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How SWEET It Is! Gene Patents Ruled Invalid as Genes are Found to be Non-patentable Subject Matter

By Andis Kaulins

Are genes patentable?
Did the Founders foresee gene patenting?
What about it, Justice Scalia? Origenetic or not?

We posted about this high tech legal topic previously here and here.

There has now been a decision issued in the so-called "Myriad case", Association for Molecular Pathology and ACLU v. USPTO and Myriad (S.D.N.Y. 2010).

Senior Judge Robert Workman Sweet of the U.S. District Court for the Southern District of New York (see Manhattan location near Foley Square) invalidated gene patents by holding composition claims invalid under 35 U.S.C. § 101, finding "patentable subject matter must be "markedly different" from a product of nature" whereas "the claimed isolated DNA is not "markedly different" from native DNA.

Patently-O in Court: Essentially All Gene Patents Are Invalid writes that "The Federal Circuit is likely to reverse this decision -- opening the door to an important Supreme Court showdown." -- There may be no reversal. In our opinion, that all depends on the coming U.S. Supreme Court decision in Bilski, to which Sweet cited in annihilating the Myriad gene patents.

Jim Dwyer at the New York Times sets out in a wonderful article the current troublesome status quo of such gene patents:

"For years, women have gone to a genetics clinic at Columbia University, stuck out their arms and watched their blood fill glass tubes.

In the tube is a map of their past ? the DNA passed down thousands of generations ? and a glimpse of their future.

You might think they would have first claim on the intimate narratives of their own genetic codes.

But over the last 20 years, private companies and academic researchers have claimed patents on more than 4,300 human genes ? about 20 percent of all genes in the human body.

Among the patented genes are two strongly associated with breast and ovarian cancer, BRCA1 and BRCA2. Women who wanted to know about this piece of their lives could be tested only by the company that held the patents, said Dr. Wendy Chung, a physician and genetics professor at Columbia

Until Monday.

A judge in Federal District Court in Manhattan ruled that the two genes were products of ?the law of nature,? and so could not be patented. The judge, Robert W. Sweet, declared that seven patents on the genes, held by Myriad Genetics of Utah, were not valid.

?If this holds up on appeal, this is a game changer,? Dr. Chung said.

In the hunt for genes linked to breast and ovarian cancer, Myriad, backed by private capital, had worked with publicly financed researchers in the United States, Canada and Britain [emphasis added]

[I]f individual women wanted to learn if they carried the mutations that raised risks for breast and ovarian cancer, Myriad insisted that only its labs test them, at a cost of $3,000, according to Dr. Harry Ostrer, director of molecular genetics at NYU Langone Medical Center. In Canada, where the patent is not honored, the test is available for under $1,000, Judge Sweet noted."

Read that article here in full. Great writing.

You want to know why the cost of health care in the United States is so high? One reason is rip-off gene patents like those of Myriad, as a few private pockets are being filled with cash generated by artificial judicially-created monopolies on YOUR genes. Those who can not afford to pay for the lab tests are just allowed to die off -- too bad, right? The price of patents.

Not if you have the right JUDGES.

In our view, sooner or later, those gene patents will be gone forever.
How SWEET it is!

Other voices on this topic:

John Conley and Dan Vorhaus, Genomics Law Report, Pigs Fly: Federal Court Invalidates Myriad?s Patent Claims -- the following paragraph from them is especially telling in view of a world waiting for the U.S. Supreme Court decision in Bilski:

"Myriad?s process claims got even less respect. In just a few pages, out of 156 in total, the court concluded that they all failed the Federal Circuit?s ?machine or transformation? test for method claims. (This test comes from the recent Bilski case. Although the Supreme Court will soon issue its own opinion Bilski, the machine or transformation test is the law unless and until the Supremes order otherwise.) Judge Sweet found that none of the methods were tied to any particular machine, nor did they bring about a tangible transformation of anything. Rather, ?because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter? (p. 4).

Judge Sweet also added that, even if the claims were construed in such a way that they constituted ?physical transformations associated with isolating and sequencing DNA, they would still fail the ?machine or transformation? test under §101 for subject matter patentability.? (p. 147)."

See also:

Turna Ray, GenomeWeb.com, Game On: Court Ruling on Myriad Patents to Kick off Protracted Legal Battle Over DNA Patentability

John Schwartz and Andrew Pollack, New York Times, Judge Invalidates Human Gene Patent

Andrew Pollack, New York Times, After Patent on Genes is Invalidated, Taking Stock

Full post as published by LawPundit on April 01, 2010 (boomark / email).