The story continues to unfold regarding the patent eligibility of diagnostics, a story that first made headlines in the fall of 2013.  Back then, the District Court for the Northern District of California issued an Order holding that medical diagnostic method claims are not eligible for patent protection (“The Sequenom Decision”).1  The decision was noteworthy, because it had been made upon remand and direction from the Federal Circuit to examine the patent eligibility of diagnostics in light of the Supreme Court’s now infamous Myriad and Mayo decisions.

Last year, the Court of Appeals for the Federal Circuit affirmed the Sequenom decision and subsequently denied a request for rehearing before its full panel.2  Now, the page for the next chapter has been turned with Sequenom’s filing on March 21st for a writ of certiorari with the Supreme Court.

At issue is US Patent No. 6,268,540, which is exclusively licensed to Sequenom, and which claims non-invasive prenatal diagnostic methods using maternal blood samples.  Such noninvasive methods employ cell free fetal DNA (cffDNA) found in the blood and provide an alternative to amniocentesis, which can pose a risk to both the mother and child.  The field of noninvasive prenatal testing is of significant commercial importance, because several companies are vying in the market with prenatal diagnostic and paternity tests.  A public policy issue that has added a complicating twist to the patent eligibility question is whether the patenting of ground-breaking discoveries that can potentially preempt a technology field should require extra and more careful scrutiny before being deemed patent eligible.

The single question now presented in Sequenom’s petition before the Supreme Court is:

Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?

This is certainly a heady question that goes to the crux of what is deemed patent eligible subject matter.  Will the Supreme Court squarely take this case on and opine on this important question?  Will it ultimately issue a decision on patent subject matter eligibility that will provide clearer guidance for biotechnology R&D efforts and the quest to develop innovative diagnostics?  It will be interesting to see what develops.  At the very least, there are certainly bound to be many highly vocal amicus briefs imploring the Court to rule on this important question.

1  Ariosa Diagnostics, Inc. v. Sequenom, Inc., Case No. C 11-06391 SI

2  Ariosa Diagnostics, Inc. v. Sequenom, Inc., Fed. Cir. 2014-1139, 2014-1144 (2015)

– Anthony D. Sabatelli, PhD, JD

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