From the mass production of life-saving medicines in cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules (often referred to as “gene patents”) are used in many ways to benefit society.
The term “gene patent” is something of a misnomer because genes as they exist in the body cannot be patented. A naturally occurring gene — even a newly discovered one — cannot be patented. Patents don’t provide ownership rights over genes newly discovered in our bodies, and nobody can infringe a patent by having a certain gene or by passing it on to their children.
Artificial preparations of isolated and purified DNA molecules, on the other hand, are patentable because they are chemicals with new qualities that fundamentally distinguish them from natural genes. Like other patentable chemicals that are derived from nature (such as antibiotics or organic dyes), purified preparations of DNA are patentable because they have been transformed through human intervention into something that is so different from the natural state that it qualifies as something new, useful, and man-made.
This transformation begins with the purification and isolation of the natural DNA, which strips it of everything that makes it capable of functioning like a natural gene. The resulting DNA preparation has new qualities, advantages, and technical applications that allow it to be used in important new ways that are not possible with the genes that exist in our bodies.
The inventor must also establish the detailed biological function of the gene from which the preparation was derived, and the claimed DNA must be new and distinct from all preexisting scientific knowledge. Finally, the inventor must disclose in a patent application a detailed scientific explanation that enables other scientists to replicate the invention. Identifying, deriving, characterizing and describing a DNA sequence in this way requires at least as much human ingenuity as synthesizing a new chemical, composing a new metal alloy, or other human creations that are commonly deemed patentable.
In May of 2009, the American Civil Liberties Union (ACLU) brought a lawsuit in the U.S. District Court of the Southern District of New York to challenge several patents owned by the University of Utah Research Foundation that relate to genetic testing for the BRCA1 and BRCA2 breast cancer genes. The licensee of these patents, Myriad Genetics Inc., the directors of the University of Utah Research Foundation, and the U. S. Patent and Trademark Office were all named in the lawsuit. The ACLU has indicated that this is intended as a test case to broadly invalidate human gene patents as unpatentable and unconstitutional.
This lawsuit aims to broaden access for clinical test providers and patients to patented genetic tests, but the legal arguments in the case reach far beyond breast cancer genetic testing, human gene patents, or even gene patents generally. If the ACLU’s legal arguments were adopted, whole classes of patents that today protect biologic drugs, biotechnology manufacturing processes, and other molecular biology inventions could be invalidated or drawn into question. Denying patent protection for such basic molecular biology inventions would not only impact genetic testing, but also remove incentives for the development of biologic therapeutics and personalized medicine products for many unmet medical needs.
In our amicus brief on the case, BIO argues that decades of case law support the patentability of DNA-based inventions and, further, that patents claiming isolated DNA molecules are an important part of the intellectual property portfolios of many biotech companies. If DNA-based inventions were not patentable, these companies could be deterred from funding further gene discovery efforts and would find it much harder to attract the investment necessary for the lengthy and expensive process of producing life-saving therapies and diagnostics.
Late in March, a federal district judge ruled some of the patents at issue in the ACLU case were products of nature that were not patentable under the Patent Act. While BIO believes this decision is in error, it is important to note that the judge explicitly excluded from his consideration of the issues the ACLU’s allegations that patents supposedly stifle research or impede patient access to genetic tests — allegations that BIO argued were contrary to the repeated findings of well-regarded research on this question. Further, the judge’s invalidation of the diagnostic method claims in the ACLU case was done under a Federal Circuit opinion (In re Bilski) that will soon be clarified further by the Supreme Court.
BIO also notes that the District Court’s determination is only a preliminary step in the legal process, does not affect how the U.S. Patent and Trademark Office (PTO) evaluates patent applications relating to DNA-based inventions, and is not binding on any other courts. Myriad Genetics has indicated that it will file an appeal to the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., and some legal analysts predict that the Supreme Court eventually could hear the case.
Additional background materials on gene patenting can be found here.
This article is by BIO’s Associate General Counsel for Intellectual Property, Hans Sauer.