In the correct decision, the U.S. Supreme Court ruled in 2013 (Association for Molecular Pathology v. Myriad Genetics) that human genes cannot be patentable as a “product of nature”. However, they left open the possibility of cDNA (the useful portion of the DNA, copied) being patentable. cDNA itself should not be patentable, however, as it is merely a replication of products of nature, although new techniques to create cDNA should be eligible for patents and Diamond v. Chakrabarty (which adjudicates non-DNA biological patents) was adjudicated correctly. In fact, the district court decision was accurate when it declared that cDNA “contains the identical protein coding informational content as the DNA in the body, even though differences exist in its physical form” as is thus ineligible for a patent. As was the dissenting opinion on appeal of Myriad, that the “[c]DNAs are not markedly different from native DNAs.” It would also be consistent with other Supreme Court opinions on biotechnology, such as in Mayo Collaborative Services v. Prometheus Laboratories, Inc. where it declared that “the ‘steps’ Prometheus added to their application are merely instructions to apply the laws of nature” and “involve well-understood, routine, conventional activity previously utilized by researchers in the field”, which should apply to cDNA.
Due to the Supreme Court’s ruling in AMP v. Myriad, naturally occurring DNA is not patentable. We shall liken this to a tree, another piece of nature that is unpatentable. Merely cutting down and moving the tree to a different location is not transformative enough to be granted that tree a patent, given the wide availability and obviousness of this technique. Therefore by analogy, cDNA, which is merely the product of replicating the DNA, should not receive unique intellectual property protections. The Supreme Court may claim that “cDNA is patent eligible because it is not naturally occurring”. However, an article in the Stanford Law Review found that the “contention that recombinant DNA is not equivalent to purified, natural DNA is scientifically unsound…therefore disqualifying cDNA as ‘under well-established patent principles, a product that is an imitation of a preexisting product (naturally occurring or not) is not patentable’’”.
In another example, even if we were to apply a certain commonly used process to the natural product (such as pruning and talking cuttings of the pruned tree), the products would not be eligible for patent. Why should cDNA be any different? Even Myriad Genetics, the company that initially defended the patentability of genes, has now concluded otherwise, stating that, “Myriad does not support patents on products of nature, including naturally occurring DNA and unmodified human genes” [emphasis added]. Another example to illustrate how farcical it is to allow cDNA to be considered unique from the products of nature might be being able to garner a new patent on an existing work merely by printing it in a new way, or a new patent on software merely by using an existing code translation service to change the format of the code to a longer version, even without adding any actual content.
This debate should not be merely theoretical, with these legal decisions having immense consequences. “It’s not just some abstract scientific concept, it impacts people’s daily lives, people’s mothers and sisters and wives. [It impacts] their health care decision,” Lisbeth Ceriani, one of the original plaintiffs in AMP v. Myriad, told the ACLU in 2017. “It’s a basic human right to see your own blood, your own genes.” Robert Nussbaum, professor at the University of California, San Francisco and an expert cited in an amicus brief on the Myriad Genetics case, also described the significance for the production of new tests: “Making it illegal to patent genes expands the genetic testing market, enables competition, and improves laboratory practices for genetic testing through standardizing next-generation-sequencing methods, variant classification, reporting, and counseling, plus acceleration of novel disease gene discoveries and better understanding of gene-disease relationships.”
In the Myriad case, the company also argued that because they “isolated” certain elements that those could be patentable. However, it is merely a selection of existing natural material, using obvious methods. The fact that they were not the ones to discover where such genes should even be isolated should disprove the ability to have any claim to a patent.
Although the eligibility of cDNA was less important than the ineligibility of natural DNA in AMP vs Myriad, cDNA’s ineligibility for patents is necessary in order to ensure the de facto protections of natural DNA. An article in the American University Intellectual Property Brief concluded that “after Myriad, cDNA patents are ideally positioned to nevertheless effectively monopolize the natural phenomena reflected in gDNA [genomic or naturally occurring DNA] sequences” [emphasis added]. This reached the same conclusion as another peer-reviewed article in the Oklahoma Journal of Law and Technology which found that “cDNA may be the most important form of DNA used.” The Oklahoma article also found that the Supreme Court’s holding in Myriad as it relates to cDNA was incorrect, as “compliments of naturally occurring DNA are not novel, nor are they non-obvious [both are requirements for something to be patentable]. If you want to work with most genes, then cDNA is going to be one of the obvious tools you use”. It especially doesn’t meet the non-obviousness requirement as “when the entire genome is mapped, and the methods and technology needed to produce complementary versions are commonplace, where is the novelty? Further, is it not obvious to a person having ordinary skill in the art to produce these complimentary versions that are easier to work with?” The American University article similarly argued that “claims to cDNA monopolize the same genetic code as isolated gDNA; there is no difference between the information monopolized by a patent on isolated gDNA and one on cDNA because they both code for the same thing”. Therefore, considering that patents on cDNA are de facto patents on the most important part of DNA without being substantially different from naturally occurring DNA and the existing precedent, cDNA should be ruled a “product of nature” and ineligible for patents.
Research for this article was conducted using the linked materials, “Gene Patenting—The Supreme Court Finally Speaks” and Biology in Focus (2014 edition).
For further reading on the subject, the author suggests the following: “Gene Patenting— The Supreme Court Finally Speaks” , “‘It’s a Trap’: cDNA is Patent Eligible? But is it Patentable?”, “The Nature of Biotechnology Patents: A Tangled Doctrinal Web of Processes and Products That Can Catch All Genes But Save None” and “Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent”.
The following older articles may also be of interest, although they focus on issues less relevant to modern questions of cDNA patenting: “Intellectual Property at the Public-Private Divide: The Case of Large-Scale cDNA Sequencing”, “Property Rights in cDNA Sequences: A New Resident for the Public Domain” and “Rethinking Utility: The Expediency of Granting Patent Protection to Partial cDNA Sequences”.
Except where otherwise noted, cDNA Should be Ineligible for Patents © 2024 by Teddy Jack. Some rights reserved. This work is licensed under CC BY-SA 4.0. The author respectfully requests contact for any commercial use or to discuss release under a less restrictive license at [email protected]. Attribution should include a link to the article, the author’s profile and email, and the publication.
