The courts are expanding their war on innovation in the United States. On Friday, June 12, the Court of Appeals for the Federal Circuit handed down a decision in Ariosa v. Sequenom finding that a breakthrough in prenatal DNA screening that offered a noninvasive and much safer alternative to existing tests was not eligible for patent protection.
The invention was based on the discovery that a pregnant woman’s blood contained the DNA of the fetus. Sequenom developed a test for determining fetal abnormalities based upon these findings, which avoided existing, more dangerous and invasive techniques of taking samples from the placenta or fetus. The company’s patent claims covered this new testing technique.
The court applied the two-prong test developed in Mayo v. Prometheus. The first prong is to determine if the claims are drawn to a judicially created exception to patentability, like a law of nature or an abstract idea. If the answer is “yes,” the second prong is to determine whether additional elements are added that transform the nature of the claim into a patent-eligible invention.
{mosads}The court concluded that, because the existence of nucleic acids and the presence of a fetus’s DNA in the mother’s blood were naturally occurring phenomena, and because the procedures used for analyzing the fetal DNA were the same techniques that were used in existing DNA tests, Sequenom’s invention failed the Mayo test.
The most disturbing aspect of this decision is that everyone agrees that the patentees made a significant contribution to the medical field with their test. Prior to the patent, no one was using the mother’s blood to check for fetal abnormalities. Distinguished medical journals had touted the patentees as revolutionizing prenatal care. In its decision, even the court acknowledged that providing the noninvasive method for determining prenatal genetic disorders was “a positive and valuable contribution to science,” but that a “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.”
So where do court decisions like this leave the biotech industry in the United States?
The patent system, as outlined in the Constitution, is intended to promote the “useful arts.” There is no question that what was done by the patentees in this case was useful. Yet the court still denied them patent protection because the claimed subject matter did not pass a test that was developed by the courts.
We want to encourage research in just these types of diagnostic methods and personalized medicines, as well as in the field of computer-implemented inventions which have also had troubles meeting the new requirements. These emerging technologies are the very areas where the United States has been leading the world and these technologies are driving economic growth and job creation.
The courts’ focus on subject matter eligibility as a mechanism to deny patents for these inventions will drive investment into research in these technologies to other areas. We will lose our edge in the world and many further valuable contributions to science will not come to fruition.
If the concern is that the inventions would be obvious or are not enabled or are not fully within the grasp of the inventor, there are other sections of the statute that could be used to deny an applicant a patent. But to deny patentability for a patent to an invention that is so clearly useful to so many people does not fulfill the requirement of the Constitution to promote the useful arts.
If the courts are unwilling to listen to the scientists and the patent community as to the effects these positions have on innovation, perhaps it is time to engage the legislators and the White House to clarify the law to ensure that we continue to promote the useful sciences.
Stoll is a partner and co-chair of the intellectual property group at Drinker Biddle & Reath and a former commissioner for patents at the United States Patent and Trademark Office.