Supreme Court Says: You Can Copy That Floppy DNA Material

[FAGuru]

Discovery, nature, and patent law collide in the groundbreaking decision rendered today by the Supreme Court in Association For Molecular Pathology v. Myriad Genetics. Justice Clarence Thomas, writing for the majority, held that merely discovering an already existing, natural chemical substance (in this case, isolating genetic material) is insufficient for patent application.

Seems fairly straight forward, right? If I find a stick, I can't claim a patent to wood, simple as that, right? Not really, since the case at issue deals with the human genome and its massive complexities. And more specifically, the issues in this case are about the BRCA1 and BRCA2 genes that Myriad discovered. These genes are of significant interest because the mutation of these genes are responsible for dramatically increasing the risk of breast cancer. The mutation's affect is profound - normally, women have a 12-13% risk of developing breast cancer, however the mutation skyrockets this chance to 50-80%. 

Needless to say, the stakes are astronomically high as whoever controls the right to isolate an individual's BRAC1 and BRAC2 genes would control a powerful market as Myriad is the company that developed the tests necessary to determine if an person has these genetic mutations.

Myriad's argument before the court coincided with nine patent claims. The most relevant of which is, as Justice Thomas explains, that Myriad's claim is related only to the discovery process and information contained within the two genes. These facts set into motion the events of today's decision that ultimately derailed their claim to virtual ownership of the two genes.

Let's take, for example, Myriad patent claim 1, which reads in part (paraphrased by the Court): "claim 1 asserts a patent claim on the DNA code that tells a cell to produce the string of BRCA1 amino acids listed in SEQ ID NO:2"

As the court points out, Myriad is claiming a patent on the information contained in the two genes, essentially arguing that nature's creation is now their property. The Court wasn't buying it. In addition to their other claims, the Court points out, a favorable opinion would give Myriad the exclusive right to isolate these genes using already preexisting techniques. As a result of Myriad's legal threats to contemporaneous research on this matter, research facilities such as University of Pennsylvania's Genetic Diagnostic Laboratory that provided testing for women, were prohibited as a result of Myriad's legal threats from continuing their studies. Not cool.

 

The question then becomes what is and is not patentable. Section 101 of the Patent Act states: "“Whoever invents or discovers any new and useful ...composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.†There's a big exception to this broad rule, however, and that comes from the recently rendered Mayo Collaborative Services v. Prometheus Laboratories case which states that " Laws of nature, natural phenomena, and abstract ideas are not patentable.†Mayo, 566 U. S., at ___ (slip op., at 1)."

And that exception would prove to be the lynchpin that derails Myriad's claim to the BRCA1 and BRCA2 genes. Justice Thomas points out the problem in Myriad's argument that merely isolating genes creates a non-naturally occurring molecules. None of Myriad's claims are based on chemical composition. The Court posits the example that a would-be infringer could try and avoid a patent dispute by isolating the two genes and then grab another nucleotide pair - the result would be matter that is chemically different from Myriad's patent claim. The Court furthers that Myriad would resist this outcome since Myriad is concerned with the information contained on those two gene rather than its composition. And since that information already exists in nature, and the techniques used to isolate genes are common amongst researchers, such a patent claim is...patently untenable.

However, the case wasn't a total loss for Myriad. The company also developed synthetic cDNA. cDNA is an exon-only strand of nucleotide which is responsible for the creation of amino acids (the building blocks of proteins). Since synthetic cDNA (a chemical that is almost identical to its natural state, but is modified to eliminate the information that doesn't produce amino acids) is Myriad's own creation, the Court finds this chemical is patent eligible.

Thus the Court is a big win for advocates of genetic testing, especially for those who are vulnerable to this mutation. If Myriad were permitted to patent the information on these genes, it would be drug companies and other pharmaceuticals that would essentially own the information that makes us human, and would likely drive up the cost of health care. Now, however, any company that knows how to isolate genes and knows how to find BRCA1 and BRCA2 can provide testing for the potentially devastating disease of breast cancer with the benefit of competitive pricing. The Court notes, its decision has no influence on the techniques or manners of isolation - if Myriad has devised a truly brilliant and unique method, perhaps they would be in a patent eligible position for that technique. But that was not the issue before the Court.