BioWorld Today Columnist

There's an old story about a man who borrows his neighbor's kettle and later returns it with a hole in the bottom. When the neighbor complains, the man says, "First, I never borrowed your kettle. Second, there is no hole in it. And lastly, the hole was already in it when I borrowed it from you."

It's been a month since the decision in Association for Molecular Pathology v. USPTO, better known as the Myriad Genetics Inc. patent ruling that declared purified and isolated gene sequences as unpatentable, and the biotech industry finds itself engaged in various defenses and descriptions of its kettle. Having taken the position that this outcome would be ruinous, the industry is now expecting the decision to be overturned on appeal while simultaneously claiming that it's not such a big deal. And actually, it all makes a lot of sense.

I had an interesting conversation recently with biotech patent attorney Gerry Elman, who raised a fascinating notion, perhaps philosophical, but potentially important to those who wish to communicate the aims and achievements of biotechnology. He suggested that the metaphors ingrained in our descriptions of biology subtly miscommunicate the nature of DNA and, in this case, may have changed Judge Robert Sweet's ruling - particularly since it was made as a summary judgment and Myriad wasn't allowed to argue the details of its discoveries in court.

We pretty universally talk about DNA as a storehouse of information, and the processes of translation and transcription (themselves metaphors) as ones of "reading" and "writing" that information. That pretty naturally leads one to think of DNA as fundamentally, philosophically different from all other molecules. Thus, the act of "purifying" a gene is viewed not as a complex lab process involving restriction enzymes that strip a polynucleotide out of the enormous chromosomal molecule, ridding it of all the other molecules that cling to it, and leaving you with something fundamentally different from anything you'd find in nature. Instead, it is an act of plagiarism - lifting a passage from the book of life and claiming it for yourself.

In that view, the "information" content of DNA is all that matters; the fact that a scientist has created something molecularly unique and not existing in nature - a novel chemical, clearly patentable in any other circumstance - seems as irrelevant as changing the font of a copied passage of text.

Is 'Intelligent Design' Science?

Elman suggested the further irony that this is an "intelligent design" view of DNA and life - something that the American Civil Liberties Union (ACLU), which supported the plaintiffs in the Myriad case, argued strenuously was not science in opposing the Dover, Pa., school board's attempt to add intelligent design to its curriculum several years ago.

Indeed, Judge Sweet explicitly framed this quasi-spiritual and seemingly extra-legal view in a footnote, noting that his opinion is based on the "unique properties of DNA that distinguish it from all other chemicals and biological molecules found in nature."

In that statement, the judge was answering a prediction made by Myriad in its brief, that (quoting Judge Sweet again) "a finding that DNA is unpatentable subject matter will . . . leave 'little to nothing' of the U.S. biotechnology industry."

Interestingly, that bit of hyperbole stands in sharp contrast to what Myriad has said since the decision - the company has assured investors that the invalidation of some claims in its BRCA-1 and BRCA-2 patents won't impact its business or its ability to protect its franchise.

So was what Myriad said before just a bit of fear mongering aimed at persuasion? Is that company just putting a brave face on a terrible situation now? Judge Sweet believes the impact of his decision is limited to gene patents alone, but I don't think everyone potentially affected by the ruling is quite so confident.

Still, the scariest thing about a world without gene patents probably isn't the lack of the patents themselves - after all, the fact that we managed to go a couple of decades without a clear legal test on patentability of genes reflects a lack of litigation in the area. The scariest thing would be to undermine the confidence of those who provide that capital that keeps the sector running. Which is why now is the time for brave talk, even in the face of uncertainty.

Bring On Bilski

The tea leaves on where this is going will become much easier to read in the coming weeks. A Supreme Court ruling in Bilski v. Doll is expected any time now (indeed was expected before now), and will add some clarity to how the high court views patent eligibility.

Bilski concerns the patenting of method claims, particularly business methods. The Court of Appeals for the Federal Circuit affirmed the rejection of a patent application on a method for commodity trading as being an abstraction rather than an invention. But in doing so, it devised a test for patentability that would seem to invalidate all kinds of claims by requiring that a patentable invention involve a machine or a transformation of matter. That has alarmed the biotech community - the Biotechnology Industry Organization has filed an amicus brief to the Supreme Court in the case - because it could have a broad impact on the industry. Just consider patents on diagnostics methods where a machine isn't specifically described and a substance isn't transformed or changed, but merely measured.

If the Supreme Court affirms Bilski, the industry will have more than just gene patents to worry about.

Karl Thiel, an analyst for the Motley Fool, can be reached at kthiel@qwest.net. His opinions do not necessarily reflect those of BioWorld Today.