Can One Bad Gene Patent Holder Spoil the Whole Barrel?

In its recent move to invalidate gene patents, the ACLU focused its lawsuit on Myriad Genetics, the poster child for gene patent challenges thanks to its miserly control of two genes associated with breast cancer.

Which begs the question: is the problem really the thousands of issued gene patents, or is it the way a select few holders of gene patents have conducted business?

Opposition to gene patents is not new. Just over two years ago, Reps. Xavier Becerra (D-Calif.) and Dave Weldon (R-Fla.) introduced the Genomic Research and Accessibility Act, which sought to prevent the patenting of “nucleotide sequences” along with their “functions, correlations, or the naturally occurring products [they] specify.”

The bill died in committee, as did a similar bill introduced back in 2002. Both bills were based on the same arguments the ACLU is raising once again: that genes are products of nature (like air or diamonds) and shouldn’t be patentable, and that such patents inhibit innovation.

The U.S. Patent Office has explained time and again that while DNA is natural, isolated and purified DNA is not. The PTO’s guidelines also state that “the incentive to make discoveries and inventions is generally spurred, not inhibited, by patents.” And while the ACLU has thrown a curve ball by claiming that gene patents violate the First Amendment by inhibiting the free flow of information, folks can counter by noting that patents — due to their public nature — actually expand the flow of information.

What’s ironic is that anti-gene-patenters tend to point the finger at the drug industry, yet the U.S. government holds nearly 400 gene patents, and the University of California holds more than 250. Several thousand patents on genes have been granted, and most patent holders routinely grant licenses as needed so scientific research can carry on.

As Patent Baristas notes:

There is nothing particularly extraordinary about gene patents that should require that they be held to a higher standard than, say, pharmaceutical patents or non-gene based diagnostics. … In the end, patents work more or less as expected. They reward innovation for a limited time.  When the patents expire, the discoveries are available to everyone.  Forever.

Myriad is technically within its rights to decide it doesn’t want to play nice in the sandbox for the 20 years it controls those patents. But that decision has made the company a target by essentially establishing a monopoly on breast cancer testing. Patients are pissed that the test is so expensive (of course the same could be said of many patented diagnostics and treatments) — but what holds more sway is the fact that women can’t get a second opinion and Myriad won’t let anyone else look at those genes. And then there’s the controversy over how much credit Myriad deserves for discovering the genes in the first place.

Industry experts seem to think the ACLU’s bid against gene patents will fail like so many others in the past. But I wonder if someone will eventually tackle Myriad directly instead of using the company as a stepping stone to challenge gene patents — and if that would lead to a different outcome.

Rotten Apples image by Flickr user alison e dunn, CC 2.0