Frivolous Atmospherics

13 April 2013 by Rosalind English

is what the technology giant Myriad calls the US First Amendment and other human rights arguments raised by their opponents in the litigation concerning Myriad’s patents over cancer gene sequences BRCA1 and BRCA2.

We’ve been here before, in this previous post and in this, and next week the US Supreme Court starts hearing arguments in the latest round of this battle. The only reason for mentioning the issue now is to draw attention to  a fascinating article by US science historian Daniel Kevles in a recent edition of the New York Review of Books.

The author provides a dispassionate view of patent law, from its roots in the philosophy of the American revolution, which gave birth to the “Progress Clause” in the American Constitution. Clause 8 authorises Congress

to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.

These principles are now embodied in  Title 35 of the United States Code, allowing patents to be obtained for “any new and useful process”—“machine, manufacture, or composition of matter, or any new and useful improvement…[thereof].”   “Products of nature” such as the naturally occurring elements in the periodic table or the creatures of the earth, being neither new in the world nor made by man, were taken to be ineligible for patents.

For the two centuries that passed after the drafting of the Progress Clause, there was not much difficulty in distinguishing between things that were eligible for patent protection and things which were not. But in the nineteen eighties, with the efflorescence of new biotechnologies riding the crest of the genetics wave, the US Patent and Trademark Office (PTO) began issuing patents on sequences of DNA that were isolated in the lab.

But it was not until 2001 that the PTO issued guidelines setting out the basis for their decision for granting such patents. There are two main principles on which these determinations rest. The first is drawn from the 1980 ruling in Diamond v Chakrabarty 447 US 303 that nature, such as a genetically modified bacterium, can be patented if the subject matter has “markedly different characteristics from any found in nature”. The second derives from a 1911 case concerning adrenalin that had been isolated and purified, where Judge Learned Hand declared (albeit in non-binding dicta), that the substance having been isolated and thus rendered usable,

became for every practical purpose a new thing commercially and therapeutically. …a good ground for a patent.

As Kevles comments, “complementary DNA”, which is made outside the body, differs markedly from the DNA inside it.

So does the raw DNA extracted from the body, whether the whole of a gene or a fragment of it: when it is chemically disentangled from its chromosomal housing it becomes a new composition of matter. The PTO holds all three versions eligible for patents in accord with Chakrabarty, and patentable in keeping with Hand’s dicta because, in isolation, they are new and useful commercially, diagnostically, and possibly therapeutically

The BRCA plaintiffs contend that none of the Myriad patents cover claims which are truly a new composition of matter; whilst they satisfied Learned Hand’s (now discredited) criterion, they said, they did not meet the “markedly different” requirement laid down by Chakrabarty . The extracted sequences only differed in trivial respects from the wild type which exposed its carriers to risk of cancer:

It was no more transformed from the natural DNA than was gold upon removal from a stream bed or the yolk after separation from the rest of the egg.

And this is where the plaintiffs’ “frivolous atmospherics” came in, because instead of sticking to the dry letter of patent law, they branched out and argued that the patents and the guidelines infringed not only the Progress Clause but the First Amendment of the US Constitution. What, one might ask – as Myriad’s lawyers witheringly did – does intellectual property have to do with free speech? The submission is artful, to say the least:

By restricting access to and use of the genetic information that the DNA embodied, [the patents] gave Myriad control over all “thought, knowledge, and ideas” concerning the genes, a monopoly that the First Amendment, in accord with judicial holdings, prohibited the PTO from granting.

Although the case against Myriad’s patents was overturned last year by the US Court of Appeals for the Federal Circuit, there are some grounds for predicting a Supreme Court root and branch review of this area of patent eligibility. At least Kevles thinks so, and his detailed account of the professional and educational backgrounds of the Court of Appeals judges is highly instructive in explaining their respective positions:

Pro-patent for all isolated DNA: organic chemist Judge Alan Lourie

Pro-patent for some isolated DNA based on utility: electrical engineer Judge Kimberley A. Moore

Anti-patent dissenter: civil lawyer Judge William Bryson (such DNA is “no more a human invention because it had been isolated from the chromosome than was a kidney taken from the body, a limb removed from the tree, or a mineral or plant extracted from the earth”.)

It will be interesting to hear what Kevles has to say about the Supreme Court justices when they reach their decision.

Frivolous atmospherics or not, there is no doubt that this litigation continues to raise fascinating ethical and commercial issues as eighteenth century property/constitutional law is stretched on the rack of twenty-first century biotechnology. The Supreme Court’s review of the Appeal Court’s ruling is confined solely to the question of whether genes are patentable – there will be no hot air balloons about free speech and patients’ rights – but the question is fundamental and far-reaching:

In effect, to borrow from Madison’s assurance that patent monopolies posed no danger in the American democracy, it will declare whether the rights of the many—scientists, physicians, and patients—will be given standing in what has long been the province of the biotechnological few.

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• Professor Jerry Coyne’s critique of Myriad’s position
• The patentability of human genes: more developments
• Should any genetic information be a trade secret?
• Can an individual claim ownership of life’s instructions?