Wednesday, March 31, 2010

Landmark (and great) decision on patents involving DNA

A landmark ruling that, I think, clarifies some of the confusion surrounding patents involving DNA. Some of the stuff in the article itself serves to illustrate confusion in peoples' understanding of what is/was/should have been patentable. The confusion boils down to a lack of understanding of the difference between 'invention' and 'discovery'.

From the NYTimes:

"A federal judge on Monday struck down patents on two genes linked to breast and ovarian cancer. The decision, if upheld, could throw into doubt the patents covering thousands of human genes and reshape the law of intellectual property."

I think this was a great ruling because the BRCA ('breast cancer gene') patents basically (I understand it) were for DNA that occurred naturally in living beings. Myriad Genetics claimed (like other companies have before) that isolating the gene transformed it chemically so it was now patentable. Shrewd lawyers and ill informed judges went along with that idea. But it was flawed from the beginning because Myriad patented the mutant version of the gene (which naturally occurred) and then got sole rights to test for those mutations (that naturally occurred in patients). There was no engineering human engineering involved that made that sequence unique and patentable. The exclusivity for the breast cancer test didn't arise from any technical innovation in the testing procedure --- just from the naturally occurring DNA sequence. Basically, they patented a discovery, not an invention. A lot of the 'gene' patents are fundamentally flawed for this reason: they are patents for discoveries, not inventions.

The NYTimes article goes on to say:

Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980.

The first part of this statement is somewhat true; but again, those patents were awarded incorrectly, due to some smart lawyering that muddied the facts about what was natural versus what was portrayed to be 'engineered'.

The second part of it was, at best, a bad example. The patent on living organisms that it refers to is one in which a microbe was engineered, using DNA that was also engineered, to be able to break down crude oil. There is no naturally occurring piece of DNA identical to that which was made and used for the engineering. Consequently, there is also no naturally occurring microbe that can break down crude oil in quite exactly the same way as that microbe --- and it is highly significant that the microbe's ability to break down crude oil is completely dependent on the engineering, and unnatural piece of DNA, that it possessed. The difference in this case, that made the DNA and the microbe patent-worthy, was that they were inventions not discoveries.

Anyway, coming back to the breast cancer gene patents---from related NYTimes article:

Although patents are not granted on things found in nature, the DNA being patented had long been considered a chemical that was isolated from, and different from, what was found in nature. But Judge Sweet ruled that the distinguishing feature of DNA is its information content, its conveyance of the genetic code. And in that regard, he wrote, the isolated DNA “is not markedly different from native DNA as it exists in nature.”

Way to go judge. Freaking nailed it!

This ruling is very significant because Myriad patented a discovery and charged patients a freaking ton of money for a simple test. They charge over $3000 for a test that shouldn't cost more than a twentieth of that. This ruling could open up a ton of competition for the simple test now, and hopefully bring down the cost of the test dramatically.

This should also set the standard for future patenting in biology. It is really not that difficult to determine invention vs discovery --- and award patents for the former and not for the latter.

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