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Personalized medicine may be in danger as the doctrine of patent eligibility –which determines technological innovations that warrant patent protection –faces legal challenges. Diagnostic tests, gene patents, and more are at stake.
Personalized medicine promises to improve treatment outcomes and reduce healthcare costs by tailoring a patient’s personal characteristics to a specific medical treatment. Personalized medicine depends, in large part, on diagnostic methods that are used to obtain information about a patient’s protein, gene, or metabolite profile, which can then be used to predict treatment response. Developing diagnostic methods is costly, making patent protection an important component in securing investment for such technologies.
The future of personalized medicine faces uncertainty, however, as the doctrine of patent eligibility — which excludes certain innovations from patent protection — is in flux.
Since about 1980, there has been a trend of expanding patent eligibility, but this trend has shifted in recent years with the Supreme Court taking a more restrictive approach to granting patent protection. One case that bears watching is In Re Bilski,1 in which the Supreme Court is reviewing the Federal Circuit’s decision that method claims must be tied to a machine or transformation of an article. Although referred to mostly as a “business methods” case, the outcome of Bilski is, nevertheless, expected to affect how and whether certain innovations, such as those related to diagnostics and pharmaceuticals, are eligible for patent protection. A decision is expected in the first half of 2010, and its outcome will have a direct impact on health-care based on personalized medicine.
The patent-eligibility doctrine serves as a gatekeeper in excluding certain discoveries from patent protection.2 The doctrine is deceptively straightforward. First, an invention must be novel. In other words, an invention that is already in the public domain cannot be patented because it is not new. Second, the invention must be nonobvious, meaning that the differences between the new invention and an invention in the same art must not be obvious to a person having ordinary skill in that type of art. Third, the invention also must have utility or usefulness.
Even if these three requirements are met, the subject matter of the invention must also fall within the subject matter that is patent eligible. According to this fourth requirement, any man-made product or process that is the result of active human intervention, as opposed to a product or process of nature, is eligible for patent protection, assuming that the other requirements of novelty, nonobviousness, and utility are met. On the other hand, laws of nature, natural phenomena, abstract ideas, and mental processes are ineligible for patent protection even if they satisfy the remaining requirements for patentability.3 Courts in this country have characterized these ineligible types of subject matter as “fundamental principles,” reasoning that these principles are “the basic tools of scientific and technological work,” and thus are “... part of the storehouse of knowledge of all men ... free to all men and reserved exclusively to none.”4
Although seemingly easy to comprehend, defining exactly what subject matter qualifies for patent protection and what subject matter is excluded often has been difficult to determine. Before 1980, patents were generally issued only for conventional technologies, such as mechanics, electronics, and chemical. In 1980, however, the U.S. Patent and Trademark Office (USPTO) began to expand its definition of patent-eligible subject matter to accommodate innovations in the biotechnology arena.
The landmark case that opened the door for this expansion was Diamond v. Chakrabarty.5 Ananda Mohan Chakrabarty, PhD, often credited for playing an important role in the development of the biotechnology industry, developed a genetically engineered bacterium that could be useful for cleaning up oil spills. In Diamond v. Chakrabarty, the USPTO refused to grant a patent on the bacterium, saying that a bacterium is a living organism and, therefore, is not patentable subject matter. The Supreme Court, however, disagreed by a 5–4 margin and held that while a naturally occurring bacterium would be unpatentable, a bacterium that was genetically engineered can be patentable because it is a product of human intervention. In view of the Supreme Court’s ruling, it appeared that the key distinction between patentable and un-patentable subject matter was, in fact, human intervention.
Only a year after Chakrabarty was decided, the Supreme Court was once again faced with a case testing the boundaries of patent eligibility. In Diamond v. Diehr,6 the Court was asked to decide the patent eligibility of an algorithm for determining the proper time and temperature for curing rubber. The Court held that even though software itself is not eligible for patent protection, a physical machine or process that makes use of a mathematical algorithm could be. Thus, if the invention involves “transforming or reducing an article to a different state or thing,” then the invention satisfies the patent-eligibility doctrine — even if it includes a software component.
As patent eligibility continued to expand into the beginning of this century, patent eligibility for many innovations in life sciences seemed limitless. In 2005, however, Labcorp v. Metabolite7 marked a possible turning point. In Labcorp, the Supreme Court was asked to decide the patent eligibility of a diagnostic test that correlated high levels of total homocysteine in the blood and a vitamin B deficiency. The claim at issue in Labcorp, referred to as Claim 13, included the steps of first assaying a body fluid for an elevated level of total homocysteine and then correlating an elevated level of total homocysteine in the body fluid with a deficiency of vitamin B.8 This claim can be infringed by anyone — a doctor, nurse, or healthcare provider — who uses this method to determine a patient’s vitamin B deficiency.
Although the Supreme Court ultimately declined to decide the case, three justices wrote a strongly worded dissent voicing concerns regarding the policy implications of Claim 13. In the dissent, joined by Justices John Paul Stevens and David Souter, Justice Stephen G. Breyer stated that “at most, respondents have simply described the natural law at issue in the abstract patent language of a ‘process.’ But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.”9 In their view, the correlation between total homocysteine and vitamin B deficiency is a natural phenomenon, and accordingly, constitutes ineligible subject matter for patent protection. Even though Labcorp was never expressly decided, the decision had a profound impact on patent law as it revitalized the doctrine of patent eligibility.
The loss of patent eligibility for certain personalized medicine technologies could discourage technological innovation involving a number of diseases.
While Labcorp opened the door for challenging the validity of a patent based on the doctrine of patent eligibility, In Re Bilski is expected to change the landscape for patent eligibility as it relates to personalized medicine. Bilski is not, at least on its face, directed toward biotechnology or the life sciences. The claims at issue relate to a business-method type of patent, with claims directed toward a method of hedging risk in the field of commodities trading. Specifically, the claim includes initiating a series of sales or options transactions between a broker and purchaser-users by which the purchaser-users buy the commodity at a first fixed rate based on historical price levels, identifying producer-sellers of the commodity, and initiating a series of sales or options transactions between the broker and producer-sellers at a second fixed rate such that the purchasers’ and sellers’ respective risk positions balance out.
In a 9–3 decision, the Federal Circuit held the claims to be patent ineligible. The court articulated a test known as the machine-or-transformation test for determining whether a claimed process is patent eligible. Under this test, a claimed process is patent eligible only if it is tied to a particular machine or apparatus, or it transforms a particular article into a different state or thing. The court also said it is not sufficient for a process to simply involve a machine or transformation. Rather, the machine or transformation must be central to the purpose of the claimed process. By being central, the machine or transformation is not merely an “insignificant extra-solution activity,” but must impose meaningful limits on the claim’s scope.
To better understand machine-or-transformation test, Bilski provided some guidance with respect to what processes would be more than “insignificant extra-solution activity.” For example, adding a data-gathering step to a claim directed toward a fundamental principle, such as a natural phenomenon or algorithm, will generally be insufficient to render the claim patent eligible, even if the data-gathering step involves a machine or transformation. The data-gathering step, in this instance, constitutes “insignificant extra-solution activity.” The court reasoned that every algorithm inherently requires the gathering of data, and simply adding the data-gathering step would not be sufficient to render a claim patent eligible. The court did note, however, that if the data-gathering step were limited to a specific methodology or reagents, the data-gathering step could be treated as substantial, and the claim could be treated as patent eligible.
Although Bilski is regarded as a “business methods” patent case, the decision has profound implications for innovations related to personalized medicine. It should be noted that Bilski applies only to process patents. Therefore, patents related to devices, drug and drug formulations, genetically engineered organisms, and diagnostic testing kits may not be affected by the decision.
Perhaps the most significant issue implicated by Bilski will be the manner in which future courts decide whether a process step amounts to mere “insignificant extra-solution activity.” Based on the court’s explanation of data gathering, Claim 13 of the Labcorp case would likely be patent ineligible, because if the step of assaying for total homocysteine were to be ignored, the claim would simply be directed toward recognizing a correlation between total homocysteine and a vitamin B deficiency. Under Bilski, this correlation could be characterized as either an algorithm or mental process and would likely be viewed as insignificant extra-solution activity.
Shortly after the Bilski decision, the Federal Circuit had an opportunity to decide how the use of pharmaceuticals may be affected. In Classen Immunotherapies, Inc. v. Biogen,10 the claim at issue is directed to methods for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in treatment groups subjected to different vaccination schedules. The Federal Circuit treated the data-gathering step in Classen as insubstantial extra-solution activity. The majority noted that the claim “describes only a general inquiry of whether the proposed correlation between an immunization schedule and the incidence of chronic disorders exists. As such, the process is indistinguishable from the idea itself.” To that end, the court viewed data collection steps as insufficient to render patentable a claim that is essentially directed to a process of analyzing the data.
The impact of Bilski on diagnostics may also be seen in Prometheus Laboratories, Inc. v. Mayo Collaborative Services.11 Prometheus challenges the validity of method claims directed to in vitro diagnostics and is specifically directed to the administration of a drug to a patient and determining the level of metabolite in the patient’s body. In contrast to Classen, the Federal Circuit found that the method claims in Prometheus satisfied the machine-or-transformation requirement, reasoning that the human body is transformed by the administering step as “drugs do not pass through the body untouched.” The court further concluded that the “determining step” is also transformative, because “some form of manipulation … is necessary to extract the metabolites from a bodily sample and determine their concentration.” To explain why these transformations do not constitute merely insignificant extra-solution activity, the court stated that the processes are not merely for the purpose of gathering data, but instead are part of a treatment protocol.
Although the court upheld the validity of in vitro diagnostics in Prometheus, the court’s opinion comes in direct conflict with Breyer’s dissenting opinion in LabCorp. While Breyer’s opinion “is not controlling law,” if and when Prometheus makes it before the Supreme Court, Breyer may not uphold the claims that were upheld by the Federal Circuit. Under Bilski, these claims might well be treated as insignificant extra solution data-gathering steps, similar to the assay step in LabCorp. Therefore, depending on outcome in Bilski, Prometheus may be overturned.
In addition to pharmaceuticals and diagnostics, another area that may be affected by Bilski involves the highly controversial human gene patents, particularly those relating to genetic diagnostic testing. Ever since the Harvard Oncomouse obtained patent protection in the early 1980s, human gene patents have pushed the boundaries of patent law’s willingness to provide protection. Examples of these patents include methods of identifying mutations. Myriad Genetics, for instance, has patent claims covering the BRCA1 and BRCA2 genes, as well as their application in diagnostic tests.12 These genes are responsible for most cases of hereditary breast and ovarian cancers. With these patents, Myriad Genetics could prevent anyone in the United States from doing any research involving these genes before the first patent expires in 2015.
On March 29, however, the U.S. District Court for the Southern District of New York invalidated several of Myriad’s patents directed to methods of detecting mutations in BRCA1 and BRCA2 genes by analyzing gene sequences for mutations or by comparing a patient’s gene sequences with the sequence of a normally occurring gene to see if differences exist.13 In view of Bilski’s machine-or-transformation test, the Court rejected the argument that the “analyzing” and “comparing” steps are transformative because they each require the isolation and analysis of a biological sample. The court, instead, found these claims to be directed only to “analyzing” and “comparing” naturally occurring genetic sequences, which are abstract mental processes. With no explicit transformation of a particular article, and no tie to any particular machine or apparatus, the court found that the steps are no more than data-gathering steps and lack the significant extra-solution step required for patent eligibility.
The Federal Circuit’s decision in Bilski signals a more restrictive approach to patent-eligible subject matter. Such an approach could result in the loss of patent protection for certain technologies in the personalized medicine area and ultimately discourage technological innovation and research involving a number of diseases. Although Bilski is wholly unrelated to medicine, the Supreme Court will have an opportunity to clarify the doctrine of patent eligibility as it relates to medical diagnostics, therapeutic methods, and personalized medicine in general. Healthcare providers, pharmaceutical companies, and organizations working in the pharmaceuticals and diagnostics fields should pay close attention to the Supreme Court’s upcoming decision in Bilski.
Joanna T. Brougher, JD, MPH, reports that she has no financial arrangements or affiliations with organizations or manufacturers of proprietary products mentioned in this article.
1In Re Bilski, 545 F3d 943 (Fed Cir 2008) (en banc), cert. granted, 129 S Ct 2735 (June 1, 2009).
2Section 101, Patent Statute (35 USC §101).
3Diamond v. Diehr, 450 U.S. 175 (1981); Gottschalk v. Benson, 409 U.S. 63 (1972)
4Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)
5Diamond v. Chakrabarty, 447 U.S. 303 (1980).
6Diamond v. Diehr, 450 U.S. 175 (1981).
7Laboratory Corp.of America v. Metabolite Laboratories, 126 S Ct 2921 (2006).
8U.S. Patent No. 4,940,658 (July 10, 1990).
9Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. 548 U.S. 124 (2006) (Justice Breyer dissenting from dismissal of writ of certiorari).
10Classen Immunotherapies, Inc. v. Biogen Idec et al, 2008 WL 5273107 (Fed Cir 2008).
11Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-14–3 (Fed Cir Sept. 16, 2009).
12U.S. Patent Nos. 5,747,282; 5,753,441; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 6,033,857.
13Association for Molecular Pathology v. U.S. Patent & Trademark Office, No. 09-Civ-4515.