Another Year, Another Genetics Test Patent Challenged In Court

Not that it was really expected, but recent action in the courts suggests that the Myriad Genetics case has not settled the legal standing of patents on testing of genetic sequences.

The new matter involves two companies in a lawsuit over the patenting of a genetic test for Down Syndrome (H/T ScienceInsider).  On the 30th, a Federal judge in California invalidated the patent licensed by Sequenom since 2011.  The test Sequenom developed and patented is new and different, utilizing a different technique and demonstrating marked increases in efficiency compared to other methods.  They were sued by Ariosa Diagnostics for a declaration that a test Ariosa developed did not infringe on Sequenom’s patent.

The judge’s order, which granted Ariosa’s motion for summary judgment (and rejected Sequenom’s motion), focuses on whether various claims of the underlying patent address eligible subject matter.  Specifically, whether or not patenting the uses of paternally-derived cell-free fetal DNA in the test constitutes the patenting of something novel and therefore patent-worthy.  The judge was persuaded that the test constituted the application of conventional techniques to a new natural phenomenon, and did not pass the patent-worthy threshold.  Relying on the decisions in both the Myriad case and the other recent medical test patenting case, Mayo v. Prometheus, the court found that the only inventive part of the patent was the use of cell-free fetal DNA, and thus not patentable.

This case is only at the District Court level, and Sequenom has stated it will appeal the decision.  Ariosa is pleased with the decision, and given the tenor of its press release, would likely meet Sequenom’s ‘vigorous’ defense with vigor of its own.  A visit to the Supreme Court in 2016 or so is plausible.