"Human Genes" and Patents

15 April 2013 Personalized Medicine Bulletin Blog

At 10:00 A.M. on April 15th, the U.S. Supreme Court will entertain oral arguments in the dispute now known as the human “gene patenting” case. The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) is likely the highest profile patent dispute before the Supreme Court in recent history, arguably because it touches on issues concerning invention, innovation, investment, property rights and the delivery of health care. Arguing against the patenting of “human genes” and reversal of 30 years of U.S. patenting precedent is Christopher A. Hansen (on behalf of the American Civil Liberties Union (“ACLU”) and plaintiffs-petitioners). Gregory A. Castanias is representing defendants-respondents Myriad Genetics Inc. et al. (“Myriad”), arguing for the continued patent-eligibility of isolated human genes, cDNA and functional fragments of DNA. Solicitor General Donald B. Verrilli, Jr. is arguing on behalf of the U.S.government as amicus, supporting neither party in full.

What is a “Human Gene?”

“Are human genes patentable” is the sole question before the Supreme Court. Hidden within this deceptively simple question is what is specifically meant by the phrase “a human gene.” During this dispute, the patent claims at issue have been argued to cover a complete human gene (including contiguous coding and non-coding regions), artificial, human-generated, contiguous DNA sequences (cDNA and recombinant DNA) and functional gene fragments being identical to portions of a human gene. In its recent Reply Brief, the ACLU argues that the term “a human gene” includes isolated human DNA, cDNA and fragments, but excludes recombinant DNA. The ultimate construction of the term “a human gene” is key to whether or not gene patents preempt the use of laws and products of nature; a policy issue that has been heavily briefed and argued by the parties and amici.

Naturally-Occurring Genes

In its Reply Brief, the ACLU responds to Myriad and its amici’s concern that a ruling in petitioner’s favor might prevent useful patents on tests, drugs, other DNA-related compositions such as recombinant DNA, or patents limited to particular uses by opining that the question before the Supreme Court does not touch recombinant DNA (DNA that results from choosing fragments from genes or chromosomes that do not appear together in nature and “stitching them together”), recombinant therapeutic proteins, or genetically engineered antibodies. (Page 2 of Reply Brief.)

The ACLU argues that in contrast to recombinant DNA, DNA isolated or purified from a human (complete gene sequences and fragments of genes) should not be patent-eligible because the acts of finding, separating and characterizing a DNA molecule do not present structural distinctions between the DNA or gene as it exists in the human body. The ACLU also dismisses Myriad’s new uses of isolated DNA over DNA in the human body, on the ground that these arguments only speak to methods for using materials (relevant only to method or use patents) and not patents claiming compositions such as isolated DNA.

Patent-Eligibility of cDNA

The ACLU takes the position that the patent-eligibility of cDNA is not at issue, but should the Supreme Court decide to take on this issue, it should find that cDNA is not patent-eligible. cDNA (an abbreviation of complementary DNA) is synthesized in a laboratory from a messenger RNA (“mRNA”) template. Certain of Myriad’s patent claims at issue are limited to cDNA by reference to a specific nucleotide sequence which was determined by a process of reverse transcribing messenger RNA. The ACLU first takes issue with Myriad’s construction of the cDNA claim because, in its opinion, the claim does not identify the sequence as cDNA. The ACLU opines that thus, the claim arguably covers any isolated DNA with that nucleotide sequence. Moreover, the act of creating cDNA is, in the ACLU’s opinion, as simple as linking the mRNA fragments to form one template that codes a functional protein like magnets on a string.

Interestingly, in the ACLU’s view, cDNA is distinct from recombinant DNA, “which is created when a geneticist selects cDNA or DNA fragments from different sources and intentionally stitches them together. (Page 10 of Reply Brief). Any cDNA that “simply mirrors naturally-occurring mRNA is a product of nature and a basic scientific tool” and therefore is argued to be patent-ineligible. (Page 10 of Reply Brief).

A Question of Claim Construction

The history of this dispute is unusual in that the patent claims at issue were never construed, a process by which the parties and at times the court interpret patent claims to determine their scope and meaning. Indeed, any patent analysis, whether to determine patent infringement or patent invalidity, requires a construction of the patent claims. Construction of Myriad’s patent claims would have served as clear notice to the amici and public as to what subject matter was objectionable and why. Without this fundamental analysis, the parties and amici have appeared to struggle with what is clearly at issue here – the patenting of any DNA that has some sequence identity to a human gene or only purified whole gene sequences? Indeed, one sensible approach for the Supreme Court would be to remand for construction of the patent claims.  

The ACLU in its Reply Brief has moved from its prior policy-heavy arguments of preemption and public health to a more traditional analysis of the claim language and whether that language satisfies the statute that governs patent-eligible subject matter. Whether and how the Supreme Court handles the same issue will be telling as to its ultimate decision and more importantly, the effect if any, of the possible exclusion of human DNA or genes from the U.S. patent system.

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