Today, the U.S. Supreme Court rendered its opinion on AMP v. Myriad on the issue of eligibility of patent protection for isolated DNA and synthetic DNA (i.e., cDNA). I previously wrote about the Fed. Cir. opinion on this case. Post title: Different structure and function required for patent eligibility. At that time, a fractured Fed. Cir. court opined that the isolated DNA and synthetic DNA were both eligible for patent protection but each judge for different reasons.
The U.S. Supreme Court simplified the analysis and provided a unanimous decision as to its reason that isolated DNA is not eligible for patent protection but that synthetic DNA (cDNA) is eligible for patent protection. As such, the Supreme Court reversed in part and affirmed in part the opinion of the Federal Circuit.
The Supreme Court recognized that finding the sequence within a DNA that might identify a marker for a disease or condition is extremely difficult. It is like finding a needle in a haystack. Chromosome 17 has approximately 80 million nucleotides and chromosome 13 has approximately 114 million. Finding the right sequence or gene that would indicate a disease or condition would require “extensive research efforts. But extensive efforts alone are insufficient to satisfy the demands of Section 101.” stated the Court. In order to broaden up the patent, the patentee claimed the information packed in the gene so that regardless of how the particular gene was modified, infringement would occur. This was done through the isolated gene claims of the patent.
Under Section 101, the Court started out by stating that the standard for determining whether an idea is eligible for patent protection is determined on whether providing patent protection would create incentives that lead to creation, invention, and discovery or impede the flow of information that might, indeed spur, invention. The Court then analyzed a few major cases such as Chakrabarty and Funk Brothers to compare the holding in those cases to the instant patent. Based on this analysis, the Court held that isolated DNA is not eligible for patent protection merely because it is isolated but held that synthetic DNA or cDNA is eligible because it is non naturally occurring.
Importantly, the court then leads the patenting community to areas in which the ‘inventor’ or discoverer of important knowledge (e.g., gene location which is not patentable) might be able to seek patent protection with that knowledge. For example, the court said that this opinion does not affect innovative methods of manipulating genes, new applications of that knowledge or the order of the naturally occuring nucleotides. Although my focus is not in bio tech, the application of this reasoning from the US Supreme Court can be applied to the mechanical, electrical and software arts.
I invite you to contact me with your patent questions at (949) 433-0900 or [email protected]. Please feel free to forward this article to your friends. As an Orange County Patent Attorney, I serve Orange County, Irvine, Los Angeles, San Diego and surrounding cities.