Diagnostic Kits/Case Law Review

Introduction and Overview

Upon the grant of a U.S. patent, an inventor receives the exclusive rights to prevent others from making, using, or selling her invention for a time-limited term. In some cases, these rights serve as a powerful incentive and for biotech companies to invest substantial resources into research and contribute major genetic and genomic advances to the field. By some reports, more than 50,000 patents have been issued involving genetic subject matter.

However, some people believe the exclusive rights granted for many patents that claim genetic material – and the way they are enforced - do so on faulty legal reasoning, foreclose entire fields of research from other scientists, and ultimately, adversely affect the general public’s ability to receive innovative medical care for harmful diseases. On the other hand, many other people believe that the law permits genetic material patents and biotech industry could not survive without the competitive advantages secured by these protections.

This debate, which encompasses both bioethical and legal theories, has raged on since the 1970’s. From the legal standpoint, whether the Patent Act permits the ability to claim exclusive ownership over genetic material continues to be extensively debated by judges, lawyers, professional clinicians, and the public at large. The legal principles at stake concern the boundaries of “patentable subject matter” and “patentable processes.” The underlying sources of authority are central to this debate: the Patent Act and, common law judicial interpretations of the Patent Act.

A large part of the problem is caused by statutory ambiguity. 35 U.S.C. § 101, the section of the Patent Act that defines the scope of patent-eligible subject matter, remains unchanged since 1952, significantly prior to the more modern scientific concept of a gene as understood in the 1970’s and beyond. Moreover, the section does not contemplate human genetic material. In its current form, the Act broadly states that “whoever invents or discovers any new or useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent.” The fundamental elements that comprise patentable subject matter are that an invention must be new and useful, and may be a process, machine, or composition of matter. Although the language appears broad on at face value, this section of the Act has been significantly limited by judicial interpretation.

This page contains a review of cases that have an immediate impact on the modern judicial interpretation of patent-eligible subject matter in regard to diagnostics. Our goal is to explain the legal doctrines formed around patenting genes, processes and methods. Part 1 contains a summary and discussion of judicially developed doctrines central to modern legal challenges of genetic patents. Part 2 contains a summary and discussion of modern challenges to genetic patent claims.

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Patent Claim Examples

Modern patents claims that cover genetic material or genetic processes tend fall into one of three categories: compositions of matter gene patents, diagnostic process or method gene claims, and functional use gene patents. A claim that covers compositions of matter tends to claim ownership of an individual genes or DNA sequence in isolated and purified forms. Process and method patent claims tend to cover the steps involved in the extraction, data analysis, and preventative diagnosis. Functional use gene claims tend to products or methods that mimic the functionality of naturally occurring genes in the human body.

For example, the following two claims were recently the subject of litigation in ACLU v. Myriad Genetics . Although these claims come from separate patents, they exemplify the scope of patents claiming specific DNA molecules in isolation and analytic methods of identifying certain genetic characteristics, like mutations, in human samples.

“An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”

The composition of matter claim above describes a specific DNA molecule that possesses a nucleotide sequence that translates into the BRCA1 protein. Because certain amino acids that comprise a DNA sequence can be the result of different combinations of nucleotides, the syntax in this claim potentially covers multiple variations of nucleotides that underlie the ultimate amino acids that are translated from a particular DNA sequence. The presence of certain genetic mutations found within BRCA1 protein has been linked to a strong likelihood of developing breast and ovarian cancer in a person’s lifetime. Thus, this patent claim potentially covers the ability to manipulate and conduct testing and further research on this isolation, and its variants, of BRCA1. At its heart, this extraordinarily valuable patent claim grants the owner the exclusive rights control the uses of isolated BRCA1 DNA sequences for a fixed period of time.

“A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from a group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.”

In the diagnostic claim above, the language describes a process for identifying genetic mutations in the BRCA1 gene. By sequencing the DNA, RNA, or cDNA made from BRCA1 obtained from a human sample and analyzing those sequences, a practitioner can determine the existence of specific mutations which ultimately relate to an interpreted propensity to develop certain types of cancer. This claim grants the exclusive right to a method of analyzing a genetic sequence; and, consequently excludes all others from the right to use it without authorization for a fixed period of time.

In contrast to composition of matter and diagnostic method claims, functional use gene claims are much broader and tend to claim the functional use of a gene, including “products or methods that achieve a particular result or serve a particular function, such as the manipulation or function of a target gene.” For example, the following claim was challenged in Ariad Pharmaceuticals v. Eli Lilly & Co. :

“A method for inhibiting expression, in a Eukaryotic cell, of a gene, whose transcription is regulated by NF-KB, the method comprising reducing NF-KB activity in the cell such that expression of said gene is inhibited.”

In the claim above, the patentee describes a method to reduce NF-kB activity, which is known to produce negative symptoms in humans with cells under attack by bacteria. Although this patent does not describe the entire method in the first claim, the remaining claims delineate a process of NF-kB reduction by using molecular inhibitors, not specifically identified in the patent, which mimic the function of certain genes. Thus, the patent owner has the exclusive rights to non-specified molecular inhibitors for purpose of reducing NF-kB activity.

As the foregoing claim examples illustrate, the breadth of some genetic patent claims is quite expansive. Although in recent years the USPTO has been using a policy which permits these types of claims, questions still remain about the ultimate validity of genetic patents on some of the fundamental requirements and limitations in the Patent Act. The following two sections will discuss the judicial interpretations of these requirements at length and develop the link between them with genetic-related inventions.

Part 1: General Case Law that Impacts Genetic Diagnostics

Patentable Subject Matter

The following cases, O’Reilly v. Morse, Funk Brothers Seed Co. v. Kalo Inoculant, and Diamond v. Chakrabarty established that patents claiming abstract ideas, natural phenomena, and laws of nature are impermissible. Most cases discussed in this section do not directly addresses the patentability of biological or genetic material. Nonetheless, the fundamental principles and limitations on patents derived from these cases often underlie modern arguments concerning the patentability of genetic material, and thus, directly impact modern biotechnology patents as well as the limits of the property rights in regard to diagnostics.

O'Relly v. Morse (Decision)

O’Reilly v. Morse is an early Supreme Court from 1853 which established that abstract ideas are not patentable. Being such an old case, O’Reilly v. Morse does not discuss the concept of genetics or even biological subject matter. Rather, the case involves the Samuel Morse’s electro-magnetic telegraph invention. Morse had been granted a patent in which he famously claimed ownership of, “electro-magnetism, however developed for marking or printing intelligible characters, signs, letters, at any distances.” The claim was ultimately ruled invalid.

The Court found Morse’s claim to be broader than his actual invention, because Morse claimed “the exclusive right to every improvement where the motive power is the electric or galvanic current, and the result is the marking or printing intelligible characters, signs, or letters at a distance.” Importantly, the Court noted that Morse “has not discovered that the electric or galvanic current will always print at a distance, no matter what may be the form of the machinery or mechanical contrivances through which it passes.” The Court found this claim to be at such a high level of abstraction that it claimed an idea, not a practical application or implementation of an idea. For the Court, a claim of private ownership over a basic and fundamental idea may unduly burden future inventors by hindering their ability to create future advances.

The prohibition on patenting an abstract idea, as discussed in the Morse case, is occasionally used to challenge genetic material patent claims. Advocates often liken genetic material, and more specifically DNA, to information that is materialized or embodied in a molecular structure. Based on this analogy, the information represents a mere scientific principle which has always existed and the molecular structure is just the medium of conveyance, just like the power of electromagnetism as a data conduit, and the underlying information that is represented by the DNA is ultimately the same whether sequenced in isolated and purified forms or in the human body in its natural state. A patent claiming ownership over something so broad is impermissible. However, to date, no court has ruled in a sweeping decision that a claim to DNA or any genetic material is too abstract to patent.

Funk Brothers Seed Co. v. Kalo Inoculant Co. (Decision)

Many years later, the Supreme Court decided Funk Bros. Seed Co. v. Kalo Inoculant Co. in 1948 and established that claiming inventions that amount to natural phenomena are not patentable. At issue was a patent which claimed several strains of Rhizobium, bacteria which enables atmospheric nitrogen fixation in the root system of leguminous plants. In the past, the bacteria cultures were sold to farmers in separate packages targeted at specific plant species—when separate strains were combined, the strains inhibited the desired effects of each other. The patentee was able to combine separate, non-mutually inhibitive, strains of the Rhizobium into single multi-use packages without adversely affecting the effectiveness of the cultures and, subsequently, was granted a patent on the product. The Court found the claims to be invalid and declared, “patents cannot issue for the discovery of the phenomena of nature.” In reaching this conclusion, the Court focused on the fact that the patentee “did not create the state of non-inhibition in the bacteria,” and instead only determined which strains could be mixed without altering the effectiveness. Thus, the desirable qualities of the bacteria could only be the result of the work of nature, and therefore, are not patentable.

Funk Brothers stands for the notion that a composition of matter which exhibits beneficial characteristics that already exists in nature is not patentable without adding something more is not patentable. Here, a claim covering genetic material may be challenged as a mere claim to the natural functionality of a human gene. However, as is the case in all subject matter challenges, the eventual success of such a challenge depends greatly on the substance of the claimed invention.

Diamond v. Chakrabarty (Decision)

Although in their natural state micro-organisms like bacteria may not be patentable, certain types of genetically engineered micro-organisms, created by humans, may be patentable inventions. Such was the case in Diamond v. Chakrabarty, one of the most influential cases related to modern biotechnology-related patents heard before the Supreme Court. The Chakrabarty case, which was decided in 1980, is attributed by some commentators to have influenced several decades’ worth of patent application filings and grants. Genetic engineer, Anada Chakrabarty, had developed a bacterium from the genus Pseudomonas that contained stable-energy plasmids that provided a hydrocarbon degradative pathway. In other words, the bacterium was a specially engineered derivative of a naturally occurring bacterium with the ability to break down the components of crude oil. These characteristics were not possessed by any naturally occurring version of the bacterium. Chakrabarty’s patent application specifically claimed ownership of the engineered bacteria, but had previously been rejected by a patent examiner before reaching the Supreme Court, on grounds that bacteria is a living mirco-organism, and thus constitutes an unpatentable “product of nature.” The Court disagreed with the patent examiner, and famously declared that the statutory subject matter was to “include anything under the sun that is made by man.”

Despite this seemingly expansive wording, the Supreme Court went on to say that “laws of nature, physical phenomena, and abstract ideas” are still not patentable and noted by example that “a new mineral discovered in the earth or a new plant found in the wild is not patentable[; and,] Einstein could not patent his celebrated E = mc² formula.” According to the Court, the distinction is that the Chakrabarty’s invention is a “non-naturally occurring manufacture or composition of matter—a product of human ingenuity.” In reaching this conclusion, the Court rejected several contrary arguments, including that “the resolution of the patentability of inventions such as [Chakrabarty’s] should be left to Congress” because “genetic technology was unforeseen when Congress created” the language in the Patent Act, and noted that “Congress is free to amend [the Patent Act] so as to exclude from patent protection organisms created by genetic engineering.”

The ruling in Chakrabarty is often credited as a boon for patenting genetic material. In the post-Chakrabarty 1980’s and 1990’s, applicants inundated the USPTO claiming genetic material inventions. The USPTO determined it was bound by the Chakrabarty ruling and rejected contrary arguments that genetic material is wholly unpatentable, provided that “one specific, substantial and credible use is disclosed and the statutory requirements are met.” Many applicants were subsequently granted patents on their genetic inventions on the basis of this policy. Nevertheless, some commentators argue that the same principles upon which Chakrabarty was decided are the same reasons that many genetic patents should be held invalid. These commentators point to the Supreme Court’s clear indication that something must be contributed to a biological invention that takes it beyond its naturally occurring form and into something that has human creativity to be patentable. Along this line of reasoning, scientists and lawyers argue that the difference between a gene as it exists in the human body is no different than a gene in its isolated and purified form. However, this reasoning has yet to obtain unquestioned adoption across court jurisdictions.

Impact of Morse, Funk Brothers, and Chakrabarty

O’Reilly v. Morse, Funk Bros. Seed Co. v. Kalo Inoculant, Co., and Diamond v. Chakrabarty are very much alive today in terms of precedential value and continue to be cited for the proposition that abstract ideas, physical phenomena, and laws of nature are not patentable. However, the gray area that applies to genetic diagnostic patents—and sets these principles under such great discussion in all parts of the world—is what level of human intervention is sufficient to turn an naturally occurring phenomena, such as an individually isolated gene or the diagnostic process of comparing genes for abnormalities, into a “[something] under the sun that is made by man.”

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Process or Method Patent Claims

The courts have placed limits on patenting processes and methods (used interchangeably) for performing a function or accomplishing a result. Occasionally, certain patents that claim invented processes or methods amount to abstract ideas, natural phenomena, and laws of nature. Some legal believe experts believe that certain classes of patents, like "business method patents," should be entirely excluded from patentable subject matter. However, whether a process or method invention is ineligible depends largely on the nature of the invention. This section will explain some of the pertinent history and current state of this standard at length.

History of Process Claim Doctrines

At present, the limits of process and method claims are in a state of flux, due to a case currently pending before the Supreme Court. Prior to now, process or method claims were patentable if it involved some practical application and produced a concrete and tangible result. This legal test, known as the “useful, concrete, and tangible results test,” came from State Street Bank & Trust Co. v. Signature Financial Group., a 1998 Federal Circuit case. In 2008, however, the Federal Circuit abandoned this test and adopted a new test in In re Bilski. Prior to both Bilski and State Street Bank, the Supreme Court decided Gottschalk v. Benson in 1972. This older case eventually became the basis of the test adopted in Bilski and illustrates some of the principal issues with patenting certain methods and processes.

Gottschalk v. Benson (Decision)

Gottschalk v. Benson, a Supreme Court decision from 1972, illustrates the principal problem with method patent claims. In Gottschalk, a patentee filed an application for a patent which claimed a method for converting binary-coded decimal numbers into pure binary numbers on a computer. The conversion method consisted of an algorithm which essentially detailed the mathematical steps of conversion, but did not specify a particular computer or other machinery that would be utilized during the conversion process, nor any particular end use after the conversion. The Supreme Court’s key inquiry in the case was whether an algorithm constituted a scientific truth, or a mere abstract idea, that was not patentable. The argument is somewhat analogous to Samuel Morse’s claim of ownership over the electromagnetism as a motive of power. Like the power electromagnetism, a series of mathematical steps represent a fundamental means of converting data by way of an abstract idea that already exists.

The Supreme Court ruled that the algorithm was not patentable and reiterated that “[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.” The Court reasoned that the “process was so abstract as to cover both known and unknown uses of the [pure binary conversion process]” and could vary extensively from “operation of a train to verification of drivers’ licenses” and be “performed through any existing machinery or future-devised machinery or without any apparatus.” Importantly, the Court pointed out that if there was to be an invention from a non-patentable discovery, “it must come from the application of the law of nature to a new and useful end.” To this end, the Court left some final thoughts on the state of a process claim and explained that a “[t]ransformation and reduction of an article to a different state or thing is the clue to the patentability of a process claim that does not include particular machines.”

In re Bilski (Decision)

At the time when Gottschalk was decided, most legal commentators believed the case would adversely impact the patentability of software programs. This prediction did not exactly hold true. Patentees continued to receive software patents and other types of process patents for several decades by tying machine apparatuses into process claims to meet the language in Gottschalk. Recently, the process claim controversy has resurfaced before the Federal Circuit in In re Bilski, a case that involves patent application claim over a method of hedging commodity trading. The Bilski application claims a business method by which user-buyers, seller-producers, and brokers of commodities initiate a series of transactions based on historical pricing levels to balance transactional risk. The patent application was initially rejected as an abstract idea by the USPTO.

In 2008, the application was appealed to the Federal Circuit and was eventually argued before an en banc panel of twelve circuit judges who affirmed the rejection of the application. In doing so, the Federal Circuit adopted a rule in part based on the Gottschalk case known as the “machine or transformation test.” Under this test, a claimed process is eligible for a patent if “(1) it is tied to a particular machine or apparatus, or (2) transforms a particular article into a different state or thing.” Importantly, the machine or transformation must be “a significant step” in the claimed process, not merely claimed to make the invention patent eligible. Ultimately, the Bilski claims failed to meet the bounds of the machine or transformation test and the Federal Circuit affirmed the rejection of the application. The Federal Circuit’s adoption of the machine or transformation test (provide concept in a footnote) presently calls into question many patents which claim methods. In mid-2009, the Supreme Court granted review of Bilski and heard oral arguments in November 2009. A decision is expected sometime prior to June 2010. (insert footnote with links to the documents of the case)

This case significantly calls the validity of many process or method patent claims into question, including patents covering diagnostic methods. Because many of these patent claims do not involve machinery, many people believe that diagnostic method claims do not sufficiently meet the “transformation” prong of the Bilski test. Here, challengers tend to argue that a diagnostic method claim is nothing more than a series of mental steps, using pre-existing scientific principles that naturally occur in genes, to evaluating the particular state of a genetic molecule. (provide citation) Building off the argument that genes do not significantly different when in isolated and purified forms, challengers argue that processes claimed in these patents cannot evince a transformation of a DNA molecule or sequence into a different state of matter. A handful of cases have addressed this argument with mixed results. These cases will be discussed in the following section.

Part 2: Case Law Specific to Genetic Diagnostics

Perhaps more than ever, the current state of the law is in flux. Two recent significant cases are making their way through the court system: In re Bilski and ACLU v. Myriad Genetics. Both cases involve landmark rulings that have, potentially, far reaching implications for the future of biotechnology patents, and, in specific diagnostics. A number of other cases, in the last ten years, have addressed specific issues with regard to genetic diagnostic patents. Many of these cases expound on some of the general principles discussed in the previous section, such as patentable subject matter, diagnostic process or method claims and the application of the machine or transformation test. Other cases concern prerequisites under the Patent Act, such as “written description,” “enablement,” and “utility” requirements.

Challenges to Genetic Subject Matter and Process Claims

Metabolite Laboratories v. Laboratory Corp. of America Holdings (Decision)

In 2004, the Federal Circuit decided Metabolite Laboratories v. Laboratory Corp. of America Holdings . This case involved a patent that claimed methods of detecting certain types of B vitamin deficiency in warm-blooded animals by correlating actual results from a bodily fluid assay that measures homocysteine, an amino acid which in high levels is associated with decreased amounts of B vitamins, with expected levels of homocysteine associated with B vitamin deficiencies. By comparing these two numbers, a clinician can determine the type of B vitamin which is deficient in a test subject and a course of treatment for the deficiency.

Lab. Corp., the party challenging the validity of the process claim, argued that the process claimed consisted of mere mental reasoning steps of comparing data and an impermissible claim on a law of nature. Prior to reaching the Federal Circuit, the case was heard in the Federal District Court for the District of Colorado, which granted a ruling in favor of Metabollite Laboratories and declared the process claim valid. In turn, the Federal Circuit affirmed the District Court’s ruling in the process claim validity without providing any reasoning. Subsequently, the case was appealed to the Supreme Court, which initially granted review of the case and heard oral arguments. After oral arguments, the Supreme Court reversed its prior decision granting review and dismissed the case in a single sentence opinion. Three Supreme Court Justices took part in a dissenting opinion which accompanying the dismissal, and characterized the Metabollite’s process claim as an invalid claim to a natural phenomenon. The dissent reasoned that the process amounted to “an instruction to read some numbers in light of medical knowledge” and thus only embodied “the correlation between homocysteine and vitamin deficiency that the researchers uncovered.”

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Decision)

Several years later, in 2009, the Federal Circuit decided Prometheus Laboratories, Inc. v. Mayo Collaborative Services, a case which challenged the validity of a patent claiming methods of calibrating a proper administrative dosage of Thiopurine drugs to treat autoimmune diseases. The substance of the method claims in this case were similar in nature to the claim made in the Metabollite v. Lab Corp. case. Essentially, the methods claimed consisted of comparing of lab results of metabolite levels measured after an the initial administration of treatment, then comparing to pre-determined levels, and determining if the levels indicate a need to increase the level of the drug to be administered, and if so, the optimal level to administer that maximizes the efficacy of the treatment while minimizing toxicity. In what seemed like an unlikely win for the Biotechnology industry, the Federal Circuit upheld the validity of the patents, and found the claims to fit “squarely into the realm of patentable subject matter”

Prior to reaching the Federal Circuit, the California District Court ruled that process claims were unpatentable natural phenomena. In drawing this conclusion, the District Court heavily relied on the Supreme Court’s dissenting opinion that accompanied the Metabollite v. Lab Corp dismissal. However, on appeal, the Federal Circuit ruled that the Justices’ dissenting remarks in Metabollite were not binding precedent, and, moreover, noted the claims in the Metabollite case were different than the ones presently before the court. In so holding, the Federal Circuit made clear it was not persuaded by the Supreme Court’s reasoning.

This case also came after the Federal Circuit decided the Bilski case and adopted the machine or transformation test for process claims and directed the test inquiry to whether the transformation was a significant step in the process. Here, the Federal Circuit found that the steps to be more than a mere correlation of data or a simple data-gathering process, because each step provides “useful information for possible dosage adjustments to the method of treatment” for a particular subject. According to the court, the transformation occurred through the administration of treatment protocol, prior to any data gathering or analysis. Following the manipulation, the results direct the next steps to assessing the optimal course of treatment. So, while the fundamental principles of the methods were based on natural processes, the methods described in the patent were caused the transformation by administering the treatment, and therefore patentable.

Although cases like Prometheus seem to confirm that many diagnostic processes, if well drafted, may be patentable even under the Bilski test (define Bilski test in footnote in a more direct way as above), the ultimate disposition of these types of claims remain in the balance of the Supreme Court’s ruling in Bilski. For this reason, much of the Biotechnology industry has its eyes on the Supreme Court’s published opinion on process and method patent claims.

ACLU v. Myriad Genetics (Decision)

Most recently, on March 29, 2010, the Southern District for New York issued a landmark ruling in favor of the American Civil Liberties Union in ACLU v. Myriad Genetics and invalidated seven patents claiming methods of predictive diagnostics of breast and ovarian cancer through an isolation, sequencing, and diagnostic processes of BRCA1 and BRCA2 genes (collectively, “BRCA1/2”). This is the first ruling, to date, that has invalidated patents which specifically claim genetic material and diagnostic processes as unpatentable subject matter and as such is receiving great national and international attention.

The ruling (provide citation) was reasoned on two different legal principles: prohibited products of nature and failure to meet the machine or transformation test. On the first point, the court concluded that the Myriad patent claims over an isolated and purified form of DNA were not patentable because “the purification of a product of nature, without more, cannot transform it into patentable subject matter.” In its reasoning, the court drew comparisons between Myriad’s isolated forms of BRCA1/2 and similar biological product claims made in Chakrabarty, Funk Brothers, and a handful of older cases , and ultimately concluded that the isolated forms of the genes, even if purified, were still products of nature. In two separate portions of the opinion, the court made the following remarks:

“DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an ‘isolated’ form alters neither this fundamental quality as it exists in the body nor the information that it encodes.”

“In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA ‘markedly different.’ This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form. The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.”

The court emphasized that a claim over a product of nature “must possess ‘markedly different characteristics’ in order to” be patentable, and that isolated BRCA1/2 did not possess those characteristics. Secondly, the court ruled that several of the Myriad patents failed to meet the machine or transformation test for methods claimed. This reasoning was based on the Federal Circuit’s decision in the Bilski case. Some of Myriad’s patents claimed process of “analyzing” and “comparing” DNA sequences of the BRCA1/2 genes and “noting whether or not the specified naturally-occurring mutations exist” that would give rise to a predictive cancer diagnosis. The court concluded that these methods of analyzing or comparing sequences were not tied to any particular machine, nor did they constitute a physical transformation of an article; therefore, the claims were not patentable processes.

The principles discussed in the Myriad case are not exactly settled points of law. Since the release of the District Court’s ruling, Myriad has already announced their plans to appeal the decision to the Federal Circuit. Because of the landmark nature of the ruling, it is difficult to speculate how the Federal Circuit will treat the District Court’s conclusion that isolated and purified genes are unpatentable products of nature. Additionally, since the second portion of the District Court’s reasoning in the opinion was based on the Bilski case, which the Supreme Court will decide in the near future, the District Court’s ruling will be subject to the Supreme Court’s decision on the machine or transformation test.

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Other Legal Challenges

In addition to challenging the scope of patentable subject matter, a few cases have challenge genetic product and method claims on the basis of other requirements under the Patent Act. Three distinct, but closely related, requirements have been challenged in court involving claims covering genetic materials: the “utility,” “written description,” and “enablement” requirements.

Utility, Written Description, and Enablement

The utility requirement is related to the subject matter of the invention and is derived from the statutory language the Patent Act that states patents may be granted for any “new, useful, process, machine, manufacture, or composition of matter.” The word “useful” thus requires an invention to have a definable utility to be eligible for a patent, and of course, has been subject to judicial interpretation and clarification.

In contrast to the utility requirement, which deals with the functionality of an invention, the written description and enablement requirements deal with the written specification of patent. The specification is the written instrument which precedes the claims stated in a patent, and, among other things, explains the nature and scope of the invention claimed. The Patent Act requires a specification to “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or is most nearly connected, to make and use the same.”

These requirements are said to serve a multitude of functions. Primarily, a detailed description of a claimed invention gives public notice of the scope of exclusive rights which are owned by the inventor and, in theory, ensures the inventor does not obtain rights more expansive than his inventive contribution to the field. Secondarily, these requirements serve a disclosure function, in that the invention is meaningfully disclosed to the public in exchange for the grant of exclusive for the term of the patent. The latter purpose is often described as the quid pro quo exchange of knowledge for limited-term exclusive ownership.

These three requirements frequently present problems for biological subject matter inventions. In practice, it sometimes proves difficult to identify a real world utility or describing an inventions based on academic research. This was the case in both In re Fisher and Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co..

In re Fisher (Decision)

In re Fisher is a Federal Circuit case from 2005 based on a rejected application for patent for want of utility. The claims which were rejected covered five expressed sequence tags (or “ESTs”) for identifying nucleic acid sequences in maize genes. Through research, the inventor had discovered that the ESTs, when combined with a sample of maize DNA, caused the expression of certain genes. However, at the time of filing, the inventor was unable to identify the precise structure or function of any of the genes or proteins encoded for by the genes. In his application, the inventor stated a number of hypothetical ways in which the ESTs might be utilized, but could not identify an actual “real world” application for the ESTs. The Federal Circuit affirmed the rejection of the patent.

In the opinion, the Federal Circuit noted that the utility requirement is not a high threshold. In short, the application need only disclose one single and substantial utility of the invention that confers a benefit to the public. Since only hypothetical uses could be claimed in the Fisher application, the claims of ESTs still required further research before they could be put to use or confirmed to have a real world use beyond further research. On another point, the court noted that if no specific utility can be identified, the invention is also not sufficiently enabled. According to the court, without a practical use of the invention, the specification could not be capable of “enabling one skilled in the art” to carry out the invention.

Ariad Pharmaceuticals v. Eli Lilly & Co. (Decision)

Several years later in 2009, the Federal Circuit took on Ariad Pharmaceuticals . This case primarily concerns the written description and enablement requirement. In the case, inventors had obtained a patent which claimed methods of reducing Nuclear Factor Kappa B (“NF-kB”) activity in Eukaryotic cells. NF-kB is a protein complex that, when activated by an extracellular influence like bacteria, travels to the nucleus of a cell and causes the production of certain proteins, like Cytokine, to help a cell survive the extracellular influence. The reaction is similar to how the human body reacts to an infection by fever; although helpful to fighting the infection, if the reaction is left unchecked for extended periods of time, it can cause damage. The claim in the Ariad patent essentially hypothesized three general molecular inhibitors that were potentially capable of reducing the NF-kB activity: specific inhibitors, dominantly interfering molecules, and decoy molecules. The patent specification did not provide any specific examples or identify any actual molecules beyond those general categories. Validity was challenged in the lawsuit by Eli Lilly & co. on grounds that the specification did not contain a sufficient written description, and separately, was the invention adequately enabled in the specification.

After a series of rulings in favor of Eli Lilly & Co which invalidated the claim, the Federal Circuit affirmed the invalidity in 2010, and clarified that a specification must meet three distinct requirements to satisfy written description and enablement. First, the written description must not only describe invention, but also do so in a manner that the specification objectively identifies that the inventor was actually in possession of the claimed invention at the time of filing. The idea here is the patent is not laying a broader claim than was actually invented. Second, and distinct from the enablement requirement, the written description must “clearly allow persons of ordinary skill in the art to recognize that the [inventor] invented what is claimed.” Finally, the Federal Circuit interpreted enablement to require recitation of sufficient materials to accomplish the function claimed.

In sum, the specification failed on both the written description and enablement counts because it did not fully describe what was invented, nor what molecules actually reduced NF-kB activity; rather, it was claim to a hypothetical solution to a problem. The Federal Circuit likened this to claim a on the entire genus of molecules that might inhibit NF-kB without actually identifying the composition of any specific molecules which were actually capable of performing the claimed function. Nonetheless, this ruling does not foreclose the possibility of permissible claims on an entire genus. The Federal Circuit noted that a claim on a genus might be permissible if the specification discloses several examples of species to the extent that all species within a genus would have the effectively accomplishing the desired functions across an entire genus.

Non-Obviousness

Finally, some cases have attempted to challenge genetic patents on issues of “obviousness.” Just as the Patent Act states that a patentable invention must be “useful,” a patent must also be “new” and “non-obvious.” These standards require that an invention must not be known to the public, published in literature, or have been merely obvious to a person skilled in the art. In other words, the USPTO will not grant patents for inventions for de minimis inventions. In the course of legal actions, challengers often point to published literature, also termed “prior art,” that existed prior to the date of invention. If the prior art essentially makes obvious to skilled practitioners in the field, it may be considered obvious, and therefore, unpatentable.

Courts have often struggled with a challenge on the grounds of obviousness because although an invention may seem obvious in the present, while an inventor was working through the process of creation, the invention may not have been obvious. This problem is often described as the “hindsight analysis.” Recently, in 2007, the Supreme Court clarified the non-obvious requirement in KSR International Co. v. Teleflex Inc. meant that if a person having skill in the art, “facing the wide range of needs created by developments in the field of endeavor, would have seen a benefit to upgrading [a prior art patent]” then the later invention would have been obvious. This is occasionally called the “obvious to try” test and it depends on (1) whether “there are a finite number of identified, predictable solutions” for the problem a invention seeks to solve, and whether the person having ordinary skill in the art “has good reason to pursue the known options within his or her technical grasp”; and, (2) whether the efforts of the person “leads to the anticipated success.” If a court can resolve these two inquiries in the affirmative, an invention is obvious, and therefore, not patentable.

Here, the contention arises that genetic material claims are not patentable because they represent “the secret to life” and “genes that have not been modified by man are not new.” A number of cases have attempted to challenge genetic patents on this basis, including Board of Trustees v. Roche and In re Kubin.

Board of Trustees v. Roche is a 2008 case that involved a series of patents claiming methods for evaluating the effectiveness of ant-HIV therapy of patients by detecting HIV encoding nucleic acids in samples. The challenger (Roche) argued that an article published prior to the date of invention described a similar, but slightly different, test assay that was so similar to make the patent fail on grounds of obviousness. In evaluating the differences between the prior art and the claimed invention, the court noted given the differences between a natural sequences of a gene and references relating to the modification, such a modification may be obvious. Therefore, a gene modified in a way that is novel to a person with ordinary skill in the arts may be patentable. In In re Kubin, stated naturally occurring genes with known homologs may not be patentable because the techniques involved in obtaining those genes are routine experiments. [to be expanded]

Summary of Case Law Review

Case law has established several critical limitations on the scope of patentable subject matter that impact the ability to patent genetic inventions. The scope of these fundamental prohibitions, and how they apply to genetic patents claims, represent the heart of many modern challenges to patents claiming genetic inventions. The prohibition on laws of nature, natural phenomena, and abstract, and the "machine or transformation test" are the two doctrinal theories most likely to impact genetic patents.

From as far back as the 19th Century, courts have prohibited inventions claiming laws of nature, natural phenomena, and abstract ideas from the scope of patent eligible subject matter. The extent to which this prohibition includes genetic inventions is unclear. To date, the March 2010 Myriad case is the only judicial decision to hold that isolated and purified genes are ineligible patent subject matter under this reasoning. Since this decision came out of a Federal District court, and not the Federal Circuit Court of Appeals or the Supreme Court, the ultimate adoption of this reasoning remains in question until the case is resolved through the appeals process.

It is worth noting that some commentators believe the Supreme Court has made its stance clear with respect to how they might resolve the genetic subject matter debate. The Supreme Court's majority opinion in Chakrabarty expressly noted a reluctance to read additional limitations in the plain language of the Patent Act in the following passage:

“The choice we are urged to make is a matter of high policy for resolution within the legislative process after the kind of investigation, examination, and study that legislative bodies can provide and courts cannot. That process involves the balancing of competing values and interests, which in our democratic system is the business of elected representatives. Whatever their validity, the contentions now pressed on us should be addressed to the political branches of the Government, the Congress, the Executive, and not to the courts.”

Importantly, the 1980 Chakrabarty case was the last time the Supreme Court opined on the laws of nature, natural phenomena, and abstract ideas prohibition in light of biological subject matter patent claims. In the thirty years since Chakrabarty was decided, many of the Supreme Court Justices who participated in the decision have retired. Consequently, additional question remain concerning how the current panel of Supreme Court Justices might resolve this ongoing debate.

The newly adopted "machine or transformation test," from the Federal Circuit's decision in In re Bilski, calls into question many process or method patent claims. This test requires method or a process inventions to either make a transformation of a physical article by changing its state, or, tie the process into a machine or apparatus to be patentable eligible. This limitation may be especially relevant to certain genetic diagnostic and other biological patents claiming methods that can be likened to a series of "mental steps" with "no meaningful or significant" transformation of physical articles or machine apparatuses. A series of courts, including the S.D.N.Y. in the recent Myriad case, have used this reasoning to invalidate genetic related process or methods. Again, the ultimate impact of this new test is very unclear, since In re Bilski is still pending a final decision from the Supreme Court. The Supreme Court may accept, reject, or modify this reasoning in its final decision.

Even if the machine or transformation test is wholly adopted by the Supreme Court, it might not completely prohibit diagnostic processes or methods in the same way that a sweeping prohibition on a class of patentable subject matter would because the machine or transformation test is applied on a case-by-case basis. Therefore, the invalidity of a process or method claim under the test will likely hinge on the precise nature of the the process or method claimed. Specifically, this would entail a detailed analysis of: the written claim language and syntax, whether a machine or other apparatus is utilized in the process or method, or whether a Judge can discern any transformation through the process or method.

Thus, the pending status of In re Bilski, and its potential affect on diagnostic and functional use patent claims, as well as the novel holding in Myriad, offer the possibility for significant changes in patent law with regard to genetic inventions. Absent legislative action, cases like Laboratory Corp. v. Metabollite Labs, may be instructive for determining the future of genetic material patents under the Bilski standard. Although the Federal Circuit did not take well to Justice Breyer’s dissent, it may prove to influence other district level courts to closely reconsider the ability the patentability of diagnostic methods. Myriad may also force a closer reexamination of the policies and legal reasoning for the issuance of patents claiming isolated and purified genetic material.

While future to patent such inventions may depend greatly on the ultimate resolution of cases like Myriad and Bilski, the present state of patent law continues to recognize genetic inventions, including processes and methods, as patent-eligible. The policies of the USPTO and the vast majority of federal courts have consistently considered isolated and purified genetic material and processes to be permissible inventions under the scope of the Patent Act. Ultimately, the current state of the law is dependent on a patent applicant’s ability to meet the subject matter standards in Chakrabarty and the In re Bilski mach

Additional Resources

If you find yourself having a difficult time understanding Patent Law concepts or want more information, the following external resources may be helpful.

• USPTO Main Website
• Cornell University Law School Information on Patent Law
• Consolidated Patent Laws (via USPTO Website
• Glossary of Patent Related Terms (via USPTO Website
• Wikipedia Patent Law Main Page
• ACLU FAQ on Genes and Patents
• Bit Law Explanations of Patent Law

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