A patent is traditionally a “government authority or license conferring a right or title for a set period, especially the sole right to exclude others from making, using or selling an invention.” It seems reasonable that no single person or company can take responsibility for inventing the products of nature. There are no patents for trees. No patents for mountains. No patents for the skin on our bodies or the hair on our heads.
For more than 150 years, the Supreme Court had not weighed in on the ability to patent natural phenomena. Then, in 2013, the landmark case of Association for Molecular Pathology v. Myriad Genetics, Inc. came before the U.S. Supreme Court. For the first time, the Supreme Court was asked to rule on the patentability of human DNA and the genes that dictate cellular function. Unanimously, the Supreme Court agreed that naturally occurring DNA sequences and genes were “products of nature” and not patentable.
In the ruling, the Supreme Court supported claims that synthetic cDNA strands, which are made in the laboratory, were patentable. However, in a footnote to the decision, the Court “express[ed] no opinion whether cDNA satisfies the other statutory requirements of patentability.” In addition to this groundbreaking decision, two other cases, Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corp v. CLS Bank International, reinforced that “laws of nature” and “abstract ideas” are not within the scope of the patent law.
The decision in the Myriad case has led to an explosion in the genetic testing lab market. It removed the monopoly of BRCA1/BRCA2 gene testing for the evaluation of hereditary breast and ovarian cancer that Myriad had owned for more than a decade and opened up the market for more labs to offer this and related genetic testing to the population. Within a day of this decision, five new laboratories announced that they would add testing for BRCA1/BRCA2 to their test menus, significantly reducing costs and increasing access. This new world of genetic testing has continued to result in more lab options, more test options and competitive pricing.
Despite the previous rulings by the Supreme Court, the Senate Judiciary Committee held three hearings this past Summer to consider amending Section 101 of the U.S. Patent Act. Supporters of the draft bill argue that the current patent language is too vague and is driving industry away from developing new drugs or treatments. However, those opposed to this bill have grave concerns about the language that removes the exceptions of patentability on laws of nature and natural phenomena, and believe this will return us to the days in which patents were pursued on human genes.
Leading the charge in opposing the amendment to Section 101 of the Patent Act is the American Civil Liberties Union (ACLU), which represented the plaintiffs in the Myriad hearings. The base argument is that returning to gene patentability will reduce the access and choice that has been gained since 2013. The ACLU and more than 150 health care organizations sent a letter to the legislators proposing the amendment: Senator Chris Coons, Senator Thom Tillis, Representative Doug Collins, Representative Hank Johnson, and Representative Steve Stivers. While acknowledging that the current patent system is in need of review, the letter conveys the message that allowing the patenting of genes will create more barriers to healthcare, and drive the cost of genetic testing upwards, in a time when these test costs are finally starting to drop due to lab competition.
The launch of InformedDNA as a company was based on the single notion that genetics expertise and services should be accessible and that by making this possible, we will empower the appropriate use of personalized healthcare. We continue to advocate for this core tenet of our vision and support the ACLU’s stance on this issue. If you agree, please reach out to your Senators and Representatives and ask them to oppose the proposed amendment to Section 101 of the Patent Act.
At this time, the hearings have concluded. The committees are reviewing the record and drafting a final bill for Congress to consider soon. We will continue to monitor this process and hope for a positive outcome. Regardless of the results, InformedDNA will continue our mission to optimize patient care and health care spending toward realizing the goal of personalized medicine for all.
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