Over thirty years ago, the USPTO awarded the first gene patent (US 4,447,538) and the Supreme Court held that biological inventions were subject to patent protection. Since then, tens of thousands of U.S. “gene” or DNA related patents have issued. However, there has been much uncertainty over the patentability of such inventions as of late.
We have previously reported on the circuitous voyage of Association for Molecular Pathology v. Myriad Genetics, et al. (“Myriad”) through the court system. On June 13, Myriad ran aground, with a unanimous Supreme Court ruling that human genes cannot be patented under §101 of the Patent Act, which sets forth the general provisions on patentability.
Justice Thomas, writing for the Court, rejected Myriad’s arguments that isolated genes should be found patentable, stating that Myriad “found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” Therefore, patent claims involving isolated DNA fail inquiry under §101.
The Court did, however, provide Myriad with a life raft regarding claims involving cDNA. According to the Court, synthesized cDNA that differed from the corresponding native DNA, and involved manipulation, did not fall under the “product of nature” exception of the patent statutes under §101, and thus were patentable. However, the Court added that in cases of cDNA corresponding to short stretches of intron-free native DNA, the “product of nature” exception could apply.
This landmark decision is likely to substantially affect holders of patents with isolated DNA claims. Such patents now appear to be vulnerable to invalidity contentions by potential infringers. This potentially could mark the end of future isolated DNA-related patent applications. Furthermore, research in such fields as medical diagnostics and testing may be disrupted, with innovators resorting to trade secret law in order to protect their intellectual property formerly secured by patents.
Another interesting issue for consideration is whether by analogy, issued patents and pending/future patent applications involving isolated proteins will face a similar fate, thereby further disrupting research in this arena.
The ramifications will become more evident in the coming years, but this decision will definitely change how biotechnology companies protect their inventions.