In a controversial ruling late last month, a federal judge ruled that several patents held by the molecular-diagnostics company Myriad Genetics in a genetic-testing product that covered two genes, BRCA1 and BRCA2, which are associated with risk for developing breast and ovarian cancers, were invalid. The decision raises the larger question of the patentability of genes, a significant issue in determining the rules of the game not only in molecular diagnostics but also in drug discovery and development.
In a press statement, Myriad Genetics specified that a federal district court ruled that certain claims covering isolated DNA sequences in seven of the company’s 23 patents covering the company’s genetic test, BRACAnalysis, were invalid. The lawsuit was brought by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT), a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law. According to Myriad, the plaintiffs were seeking a declaratory ruling that 15 claims under the seven BRCA patents owned or exclusively licensed to Myriad were invalid and unenforceable. Myriad Genetics said it will appeal the ruling.
“While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress’s intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation,” said Peter Meldrum, president and CEO of Myriad Genetics, in the company’s statement. “More importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad’s operations due to the patent protection afforded Myriad by its remaining patents.”
The Biotechnology Industry Organization (BIO) issued a statement questioning the ruling, but added that the ruling was only a preliminary step in a legal process, and reasserted the association’s position on the patentability of DNA-based inventions. “The District Court’s determination is only a preliminary step in the legal process that does not affect how the US Patent and Trademark Office (PTO) evaluates patent applications relating to DNA-based inventions,” said BIO president and CEO Jim Greenwood in the statement. “…From the mass production of life-savings medicines by cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules have been put to countless uses that have benefited society. Preparations of isolated and purified DNA molecules, which alone can be put to use in these ways, are patentable because they are fundamentally different from anything that occurs in nature,” he said.
However, the ACLU, one of the plaintiffs in the Myriad Genetic case, pointed to the significance of the ruling. “The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2000 human genes,” according to an ACLU statement.
In their lawsuit against the US PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes, the ACLU and PUBPAT asserted that the patents were illegal and restricted scientific research and patients’ access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are “products of nature,” according to the ACLU statement. “[The] ruling is a victory for the free flow of ideas in scientific research,” said Chris Hansen, a staff attorney with the ACLU First Amendment Working Group, in the statement. “The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.” Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit added: “The court correctly saw that companies should not be able to own the rights to a piece of the human genome,” he said. “No one invented genes. Inventions are specific tests or drugs, which can be patented, but genes are not inventions.”
The crux of the case and the significance of the ruling in assessing the patentability of genes is the determination of the point at which the application of genomic information transforms from broad scientific knowledge, to which there should be unlimited access, to an “invention,” and therefore enforceable by patent protection. BIO filed an amicus brief outlining case law and statutory provisions in support of patentability and the significance of this case to the biotechnology industry. “Plaintiffs’ unprecedented constitutional and statutory challenges to the patenting of isolated DNA molecules go far beyond the BRCA1 and BRCA2 genes at issue in this case; consequently, they are of tremendous concern to the Biotechnology Industry Organization and its membership,” said BIO in the brief. “For almost a century, jurisprudence originating in this Court has recognized the patent-eligibility of isolated substances that differ in kind, and not merely in degree of purity, from their natural counterparts.”
It is not yet clear what the repercussions will be from the Myriad ruling. The Myriad ruling concerned the patentability of human genes for diagnosis, but raises the question, if the ruling stands through the appeal process, how it might be applied not only in molecular diagnostics but in the legal framework for genomic information as it relates to drug discovery and development. As the pharmaceutical industry increasingly adapts it drug-development efforts to more specialized treatments for patient-specific populations, which include the use of molecular diagnostics and potentially personalized medicine, the legal framework for intellectual property protection of genomic information is significant and will be an important issue to watch in the coming months.