[Legal Perspective] Can Human Genes Be Patented?

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Earlier this month, the United States Supreme Court heard oral arguments in a case that comes down to a single question: can human genes be patented? There's a lot riding in the outcome of Association for Molecular Pathology v. Myriad Genetics, Inc. explains attorney Randy Clower of law firm Phillips Lytle:

“… if the Court determines that isolated DNA molecules are tantamount to genetic products of nature, many, if not all, claims in the more than 30,000 issued patents directed to such subject matter will be at risk.”

The high court justices are expected to rule in June. In the meantime, here's a legal perspective on the case from lawyers on JD Supra:

There’s no clear definition of “human gene”

Antoinette Konski of Foley & Lardner: “’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… 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.”

Patent law on the issue is vague (and complicated)

Randy Clower again: “The sole question before the Court concerns whether human genes qualify as patentable subject matter pursuant to [Section 101 of the Patent Act], which recites that ‘any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof …’ is eligible for patent protection. Patent eligible subject matter, moreover, has been apophatically defined by the Supreme Court in previous decades… These ‘exceptions’ to patent eligibility, i.e., abstract ideas, laws of nature, and natural phenomena (also referred to as the ‘products of nature’ exception), are coterminous with the statutory categories outlined above, but serve as ‘carve-outs’ which proscribe patent eligibility.”

The question before the court is misleading

Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff: “The Supreme Court's grant of certiorari over the question ‘Are human genes patentable’ had raised for many the specter of an uninformed generalist court rendering a decision containing dicta that would negatively affect biotechnology.  This possibility is real, in view of the voices raised against patenting human genes based on moral, policy, or ideological grounds.  While strongly felt, these sentiments are based, in large part, on a misunderstanding or mischaracterization of either the facts or the law, specifically patent law. These misstatements include arguments based on patent claims somehow exerting an ownership interest in individual's DNA, or that isolated human nucleic acid claims preempt future research (in the face of thousands of published scientific journal articles published since the BRCA gene patents were granted), or that isolated DNA patents inhibit future technologies like personalized medicine.

The parties involved disagree on certain essential terms

Antoinette Konski of Foley & Lardner: “[T]he ACLU argues that the term ‘a human gene’ includes isolated human DNA, cDNA and fragments, but excludes recombinant DNA… The ACLU argues that in contrast to recombinant DNA [(DNA that results from choosing fragments from genes or chromosomes that do not appear together in nature and ‘stitching them together’)], 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.”

And then Ms. Konski again: "Myriad noted in its brief, […] [that its] patent claims are not an attempt to patent ‘human genes’ but rather isolated DNA molecules not found in nature… Myriad also responded to the ACLU’s contention that standard isolation results in random DNA fragments that are identical to those that exist in the body. By definition, Myriad noted, isolated DNA is a molecule that has been removed from the body. It cannot simultaneously be removed from the body and be in the human body. With respect to the ACLU’s claim that covalent bonds of DNA molecules may be broken in the body, this fact, Myriad argued, is irrelevant because this assertion omits critical elements of the definition of isolated DNA. Isolated DNA is more than just DNA with bonds broken, Myriad explained, the DNA must also be separated from the body and other DNA not of interest."

The patents in question will soon be irrelevant

Kevin Noonan again: "… the day of the DNA patent claim is rapidly coming to a close.  These types of patents were first filed directed to specific genes encoding biologically relevant proteins having therapeutic benefits…Myriad's BRCA gene patent claims are in this form, one of the reasons why these claims are not infringed by genetic diagnostic methods used today. The vast majority of gene patent applications, however, were filled as the result of the Human Genome Project. […] [B]ecause almost all of these patents were filed at the turn of the century, and the term of these patents will expire no later than 20 years after application filing, the ‘problem’ of gene patents will disappear no later than 2020 (and in many instances much earlier…)."

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Stay tuned for the Supreme Court's decision on this well-watched case.