Earlier today the United States Supreme Court issued a decision that fundamentally changed the law of patent eligibility that has existed in the United States for the past 30 years, calling into question at least many tens of thousands of issued patents and many tens of thousands of pending patent applications. See Supremes Rule Isolated DNA and some cDNA Patent Ineligible.
With lightening speed, the United States Patent and Trademark Office has sent a memorandum to patent examiners relating to the aforementioned Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. The 1-page memorandum from Drew Hirshfeld, who is Deputy Commissioner for Patent Examination Policy, is direct. “Examiners should now reject…”
The memorandum in its entirety reads:
Today in Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad), the Supreme Court held that claims to isolated DNA are not patent-eligible under 35 U.S.C. § 101. Myriad significantly changes the Office’s examination policy regarding nucleic acid-related technology. The purpose of this memorandum is to provide preliminary guidance to the Patent Examining Corps.
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-occuring nucleic acids, such as a cDNA or 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.
In Myriad, the Supreme Court considered the patent eligibility of several claims directed to isolated DNA related to the human BRAC1 and BRCA2 cancer susceptibility genes. The Supreme Court held that certain of the Myriad Genetics’ claims to isolated DNA are not patent-eligible, because they read on isolated naturally-occurring DNA that is a “product of nature.” The Court held that isolating a “gene from its surrounding genetic material is not an act of invention.” The Supreme Court held that other claims are patent-eligible, because they are limited to cDNA, which is a type of man-made DNA composition that is not naturally-occurring. The Court held that “cDNA is not a ‘product of nature’ and is patent eligible under § 101.”
The USPTO is closely reviewing the decision in Myriad and will issue more comprehensive guidance on patent subject matter eligibility determinations, including the role isolation plays in those determinations.
The only thing I will observe here and now is that the ruling relative to cDNA is not as the USPTO has characterized. The Supreme Court did not make a blanket statement that all cDNA is patent eligible. In fact, the decision envisions that some cDNA will be unpatentable even though cDNA by definition is synthetically created. The Supreme Court said:
cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.
Thus, at least some cDNA is not patent eligible. It is that caveat that scares me most. This will be used to say that even if something is synthetically created it cannot be patent eligible if it is identical to what is produced in nature. This will have a chilling effect on medical technologies that endeavor to create a replica of nature, such as grown organs that can be transplanted.
I have to wonder whether the phone lines to Members of Congress are burning up. The biotechnology industry is a very important industry to the U.S. economy and many promising companies have had the value of their patent portfolios erased today, which will make it impossible to raise much needed capital in order to continue ongoing operations. This is true because it easily takes 10 to 12 years for a biotech company to become profitable, and that is assuming they ever will become profitable. So look for many companies younger than 10 years old who operate in the gene space to suffer mightily and encounter much resistance when seeking investment necessary to keep the companies alive.