The Supreme Court of the United States released its ruling on the ‘Association for Medical Pathology v. Myriad Genetics, Inc.’ case today. Briefly, they ruled that Myriad’s patent is invalid as they merely discovered a natural entity. Because they did not alter the material in any way vital to their industry or possess a methods claim associated with this material, their patent fails because “laws of nature [or] natural phenomena …lie beyond the domain of patent protection” according to precedent set under United States Code.
Wait – you mean the USC clearly states that they couldn’t patent this stuff? Well, no.
USC Title 35 Part II Chapter 10 Section 101
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…”
The applicable precedent case is Mayo v. Prometheus___566 U.S. In that case, Prometheus had a patented clinical diagnostic kit that Mayo Collaborative Services (a nonprofit affiliated with the Mayo Clinic) used for some time until they developed their own version of the kit. (A pretty close precedent). In this case, the court ruled that, “Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”
From these rulings it appears that in order to become a patentable entity a gene must be novelly transformed in some manner that makes it functionally distinct from the naturally occurring entity, or that the method for interrogating the gene involves some novel method beyond what is previously known art.