Are patent decisions strangling our economy?
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When the federal circuit handed down the decision in Ariosa Diagnostics v. Sequenom, the biotech community was stunned. Sequenom had developed a new process that provided a simple and safe way to detect fetal abnormalities instead of using invasive and dangerous amniocentesis. When this breakthrough was announced, all of the prominent medical journals heralded Sequenom for revolutionizing the standard of neonatal medicine. But suddenly, in the eyes of the courts, this remarkable biotech innovation could no longer be considered patent protected.

Why?

The Sequenom case highlights an ongoing challenge that diverse industries are facing in the wake of landmark Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories that have clouded the certainty over what is in fact patent eligible.

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Sequenom claims the invention here involves the startling discovery that the paternally derived portion of the DNA in the mother's blood, through a combination of steps, can be used to detect, for example, Down syndrome. Sequenom asserts that it is the combination of steps which are patentable, not the individual steps, which were known.

The federal circuit reluctantly determined that the instant claims related to one of the Supreme Court-created exclusions for patentable subject matter, a law of nature, and that detecting and amplifying were routine and did not transform the unpatentable law of nature into a patent-eligible application of a law of nature.

The high-tech community has also been pulled into the fray when the Supreme Court extended its earlier decisions relating to "laws of nature" to "abstract ideas" and created uncertainty in the field of computer-implemented processes.

This spate of decisions is clouding the validity of patents in everything from diagnostic methods to personalized medicine to business methods and gaming. And the limits on patentable subject matter could curtail further research and investment in areas broader than these that are deemed to preempt basic research. In fact, Microsoft's brief in support of Sequenom reflects the full scale and scope of the courts' unpredictability in patent eligibility, which extends beyond the biomedical concerns of this case. Microsoft argues that the Supreme Court needs to provide guidance to the courts because software patents are being invalidated at a rate that could have a lasting impact on the industry in the U.S.

Overturning years of precedence and applying the new, unclear Supreme Court standard will clearly have a harmful effect on investment, research and job creation in the biotech disciplines, but the problems go much further than that.

The devastation from decisions like Sequenom are evident. Investing in research for vaccines, such those needed to protect against the Zika virus, will be redirected if patent protection is unavailable. And whole industries, including diagnostic methods and personalized medicine, will disappear without the funding necessary to spur the development for those tests and cures.

In effect, the murkiness over what is considered patent-eligible holds a sword of Damocles over some of the fastest-growing and most innovative industries in the country.

The uncertainty caused by the Supreme Court's recent jurisprudence has now become so significant that prominent leaders in the patent community are now calling for a legislative fix as a solution. While it's not clear that this would be a politically viable option, what is obvious is that something must be done — either by the court or by Congress — to resolve this increasingly problematic issue.

The Supreme Court now has the opportunity to provide much-needed guidance and choke off research-killing decisions at lower courts, as Sequenom has now filed its much anticipated certiorari petition. The Supreme Court should take up the case given the number of inventions being denied patent protection in emerging technologies. Such inventions are critical to job creation and economic growth in the U.S. and we cannot wait.

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.