Thursday, June 13, 2013

Patents And Patients

Owners of patents claiming isolated or purified DNA sequences plucked from naturally-occurring genomes are justified in suffering from triskaidekaphobia.  Today, June 13, 2013, they suffered a bodyblow when the United States Supreme Court declared these types of patents invalid as claiming unprotectable subject matter.  The decision, in AMP v. Myriad, caps a long trend in which patents claiming aspects of humans, their bodies, their physiology, and their thoughts, have been struck down as patent-ineligible.  I was asked to write about this trend earlier this year by SCOTUSblog.  Myriad Genetics owns several patents that claim variants of the BRCA gene (that is, BRCA1 and BRCA2) indicative of heightened risk for breast or ovarian cancer.  By necessity, the patents in suit claim variants with the same nucleotide sequences as those occurring within their human genome sources.  The Court minimized any inventive contribution made by the "inventors" of Myriad's claimed sequences:
Myriad did not create anything.  To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.
Although this analysis seems to mix concepts of patent subject matter with those of novelty and nonobviousness, the result is that
A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated...
The Court appeared to contemplate the patentability of synthetic DNA, even minimally-modified cDNA.  In addition, it explicitly noted that the patentability of methods using isolated or purified DNA were not at issue in the case, perhaps because the Court had already considered the patent-eligibility of similar methods in its 2012 Mayo v. Prometheus decision.

One highly-distinctive feature of the decision was a very short concurrence by Justice Antonin Scalia, where he expressed how overwhelmingly difficult and complex the molecular biology underlying the Court's decision is.  There, he confessed that
I am unable to affirm those details on my own knowledge or even my own belief.
Although lack of mastery of scientific facts is seldom admitted by judges, it is most admirable that a member of the Supreme Court has been so candid.

Although the world did not end today for the biotechnology and pharmaceutical industries, they and their stock prices now feel a chill wind blowing.  Shares of Myriad Genetics alone traded down more than 5% on the day of the decision, June 13, 2013, lopping off many millions of dollars in market capitalization.  More ominously for gene patent owners, within hours of the Court's decision, alternative providers of the BRCA1 and BRCA2 diagnostic tests, such as DNATraits, a division of Gene By Gene, Ltd., began to advertise substantially lower prices to patients.

It is a brave new world for genes.  Patents remain a strongly-viable option for modified or designed synthetic DNA sequences.  However, the gene rush of patenting unmodified DNA sequences plucked from human genomes has come to an end.