Letter to Donald Verrilli, Solicitor General of the United States - Praises Unanimous SCOTUS Ban on Gene Patents
Letter
Today, Congresswoman Louise M. Slaughter (D-NY), the only microbiologist in Congress, a leader on genetic issues, and the author of the landmark Genetic Information Nondiscrimination Act (GINA), praised the Supreme Court's unanimous ban on patenting naturally-occurring human genes.
"The human body is not a piece of property for a company to patent, and today's Supreme Court decision affirms that fundamental belief," Rep. Slaughter said. "I wrote GINA because no person should face discrimination from an insurance company or an employer based on his or her genetic makeup, and today's Supreme Court decision confirms that people -- not private companies -- own their genes. Jonas Salk once said that the polio vaccine could not be patented -- it belonged to the public. I am pleased the Supreme Court has applied this same standard to all genetic material."
In December of 2011, Congresswoman Slaughter wrote a letter to Solicitor General Donald Verrilli asking him to call upon the Supreme Court to take up the case. In the letter, Congresswoman Slaughter states, "The patent system was designed to encourage and reward innovation by protecting the rights of inventors. This system was not meant to cover parts of the human body or the natural world." Please find the letter below this press release.
The Supreme Court's decision is the latest in a number of positive developments in recent years for Americans at risk for hereditary diseases, especially cancer. The passage of GINA in 2008, called "the first civil rights bill of the new century" by the late Senator Edward M. Kennedy (D-MA), prohibited employers and health insurance companies from discriminating against individuals based on their genetic makeup. The passage of the Affordable Care Act in 2010 stipulated that insurance companies could not discriminate against those with pre-existing conditions. Today's Supreme Court decision means that no company will have a monopoly on providing genetic tests to patients, which will drive down the cost of cancer testing and encourage more Americans to get tested for hereditary conditions.
December 6, 2011
Donald B. Verrilli, Jr.
Solicitor General of the United States
U.S. Department of Justice
950 Pennsylvania Avenue, NW
Washington, DC 20530-0001
Dear Solicitor General Verrilli:
Re: The Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., Federal Circuit Docket No. 2010-1406
I am writing with regard to the case challenging patents on the BRCA1 and BRCA2 genes held by Myriad Genetics. While I recognize that the Department of Justice is reluctant to advance its views on cases in which the United States is not a direct party, United States involvement in granting the patents, followed by participation in the Federal Circuit in arguing against the validity of these same patents, make this an exceptional case. Therefore, I urge you to ask the Supreme Court to grant the original plaintiffs' forthcoming petition for writ of certiorari in order to address the questions raised by the decision of the United States Appeals Court for the Federal Circuit.
The sequencing of the human genome was the most momentous medical achievement in this century, with unparalleled implications for public health and personalized medicine. As a result, American innovation in genetic testing is redefining cancer treatment. Genetic tests now exist for 1,500 diseases -- hundreds of which are used in cancer care. As we have learned over the years, disease is often the result of complex interactions of many different genes. Dr. Stieglitz, Nobel Prize winning economist, has said that, "Our genetic makeup is far too complicated for a single entity to hold the keys to any given gene and to be able to choose when, if ever, to share." We cannot reap the full benefits of personalized medicine if researchers must each time go to patent holders in order to analyze a patient's DNA. Unfortunately, the U.S. Patent and Trademark Office has been issuing patents on genetic material for decades, and currently twenty percent of our genes have already been claimed as intellectual property.
The patent system was designed to encourage and reward innovation by protecting the rights of inventors. This system was not meant to cover parts of the human body or the natural world. The opposition may say that genes isolated in a test tube are not the same as genes found in the human body. Yet these genes share the same genetic sequence and encode for the same proteins. As the Department of Justice has clearly stated,
"...the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a 'human-made invention.' Nor is the fact that particular natural mutations in that unique chain increase a woman's chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell -- that is, the relationship between genotype and phenotype -- is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth."
The Myriad Genetics monopoly on BRCA1 and BRCA2 clinical diagnosis leads to significant disadvantages for patients, particularly women. When a genetic diagnostic test is offered by only one laboratory, patients do not have an opportunity for a second opinion. Without competition there is little assurance that Myriad will continue to update its test in a timely manner or that it will offer this test at a reasonable price. As a result, Myriad has dictated the standards for breast cancer genetic testing, which has limited patient care and genetic counseling -- an unacceptable restriction to place on women seeking medical attention.
Congress intended for Section 101 of Title 35 U.S. Code to stand as a threshold test of patentability, making Court review particularly appropriate in this case. While gene patent proponents often cite Diamond v. Chakrabarty for the proposition that "anything under the sun that is made by man" is patentable, 447 U.S. 303, 309 (1980), that phrase is a misleading quotation from the legislative history of the Patent Act of 1952. The full quote clearly acknowledges the statutory limitations to patentable subject matter: "A person may have 'invented' a machine or a manufacture, which may include anything under the sun made by man, but it is not necessarily patentable under section 101 unless the conditions of the title are fulfilled." H.R.Rep. No.1923, 82d Cong., 2d Sess. 6 (1952). In passing the Patent Act of 1952, Congress reaffirmed that Section 101 would continue to limit the scope of what is considered a true invention by prohibiting the patenting of products of nature, as already established by the Court in cases such as Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), and American Fruit Growers v. Brogdex Co., 283 U.S. 1 (1931).
In March, 2010, in the case, In Association for Molecular Pathology, et al v. United States Patent and Trademark Office, et al, Judge Robert W. Sweet, U.S. District Court for the Southern District of New York, ruled that the Myriad patents on BRCA1 and BRCA2 were invalid. In contrast, the Court of Appeals for the Federal Circuit, said that Myriad Genetics is entitled to these patents, but also ruled that Myriad's patent on mutation analysis was not patentable. Judicial conflict on such an important legal and medical issue deserves resolution. The significant and directly contrary positions taken within the administration on the part of the Department of Commerce and the Department of Justice further support the need to seek an authoritative final opinion of the Supreme Court.
In 1995, I introduced legislation called the Genetic Information Nondiscrimination Act (GINA), considered the first civil rights legislation of the 21st Century, which helped open the door to personalized medicine. By passing GINA in 2008, the U.S. Congress showed itself to be at the forefront of genetics policy. I expect no less of our government when it comes to gene patenting. A decision by the Supreme Court will help clarify the role of Congress and determine if there is a need for congressional directive. Intellectual freedom is critically important for the advancement of science for the good of public health. Therefore, I urge the Solicitor General to join the American Civil Liberties Union, the Public Patent Foundation, and the researchers, genetic counselors, women patients, cancer survivors, breast cancer and women's health groups, and scientific associations, including 150,000 geneticists, pathologists, and laboratory professionals they represent in asking the Supreme Court to grant their petition for writ certiorari.
Sincerely,
Louise M. Slaughter
MEMBER OF CONGRESS
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