Myriad Genetics first identified and isolated the BRCA1 and BRCA2 genes responsible for diagnosing an elevated risk of breast and ovarian cancer. Myriad claims patents on the isolated BRCA genes along with cDNA, which is a synthetic product that mirrors the coding sections of the BRCA genes, and "primers" used in diagnostics. The Patent Act defines the scope of patentable subject-matter in 35 U.S.C. § 101; however, the Supreme Court has consistently held that laws of nature, abstract ideas, and natural phenomenon cannot be patented. Myriad claims that the isolated and modified genes that they hold patents for never occur in nature, and subsequently are patentable subject-matter. Conversely, the Association for Molecular Pathologists contends that Myriad only isolated, and did not modify, a gene already existing in nature and that this isolated gene performs a similar function as the gene in natural form. The district court held that naturally-occurring genes were not patentable subject-matter, but the Federal Circuit court reversed. How the Supreme Court decides this case will greatly impact the scope of patentable subject-matter. A narrowing or a broadening of current subject-matter eligibility will have significant effects on the incentives for inventors as well as what information is available for and usable by the general public.
Questions as Framed for the Court by the Parties
Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent-eligible simply by removing ("isolating") the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case therefore presents the following questions:
- Are human genes patentable?
- Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
- Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?
LIMITED TO QUESTION 1 PRESENTED BY THE PETITION.
Whether Myriad’s claimed invention, the sequence of certain human genes in both isolated and purified forms, falls within the scope of inventions for which a patent may be granted.
Although the question before the Supreme Court is whether human genes are patentable, in fact, three different kinds of “genes” are in question. The challenged patents cover the “isolated” human genes, BRCA1 and BRCA2 (collectively “BRCA1/2”) and alterations of those genes. The patent claims for these genes relate to the isolated gene sequences and the methods used to determine whether a patient has these genes or mutations of these genes in their body.
Cells in the human body have twenty-three pairs of chromosomes and each chromosome has numerous genes. These genes are sequences that contain information relating to various bodily processes, however, chromosomes will also include a lot of “noncoding DNA” or additional gene-like molecules that do not contain any known functional information. Myriad Genetics (“Myriad”) was the first company to identify and isolate two genes that relate to certain types of breast and ovarian cancer.
One patent Myriad has claimed relates to “isolated” DNA. An overly simplified example is if the chromosome was a sequence of numbers, say 1-2-3-4-5-6-7-8-9-10-11-12, and the BRCA1/2 gene was 7-8-9, Myriad’s “isolated” DNA claim just covers the compound 7-8-9, or the gene “cut out” from the rest of the chromosome.
Myriad also claims an invention on the BRCA1/2 cDNA. cDNA is the functional part of the gene, without any “noncoding DNA.” For example, if 7 and 9 were the only “functional” part of the gene and 8 was noncoding DNA, Myriad’s cDNA patent would be for the composition of the molecule 7-9. The process involved in creating cDNA is very complicated and involves taking advantage of the way RNA mirrors the coding of DNA. RNA only “reads” the exons, or coding DNA, and ignores the introns, or noncoding DNA, and the genetic sequence made from mirroring the RNA is known as cDNA.
Finally, Myriad also claims a patent for “primers.” “Primers” are useful in diagnosing whether or not a patient has a certain gene in their body and thus in this example a primer could be just 7. Like cDNA, the process of creating primers is complicated, but only the composition of the primer, i.e. 7, is in question.
The Association for Molecular Pathology ("AMP") represents a variety of genetic researchers, counselors, medical organizations, and patients throughout the country who have been accused of infringing upon Myriad’s patents on the BRCA1/2 genes. The district and appellate courts have determined that AMP has standing to bring the lawsuit against Myriad, and the current question is whether the different patent claims are patentable subject-matter.
This lawsuit has been in the courts for many years with multiple appeals; however, regarding the issue of whether or not genes are patentable subject-matter, the United States District Court for the Southern District of New York held that these gene patents were not subject-matter eligible. On appeal, the Federal Circuit Court of Appeals reversed the District Court and held that Myriad’s patents were valid.
The parties dispute the scope of what may be patented under 35 U.S.C. § 101. The Association for Molecular Pathology ("AMP") argues that the form and function of isolated DNA is the same as that in nature, and that cDNA is identical in form and function to the functional components of the same strand of DNA in nature. In opposition, Myriad contends that the patent claims fall with the plain language of § 101 and that the patents are for inventions—something clearly patentable. Generally, this case has garnered significant interest in the intellectual property community because the Supreme Court will likely clarify the bounds of patentable subject-matter.
The Current Bounds of Patentable Subject-Matter
The Founding Fathers acknowledged the importance of protecting intellectual property and Article I, § 8, cl. 8 empowered Congress to pass legislation to promote arts and sciences. Both AMP and Myriad, however, acknowledge the inherent conflict of patent law: exclusive rights granted by patents are essential to encourage innovation, however, not enabling society sufficient access to ideas and innovations ultimately stifles further innovation. Thus, while it was said that “anything under the sun that is made by man,” there are limits to patentable subject-matter.
The general economic theory behind patent law is that inventors will be incentivized by a limited monopoly period. A common example of this theory is the pharmaceutical industry, where drug companies sometimes need to invest billions of dollars to invent new drugs, and patents for these drugs provide a mechanism for the company to recoup their investment. Alternatively, proper patent policy is less clear in other industries, especially because the Supreme Court has consistently held that patents are not available for laws of nature, natural phenomena, and abstract ideas. This case is important because it will likely help clarify the bounds of these exceptions to patentability.
AMP argues that patents on the BRCA1 and BRCA2 (collectively “BRCA1/2”) genes go beyond the scope of patentable subject-matter. AMP asserts that the patents fail because the BRCA1/2 genes are products of nature. AMP also claims that gene patents do not fulfill the general economic theory behind patent law. For instance, AMP notes that a survey found that 46% of geneticists felt that their research was delayed or limited by gene patents. Additionally, AMP claims that patents on genes are inherently too broad because they prohibit additional research that is not related to Myriad’s breast cancer test. Finally, Academics in Law, Medicine, Health Policy and Clinical Genetics (“Academics”) note that normal patent incentives may not apply to genes because patent protection made no impact on a company’s ability to bring a product to the market.
Myriad counters that general theory of patent protection worked here because Myriad was able to find the BRCA1/2 genes where many other companies had failed. Myriad contends that significant resources were expended to find the BRCA1/2 genes and that Myriad spends hundreds of millions of dollars educating patients and providers about the benefits of the genetic test. Myriad asserts that patent protection is necessary to recoup these big investments. Thus, Myriad asserts that providing patent protection is consistent with the general policy of rewarding inventors who unlock mysteries that previously provided no benefit to humanity. Additionally, the Academics note that patent protection plays a significant role in enticing private investment to genetic research.
Effect of Current Government Policy
Myriad asserts that the current Patent and Trademark Office (“PTO”) Guidelines explicitly support validating patents for isolated DNA molecules. Myriad notes that parties have relied on the PTO’s interpretation of gene patents for more than thirty years and that there have been more than three thousand patents on isolated DNA molecules. Myriad contends that the reliance interests of inventors, investors, and the genomic industry add to the persuasiveness of the PTO’s interpretation and the importance of not upsetting the current interpretation of the law.
The United States counters Myriad’s assertion by noting that PTO Guidelines do not have the force of law. Additionally, the United States notes that Guidelines are unique from agency rulemaking because creating guidelines does not involve a solicitation of public comment. The United States notes that formal rulemaking is much more “visible” and requires the PTO explain the agency’s interpretation of Section 101. Finally, AMP notes that placing such emphasis on the PTO interpretation of Section 101 would be nonsensical because courts frequently invalidate patents where the PTO interpreted patentable subject-matter incorrectly.
Myriad also contends that Congress implicitly supported the PTO interpretation of Section 101 because the Patent Act has been subsequently amended. Myriad notes that this interpretation is consistent with patent policy in Europe and Japan, providing more weight to Congress’s implicit support. Conversely, the United States notes that Congress has only addressed general legislation, and no specific support or opposition can be assumed.
Potential Chilling Effect on Genetic Research
A general patent policy concern is that if exclusive rights are too strong, then there will be a chilling effect on scientific research and instead of promoting the advancement of arts and science, patents would act to deter advance. AMP asserts that scientific research has been chilled because Myriad holds patents to the BRCA1/2 genes. In fact, AMP notes that 46% of geneticists felt that their work was delayed or limited by gene patents. The Academics also assert gene patents prevent the development of a comprehensive genetic test, forcing patients and providers to use multiple tests, decreasing the efficiency, effectiveness, and timeliness.
Myriad counters that there has been no chilling effect on research and, in fact, the BRCA1/2 gene patents have increased the stock of human knowledge. Myriad notes that the patent process requires making the process and information public, and that many researchers, including one of the petitioners, have used the BRCA1/2 genes “without impediment.” Consequently, Myriad asserts that gene patents do not cause a chilling effect on scientific research.
By statute, only four categories of invention are eligible for patents: processes, machines, manufactures, and compositions of matter. Courts have further restricted the reach of patent law by carving out three exceptions to these categories, stating that laws of nature, natural phenomena, and abstract ideas may not be patented. In this case, the Supreme Court will determine whether a patent may be granted for a human gene. The parties dispute the nature of Myriad’s claimed invention and the effects of allowing such patents.
PATENTING PRODUCTS OF NATURE
The Association for Molecular Pathology ("AMP") points to the Supreme Court’s decision in Diamond v. Chakrabarty for the proposition that a composition of matter must have “markedly different characteristics” from a thing found in nature to qualify as patent-eligible subject matter. According to AMP, isolated DNA is not different enough from DNA found in the body to satisfy this standard; instead, Myriad’s patent claims improperly cover products of nature. AMP argues that a product of nature, such as DNA, is no more patentable when separated from a larger combination or natural location than when found in such place. Additionally, AMP maintains that separating a product of nature from its natural location does not give the product markedly distinct characteristics from those it had before, even if more useful in that new form. Finally, AMP argues that Myriad’s patent is not limited to a specified use or function of the isolated DNA but instead would cover any use, thus claiming an entire product of nature.
Myriad counters that the DNA molecules claimed in its patent were not found in nature but rather were created in the lab. Additionally, these molecules are only useful because they were produced in the lab, not due to any naturally occurring phenomena. According to Myriad, the act of separating a composition from a larger combination in which it is naturally found does involve sufficient human ingenuity to render that composition patent-eligible. Myriad also cautions against determining patent eligibility based on how similar a claimed invention is to what is found in nature, noting that everything is composed of substances found in nature. Myriad states that the focus should be on its contributions to the DNA molecules and the changes resulting therefrom, as opposed to properties shared with DNA as found in nature. Myriad adds that its work on the patented molecules actually added properties and functions to the molecules, rather than simply making existing properties and functions more accessible, thus resulting in a new product that is patent-eligible.
In support of its argument that isolated DNA molecules may be patented, Myriad points to the Patent and Trademark Office’s ("PTO’s") history of granting patents on DNA molecules and contends that the Court should defer to this established practice. Myriad explains that not only have thousands of patents been issued for DNA molecules, but that Congress has not chosen to intervene to prevent them. On the other hand, AMP argues against giving weight to the PTO’s history of granting patents on genes as the Federal Circuit did. AMP argues that simply deferring to the PTO in this way would result in few patents ever being invalidated.
AMP also argues that cDNA would be unpatentable because cDNA would also be drawn to a product or law of nature. According to AMP, cDNA performs the same function as DNA with the only difference being the removal of some unneeded parts. Further, those unneeded parts are removed from DNA by the body on its own. As a result, AMP argues that cDNA should be analyzed in the same way as DNA and should be found ineligible for patenting. Myriad responds that cDNA molecules should be patent-eligible because they are produced in the lab and are entirely man-made. However, Myriad also contends that cDNA should not be treated any differently from DNA molecules. Myriad argues that both DNA and cDNA should be patent-eligible.
THE REQUIREMENT OF HUMAN INVENTION
According to Myriad, the categories of patent-eligible subject matter found in Section 101 of the statute are broad. Myriad argues that the three judicially created exceptions to Section 101 merely designate purported inventions that involve no human act of creation. Myriad thus contends that the patent-eligibility inquiry boils down to whether or not a claimed invention was the “product of human ingenuity.” Myriad states that the Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc. asked the same question but phrased it instead as whether a patent’s claimed subject matter involved any “inventive concept.” Myriad emphasizes that this inquiry is limited, as patent-eligibility is meant to be a threshold question and should not be confused with other requirements of patentability, such as obviousness. Under that framework, Myriad argues, DNA molecules may be patented because they meet the low threshold requirement of human invention.
AMP also points to the Supreme Court’s test in Mayo considering whether a claimed invention involved any “inventive concept.” According to AMP, the process of isolating DNA was well-known and widely used before Myriad isolated the particular genes at issue in this case, so Myriad’s only scientific contribution was finding the link between the genes and breast cancer. Thus, AMP argues, Myriad is simply trying to patent a natural occurrence that does not involve any invention. AMP also contends that Myriad’s patent claims cover any genes that are found to have a link to cancer but that Myriad is not inventing anything when others find genes with the same properties. AMP concludes that because Myriad invented neither the isolated DNA nor its properties, it is not entitled to a patent.
CONTROL OVER KNOWLEDGE
AMP notes that the Supreme Court in Mayo also considered whether a patent would prevent others from making use of laws or products of nature as this would hinder innovation. AMP contends that Myriad’s patent has such an effect here, preventing researchers from conducting further studies on uses of DNA. Instead, the patents give Myriad the exclusive right to use these genes for any purpose, thus hindering research and innovation. AMP concedes that Myriad has found a beneficial use for the DNA that it has isolated, however AMP maintains that this benefit is outweighed by the chance that other useful developments and medical treatments might be prevented due to Myriad’s patent.
Myriad contends that AMP’s arguments about preempting use of patented matter is misguided as all patents serve to prevent others from using the covered matter. Myriad also disputes that its claims cover broad expanses of knowledge, arguing instead that they could easily be constricted to cover only limited matter in a normal patent-infringement analysis. Consequently, Myriad does not think that scientific research is unduly hindered by its patent. Instead, Myriad argues that its discoveries have actually advanced research, and that its patent precludes neither further work nor patient treatment.
AMP analogizes to the limits placed on the scope of copyrights to preserve First Amendment freedoms to argue that patents on genes should not be issued so as to prevent patents from restricting use of knowledge. AMP contends that, unlike patents on mechanical devices that allow others to learn from the patented technology, patents on genes would prevent others from working on the same material since one could not invent a new human gene. Myriad counters that AMP cannot raise a First Amendment challenge because it did not make any such argument in its previous filings with the Court. Moreover, Myriad disputes that the First Amendment is even implicated in this case because its patent does not cover any broad array of knowledge as AMP claims. Myriad instead argues that its patent merely claims physical things--the isolated DNA molecules.
This case involves the question of whether DNA molecules fall within the scope of patent-eligible subject matter. At issue are Myriad’s patent claims for the isolated sequences of two human genes that have been linked to an increased risk for breast cancer. The Association for Molecular Pathology ("AMP") argues that DNA molecules that have been isolated in the lab are not substantially different from DNA as it is found in nature, and therefore they may not be patented. Myriad counters that the action of isolating DNA molecules rendered them in a form not known in nature and with different properties, making it appropriate subject matter for a patent. AMP cites the danger in allowing a patentee, such as Myriad, to control a property of nature and a general body of knowledge, while Myriad contends that its patent claims at issue in this case are limited to distinct physical compositions. In deciding this case, the Supreme Court may address the extent to which products similar to or copied from those in nature may be patented.
The authors would like to thank Professor Oskar Liivak for his insight into this case.
- John Golden & William Sage, A Cure for Patent Pathology? The Supreme Court Reviews the Patentability of Human Genes, Health Affairs Blog (Dec. 7, 2012).
- Susan Decker & Kayla Bruun, Myriad Defends Patent Claims on Genetic Material in Court Case, Bloomberg Businessweek (July 20, 2012).