The U.S. Supreme Court recently delivered two unanimous decisions, Bowman v. Monsanto (Bowman) and Association for Molecular Pathology v. Myriad Genetics (Myriad). One affirmed industry legal analysis, and the other upended it. In Bowman, the Court held that growing a patented plant and harvesting its seed is equivalent to making the patented seed. In Myriad, the Court reversed thirty years of industry practice and held that isolated DNA is not patentable, but human-made cDNA is.

BOWMAN v. MONSANTO

Summary: The Doctrine of Patent Exhaustion provides that once a patented article is sold, the buyer has a right to use or resell that article. This doctrine, however, does not give the buyer the right to reproduce the patented invention. In Bowman, the Court held that Vernon Bowman, a commercial farmer, improperly reproduced Monsanto’s patented soybeans when he replanted soybeans grown from patented seed.

Background: Monsanto has patented RoundUp Ready™ soybeans, which are resistant to glyphosate-based herbicides. Monsanto sells its patented soybeans to farmers who agree to plant the seeds for one growing season only. The purchasing farmer must agree not to save and replant any of the harvested soybeans.

Bowman purchased soybeans from grain elevators. Instead of consuming or reselling them, he planted the soybeans in his field, and applied glyphosate to weed out any non-RoundUp Ready™ plants from the growing crop. From the surviving plants, Bowman harvested and saved the seed to use in the next growing season. He harvested eight crops in this manner. Bowman argued that the Doctrine of Patent Exhaustion prevented Monsanto from prohibiting his right to use the seed.

Outcome: The Court held that Bowman, while retaining the right to resell or consume the soybeans, did not have the right to make additional patented soybean seeds. Because his activities equaled reproduction of Monsanto’s patented invention, Bowman was not protected by the doctrine of patent exhaustion.

Impact: This decision represents an affirmation of agribusiness’s interpretation of the doctrine of patent exhaustion. Expect no changes to agribusiness and biotech companies’ business practices and patent applications based on this case.

ASSOCIATION FOR MOLECULAR PATHOLOGY v. MYRIAD GENETICS

Summary: U.S. patent law allows an inventor to obtain a patent on a new and useful composition of matter. In Myriad, the Court held that a DNA sequence, whose only difference from naturally occurring DNA is that it is isolated, is not patentable because it is a product of nature.

Background: Myriad discovered the chromosomal location and sequence of genes BRCA1 and BRCA2, whose presence drastically increases an individual’s risk of breast and ovarian cancers. Myriad obtained patents covering these isolated genes, methods of detecting the presence of these genes, and synthetic sequences of these genes (i.e. cDNA forms of BRCA1 and BRCA2, from which the introns were removed). Myriad used its patents to stop doctors and healthcare institutions from offering BRCA testing services without first obtaining licenses and paying royalties.

Challenges were made on the basis that DNA is a naturally occurring composition of matter and is therefore unpatentable. Previous Supreme Court decisions held that natural phenomena are not patentable, but that “anything under the sun that is made by man” is patentable. However, the Court has further noted that products of nature are not created, and as such, are “free to all … and reserved exclusively to none.”

Outcome: The Court held Myriad’s claims to isolated, unaltered DNA sequences were invalid as drawn to unpatentable subject matter. In making its decision, the Court drew a distinction between merely isolated DNA and lab-created cDNA. Noting that its informational content is identical to naturally occurring DNA, isolated DNA is not a new composition of matter. However, the Court held that Myriad’s claims to cDNA were patentable and therefore valid because cDNA is a human-created sequence whose informational content is different from naturally occurring DNA (e.g. the introns are removed). Therefore, subject to novelty and non-obvious requirements, cDNA is patentable subject matter.

Impact: Hours after the release of this decision, at least one company began offering BRCA testing services, even though Myriad’s patents on methods of detecting BRCA remain valid. It is unknown whether Myriad will assert its surviving patents.

This decision is a landmark case for the biotechnology industry, and there is great division among patent law experts about what effects Myriad will ultimately have. For over thirty years, medical, pharmaceutical, and agricultural industries, as well as universities, have obtained patents on isolated DNA sequences. It is impossible to say exactly how the industry will respond, but expect to see more patent litigation, more reexamination applications, and more information kept as trade secrets.

For additional details on these decisions, please contact Chris Leming at christopher.leming@unh.edu.