Patent Law Practice Center

SCOTUS Ending Term with Patent Decisions

Over the past several days, the United States Supreme Court has issued several important decisions that will impact the patent system.

First, on June 13, 2013, the Supreme Court issued a decision in Association of Molecular Pathology v. Myriad Genetics, which has sometimes been referred to as “ACLU v. Myriad” in recognition of the fact that it was the American Civil Liberties Union that was responsible for bringing the challenge in the district court and pursuing the matter through the judicial system.

In Myriad, Justice Thomas wrote for a nearly unanimous Court.  Only Justice Scalia wrote a brief separate opinion in which he concurred in part and concurred in the judgment.

The majority decision in Myriad is not long, and the first 10 pages are background. Despite not giving much detailed attention to the significant legal issues presented, the Supreme Court did manage to do real and serious harm to much of the biotechnology industry.

Justice Thomas summarized the Court’s decision by saying:

“[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”

The decision has widely been reported as the Court recognizing that cDNA is patent eligible, but the ruling is far more nuanced. In fact, Justice Thomas specifically recognized that some cDNA is not patent eligible. He wrote:

“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.”

I have spoken with a number of people who are in the biotech industry and they all seem to think this decision means that cDNA is patent eligible and I shouldn’t make too much out of Thomas specifically saying that at least some cDNA is not patent eligible. Personally, I think this is misplaced hope; we all know how the district courts will respond, and it won’t be to an expansive reading of patent eligibility. While the USPTO seems poised to say that cDNA is patent eligible, the fact that some has been determined not patent eligible will be used by challengers and likely successfully so. Further, it seems clear that Thomas is saying that if something is man-made but identical to what appears in nature, it is not patent eligible. This fundamentally undercuts the most important aspects of Chakrabarty and would effectively kill research into such important areas as artificially grown organs, which by their very nature must be identical to what is produced in nature to be transplanted into the human body, for example.

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Prometheus: Implications of the U.S. Supreme Court’s Decision

In a case that will have a profound effect on biotech and pharmaceutical companies, the U.S. Supreme Court on March 20, 2012 issued its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., and addressed the question as to when medical diagnostic methods fulfill the patentable subject matter requirement of Section 101 in the Patent Code.

As held by the Supreme Court, claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of natural phenomena or laws of nature rather than correlations involving those laws. In addition, the U.S. Supreme Court clarified that the so called “machine or transformation test” articulated in Bilski v. Kappos is not a definitive test of patent eligibility.

As the U.S. Supreme Court has recently remanded Association for Molecular Pathology v. Myriad to the Federal Circuit for consideration in light the decision in Mayo v. Prometheus,  the question of when are genes and gene fragments, methods of drug screening and medical diagnosis using genetic material and information patentable subject matter will again be addressed.

For more on the matter, you should really attend PLI’s next One Hour Briefing. On Wednesday, April 4th, at 1pm, PLI is hosting a One Hour Briefing entitled, “Prometheus: Implications of the U.S. Supreme Court’s Decision.” This briefing will be conducted by Keith J. McWha, partner in the law firm Day Pitney LLP, and Paul T. Martin Associate Director Intellectual Property and Assistant General Counsel at PTC Therapeutics Inc. Specific topics include:

• What are the consequences of the Court’s ruling on the patentability of process patent claims generally?
• How might this decision affect biotech and pharmaceutical patent claims such as dosage or method of use and naturally occurring therapeutics?
• What can be done to ensure that method claims for drug screening, diagnostics and dosing satisfy the Prometheus test for patentable subject matter?