Appeals Court Says Genes Are Patentable, Because They're 'Separate' From Your DNA

Patents

from the chop-off-a-finger-and-patent-it dept

Well, this is unfortunate. We were quite happy with US district court judge Robert Sweet last year for making it clear that isolated genes are not patentable material in the Myriad Genetics case. This was one of those annoying patent situations where so many people had just assumed that genes were patentable for decades, without a single court testing that theory out. So industries were built up around the idea that genes could be patented. Thankfully, Sweet didn’t let that bother him in pointing out that gene patents “are directed to a law of nature and were therefore improperly granted.”

Of course, as expected, Myriad appealed, and even the Justice Department weighed in, saying genes shouldn’t be patentable. However, the results of the appeal are in… and the Federal Circuit appeals court (CAFC) has reversed the lower court and said that patenting genes is just fine. The reasoning is bordering on ridiculous. The court effectively states that because isolated genes are isolated rather than a part of the full DNA strand, they are not “found in nature.”

It is undisputed that Myriad?s claimed isolated DNAs exist in a distinctive chemical form–as distinctive chemical molecules–from DNAs in the human body, i.e., native DNA. Native DNA exists in the body as one of forty-six large, contiguous DNA molecules. Each DNA molecule is itself an integral part of a larger structural complex, a chromosome. In each chromosome, the DNA molecule is packaged around histone proteins into a structure called chromatin, which in turn is packaged into the chromosomal structure….

Isolated DNA, in contrast, is a free-standing portion of a native DNA molecule, frequently a single gene. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule.

Later, it reiterates that separating out these genes make them somehow “different” and not a part of nature:

In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

Basically, they seem to be arguing that because a severed finger is not attached to a hand, the finger is not naturally occurring, and, thus, is patentable. Think about that. The dissenting judge in this ruling used a slightly less gruesome analogy, saying that the majority was basically saying that while a tree occurs in nature, snapping a leaf off the tree makes that leaf patentable.

The one good thing about the ruling is that it still rejects parts of Myriad’s patents, but for other reasons, not because they’re unpatentable parts of nature. The dissenting opinion from Judge Bryson (starting on page 88 of the ruling) is well worth reading. It starts out by attacking the problem with common sense, saying that if you were to ask someone if genes should be patented, they would answer, “Of course not. Patents are for inventions. A human gene is not an invention.” But then Bryson goes on to discuss the more specific points raised by Myriad. First, he points out that Myriad didn’t even really “invent” the key parts here:

At the outset, it is important to identify the inventive contribution underlying Myriad?s patents. Myriad was not the first to map a BRCA gene to its chromosomal location. That discovery was made by a team of researchers led by Dr. Mary-Claire King…. And Myriad did not invent a new method of nucleotide sequencing. Instead, it applied known sequencing techniques to identify the nucleotide order of the BRCA genes. Myriad?s discovery of those sequences entailed difficult work, and the identified sequences have had important applications in the fight against breast cancer. But the discovery of the sequences is an unprotectable fact, just like Dr. King?s discovery of the chromosomal location of the BRCA1 gene.

From there, Judge Bryson points out that an isolated gene clearly is a part of nature, and thus unpatentable:

Myriad is claiming the genes themselves, which appear in nature on the chromosomes of living human beings. The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature. While the process of extraction is no doubt difficult, and may itself be patentable, the isolated genes are not materially different from the native genes. In this respect, the genes are analogous to the ?new mineral discovered in the earth,? or the ?new plant found in the wild? that the Supreme Court referred to in Chakrabarty. It may be very difficult to extract the newly found mineral or to find, extract, and propagate the newly discovered plant. But that does not make those naturally occurring items the products of invention.

The same is true for human genes.

This case is far from over. It seems likely that CAFC will quickly be asked to rehear the case en banc (with the full slate of judges in the court, rather than just a panel of three), and after that it will likely go to the Supreme Court. Still, it’s unfortunate that CAFC went this way, and hopefully a later ruling rejects this momentary lapse of reason.

In the meantime, it’ll be important to pay close attention to what happens in the “sister” case to this one, Prometheus Laboratories v. Mayo Collaborative Services, in which there’s a question of whether or not diagnostic tests can be patentable. In that case, like this one, CAFC said diagnostic tests are patentable, and that case has now moved on to the Supreme Court, which will likely hear the case in the fall. That may be a precursor to the final result in this case.

Filed Under: brca1, brca2, cafc, dna, gene patents, patents
Companies: aclu, myriad genetics