Patenting Human Genes: The Supreme Court’s Myriad Genetics Opinion

In its much-anticipated opinion on the patenting of human genes, the Supreme Court decided to split the baby. In Association For Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013), a unanimous court ruled that a naturally occurring DNA segment was not patent eligible, but synthetic or complementary (composite) DNA (cDNA) was.

The case before the court involved patents which were granted on both DNA and cDNA. Myriad Genetics, the patentee, had discovered the exact location and sequence of two genes, mutations in which had the capacity to significantly increase the risk of developing breast and ovarian cancer. Several patents were granted on both isolated DNA and synthetic DNA.

In ruling that the isolated DNA was not patent eligible, Justice Thomas’ opinion for eight members of the court relied upon section 101 of the Patent Act, which requires an invention or discovery to be “new and useful.” The court pointed out that there is a judicially-created exception providing that “Laws of nature, natural phenomenon and abstract ideas are not patentable” under this section, because “without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.'” This is so even when the discoveries at issue, including those made by Myriad Genetics, were “[g]roundbreaking, innovative or even brilliant,” and even when extensive research efforts were required to locate and isolate the genes.

With respect to naturally occurring DNA, “Myriad did not create anything,” so the patent on that DNA was improperly granted.

By contrast, “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” This is so because a cDNA segment is created, rather than naturally occurring. Indeed, even if the sequence at issue is “dictated by nature,” nevertheless “the lab technician unquestionably creates something new when cDNA is made.”¬†As such, if all of the other requirements for patentability were satisfied, the patents granted “would… Give Myriad the exclusive right to synthetically create BRCA cDNA.”

On this issue, the court significantly cautioned in footnote 9 that “We express no opinion whether cDNA satisfies the other statutory requirements of patentability.” These include such requirements as the novelty and non-obviousness of the invention. Thus, those who criticize the decision as granting patents on subject matter that is obvious neglect this part of the majority opinion, and the comment in that opinion regarding the sequence being “dictated by nature” could make the cDNA claims subject to attack under section 103, a point the court did not reach.

As we noted in our April 16 post on the oral argument in this case, many of the justices were concerned with rendering a broad decision on the patentability of human genes because of the polar fears of inhibiting competition by granting broad patents, on the one hand, and of discouraging innovation by denying patents on new discoveries, on the other hand. Thus in addition to not deciding the question of whether cDNA met the other requirements for obtaining a patent, the majority opinion in its final substantive paragraph specifically stated that “It is important to note what is not implicated by this decision.” First, since no method claims relating to DNA were before the court, the question of whether a method patent could be granted on some aspect of “manipulating genes” was not ruled out. Second, the opinion did not cover patents on “new applications of knowledge” about genes, and indeed several unchallenged claims in Myriad’s patents were limited to such applications. Third, the court declined to decide whether DNA could be patented where “the order of the naturally occurring nucleotides has been altered.” In sum, the Supreme Court made clear that it was “merely” holding that “genes and the information they encode are not patent eligible under [section] 101 simply because they have been isolated from the surrounding genetic material.”

By carefully limiting the scope of its opinion to a single ground of patent eligibility, and by specifically leaving open the possibility of obtaining patents on (1) methods of manipulating genes, (2) applications of knowledge regarding human genes, or (3) alterations of genetic codes, the Supreme Court wisely held back from a premature ruling which could inhibit future research and development in this area, which inevitably is both lengthy and costly to undertake.

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