SCOTUS Rules Lab-Created Genes Can Be Patented, Natural Genes Can't

Nobody can claim a patent on genes naturally found in human DNA, but you can patent them if you created them in a lab, the Supreme Court ruled today.

Molecular biology is on the cutting edge of modern technology and now poses novel legal questions. When someone creates a new invention, patent laws exist to protect the intellectual property of the creator. But can anyone claim that human genes found in DNA is intellectual property in a patent (except maybe God, who was not named as a party to this lawsuit)?

Myriad Genetics discovered the location and code sequence of two genes, which when they mutate increases the odds of breast and ovarian cancer. The company received patents on this information. Another organization disputed whether this information had to be regarded as truly belonging to Myriad Genetics and separately argued that even synthetic (lab-created) genetic material cannot be patented either.

Writing for the Court in the 9-0 decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., Justice Clarence Thomas said the first issue is, “whether the act of isolating DNA–separating a specific gene or sequence of nucleotides from the rest of the chromosome–is an inventive act that entitles the individual who first isolates it to a patent.” The second aspect is whether the same holds true for lab-created genetic material.

Thomas noted that the Court had long held that an implicit exception to the Patent Act is, “Laws of nature, natural phenomena, and abstract ideas are not patentable.” However, this exception cannot be read broadly, because:

…all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas, and [so] too broad an interpretation of this exclusionary principle would eviscerate patent law. As we have recognized before, patent protection strikes a delicate balance between creating incentives that lead to creation, invention, and discovery, and impeding the flow of information that might permit, indeed spur, invention.

Thomas later continued, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [statutory] inquiry.” The Court held that isolating natural genes could not in itself be patented.

Regarding synthetic material, although conceding the lab-modified genetic material is (by definition) not naturally occurring, the petitioners here, “nevertheless argue that cDNA [the lab-created material] is not patent eligible because the nucleotide sequence of cDNA is dictated by nature, not by the lab technician.”

To this, Thomas responds:

That may be so, but the lab technician unquestionably creates something new when cDNA is made… it is distinct from the DNA from which it was derived. As a result, cDNA is not a product of nature and is patent eligible under § 101 [of the Patent Act], except insofar as very short series of DNA may… be indistinguishable from natural DNA.

There are other statutory requirements for a patent, and the justices expressed no view on whether those requirements are also satisfied.

Thomas cautioned that the Court was not in this case saying whether new methods of exploring natural genes could be patented. But this did not protect Myriad Genetics patent on the isolated material, because the processes used by Myriad Genetics for their patented matieral “were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach.”

Thomas added that this ruling did not shut the door on new applications of the knowledge gained on any genes, including isolated natural genes. Nor does this ruling apply to situations where the order of natural genes might be modified.

Those questions will await future cases as the Supreme Court moves into these new waters opened by science.

Breitbart News legal columnist Ken Klukowski is on faculty at Liberty University School of Law.