UPDATE: Just hours after the Supreme Court ruled today, at least one company announced it would be offering genetic testing on the BRCA genes for $995—barely one quarter of the approximately $4000 Myriad charges for the same tests.
For the second time in just over a year, the Supreme Court has unanimously weighed in on what is and isn't patentable. And in this case—Association for Molecular Pathology v. Myriad—the high court got it right again.
At issue in this case were the infamous "breast cancer genes," BRCA1 and BRCA2, mutations in which signify increased risk of both breast and ovarian cancers. Myriad isolated these genes and proceeded to use patents to limit who could administer the genetic tests that signal presence of the genes. This raised several concerns, such as the inherent problem with only having one entity administer the tests and the resulting costs—making it nearly impossible for many to afford—and limiting availability of second opinions.
And, more importantly for patent law: these genes exist in nature. Myriad didn't invent or create them, it merely found them, using methods that were well-known among geneticists at the time of discovery. As the Court said
In this case, ... Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.
Patenting genes had been happening for some time, despite long-standing Supreme Court precedent that, in order to be eligible for a patent, an invention must have a "new or distinctive form, quality or property" and may not be a product of nature. The district court in this case agreed and sided with plaintiffs—geneticists, pathologists, laboratory professionals, and individual breast cancer patients, represented by the ACLU and the Public Patent Foundation— finding that isolated breast cancer genes did not meet this standard and invalidating Myriad's two patents. The Federal Circuit reversed, holding that the isolated genes contained molecules that were "markedly different" than those that occur in nature.
In the interim, the Supreme Court issued another unanimous decision in Mayo v. Prometheus, striking down a patent covering a medical diagnostic test. The Court there found the patent invalid because it took laws of nature and merely included “well-understood, routine, conventional activity previously engaged in by researchers in [the] field.”
We were encouraged by Mayo's strong language that "the basic tools of scientific and technological work" are not patentable. Today, the Court went even further, reversing the Federal Circuit and stating that
As the Court has explained, without this exception, there would be considerable danger that the grant of patents would "tie up'" the use of such tools and thereby "inhibit future innovation premised upon them." This would be at odds with the very point of patents, which exist to promote creation.
We couldn't agree more. The Supreme Court went on to say that "patent protection strikes a delicate balance between creating 'incentives that lead to creation, invention, and discovery' and 'imped[ing] the flow of information that might permit, indeed spur, invention.'"
We're glad to see some sanity in the world of gene patents and diagnostic testing—specifically, more direction from the Supreme Court as to what is an unpatentable "law of nature". (The Court did uphold patents that cover cDNA—genetic material that is developed in a lab and does not naturally exist.) But the so-called "delicate balance" is completely out of whack when it comes to patents that cover software and many other inventions that we believe are similarly unpatentable "abstract ideas". The good news is that this question might end up in front of the Supreme Court soon, and if recent Supreme Court trends hold true, we could see some scaling back of a broken system full of overbroad, vague, and frankly stupid patents.