Fact-Check: Clarifying the Myriad Genetics Supreme Court Decision for IndustryFact-Check: Clarifying the Myriad Genetics Supreme Court Decision for Industry

On June 13, the Supreme Court issued its long-awaited decision in Association for Molecular Pathology v. Myriad Pharmaceuticals, Inc. In a 9-0 decision, the Court ruled that naturally occurring human genes are not patent-eligible subject matter under the U.S. Patent Act, but cDNA can be patented. The Court did not address Myriad patents covering genetic testing methods based on specific mutations in human genes. The full decision is available online.

June 19, 2013

4 Min Read
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The Myriad decision has caused a fair degree of confusion in the biotech and IVD communities. Although the full ramifications of the decision may take years to play out, some things are clear.

 

1. Isolated Human DNA Sequences Are Not Patentable. As the USPTO instructed the examining corps immediately after the decision:

 

As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101. Claims clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible. Other claims, including method claims that involve naturally occurring nucleic acids, may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.

 

2. But How Much Change Is Enough? The basic line drawn in the decision is that while naturally occurring DNA is an unpatentable “product of nature,” cDNA synthesized in a laboratory is potentially patentable. But the Court left undefined exactly how much physical change is necessary to make a molecule patentable. The Court rejected the Federal Circuit’s determination that chemical changes resulting from isolating DNA sequences by cleaving or extracting them from cells were enough to alter the DNA’s “products of nature” status. Future cases will be needed to define whether and to what extent manipulations of oligonucleotides and proteins, such as insertions, deletions, or other structural modifications, are enough to establish patentability. On this point, one could argue that DNA requires a more substantial chemical change to be patentable, because lesser chemical changes do not affect the essential coding information. The same amount of change may not be required for proteins.

 

3. Eligible Does Not Equal Patentable. The issue in Myriad was eligibility, not patentability in the narrower sense. Eligibility is a threshold issue, and just requires an invention to be a “machine, manufacture, process or composition of matter” (or an improvement of any of those), not an abstract idea, law of nature, or natural phenomenon. Even if cDNA molecules are eligible for patenting, they still must be novel and nonobvious. If unpatentable laws of nature and natural phenomena are prior art, as the Federal Circuit has suggested, then it may prove difficult to establish that cDNA is not obvious in light of the corresponding prior-art DNA sequence. As a result, Myriad should not be taken as the Supreme Court’s green light that all cDNAs are worthy of a patent.

 

4. Justices Are Fuzzy on Facts. Some researchers were concerned that the Court’s recitation of the science underlying Myriad’s inventions was inaccurate or incomplete. Some of those errors (including the reference to “composite DNA”) were in the reporter’s syllabus, which is not part of the decision written by Justice Thomas. The general discussion of DNA and its function was not as complete as biochemists would like, but it was probably more detailed than necessary to support the Court’s ruling. Courts often devote time to reciting facts in order to make their decisions as persuasive as possible. Justice Thomas may not have accomplished that goal, but the shortcomings do not appear to undermine the basic distinction between isolated and synthesized DNA molecules. In fact, Justice Scalia’s concurrence could be read as a tweak to Thomas’s opinion, essentially saying, “I came to the same conclusion without all those unnecessary scientific details.”

 

The legal framework established in Myriad will now be applied to other patents and technologies by lower courts, including the Federal Circuit. How those courts interpret Myriad in those cases will determine the long-term impact of the ruling on the patentability of biotech discoveries.

 

tyler-headshot_200.jpgDavid C. Berry is Professor of Law at Thomas M. Cooley Law School in Auburn Hills, Michigan and is Director of the Graduate Program in Intellectual Property Law. He is a registered patent attorney and has more than 25 years of experience in private practice and teaching patent law and litigation. www.cooley.edu/llm/intellprop

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