A federal judge recently made a decision to invalidate a patent on the process of detecting Down syndrome in fetuses using genetic sequences.  The biological science community seems to concur with the ruling that naturally occurring genes are not patentable.  The patent holder’s own biological patent expert witness agree that the amplification and detection of DNA sequences in plasma was commonly used prior to the patent registration.

In deciding that the patent was invalid, Judge Illston’s principal rationale was that the patent ultimately covered a natural phenomenon, and was thus not patentable subject matter. Yet the decision comes on the heels of a number of decisions from high courts that have reigned in the scope of patentability for biological subject matter, and processes relating to biotechnology.

In Mayo v. Prometheus, the Supreme Court found that claims relating to a method of giving a drug to a patient were not eligible for patent protection. Judge Illston relied upon this ruling in reaching the conclusion that a non-invasive test for a genetic defect, i.e. Down syndrome, was not eligible for patent protection. However, the legal community decried the potentially invalidity of thousands of pre-existing patents on methods of treatment, and lamented the uncertainty that the decision injected into the contours of patentable subject matter.

The Judge also relied upon a more recent ruling in the Myriad case involving a method for the detection of the BRCA 1 or BRCA 2 gene mutation known to be closely associated with breast cancer in women. In that case, the Supreme Court found that the act of isolating a portion of genetic material from humans was not, in and of itself, a patentable process. Rather, a more significant alteration to the subject matter otherwise found in nature would have to be made in order for the subject matter to be protected by a patent.

Genetic patent holders might choose to appeal, but the likelihood of success of their appeals is unclear.  They will clearly have to show through the use additional biological patent experts in the field that the patent covers processes that go beyond the isolation of genetic abnormalities, and actually rise to the level of patentable subject matter post-Myriad.

By: Sam Eichner,  Attorney At Law