Drawing a sharp distinction between “nature’s handiwork” and human invention, the Obama Administration has urged a federal appeals court to rule that no U.S. patent can be issued to give sole rights to a natural gene taken out of the body and used for medical research.  The stance is directly contrary to long-standing government policy.  The issue almost surely is headed  ultimately to the Supreme Court.

The U.S. Court of Appeals for the Federal Circuit — the nation’s specialized court for patent litigation — is now considering whether scientists working with basic DNA in the form of unmodified human genes — that is, extracted from the human body but changed in no way from their natural state — can get patent protection for the genes themselves.  A federal judge in New York City said no last March, but a genetic research company, Myriad Genetics, Inc., has appealed.  (The judge’s 152-page opinion is here.)

The idea of patenting genes and their DNA components when “isolated” in a laboratory is linked to a very practical pursuit in basic genetic research: the gene’s natural characteristics are studied in order to be able to understand susceptibility to disease, enabling medical diagnoses and suggesting treatment options.  In isolated form, the DNA in its unchanged gene form retains the identical characteristics found in native DNA in the body, and that is precisely why it is valuable medical research material.

For years, the U.S. Patent Office has taken the position that extracted genes, or “isolated DNA,” can be patented. And, in fact, it has issued thousands of patents on human genes, with perhaps one of every five human genes now under patent.  Patent rights to a gene, of course, give the owner the exclusive right to study, test and experiment on the gene to see how its natural characteristics work.

It has been more than 20 years since the Patnet Office began approving patents for human genes in the form of “isolated” DNA.  Prior to that, the Office had issued patents for synthetic DNA, but then moved on to grant monopoly rights on the natural material when extracted directly from the body and not modified.  The Obama Administration, in the brief it filed late Fridiay in the Federal Circuit, is not challenging patents on synthetic DNA, or on the process of extracting DNA, but only on unmodified genes themselves.

The Patent Office’s long-running approach to genetic patents was challenged in a lawsuit filed in May 2009 by the American Civil Liberties Union and the Public Patent Foundation, contending that locking up genes in the monopoly rights of a patent would inhibit research by other scientists on diseases that might be flagged by the coding or mutations of the genes.   The lawsuit targeted both the Patent Office and Myriad Genetics, specifically because of patents that company was issued on human genes that have been labeled “BRCA1” and “BRCA2.’  Mutations of those two genes are associted with significantly higher risks of breast cancer and ovarian cancer. 

The Patent Office and Myriad vigorously contested the challenges, which were based both on the Constitution and on federal patent law.  In his ruling finding all seven of the patents and all 15 of the specific invention claims invalid, U.S. District Judge Robert W. Sweet of New York City ruled only on the federal law challenges, saying it was unnecessary, therefore, to rule on the constitutional issues.

In voluntarily stepping into the dispute at the Federal Circuit, the Obama Administration said in its brief that this was the first time the government has expressed its view in a court case on the patentability of natural genes.  And, in fact, it noted that, “until this case, no court had previously addressed whether such an isolated DNA molecule is patentable subject matter” under federal law.

The brief argued that Judge Sweet went too far in striking down claims that were based on Myriad’s claims about synthetic DNA of the two gene sequences.  But he was right, the Administration said, in nullifying the patents as they applied to “isolated but otherwise unmodified human genomic DNA itself.”

In going as far as he did on the synthetic DNA claims, the brief said, Judge Sweet “erroneously cast doubt on the patent eligibility of a broad range of man-made compositions of matter whose value derives from the information encoding capacity of DNA.”  It suggested that that part of the decision may have affected patent rights on “countless industrial products, such as vaccines and genetically modified crops.”

But, on the issue of whether “genomic DNA that has merely been isolated from the human body without further alteration of manipulaton,” the brief said, Judge Sweee’s decision correctly applied federal law.  The unique characteristics of chemical chains in a gene that induces a human cell to produce a certain amount of protein, to influence an organ’s characteristic or function, “ss not a human-made invention,” it asserted.

“The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth,” the brief argued.  To satisfy the requiement of patent law that an invention not be something that exists in nature, it added, “requires something more than identifying and isolating what has always existed in nature, no matter how difficult or  useful that discovery may be.”

In acknowledging that it was taking a stance directly contrary to what the Patent Office has done, and contrary to the practice that the government’s premier medical research organziation — the National Institute of Health — has done, the Administration said Judge Sweet’s rulng had prompted it “to reevaluate the relationship between such patents [for human genes in the form of “isolated DNA”} and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature….The United States has concluded that isolated but otherwise unaltered genomic GNA is not patent-eligible subject matter…”

The brief said in a footnote that the U.S. government is actually the co-owner of four of the seven patents that are involved in the case.  It has granted Myriad an exclusive license under those patents — contrary, it said, to NIH’s usual practice of not granting exclusive licenses under DNA patents for “diagnostic applications.”  In the past, NIH and other government agencies have sought and obtained patents for human genes in the form of “isolated genomic DNA,” according to the brief.

The brief did not say which claims under the four patents co-owned by NIH would be invalid under its theory of patentability.

Posted in Cases in the Pipeline, Featured

Recommended Citation: Lyle Denniston, U.S.: No patent on human genes, SCOTUSblog (Oct. 30, 2010, 9:01 PM), https://www.scotusblog.com/2010/10/u-s-no-patent-on-human-genes/