On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the biotech field.
Impact on Genetic Innovations and Personalized Medicine
The Court specifically refrained from considering the patentability of method claims for manipulating genes or of claims for new applications of DNA sequences. Myriad officials stressed how the Court upheld the patentability of lab-synthesized genetic sequences and scientific methods of testing for cancer susceptibility using genetic material. Myriad’s chief executive, Peter D. Meldrum, stated, “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our test moving forward.” Thus, even in the potential absence of composition claims for DNA sequences (whether isolated or synthetically created), companies may gain patent protection for genetic innovations through method claims.
The ruling impacts thousands of patents that have been granted on isolated genes, and will likely have an immediate impact on the development of personalized medicine as rival companies enter the market of genetic testing involving patented genes. The new inability to patent isolated DNA sequences could create financial difficulties for biotechnology companies seeking investment for genetic research. However, the ability to freely research using previously isolated DNA sequences may speed developments in the personalized medicine arena. In addition, as more companies enter the personalized medicine market, competition may improve the quality of genetic testing and will likely drive down the costs of such testing. Several companies have already announced that they will begin offering genetic testing for breast cancer risk assessment. For example, mere hours after the ruling, DNATraits, a part of the Houston-based company Gene By Gene, Ltd., stated that it would offer the BRCA gene testing for under $1,000, less than one-third of Myriad’s current price.
The Court began its patentability analysis by highlighting that “patent protection strikes a delicate balance between creating ‘incentives that lead to creation, innovation, and discovery,’ and ‘imped[ing] the flow of information that might permit, indeed spur, invention’” (internal citations omitted). The Court’s holding maintains that balance by preventing patent-derived monopolization of isolated, naturally occurring genes while preserving patent protection for genetic innovations derived from these genes, such as artificially created DNA sequences and genetic testing methods in the growing field of personalized medicine.
Impact on GM Crops
Experts say the ruling has implications for agricultural biotechnology and beyond.The decision applies equally to all genes,” said George Kimbrell, an attorney for the Center for Food Safety, a nonprofit that opposes plant and animal patents. How the ruling affects biotech traits remains to be seen, but it does have a groundbreaking effect on gene patents, he said. “Those are no longer valid.”
Modification of genes, like splicing one sequence into another, remains patentable under the ruling, said Hans Sauer, deputy general counsel for the Biotechnology Industry Organization. The decision may nonetheless weaken patent protections for transgenic crops because the underlying gene is fair game for competitors, he said. “Because the gene is often the first thing that gets discovered it’s prudent to get a patent on that.”
While the ruling seems fairly clear-cut, it’s probably destined to create further confusion in patent disputes, said Chris Holman, a law professor specializing in biotech patents at the University of Missouri-Kansas City. “More work for lawyers,” he said.
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