A U.S. Supreme Court decision could affect the patentability of viruses

The most recent case that U.S. Supreme Court decided regarding patenting things derived from nature is Ass’n for Molecular Pathology v. Myriad Genetics Inc. The controversy in this case was whether DNA and cDNA could be patented.

DNA (deoxyribonucleic acids) makes up the genetic code of organisms. “Genes” are basically sequences of phosphorylated sugars connected by hydrogen bonds. These phosphorylated sugars are called “nucleotides.” There are four nucleotides in DNA: thymine, adenine, guanine, and cytosine.

In Ass’n for Molecular Pathology, Myriad found two genes that cause breast and ovarian cancer, BRCA1 and BRCA2. Ass’n for Molecular Pathology v. Myriad Genetics,  Inc., 133 S. Ct. 2107, 2111  (2013). After finding the precise location and genetic sequences of the genes, Myriad sought to patent its discovery.  The Court addressed two issues. Id. 1. Whether a DNA segment found in nature is patentable based on its location, and 2. whether “synthetic” DNA, known as complementary DNA (“cDNA”) is patentable. Id. The Court held that DNA is a product of nature and is therefore not patentable but cDNA does not naturally occur and is patentable. Id. The Court also found that mere isolation of genetic material is insufficient to warrant patentability. Id at 2120. During the analysis, Justice Thomas cited 35 USC § 101, and Diamond v. Chakrabarty (among other cases) to support the Court’s decision. (The Court’s opinion in the case will be discussed in further detail in later posts in the context of bacterial patenting.)

So what does this have to do with viruses?

Well viruses are basically “bags” of DNA or RNA. David Baltimore, a renowned virologist, divided viruses into four categories based on genetic material. Viruses either have single-stranded RNA (“ssRNA”), double-stranded RNA (“dsRNA”), single-stranded DNA (“ssDNA”) or double-stranded DNA (“dsDNA”). This is known as the “Baltimore classification.” Baltimore also divided the viruses even further by method of replication.

Viruses are generally not considered living things, but they are found in nature. Hypothetically speaking, if a scientist sought to patent a virus that could benefit the world in some way I believe the Ass’n for Molecular Pathology case could affect whether or not the virus was patent eligible because the case rules on patenting genetic material. However, the extent to which the case would affect virus patentability would depend on the facts.

I believe that patenting entities that derive from nature is not merely determined by a bright line rule. On the contrary, the Court takes an ample amount of time discussing the facts of each case before ruling on patentability. Arguably, the controversy could be settled with one question: is this “thing” a part of nature or not? However, Justice Thomas in his opinion cites the Court in Mayo Collaborative Servs. v. Prometheus Labs, stating that ” [t]he rule against patents on naturally occurring things is not without limits, however, for ‘all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas’ and ‘too broad an interpretation of this exclusionary principle could eviscerate patent law.'” This means that the rule does not exclude all things derived from nature. To do so would impair discovery and inventions. So perhaps the Court uses a rule of reason instead?

 

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