New Rochelle, NY—A landmark case for the biotechnology industry awaits a Supreme Court ruling, expected in June, on whether polynucleotides isolated from human genes should continue to be subject to patent protection. On April 15, each side in the so-called Myriad Genetics case presented an oral argument, during which the Supreme Court Justices, in their questions and comments, may have hinted at which way they lean. An insightful analysis of the issues, the legal briefs presented to the Court, and the oral arguments is presented in a set of articles published in Biotechnology Law Report, a publication of Mary Ann Liebert, Inc., publishers.
The two articles “After Myriad Oral Argument, Supreme Court Set to Decide Patentability of Isolated Human DNA Molecules,” authored by Marc Hearron, James Mullen, III, and Matthew Kreeger, attorneys with Morrison & Foerster (Washington, D.C., San Diego, and San Francisco offices, respectively), and ” The Supreme Court Takes On the Patent Eligibility of Human Genes: AMP v. Myriad,” by Dalila Argaez Wendlandt and Joseph van Tassel, Ropes & Gray, Boston, MA, provide essential background to the issues in the Myriad Genetics case and help the reader prognosticate on the likely outcome of the case. The articles are available free on the Biotechnology Law Report website.
The defendant company has developed tests for the presence of the BRCA1 and BRCA2 gene variants and provides them, for significant fees, to help genetic counselors and physicians predict a patient’s risk of developing breast or ovarian cancer. Among the plaintiffs in the case is the Association for Molecular Pathology, whose members wish to compete with Myriad Genetics to offer testing for such genetic mutations.
Represented by Daniel Ravicher of the Public Patent Foundation, as well as attorneys with the American Civil Liberties Union, the plaintiffs seek to reshape previously applied principles of chemical patent law to invalidate all patents that claim isolated genes and methods of testing with them. They challenge the validity of those patents on the ground that human genes are “products of nature.” They say that this should not be considered patentable subject matter, even if the useful properties of the patented molecules hadn’t been appreciated before their discovery by the “inventors” named in the patents.
“Those who hope the court will rule adversely to the patentees are encouraged by last year’s Supreme Court decision in Mayo Collaborative Services v. Prometheus Labs. In that case, the Court said that a newly discovered ‘law of nature’ is not patentable and invalidated patents that had been granted to a Canadian hospital for a method of determining how to regulate dosage of a drug, based on measuring the concentration of drug metabolites,” states Gerry J. Elman, Editor-in-Chief of Biotechnology Law Report and President of Elman Technology Law (Media, PA). “But last week, in Bowman v. Monsanto, the Supreme Court showed that they are more willing to enforce biotechnology-related patents than some had surmised from the Mayo decision.” Keep watching Biotechnology Law Report after the June ruling in Myriad Genetics, for further analysis of its anticipated impact on the evolution of personalized medicine and other developments in biotechnology.
About the Journal
Biotechnology Law Report is an authoritative journal published bimonthly online with Open Access options and in print. First published in 1982, the Journal continues to lead the field in its coverage of the evolving body of law and government regulation concerning biotechnology. Focusing primarily on industries in which biotechnology underlies the rapid development of new products, including pharmaceuticals, chemicals, agriculture, food processing, energy, mineral recovery, and waste treatment, Biotechnology Law Report provides information and critical assessment of all legal aspects of these technologies as they move toward commercialization. Complete tables of content and a sample issue may be viewed on the Biotechnology Law Report website.
About the Publisher
Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science, biomedical research, and law, including Election Law Journal, Gaming Law Review and Economics, and Environmental Justice. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry’s most widely read publication worldwide. A complete list of the firm’s over 70 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.