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The Patent Eligibility of Personalized Medicine Technologies Leah Octavio Published online: 10 Sep 2014.
Click for updates To cite this article: Leah Octavio (2014) The Patent Eligibility of Personalized Medicine Technologies, Journal of Legal Medicine, 35:3, 423-431, DOI: 10.1080/01947648.2014.936264 To link to this article: http://dx.doi.org/10.1080/01947648.2014.936264
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http://www.tandfonline.com/page/termsand-conditions
Journal of Legal Medicine, 35:423–431 C 2014 American College of Legal Medicine Copyright 0194-7648 print / 1521-057X online DOI: 10.1080/01947648.2014.936264
THE PATENT ELIGIBILITY OF PERSONALIZED MEDICINE TECHNOLOGIES Downloaded by [Massachusetts PRIM Board] at 20:28 02 April 2015
Leah Octavio* First Prize Orr Postdoctoral Student Writing Competition 2014
INTRODUCTION Personalized medicine holds great promise for improving the diagnosis, treatment, and management of cancer. Personalized cancer therapies rely on the use of biomarkers for information valuable to diagnosis or treatment of an individual.1 The presence of certain biomarkers, for example, may indicate an increased susceptibility to certain forms of cancer.2 Biomarkers may also be used to optimize patient treatment.3 With personalized cancer therapy, the levels of biomarkers in a patient can be used to determine how well the patient is responding to a course of treatment, whether ∗ Third-year
law student at Villanova University School of Law. Direct correspondence to Ms. Octavio at Villanova University School of Law, 299 North Spring Mill Road, Villanova, PA 19085, or via e-mail at [email protected]. 1 See Biomarker, NAT’L CANCER INST., http://www.cancer.gov/dictionary?cdrid=45618 (last visited Jan. 5, 2014). A biomarker is “[a] biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.” Id. For further discussion on biomarkers used in clinical applications, see, e.g., Ignacio I. Wistuba et al., Methodological and Practical Challenges for Personalized Cancer Therapies, 8 NAT’L REV. CLIN. ONC. 135, 136 (2011). 2 For example, HER2 amplification, PIK3CA mutations, and BRCA1/2 mutations are associated with breast cancer. See, e.g., Yardena Samuels et al., High Frequency of Mutations of the PIK3CA Gene in Human Cancers, 304 SCIENCE 554 (2004); Giuseppe Curigliano et al., Clinical Relevance of HER2 Overexpression/Amplification in Patients with Small Tumor Size and Node-Negative Breast Cancer, 27 J. CLIN. ONC. 5693 (2009); Allison W. Kurian, BRCA1 and BRCA2 Mutations Across Race and Ethnicity: Distribution and Clinical Implications, 22 CURRENT OPIN. OBS. & GYN. 72 (2010). EGFR mutations and EML4-ALK translocation are associated with lung cancer. Roy S. Herbst et al., Lung Cancer, 359 N. ENG. J. MED. 1367 (2008). 3 Treatment of cancer may be improved by knowledge of an individual patient’s molecular characteristics. See Wistuba, supra note 1, at 135. Although chemotherapeutic drugs have been widely used in cancer therapy during the past few decades, research has revealed that most human tumors are heterogeneous. Id. Thus, a “one size fits all” drug regimen for patients with the same tumor type may not be optimal. Id.
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the dosage of the patient’s medication should be adjusted, or the likelihood of the patient to experience side effects from the medication. Also, certain diseased states have been correlated with specific gene expression profiles, protein levels, or metabolite levels, so detecting these “signature profiles” in a patient could further inform physicians of the progression of the patient’s disease. Although new technologies in personalized medicine hold great promise to be highly effective in disease treatment and management, several challenges inhibit their advancement and widespread use. One challenge is the economics and cost-effectiveness of their use in disease treatment.4 Because some of these technologies are not yet fully developed, the tests may be unreliable, and many health insurance providers are unwilling to cover the costs of using the tests.5 But, as the reliability of these technologies improves, they are expected to become cost effective. Another challenge, however, that may hinder further development of personalized medicine is the increasing risk that biomarker technology will not receive patent protection. Recent U.S. Supreme Court decisions indicate that biomarker technology will be less likely to receive patent protection because it is considered to be patent ineligible subject matter. Part I of this article provides an overview of the law on patent subject matter eligibility.6 Part II explains why, under the current patent subject matter eligibility doctrine, biomarker-related technologies are not likely to be considered patent eligible subject matter.7 Finally, part III suggests various alternative approaches that Congress or the courts may adopt to determine the patentability of biomarker and personalized medicine technologies.8 I. SUBJECT MATTER ELIGIBILITY AND THE JUDICIAL DOCTRINE OF SUBJECT MATTER EXCLUSIONS The patent system in the United States was created to incentivize development and innovation in science and technology. To promote development of new technologies, the patent system grants an inventor a limited monopoly on his or her invention in exchange for the public disclosure of the invention.9 4
See Jerel Davis et al., The Microeconomics of Personalized Medicine, MCKINSEY & CO. (Feb. 2010), http://www.mckinsey.com/insights/health systems and services/the microeconomics of personalized medicine (discussing economic challenges to the advancement of personalized medicine). 5 Id. 6 See infra notes 9-31 and accompanying text (discussing the law on patent subject matter eligibility). 7 See infra notes 32-35 and accompanying text (discussing why biomarker-related technologies are not likely to be patent eligible). 8 See infra notes 36-39 (discussing alternative approaches to determining subject matter eligibility). 9 The patent system has its basis in the U.S. Constitution. See U.S. CONST. art. I, § 8 (“Congress shall have the power to . . . promote the Progress of Science and useful Arts, by securing for limited Times to . . . Inventors . . . the exclusive Right to their . . . Discoveries.”).
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The patent statutes set out various criteria necessary for an inventor to receive a patent on an invention, such as novelty, non-obviousness, and subject matter eligibility of the invention.10 Subject matter eligible for patent protection is very broad.11 Over the years, however, the U.S. Supreme Court has carved out subject matter to be excluded from patent protection. Laws of nature, naturally occurring phenomena, and abstract ideas are not patent eligible.12 A natural phenomenon, like the rising of the sun, for example, cannot be patented. Likewise, laws of nature, such as Newton’s laws of motion or Einstein’s law of mass-energy equivalence, cannot be patented. On the other hand, useful applications of laws of nature, such as an engine or rocket designed using the laws of physics, are generally patent eligible. Courts have offered at least two justifications for these exceptions. A naturally occurring phenomenon cannot be patented because it is not something a human created or invented, and it has always been freely available to all persons.13 Laws of nature cannot be patented because of the danger of inhibiting technological progress. Courts feared that “tying up” natural laws would foreclose the development of useful applications of the natural laws.14 Distinguishing patent eligible applications of laws of nature from patent ineligible laws of nature or naturally occurring phenomena may be relatively simple for inventions that have a clearly man-made physical form. New machines or synthetic chemicals, for example, clearly do not exist in nature
10
For details about the criteria for receiving a patent on an invention, see 35 U.S.C. § 101 (2012) (subject matter eligibility); id. § 102 (novelty); id. § 103 (2013) (obviousness); id. § 112 (2012) (written description and enablement). 11 See 35 U.S.C. § 101 (2012) (“Whoever 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.”). 12 See Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (stating that the Court’s precedents excluded “laws of nature, physical phenomena, and abstract ideas” from broad patent-eligibility principles of section 101 (citing Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); Mackay Radio & Tel. v. Radio Corp. of Am., 306 U.S. 86, 94 (1939) (“scientific truth, or mathematical expression of it, is not patentable”); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (“patents cannot issue for the discovery of the phenomena of nature”); Gottschalk v. Benson, 409 U.S. 63, 67 (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”); Parker v. Flook, 437 U.S. 584, 589 (1978) (“an algorithm, or mathematical formula, is like a law of nature”); see also Rebecca S. Eisenberg, Wisdom of the Ages or Dead-Hand Control? Patentable Subject Matter for Diagnostic Methods After In Re Bilski, 3 CASE W. RESERVE J.L. TECH. & INTERNET 1, 8-9 (2012) (reviewing courts’ doctrines on subject matter exclusion). 13 See Kalo Inoculant Co., 333 U.S. at 130 (Naturally occurring phenomena and laws of nature are “manifestations of . . . nature, free to all men and reserved exclusively to none.”). 14 Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1292 (2012) (“Rewarding with patents those who discover laws of nature might encourage their discovery. But because those laws and principles are ‘the basic tools of scientific and technological work,’ there is a danger that granting patents that tie up their use will inhibit future innovation.”).
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and have a physical, tangible form. But, determining patentability of inventions that conveyed or processed information has proven more difficult.15 New methods invented for processing information did not have a physical form. To courts, these inventions appeared to be patent ineligible “laws of nature” or “abstract ideas.” Where the Supreme Court drew the line between patentable and unpatentable processes using laws of nature or abstract ideas was unpredictable.16 Inventions in the biotechnological fields were also at risk of being considered patent ineligible subject matter because many of these inventions comprised of “naturally occurring” elements. Generally, mere human intervention or human design is not sufficient to make an invention with naturally occurring elements patent eligible. In Funk Brothers, the Court found that a specific mixture of bacterial strains to be used as a fertilizer with superior properties was not patent eligible because each strain of bacteria in the mix occurred naturally and the properties of the bacteria in the mix occurred naturally.17 Although each of the bacterial strains was naturally occurring, the particular blend itself, which the inventor used as a fertilizer, did not occur in 15
In Benson and Flook, the Supreme Court found patents for algorithmic processes invalid. See Benson, 409 U.S. at 93 (finding a method for converting binary-coded decimal digits to pure decimal digits patent ineligible under 35 U.S.C. § 101); Flook, 437 U.S. at 594-95 (finding a process relating to updating alarm limits during catalytic conversion of hydrocarbons patent ineligible). But, surprisingly in Diehr, the Supreme Court found a patent that used a well-known equation to calculate the optimal curing time of rubber valid. See Diamond v. Diehr, 450 U.S. 175, 184 (1981) (finding a process using Arrhenius equation to compute and adjust mold temperature during curing of rubber patent eligible under 35 U.S.C. § 101). Some scholars have criticized the distinctions the Court drew between the claims in Flook and in Diehr, claiming that the result in both cases should have been the same because the claims in both cases covered processes for computing and adjusting temperatures of chemical reactions for optimal production of a desired substance. See, e.g., Iver P. Cooper, Process Patent Eligibility: The “Mental Steps” Doctrine, Computer Programs, and Business Methods, 1 BIOTECH. & L. § 3:9 (June 2012) (finding that the steps in the Diehr process were “quite analogous” to those in the Flook process); Andrew L. Schwartz, More Than Just an Algorithm: Reconciling the Necessity for Disaggregating the Business Method, with Bilski’s Abstract Test, NAT’L L. FORUM, http://nationallawforum.com/2011/04/ 25/more-than-just-an-algorithm-reconciling-the-necessity-for-disaggregating-the-business-methodwith-bilski%E2%80%99s-abstract-test/ (last visited Mar. 29, 2014) (discussing how the Diehr decision, which did not overrule the Benson and Flook decisions, never resolved “physical component ambiguities” when determining patentability of processes that were “part physical, part algorithm”). 16 See Michael Risch, Everything Is Patentable, 75 TENN. L. REV. 591, 592 (2008) (stating that, “due to the lack of clear and rigorous precedential support for limiting patentable subject matter, current patentable subject matter jurisprudence is inconsistent”); see also Kristen Osenga, Ants, Elephants, Guns, and Statutory Subject Matter, 39 ARIZ. ST. L.J. 1087, 1093-1103 (2007) (describing inconsistent decisions on patentable subject matter). 17 Kalo Inoculant Co., 333 U.S. 127, 130 (1948). The claimed invention in Kalo concerned a mixture of different strains of Rhizobium bacteria used to inoculate seeds of leguminous plants. Id. at 128-29. The ability of the leguminous plants to fix nitrogen depended on the presence of Rhizobium in the plant roots. Id. at 128. No single species of Rhizobium could infect all leguminous plant species, but each species of Rhizobium could infect a particular group of leguminous plant species. Id. at 129. Thus, to fertilize leguminous plants of different species, a farmer typically had to buy separate strains of Rhizobium for each plant species because using a mixture of Rhizobium species often worked poorly due to the inhibiting effect each bacterial strain had on the other. Id. The inventor in Kalo discovered a certain
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nature. On the other hand, human manipulation of an organism’s genetic material may be sufficient to make an organism patent eligible. In Chakrabarty, the Court held that a strain of genetically engineered bacteria was patent eligible because it did not occur in nature.18 The strain of bacteria in Chakrabarty was engineered to metabolize oil by transforming the bacteria with plasmids bearing genes encoding oil-degrading enzymes.19 Recently, the Supreme Court has ruled on the patent eligibility of biomarker technology.20 In Prometheus, the Court considered the validity of patents claiming a process for using levels of biomarkers to optimize the drug dosage of a patient.21 Meanwhile, the Court in Myriad looked at patents relating to breast cancer diagnostic tests.22 Myriad’s patents claimed isolated DNA and cDNA encoding human genes with point mutations associated with elevated risk of breast cancer.23 In both cases, the Court found the patents claimed patent ineligible subject matter, except cDNA was patent eligible.24 When determining patent eligibility of the biomarker-related technology in Prometheus and Myriad, the Court looked closely at whether the claimed subject matter fell within the patent ineligible “laws of nature” or “naturally occurring phenomena” categories. When considering the subject matter eligibility of genes, gene mutations, or gene products, the Court in Myriad focused heavily on whether the subject matter claimed is naturally occurring or contains naturally occurring elements.25 Mere isolation of DNA was insufficient to make otherwise naturally occurring DNA patent eligible.26 But cDNA was patentable because the
mixture of Rhizobium bacteria in which the different bacterial strains did not exert an inhibiting effect on each other, thus creating a single mixture of Rhizobium that could be used on different leguminous plant strains. Id. 18 Chakrabarty, 447 U.S. at 310. 19 Id. at 305. 20 See Mayo Collaborative Servs., 132 S. Ct. at 1292; Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2109-10 (2013). 21 Prometheus, 132 S. Ct. at 1294-95. The patents-in-suit covered a method for optimizing the therapeutic efficacy of thiopurine drugs used to treat autoimmune disorders. Id. At high concentrations in the body, the drug is toxic, but at low enough concentrations, the drug is therapeutically ineffective. Id. at 1295. The optimal drug dose is not the same for all patients because individual patients metabolize the drug differently, and doctors need to be able to determine the right dose to administer to a patient. Id. The patents described a method for determining the right drug dose by measuring the levels of particular metabolites that researchers have found to be correlated with likely toxicity or ineffectiveness of the drug. Id. 22 Myriad Genetics, Inc., 133 S. Ct. at 2109-10. 23 Id. 24 See Prometheus, 132 S. Ct. at 1296-98; Myriad, 133 S. Ct at 2109-10. 25 Myriad, 133 S. Ct. at 2116 (“We must . . . determine whether Myriad’s patents claim any ‘new and useful . . . composition of matter,’ § 101, or instead claim naturally occurring phenomena.”). 26 See id. at 2117 (“Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”).
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Court deemed that it did not naturally occur in human cells.27 Meanwhile, when evaluating the patentability of processes relating to use of biomarkers, the Court in Prometheus deemed biomarker correlations to be “laws of nature.”28 The Court’s inquiry then focused on whether the application of knowledge of the biomarker to find patent correlations involved “particular, inventive” steps.29 The Court found that merely using biomarker correlations to determine the appropriate dosage of a drug for a patient was not sufficiently “inventive.”30 Thus, the Court found the claimed processes patent ineligible.31 Overall, the Court’s decisions on subject matter eligibility reflect a tendency toward eligibility based on the form of the invention. Although the Court has rejected a test for patent eligibility that rested solely on an invention’s machine-like or synthetic form,32 when determining patent eligibility, the Court, nevertheless, looked for “bells and whistles” in an invention as indications of inventiveness that transform patent ineligible subject matter into patent eligible inventions. II. WHY THE CURRENT SUBJECT MATTER ELIGIBILITY TESTS FAIL WHEN APPLIED TO BIOMARKER TECHNOLOGY Biomarker-related technologies will likely fail the Court’s patent eligibility tests because of the non-physical nature of these technologies. Based on the Court’s “law of nature” or “naturally occurring” tests, the nature of these technologies makes them appear much like patent ineligible natural laws or phenomena. Thus, while the use of synthetic drugs or mechanical devices to treat a patient is likely to be patent eligible because of their physical form, 27
Id. at 2110 (discussing patentability of cDNA). According to the Court, because cDNA is not a “product of nature,” it is patent eligible. Id. “Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.” Id. 28 Mayo Collaborative Servs., 132 S. Ct. at 1296-98. The Court found the correlations between the metabolite levels in the body and the likelihood of the drug’s ineffective or toxic effect were “natural laws.” Id. 29 Id. at 1290 (“But to transform an unpatentable law of nature into a patent-eligible application of such a law, a patent must do more than simply state the law of nature while adding the words ‘apply it.’ It must limit its reach to a particular, inventive application of the law.” (emphasis added)). 30 Id. at 1298 (discussing why the claimed process was not inventive). According to the Court, the additional steps of administering the drug, measuring subsequent levels of the metabolites, and then determining whether the amount of drug administered was likely to be toxic or effective based on the levels of metabolites measured were simply steps that were “well-understood, routine, conventional activity previously engaged in by scientists who work in the field.” Id. 31 Id. 32 Id. at 1296 (“[T]he ‘machine or transformation test’ is not a definitive test of patent eligibility, but only an important and useful clue.”) (citing Bilski v. Kappos, 130 S. Ct. 3218 (2010)). Under the “machine or transformation” test, a claimed process was patent eligible if: (1) the claimed process was “tied to a particular machine or apparatus,” or (2) the claimed process “transforms a particular article into a different state or thing.” In re Bilski, 545 F.3d 943, 954 (Fed. Cir. 2008).
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methods for treating a disease using information from the presence or levels of biomarkers in a patient are not likely to be patentable. The results of the Court’s subject matter eligibility analysis of biomarkerrelated technologies illustrate pitfalls of the “law of nature” or “naturally occurring” tests. These tests focus on the form rather than the substance of the invention. As a result, these tests will likely foreclose patentability of inventions that do not have a physical or synthetic form. Further, the application of these tests to biomarker technology has yielded results that are inconsistent with the rationale underlying subject matter exclusions. Laws of nature, for example, are not patentable because of the potential danger of “tying up” general laws and foreclosing development of many useful applications of the general law.33 But correlations of particular biomarker levels in response to a drug dose are not like general laws of physics because particular biomarker correlations have narrow applicability. It is therefore difficult to see how patenting the use of particular biomarker correlations triggers the concerns that tying up general, broadly applicable laws of nature might bring. Further, the “law of nature” and “naturally occurring” tests embroil the courts in confounding inquiries into issues concerning what should be considered natural laws and natural phenomena. These are questions with no clear answers. When considering what is “naturally occurring,” the Court has not set any clear standard and, instead, has decided the question on a caseby-case basis. In some cases, human intervention could make an invention with “naturally occurring” elements patentable, but, in other cases, it is not sufficient.34 Likewise, the frequency of occurrence of a particular phenomenon in nature does not absolutely determine whether the phenomenon is “naturally occurring.”35 The Court has also found correlations of levels of specific biomarkers in a particular context to be “laws of nature,” even though these are arguably not general laws of nature.36 As the Court’s decisions illustrate, the inquiry into whether a claimed subject matter is a natural law or phenomenon 33
Prometheus has argued that the biomarker correlations in its patent claims were “narrow” laws and should not be excluded from patent eligibility because of the concerns with tying up broad, general laws of nature. Prometheus, 132 S. Ct. at 1303. The Court, however, refrained from analyzing in-depth whether certain laws of nature were broad or narrow. Id. The Court also stated that tying up even narrow laws of nature could inhibit technological progress. Id. 34 Compare Kalo Inoculant Co., 333 U.S. at 130 (finding a human-designed mixture of bacterial species used as a fertilizer not patent eligible), with Chakrabarty, 447 U.S. at 310 (finding bacteria transformed with plasmids bearing genes encoding oil-degrading enzymes patent eligible). 35 See, e.g., Myriad Genetics, Inc., 133 S. Ct. at 2109-10 (2013). The Court found that Myriad’s claimed isolated human genes were not patent eligible, even if the genes encoded point mutations occurred with low frequency in the natural population. Id. But, even if transcription of cDNA occurred in human cells at a very low frequency by viruses that infected the cells, the Court found that cDNA was still patent eligible. Id. at n.8 (“The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable”). 36 Prometheus Labs., Inc., 132 S. Ct. at 1296-98.
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creates a haphazard standard, and the inquiries steer the Court away from important questions concerning the polices that underlie the patent system.
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III. ALTERNATIVE APPROACHES TO DETERMINING PATENTABILITY OF PERSONALIZED MEDICINE TECHNOLOGIES With the Court’s current subject matter eligibility tests, how a court will rule when determining patent eligibility of biomarker-related technologies is unpredictable. Because the Court’s analysis focuses heavily on the form rather than the substance of the claimed invention, inventors and patent drafters may be able to circumvent the Court’s tests by adding more “bells and whistles” to the invention or by clever claim drafting.37 But this is not a long-term solution to the issue of subject matter eligibility of biomarker technology. Other approaches to dealing with this issue are available. One approach is to make all subject matter eligible for patent protection.38 The patentability of an invention can then be determined using the other criteria set out in the patent statutes, such as novelty and non-obviousness.39 Another approach is to revert to the broad subject matter eligibility standard set out in the patent statutes.40 Section 101 of 35 U.S.C. states that “[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.”41 According to the plain language of the statute, a new and useful process or 37
See Sanjesh P. Sharma, Patent-Eligible Subject Matter in Light of Mayo v. Prometheus, 24 INTELL. PROP. & TECH. L.J. 9 (2012). The author noted that, while some commentators have taken the Court’s decision in Prometheus as a death knell for all patents relating to personalized medicine and biomarker technology, others believe that the decision would not be interpreted or applied too broadly, as all inventions embody abstract ideas or natural laws at some level. Id. The author also analyzed recent decisions after Prometheus and concluded that Prometheus could be used both to invalidate and uphold patents. Id. at 13. Therefore, the author suggested that, in view of the Supreme Court’s decision, “cautious practitioners and patentees should consider saving similar types of claims in patents and patent applications from suffering Prometheus’ fate” by “skillful drafting” that ensured that “recited steps do more than just limit the claimed process to a particular technological environment” and that the steps “do not merely add broad post-solution activity that is well-known in the art.” Id. 38 See Risch, supra note 16, at 591-93 (arguing for an approach that eliminates section 101 subject matter eligibility as a criterion for patentability). The author suggests an approach that uses other sections of the patent statutes (sections 102, 103, 112) instead of section 101 to determine patent eligibility. Id. The author argues that “a historic review of United States Supreme Court opinions provides evidence that general patentability criteria-and not subject matter-were key to the Court’s primary subject matter precedents” and that, “[i]n each case reviewed, the Court’s analysis concerned the underlying patentability of the particular claim at issue—problems such as obviousness [patentability requirement under section 103] or insufficient disclosure [patentability requirement under section 112]—even if its opinions nominally recited broad subject matter limitations.” Id. at 591-92. 39 Id. 40 Id. 41 35 U.S.C. § 101 (2012).
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new and useful improvements to a process are patent eligible.42 Therefore, new methods of cancer treatment using personalized genomics or biomarkers should be patent eligible as “new and useful” processes. Alternatively, if Congress wishes to create a separate policy for protecting and incentivizing the development of personalized medicine technologies, it may draft new legislation to specifically address their patent eligibility.43 As it stands, the Court’s current approach for determining patent subject matter eligibility threatens to exclude technology relating to personalized medicine from patent protection. The uncertain status of their patent eligibility may ward off investment into further development of personalized medicine. With the future of cancer medicine heading toward personalized technologies, patent doctrine cannot remain stubbornly rooted in the past and risk jeopardizing the advancement of technology that holds tremendous promise in improving cancer treatment.
42 43
See id. See Prometheus Labs., Inc., 132 S. Ct. at 1305 (discussing the future of patent policy concerning medical diagnostic technologies). In its discussion of the appropriate policy for protecting diagnostic technologies, the Court suggested that Congress may craft “more finely tailored rules” where necessary. Id. The Court hesitated from making extensive policy decisions regarding the protection of diagnostic technologies. Id.
Journal of Legal Medicine Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/ulgm20
The Patent Eligibility of Personalized Medicine Technologies Leah Octavio Published online: 10 Sep 2014.
Click for updates To cite this article: Leah Octavio (2014) The Patent Eligibility of Personalized Medicine Technologies, Journal of Legal Medicine, 35:3, 423-431, DOI: 10.1080/01947648.2014.936264 To link to this article: http://dx.doi.org/10.1080/01947648.2014.936264
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http://www.tandfonline.com/page/termsand-conditions
Journal of Legal Medicine, 35:423–431 C 2014 American College of Legal Medicine Copyright 0194-7648 print / 1521-057X online DOI: 10.1080/01947648.2014.936264
THE PATENT ELIGIBILITY OF PERSONALIZED MEDICINE TECHNOLOGIES Downloaded by [Massachusetts PRIM Board] at 20:28 02 April 2015
Leah Octavio* First Prize Orr Postdoctoral Student Writing Competition 2014
INTRODUCTION Personalized medicine holds great promise for improving the diagnosis, treatment, and management of cancer. Personalized cancer therapies rely on the use of biomarkers for information valuable to diagnosis or treatment of an individual.1 The presence of certain biomarkers, for example, may indicate an increased susceptibility to certain forms of cancer.2 Biomarkers may also be used to optimize patient treatment.3 With personalized cancer therapy, the levels of biomarkers in a patient can be used to determine how well the patient is responding to a course of treatment, whether ∗ Third-year
law student at Villanova University School of Law. Direct correspondence to Ms. Octavio at Villanova University School of Law, 299 North Spring Mill Road, Villanova, PA 19085, or via e-mail at [email protected]. 1 See Biomarker, NAT’L CANCER INST., http://www.cancer.gov/dictionary?cdrid=45618 (last visited Jan. 5, 2014). A biomarker is “[a] biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.” Id. For further discussion on biomarkers used in clinical applications, see, e.g., Ignacio I. Wistuba et al., Methodological and Practical Challenges for Personalized Cancer Therapies, 8 NAT’L REV. CLIN. ONC. 135, 136 (2011). 2 For example, HER2 amplification, PIK3CA mutations, and BRCA1/2 mutations are associated with breast cancer. See, e.g., Yardena Samuels et al., High Frequency of Mutations of the PIK3CA Gene in Human Cancers, 304 SCIENCE 554 (2004); Giuseppe Curigliano et al., Clinical Relevance of HER2 Overexpression/Amplification in Patients with Small Tumor Size and Node-Negative Breast Cancer, 27 J. CLIN. ONC. 5693 (2009); Allison W. Kurian, BRCA1 and BRCA2 Mutations Across Race and Ethnicity: Distribution and Clinical Implications, 22 CURRENT OPIN. OBS. & GYN. 72 (2010). EGFR mutations and EML4-ALK translocation are associated with lung cancer. Roy S. Herbst et al., Lung Cancer, 359 N. ENG. J. MED. 1367 (2008). 3 Treatment of cancer may be improved by knowledge of an individual patient’s molecular characteristics. See Wistuba, supra note 1, at 135. Although chemotherapeutic drugs have been widely used in cancer therapy during the past few decades, research has revealed that most human tumors are heterogeneous. Id. Thus, a “one size fits all” drug regimen for patients with the same tumor type may not be optimal. Id.
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the dosage of the patient’s medication should be adjusted, or the likelihood of the patient to experience side effects from the medication. Also, certain diseased states have been correlated with specific gene expression profiles, protein levels, or metabolite levels, so detecting these “signature profiles” in a patient could further inform physicians of the progression of the patient’s disease. Although new technologies in personalized medicine hold great promise to be highly effective in disease treatment and management, several challenges inhibit their advancement and widespread use. One challenge is the economics and cost-effectiveness of their use in disease treatment.4 Because some of these technologies are not yet fully developed, the tests may be unreliable, and many health insurance providers are unwilling to cover the costs of using the tests.5 But, as the reliability of these technologies improves, they are expected to become cost effective. Another challenge, however, that may hinder further development of personalized medicine is the increasing risk that biomarker technology will not receive patent protection. Recent U.S. Supreme Court decisions indicate that biomarker technology will be less likely to receive patent protection because it is considered to be patent ineligible subject matter. Part I of this article provides an overview of the law on patent subject matter eligibility.6 Part II explains why, under the current patent subject matter eligibility doctrine, biomarker-related technologies are not likely to be considered patent eligible subject matter.7 Finally, part III suggests various alternative approaches that Congress or the courts may adopt to determine the patentability of biomarker and personalized medicine technologies.8 I. SUBJECT MATTER ELIGIBILITY AND THE JUDICIAL DOCTRINE OF SUBJECT MATTER EXCLUSIONS The patent system in the United States was created to incentivize development and innovation in science and technology. To promote development of new technologies, the patent system grants an inventor a limited monopoly on his or her invention in exchange for the public disclosure of the invention.9 4
See Jerel Davis et al., The Microeconomics of Personalized Medicine, MCKINSEY & CO. (Feb. 2010), http://www.mckinsey.com/insights/health systems and services/the microeconomics of personalized medicine (discussing economic challenges to the advancement of personalized medicine). 5 Id. 6 See infra notes 9-31 and accompanying text (discussing the law on patent subject matter eligibility). 7 See infra notes 32-35 and accompanying text (discussing why biomarker-related technologies are not likely to be patent eligible). 8 See infra notes 36-39 (discussing alternative approaches to determining subject matter eligibility). 9 The patent system has its basis in the U.S. Constitution. See U.S. CONST. art. I, § 8 (“Congress shall have the power to . . . promote the Progress of Science and useful Arts, by securing for limited Times to . . . Inventors . . . the exclusive Right to their . . . Discoveries.”).
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The patent statutes set out various criteria necessary for an inventor to receive a patent on an invention, such as novelty, non-obviousness, and subject matter eligibility of the invention.10 Subject matter eligible for patent protection is very broad.11 Over the years, however, the U.S. Supreme Court has carved out subject matter to be excluded from patent protection. Laws of nature, naturally occurring phenomena, and abstract ideas are not patent eligible.12 A natural phenomenon, like the rising of the sun, for example, cannot be patented. Likewise, laws of nature, such as Newton’s laws of motion or Einstein’s law of mass-energy equivalence, cannot be patented. On the other hand, useful applications of laws of nature, such as an engine or rocket designed using the laws of physics, are generally patent eligible. Courts have offered at least two justifications for these exceptions. A naturally occurring phenomenon cannot be patented because it is not something a human created or invented, and it has always been freely available to all persons.13 Laws of nature cannot be patented because of the danger of inhibiting technological progress. Courts feared that “tying up” natural laws would foreclose the development of useful applications of the natural laws.14 Distinguishing patent eligible applications of laws of nature from patent ineligible laws of nature or naturally occurring phenomena may be relatively simple for inventions that have a clearly man-made physical form. New machines or synthetic chemicals, for example, clearly do not exist in nature
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For details about the criteria for receiving a patent on an invention, see 35 U.S.C. § 101 (2012) (subject matter eligibility); id. § 102 (novelty); id. § 103 (2013) (obviousness); id. § 112 (2012) (written description and enablement). 11 See 35 U.S.C. § 101 (2012) (“Whoever 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.”). 12 See Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (stating that the Court’s precedents excluded “laws of nature, physical phenomena, and abstract ideas” from broad patent-eligibility principles of section 101 (citing Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); Mackay Radio & Tel. v. Radio Corp. of Am., 306 U.S. 86, 94 (1939) (“scientific truth, or mathematical expression of it, is not patentable”); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (“patents cannot issue for the discovery of the phenomena of nature”); Gottschalk v. Benson, 409 U.S. 63, 67 (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”); Parker v. Flook, 437 U.S. 584, 589 (1978) (“an algorithm, or mathematical formula, is like a law of nature”); see also Rebecca S. Eisenberg, Wisdom of the Ages or Dead-Hand Control? Patentable Subject Matter for Diagnostic Methods After In Re Bilski, 3 CASE W. RESERVE J.L. TECH. & INTERNET 1, 8-9 (2012) (reviewing courts’ doctrines on subject matter exclusion). 13 See Kalo Inoculant Co., 333 U.S. at 130 (Naturally occurring phenomena and laws of nature are “manifestations of . . . nature, free to all men and reserved exclusively to none.”). 14 Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1292 (2012) (“Rewarding with patents those who discover laws of nature might encourage their discovery. But because those laws and principles are ‘the basic tools of scientific and technological work,’ there is a danger that granting patents that tie up their use will inhibit future innovation.”).
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and have a physical, tangible form. But, determining patentability of inventions that conveyed or processed information has proven more difficult.15 New methods invented for processing information did not have a physical form. To courts, these inventions appeared to be patent ineligible “laws of nature” or “abstract ideas.” Where the Supreme Court drew the line between patentable and unpatentable processes using laws of nature or abstract ideas was unpredictable.16 Inventions in the biotechnological fields were also at risk of being considered patent ineligible subject matter because many of these inventions comprised of “naturally occurring” elements. Generally, mere human intervention or human design is not sufficient to make an invention with naturally occurring elements patent eligible. In Funk Brothers, the Court found that a specific mixture of bacterial strains to be used as a fertilizer with superior properties was not patent eligible because each strain of bacteria in the mix occurred naturally and the properties of the bacteria in the mix occurred naturally.17 Although each of the bacterial strains was naturally occurring, the particular blend itself, which the inventor used as a fertilizer, did not occur in 15
In Benson and Flook, the Supreme Court found patents for algorithmic processes invalid. See Benson, 409 U.S. at 93 (finding a method for converting binary-coded decimal digits to pure decimal digits patent ineligible under 35 U.S.C. § 101); Flook, 437 U.S. at 594-95 (finding a process relating to updating alarm limits during catalytic conversion of hydrocarbons patent ineligible). But, surprisingly in Diehr, the Supreme Court found a patent that used a well-known equation to calculate the optimal curing time of rubber valid. See Diamond v. Diehr, 450 U.S. 175, 184 (1981) (finding a process using Arrhenius equation to compute and adjust mold temperature during curing of rubber patent eligible under 35 U.S.C. § 101). Some scholars have criticized the distinctions the Court drew between the claims in Flook and in Diehr, claiming that the result in both cases should have been the same because the claims in both cases covered processes for computing and adjusting temperatures of chemical reactions for optimal production of a desired substance. See, e.g., Iver P. Cooper, Process Patent Eligibility: The “Mental Steps” Doctrine, Computer Programs, and Business Methods, 1 BIOTECH. & L. § 3:9 (June 2012) (finding that the steps in the Diehr process were “quite analogous” to those in the Flook process); Andrew L. Schwartz, More Than Just an Algorithm: Reconciling the Necessity for Disaggregating the Business Method, with Bilski’s Abstract Test, NAT’L L. FORUM, http://nationallawforum.com/2011/04/ 25/more-than-just-an-algorithm-reconciling-the-necessity-for-disaggregating-the-business-methodwith-bilski%E2%80%99s-abstract-test/ (last visited Mar. 29, 2014) (discussing how the Diehr decision, which did not overrule the Benson and Flook decisions, never resolved “physical component ambiguities” when determining patentability of processes that were “part physical, part algorithm”). 16 See Michael Risch, Everything Is Patentable, 75 TENN. L. REV. 591, 592 (2008) (stating that, “due to the lack of clear and rigorous precedential support for limiting patentable subject matter, current patentable subject matter jurisprudence is inconsistent”); see also Kristen Osenga, Ants, Elephants, Guns, and Statutory Subject Matter, 39 ARIZ. ST. L.J. 1087, 1093-1103 (2007) (describing inconsistent decisions on patentable subject matter). 17 Kalo Inoculant Co., 333 U.S. 127, 130 (1948). The claimed invention in Kalo concerned a mixture of different strains of Rhizobium bacteria used to inoculate seeds of leguminous plants. Id. at 128-29. The ability of the leguminous plants to fix nitrogen depended on the presence of Rhizobium in the plant roots. Id. at 128. No single species of Rhizobium could infect all leguminous plant species, but each species of Rhizobium could infect a particular group of leguminous plant species. Id. at 129. Thus, to fertilize leguminous plants of different species, a farmer typically had to buy separate strains of Rhizobium for each plant species because using a mixture of Rhizobium species often worked poorly due to the inhibiting effect each bacterial strain had on the other. Id. The inventor in Kalo discovered a certain
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nature. On the other hand, human manipulation of an organism’s genetic material may be sufficient to make an organism patent eligible. In Chakrabarty, the Court held that a strain of genetically engineered bacteria was patent eligible because it did not occur in nature.18 The strain of bacteria in Chakrabarty was engineered to metabolize oil by transforming the bacteria with plasmids bearing genes encoding oil-degrading enzymes.19 Recently, the Supreme Court has ruled on the patent eligibility of biomarker technology.20 In Prometheus, the Court considered the validity of patents claiming a process for using levels of biomarkers to optimize the drug dosage of a patient.21 Meanwhile, the Court in Myriad looked at patents relating to breast cancer diagnostic tests.22 Myriad’s patents claimed isolated DNA and cDNA encoding human genes with point mutations associated with elevated risk of breast cancer.23 In both cases, the Court found the patents claimed patent ineligible subject matter, except cDNA was patent eligible.24 When determining patent eligibility of the biomarker-related technology in Prometheus and Myriad, the Court looked closely at whether the claimed subject matter fell within the patent ineligible “laws of nature” or “naturally occurring phenomena” categories. When considering the subject matter eligibility of genes, gene mutations, or gene products, the Court in Myriad focused heavily on whether the subject matter claimed is naturally occurring or contains naturally occurring elements.25 Mere isolation of DNA was insufficient to make otherwise naturally occurring DNA patent eligible.26 But cDNA was patentable because the
mixture of Rhizobium bacteria in which the different bacterial strains did not exert an inhibiting effect on each other, thus creating a single mixture of Rhizobium that could be used on different leguminous plant strains. Id. 18 Chakrabarty, 447 U.S. at 310. 19 Id. at 305. 20 See Mayo Collaborative Servs., 132 S. Ct. at 1292; Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2109-10 (2013). 21 Prometheus, 132 S. Ct. at 1294-95. The patents-in-suit covered a method for optimizing the therapeutic efficacy of thiopurine drugs used to treat autoimmune disorders. Id. At high concentrations in the body, the drug is toxic, but at low enough concentrations, the drug is therapeutically ineffective. Id. at 1295. The optimal drug dose is not the same for all patients because individual patients metabolize the drug differently, and doctors need to be able to determine the right dose to administer to a patient. Id. The patents described a method for determining the right drug dose by measuring the levels of particular metabolites that researchers have found to be correlated with likely toxicity or ineffectiveness of the drug. Id. 22 Myriad Genetics, Inc., 133 S. Ct. at 2109-10. 23 Id. 24 See Prometheus, 132 S. Ct. at 1296-98; Myriad, 133 S. Ct at 2109-10. 25 Myriad, 133 S. Ct. at 2116 (“We must . . . determine whether Myriad’s patents claim any ‘new and useful . . . composition of matter,’ § 101, or instead claim naturally occurring phenomena.”). 26 See id. at 2117 (“Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”).
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Court deemed that it did not naturally occur in human cells.27 Meanwhile, when evaluating the patentability of processes relating to use of biomarkers, the Court in Prometheus deemed biomarker correlations to be “laws of nature.”28 The Court’s inquiry then focused on whether the application of knowledge of the biomarker to find patent correlations involved “particular, inventive” steps.29 The Court found that merely using biomarker correlations to determine the appropriate dosage of a drug for a patient was not sufficiently “inventive.”30 Thus, the Court found the claimed processes patent ineligible.31 Overall, the Court’s decisions on subject matter eligibility reflect a tendency toward eligibility based on the form of the invention. Although the Court has rejected a test for patent eligibility that rested solely on an invention’s machine-like or synthetic form,32 when determining patent eligibility, the Court, nevertheless, looked for “bells and whistles” in an invention as indications of inventiveness that transform patent ineligible subject matter into patent eligible inventions. II. WHY THE CURRENT SUBJECT MATTER ELIGIBILITY TESTS FAIL WHEN APPLIED TO BIOMARKER TECHNOLOGY Biomarker-related technologies will likely fail the Court’s patent eligibility tests because of the non-physical nature of these technologies. Based on the Court’s “law of nature” or “naturally occurring” tests, the nature of these technologies makes them appear much like patent ineligible natural laws or phenomena. Thus, while the use of synthetic drugs or mechanical devices to treat a patient is likely to be patent eligible because of their physical form, 27
Id. at 2110 (discussing patentability of cDNA). According to the Court, because cDNA is not a “product of nature,” it is patent eligible. Id. “Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.” Id. 28 Mayo Collaborative Servs., 132 S. Ct. at 1296-98. The Court found the correlations between the metabolite levels in the body and the likelihood of the drug’s ineffective or toxic effect were “natural laws.” Id. 29 Id. at 1290 (“But to transform an unpatentable law of nature into a patent-eligible application of such a law, a patent must do more than simply state the law of nature while adding the words ‘apply it.’ It must limit its reach to a particular, inventive application of the law.” (emphasis added)). 30 Id. at 1298 (discussing why the claimed process was not inventive). According to the Court, the additional steps of administering the drug, measuring subsequent levels of the metabolites, and then determining whether the amount of drug administered was likely to be toxic or effective based on the levels of metabolites measured were simply steps that were “well-understood, routine, conventional activity previously engaged in by scientists who work in the field.” Id. 31 Id. 32 Id. at 1296 (“[T]he ‘machine or transformation test’ is not a definitive test of patent eligibility, but only an important and useful clue.”) (citing Bilski v. Kappos, 130 S. Ct. 3218 (2010)). Under the “machine or transformation” test, a claimed process was patent eligible if: (1) the claimed process was “tied to a particular machine or apparatus,” or (2) the claimed process “transforms a particular article into a different state or thing.” In re Bilski, 545 F.3d 943, 954 (Fed. Cir. 2008).
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methods for treating a disease using information from the presence or levels of biomarkers in a patient are not likely to be patentable. The results of the Court’s subject matter eligibility analysis of biomarkerrelated technologies illustrate pitfalls of the “law of nature” or “naturally occurring” tests. These tests focus on the form rather than the substance of the invention. As a result, these tests will likely foreclose patentability of inventions that do not have a physical or synthetic form. Further, the application of these tests to biomarker technology has yielded results that are inconsistent with the rationale underlying subject matter exclusions. Laws of nature, for example, are not patentable because of the potential danger of “tying up” general laws and foreclosing development of many useful applications of the general law.33 But correlations of particular biomarker levels in response to a drug dose are not like general laws of physics because particular biomarker correlations have narrow applicability. It is therefore difficult to see how patenting the use of particular biomarker correlations triggers the concerns that tying up general, broadly applicable laws of nature might bring. Further, the “law of nature” and “naturally occurring” tests embroil the courts in confounding inquiries into issues concerning what should be considered natural laws and natural phenomena. These are questions with no clear answers. When considering what is “naturally occurring,” the Court has not set any clear standard and, instead, has decided the question on a caseby-case basis. In some cases, human intervention could make an invention with “naturally occurring” elements patentable, but, in other cases, it is not sufficient.34 Likewise, the frequency of occurrence of a particular phenomenon in nature does not absolutely determine whether the phenomenon is “naturally occurring.”35 The Court has also found correlations of levels of specific biomarkers in a particular context to be “laws of nature,” even though these are arguably not general laws of nature.36 As the Court’s decisions illustrate, the inquiry into whether a claimed subject matter is a natural law or phenomenon 33
Prometheus has argued that the biomarker correlations in its patent claims were “narrow” laws and should not be excluded from patent eligibility because of the concerns with tying up broad, general laws of nature. Prometheus, 132 S. Ct. at 1303. The Court, however, refrained from analyzing in-depth whether certain laws of nature were broad or narrow. Id. The Court also stated that tying up even narrow laws of nature could inhibit technological progress. Id. 34 Compare Kalo Inoculant Co., 333 U.S. at 130 (finding a human-designed mixture of bacterial species used as a fertilizer not patent eligible), with Chakrabarty, 447 U.S. at 310 (finding bacteria transformed with plasmids bearing genes encoding oil-degrading enzymes patent eligible). 35 See, e.g., Myriad Genetics, Inc., 133 S. Ct. at 2109-10 (2013). The Court found that Myriad’s claimed isolated human genes were not patent eligible, even if the genes encoded point mutations occurred with low frequency in the natural population. Id. But, even if transcription of cDNA occurred in human cells at a very low frequency by viruses that infected the cells, the Court found that cDNA was still patent eligible. Id. at n.8 (“The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable”). 36 Prometheus Labs., Inc., 132 S. Ct. at 1296-98.
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creates a haphazard standard, and the inquiries steer the Court away from important questions concerning the polices that underlie the patent system.
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III. ALTERNATIVE APPROACHES TO DETERMINING PATENTABILITY OF PERSONALIZED MEDICINE TECHNOLOGIES With the Court’s current subject matter eligibility tests, how a court will rule when determining patent eligibility of biomarker-related technologies is unpredictable. Because the Court’s analysis focuses heavily on the form rather than the substance of the claimed invention, inventors and patent drafters may be able to circumvent the Court’s tests by adding more “bells and whistles” to the invention or by clever claim drafting.37 But this is not a long-term solution to the issue of subject matter eligibility of biomarker technology. Other approaches to dealing with this issue are available. One approach is to make all subject matter eligible for patent protection.38 The patentability of an invention can then be determined using the other criteria set out in the patent statutes, such as novelty and non-obviousness.39 Another approach is to revert to the broad subject matter eligibility standard set out in the patent statutes.40 Section 101 of 35 U.S.C. states that “[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.”41 According to the plain language of the statute, a new and useful process or 37
See Sanjesh P. Sharma, Patent-Eligible Subject Matter in Light of Mayo v. Prometheus, 24 INTELL. PROP. & TECH. L.J. 9 (2012). The author noted that, while some commentators have taken the Court’s decision in Prometheus as a death knell for all patents relating to personalized medicine and biomarker technology, others believe that the decision would not be interpreted or applied too broadly, as all inventions embody abstract ideas or natural laws at some level. Id. The author also analyzed recent decisions after Prometheus and concluded that Prometheus could be used both to invalidate and uphold patents. Id. at 13. Therefore, the author suggested that, in view of the Supreme Court’s decision, “cautious practitioners and patentees should consider saving similar types of claims in patents and patent applications from suffering Prometheus’ fate” by “skillful drafting” that ensured that “recited steps do more than just limit the claimed process to a particular technological environment” and that the steps “do not merely add broad post-solution activity that is well-known in the art.” Id. 38 See Risch, supra note 16, at 591-93 (arguing for an approach that eliminates section 101 subject matter eligibility as a criterion for patentability). The author suggests an approach that uses other sections of the patent statutes (sections 102, 103, 112) instead of section 101 to determine patent eligibility. Id. The author argues that “a historic review of United States Supreme Court opinions provides evidence that general patentability criteria-and not subject matter-were key to the Court’s primary subject matter precedents” and that, “[i]n each case reviewed, the Court’s analysis concerned the underlying patentability of the particular claim at issue—problems such as obviousness [patentability requirement under section 103] or insufficient disclosure [patentability requirement under section 112]—even if its opinions nominally recited broad subject matter limitations.” Id. at 591-92. 39 Id. 40 Id. 41 35 U.S.C. § 101 (2012).
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new and useful improvements to a process are patent eligible.42 Therefore, new methods of cancer treatment using personalized genomics or biomarkers should be patent eligible as “new and useful” processes. Alternatively, if Congress wishes to create a separate policy for protecting and incentivizing the development of personalized medicine technologies, it may draft new legislation to specifically address their patent eligibility.43 As it stands, the Court’s current approach for determining patent subject matter eligibility threatens to exclude technology relating to personalized medicine from patent protection. The uncertain status of their patent eligibility may ward off investment into further development of personalized medicine. With the future of cancer medicine heading toward personalized technologies, patent doctrine cannot remain stubbornly rooted in the past and risk jeopardizing the advancement of technology that holds tremendous promise in improving cancer treatment.
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See id. See Prometheus Labs., Inc., 132 S. Ct. at 1305 (discussing the future of patent policy concerning medical diagnostic technologies). In its discussion of the appropriate policy for protecting diagnostic technologies, the Court suggested that Congress may craft “more finely tailored rules” where necessary. Id. The Court hesitated from making extensive policy decisions regarding the protection of diagnostic technologies. Id.
