorsed the notion that congressional revision of the Patent Act of 1952, adding the nonobvious requirement, was not intended to reduce the level of invention patentability; rather it was a codification of judicial precedent, 100 with a directive to inquire further into the obviousness of the subject matter prior to granting the patent. 101 While the Court made judicial strides to clarify the process of evaluating the patentability of improvements 94. Diamond, 100 S. Ct. at Id. at (citing S.Rep.No.1979, 82nd Cong., 2d Sess., 5 (1952); H.R.Rep.No.1923, 82nd Cong., 2d Sess., 6 (1952)). 96. Graham, 86 S. Ct. at 686. See 35 U.S.C As set forth in 103, the test for obviousness is whether: [T]he 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. Id S. Ct. 127, (1950) (holding that a combination of elements known to prior art with no respective change in their function are unpatentable, as they withdraw from what is already known). 98. See Graham, 86 S. Ct. at S. Ct Id. at (positing the general condition of patentability that required a comparison between the subject matter of the patent, or application, with the skill required to create the invention ) (citing Hotchkiss v. Greenwood, 11 How. 248 (1850)) Graham, 86 S. Ct. at 693.

15 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 129 to existing patents, or prior art, 102 the advent of the digital computer and attendant patent applications for software spawned a distinct legal beast. 103 The first Supreme Court decision addressing software patentability was Gottschalk v. Benson, 104 wherein the Court invalidated a patent application for a method of converting binary code decimals into pure binary numerals for use with any general-purpose digital computer. 105 The claimed process essentially implemented an algorithm, 106 or sequence of coded instructions, directing the computer to convert one form of numerical representation into another. 107 The denial of patent eligibility was predicated on the concept that the algorithm had no practical application sans a digital computer, and affirming its patentability would essentially permit a patent on the algorithm itself, and wholly pre-empting its use in any other application. 108 While the Court recognized the uncertainty as to whether patent laws could be extended to provide patent protection to computer software, it ultimately deferred to Congress Black s Law Dictionary 126 (Bryan A. Garner ed., 9th ed., West 2009). Prior art (in the context of patent law) is defined as: [k]nowledge that is publicly known, used by others, or available on the date of invention to a person of ordinary skill in an art, including what would be obvious from that knowledge. Prior art includes (1) information in applications for previously patented inventions; (2) information that was published more than one year before a patent application is filed; and (3) information in other patent applications and inventor's certificates filed more than a year before the application is filed. The U.S. Patent and Trademark Office and courts analyze prior art before deciding the patentability of a comparable invention. Id See Benson, 93 S. Ct. 253; Flook, 98 S. Ct ; Diehr, 101 S. Ct (hereinafter referred to as, The Patent-Eligibility Trilogy ) S. Ct Id Merriam Webster Online Dictionary. /dictionary/ algorithm?show=0&t= (last accessed Nov. 15, 2012). Algorithm is defined as a procedure for solving a mathematical problem (as of finding the greatest common divisor) in a finite number of steps that frequently involves repetition of an operation; broadly: a step-by-step procedure for solving a problem or accomplishing some end especially by a computer, 107. Benson, 93 S. Ct. at Id. at Id.

16 130 Duquesne Business Law Journal Vol The second case considered by the Supreme, Parker v. Flook, 110 involved a patent application for a method of automatically updating alarm limits (a number) during catalytic conversion processes, whilst continually monitoring temperature, pressure, and flow rates. 111 The steps in the process included (1) a measure of the present value of a given process variable (i.e., temperature); (2) use of an algorithm to update the alarm limit variable; and (3) the alarm limit was adjusted to the updated value. 112 The only novelty to the process was the algorithm itself. 113 In its decision, the Supreme Court tailored its analysis so as to examine the patentability of the claim pursuant to In so doing, the Court presumed the novelty and non-obviousness of the process, and instead sought to answer whether the applicant s contention that isolated use of the formula within the petrochemical and oilrefining industries alone did not seek to wholly pre-empt use of the algorithm in other fields. 115 Additionally, the applicant urged that the existence of a postsolution activity (i.e., adjustment of the alarm levels in accordance with the algorithm) made the process patent eligible and distinguishable from the holding in Benson. 116 The Court indicated that granting a patent for an unpatentable principle, simply because it expressed a post-solution activity, disregarded substance in favor of artful draftsmanship the result of which would allow almost any algorithm with a post-solution activity to become patent eligible. 117 The Court was sure to caution that the process was not unpatentable under 101 because it contained an algorithm, but because once the algorithm is presumed to be in the realm of prior art, the process when considered as a whole, contained no patentable claim. 118 The Court reaffirmed its hesitation to expand patent rights for individuals and entities, while narrowing the public s use, without some directive from Congress. 119 Finally, in the last of The Patent-Eligibility Trilogy, the Court was presented with the question of whether a process for molding raw syn S. Ct Id Id Id Id. at Flook, 98 S. Ct. at Id Id Id. at Id. at

17 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 131 thetic rubber into precision components, which required utilization of a well-known equation 120 to determine precisely when the product had cured, could enjoy patent protection. 121 The applicants characterized their contribution to prior art as a method of constantly measuring the internal temperature of the press mold, and through use of the equation, determined the precise time to open the device for any given product. 122 With the temperature inside the press being the uncontrolled variable, and inherent differences in cure times for different products, in some instances there was a tendency to overcure or undercure the rubber. 123 The claimed method sought to avoid this manufacturing defect by processing the temperature information through a digital computer, which used the algorithm to recalculate the cure time, and when the actual time equaled the recalculated time the press would automatically open. 124 The Court commenced its inquiry by pronouncing that the claimed process was subject to analysis under 101, as the uncured rubber underwent a physical and chemical transformation while in the mold, and similar industrial processes have been patentable in the past. 125 While the Court was certain to note that claims seeking to patent laws of nature, natural phenomena, and abstract ideas are in contravention of 101, it was determined that the at-issue patent did not seek to preempt use of the equation. 126 Instead, the applicants were seeking to patent a process to cure synthetic rubber, the distinction being that use of the equation itself was not foreclosed, but rather use of the equation in conjunction with the additional steps of the method. 127 The Court reiterated its earlier decisions in Benson and Flook finding that abstract mathematical formulas are not patent-eligible, but held that application of an equation in the transformation or reduction of a structure or process, when considered as a whole, satisfied the statutory conditions of 101 for patent eligibility The Arrhenius equation may be expressed as: k = Ae-Ea/RT Diehr, 101 S. Ct. at Id. at Id. at Id. at Id. at Diehr, 101 S. Ct. at Id. at Id. at

18 132 Duquesne Business Law Journal Vol C. In Light of Bilski v. Kappos During the pendency of the Prometheus v. Mayo litigation, the Supreme Court handed down its decision in Bilski v. Kappos, which dictated that the machine-or-transformation test is not the only test for determining patent eligibility, rather it should provide insight into whether a claimed invention is considered a patentable process under In Bilski, the applicant sought to patent a method to hedge risk in commodities trading. 130 The Court stated that while the machine-or-transformation test may be sufficient for physical inventions, it is less than appropriate when considering the patentability of claims in the Information Age. 131 While the claimed patent may be characterized as a business method, the Court sought to allay potential concerns prompted by its conclusion that, though patents for business methods are rarely granted, they are not categorically outside the scope of Furthermore, the Court explained that this finding of a process does not broaden patent-eligibility of business methods, as they are still required to be novel, nonobvious, and fully and particularly described. 133 Basing its decision on the precedent set forth in The Patent-Eligibility Trilogy, the patent application in Bilski was rejected, as it sought to patent an abstract idea. 134 The Court was cautious to explain that in so holding it was not endorsing the idea of the machineor-transformation test as the sole factor in determining the patentability of business methods, as previously applied by the Court of Appeals for the Federal Circuit. 135 Aware of the scant case law placing restrictions on business methods patents, the Court acknowledged that use of the machine-or-transformation test by the Federal Circuit may have been due to the absence of less extreme alternatives. 136 Most importantly, the Court indicated that it again declined to impose limitations on the Patent Act inconsistent with its text, and that the deci Bilski, 130 S. Ct. at Id. at Id. at Id. at Id. at See 35 U.S.C. 102, 103, Bilski, 130 S. Ct. at Id Id.

19 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 133 sion was rendered on the basis of precedent invalidating the patentability of abstract ideas. 137 During the pendency of Bilski, Mayo sought certiorari after the Court of Appeals decided to reverse and remand the judgment of the District Court 138 granting Mayo s motions for summary judgment. 139 In turn, the Court vacated the judgment and directed that the Court of Appeals of the Federal Circuit to examine the dispute in light of their recent decision in Bilski. 140 III. Analysis The Court has long held that 101 contains an important, but implicit exception to patentability that laws of nature, natural phenomena, and abstract ideas are not patentable 141 as they are the foundation of scientific and technological study. 142 But all inventions necessarily conform to a law of nature, natural phenomena, and abstract idea what then allows an otherwise non-patentable process to cross the threshold into the arena of patent-eligibility? Does 101 serve as the litmus test for whether the application should undergo additional scrutiny under sections 102, 103, and 112, or is it a high bar standard to patentability? As is sometimes the case, the Court is not clear in its explanation as to what the decision in Prometheus should dictate in that regard. Though, so as not to disrupt its precedence with respect to the patentability of process, nor the statutory interpretation of 101, the Court is sure to adhere to prior precedence, and in an exercise of judicial restraint, to keep its toes from the patent quagmire. Though one would be hard-pressed to find a patent that does not at least referentially include a law of nature, natural phenomena, or abstract idea, the Court made a point to reiterate the notion that a process is not unpatentable simply because it calls upon a law of nature or mathematical algorithm. 143 The trouble in Prometheus was that although the determination of the levels at which thiopurine drugs were toxic or effective, relative to their dosage in any given patient, may arguably have been in need of patent protection, the question of 137. Id Prometheus Laboratories, Inc., 2008 WL Prometheus I, 581 F.3d Mayo Collaborative Services, 130 S. Ct Mayo, 132 S. Ct. at 1293 (quoting Diamond, 101 S. Ct. at 1067) Id. (quoting Benson, 93 S. Ct. at 253) Id. (quoting Flook, 98 S. Ct. at 2526).

20 134 Duquesne Business Law Journal Vol whether it sought to patent the process of applying a well-known correlation, or alternatively, patent the levels themselves was a fine line to tread. What Prometheus suffered in its application for the patentsin-suit was lack of specificity that in fact, the patents themselves were too abstract. The Court found great difficulty in distinguishing whether the Prometheus patents were adding enough to an existing law of nature, or else it was an attempt in creative drafting to claim the idea itself. The Court has also made clear that patent eligibility of an invention dependent upon the application of a law of nature must provide a new and useful end. It is not just a matter of stating a law of nature with the direction to apply it. 144 As the Court s vetting in Prometheus focused on an inquiry into whether the claimed patents embodied a law of nature, the latter question became whether the claimed patents transformed the law of nature as applied into a patent-eligible subject matter. It is apparent from the decision that the Court made strides not to disturb (for better or worse) the precedent regarding interpretation of the Patent Act, and reiterated the guiding principles that patent eligibility should not be contingent upon draftsman s art, 145 nor should patents be allowed to broadly claim processes that effectively preempt the use of a natural law. 146 Moreover, the Court urged that prohibitions on patentability in the abstract could not be overcome by limiting use of the patent to a particular field, or in the case of Prometheus, adding an insignificant post-solution activity. 147 Though the Court engages in a lofty analysis when providing its rationale for the decision in Prometheus, at its core rests the principle of an avoidance of monopolizing the use of laws of nature in future in See Benson, 93 S. Ct. at 255 (stating that [h]e who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end ) (internal citations omitted) Flook, 98 S. Ct. at 2527 (stating that [i]t would make the determination of patentable subject matter depend simply on the draftsman s art and would ill serve the principles underlying the prohibition against patents for ideas or phenomena of nature ) Benson, 93 S. Ct. at 257 (stating that [t]he mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly pre-empt the mathematical formular and in practical effect would be a patent on the algorithm itself ) Mayo, 132 S. Ct. at 1294 (quoting Diehr, 101 S. Ct. at 1059).

21 2013 Mayo Collaborative Serv. v. Prometheus Lab., Inc. 135 novation. The Court concerned itself not with protecting a so-called personalized medicine patent, but instead favored promoting free reign in the patenting of future medical discoveries. While the need to protect truly novel inventive concepts is great, there exists an equally great need to ensure flexibility in future innovation. In reality, all that the Prometheus patents added to existing knowledge was a certain level of precision in the administration of the thiopurine drugs, based on arbitrary levels, relative to correlations known to the scientific community. 148 The Court boiled the process patent down to three steps: (1) administering the drug; (2) a wherein step which essentially apprises the individual administering the drug of natural law; and (3) determining the need or lack thereof in altering the dosage to avoid toxicity or to increase efficacy of the thiopurine drugs. Is this not the staged inquiry concomitant with any physician-patient encounter? In all practicality, and at a most rudimentary level, the patent claimed process tells doctors to gather data, consider a law of nature, draw an inference, and adjust the dosage accordingly. What was Mayo s alleged infringement of Prometheus s patents? It was the implementation of a similar diagnostic process through use of alternative levels to determine the threshold at which thiopurine drugs become toxic after metabolization by the body, or else at what dosage the drug is ineffective. The correlation between the level of metabolites in the blood and the respective efficacy and toxicity of thiopurine drugs was a concept already understood by the scientific community. All the Prometheus patents did was describe the natural relationship, and put a numerical value to a naturally occurring interaction created by the administration of thiopurine drugs and metabolization of the drugs by the body. The patents-in-suit attempted to lay claim to the human body s natural response to thiopurine drugs. CONCLUSION Could Prometheus s patents have passed 101 muster were they penned with greater specificity? Perhaps. One may argue that the Court s hesitation to deviate from precedent, and/or declining to adopt some protective rule particular to the field of diagnostic test patents in fact undermines the incentive to innovate, rather than protect it. Critics of the decision have argued that the correlations upon which Pro Cuffari, Theoret, Latour, & Seidman, 6 Mercaptopurine Metabolism in Crohn s Disease: Correlation with Efficacy and Toxicity, 39 Gut 401 (1996).