IP Law: Rulings Focus On Genetic Testing And Modified Soybeans

, The Connecticut Law Tribune

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This year, the U.S. Supreme Court issued two significant opinions that will impact patent protection in the life sciences arena for many years to come. Arguably, the court seesawed by strengthening patent protection in one opinion while weakening patent protection in the other by declaring that certain discoveries cannot be patented. Nonetheless, the court has provided valuable guidance to those who seek patent protection, and a close inspection of these two opinions — Association for Molecular Pathology v. Myriad Genetics Inc., 133 S. Ct. 2107 (2013), and Bowman v. Monsanto Co., 133 S. Ct. 1761, rehearing denied, 2013 WL 3778991 (2013) — reveals that the court has adhered to the principle that innovation should be rewarded.

Patent Eligibility

The first opinion that warrants analysis concerns the Myriad case. For years, patents have issued concerning "isolated DNA" molecules, and patent owners have claimed that they have protection over naturally occurring DNA molecules that have been isolated from a genome. In the closely watched Myriad case, the court addressed whether certain types of DNA molecules are patentable. Although the court determined that isolated DNA molecules are not patentable, it recognized that an inventor may patent certain types of DNA molecules.

Myriad concerned patents that served as the basis for diagnostic tests that Myriad Genetics Inc. used to assess a patient's risk of developing cancer. Myriad's patents contained, among other things, claims concerning isolated DNA molecules with sequences that correspond to the BRCA1 and BRCA2 genes. Mutations in these genes may indicate that an individual has an increased risk of developing breast and ovarian cancer. Accordingly, in light of its patents, Myriad attempted to prevent others from offering diagnostic testing regarding the genes. Eventually, various groups filed a lawsuit against Myriad and sought a declaration that Myriad's patent claims were invalid because they concerned subject matter that cannot be patented.

The Supreme Court determined that the act of uncovering the location and sequence of the BRCA1 and BRCA2 genes did not render the genes patentable, and, as such, isolated DNA molecules are not patentable. However, the court determined that claims directed to cDNA molecules concern patentable subject matter. The key distinguishing characteristic of the cDNA claims at issue was that the court considered cDNA molecules synthetically made. The court left open whether methods of manipulating genes, new applications of knowledge about the BRCA1 and BRCA2 genes, and DNA in which the order of the genetic code has been altered should qualify as patentable subject matter.

Self-Replicating Products

One month before it issued its opinion in Myriad, the Supreme Court addressed a dispute concerning self-replicating technology in Bowman v. Monsanto Co. In Monsanto, the court strengthened the rights of patent holders by recognizing that in certain circumstances, limitations should be placed on a purchaser of patented, self-replicating technology.

Monsanto concerned a dispute regarding genetically modified soybeans. Monsanto sells Roundup Ready soybean seeds, which are covered by Monsanto patents and have been genetically modified to be resistant to the herbicide glyphosate. Planted Roundup Ready soybean seeds give rise to soybean plants that are resistant to this herbicide. A purchaser of these genetically-modified soybean seeds agrees to enter into a licensing agreement with Monsanto. Under the agreement, the purchaser may use the seeds to create a crop of glyphosate-resistant soybean plants for only one growing season. In other words, the purchaser agrees that it will not save the soybean seeds that it harvests from the glyphosate-resistant plants for replanting. Nonetheless, the harvested soybeans seeds may be consumed or sold as a commodity.

Vernon Bowman, a farmer in Indiana, was a regular purchaser of Roundup Ready soybean seeds. He would sell his first soybean crop of the season, which consisted of soybeans harvested from Roundup Ready soybean seed plants, to a grain elevator. Thereafter, the grain elevator would normally resell the soybeans to an agricultural processor, and the soybeans would be used for human or animal consumption.

For his second season planting, Bowman used soybean seeds that were not purchased from a seller of Monsanto's Roundup Ready seeds. Instead, Bowman purchased commodity soybeans from a grain elevator, planted these soybeans, and then treated his fields with glyphosate. Because a portion of the commodity soybeans consisted of soybeans that were grown by farmers who used Roundup Ready seeds, some of the plants in his field survived the treatment. Bowman saved seed from this crop and used it for his second season planting for the next year. He continued to save seed from his second season planting — which he occasionally supplemented with additional soybeans from the grain elevator — in subsequent years. Eventually, Bowman harvested eight crops that arose from glyphosate-resistant seeds that he obtained from a grain elevator.

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