Mar 31, 2010

District Court Holds Human Genes Unpatentable

The United States District Court for the Southern District of New York was recently faced with an important question: Are isolated human genes and the comparison of their sequences patentable? Judge Sweet handed down his much-anticipated decision on Monday in the case of Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., No. 09-Civ-4515 (S.D.N.Y.), and answered this question with a controversial, yet resounding, “No.”

The Plaintiffs (including several physicians and individuals diagnosed with breast cancer), represented by the ACLU and the Public Patent Foundation, sought to invalidate seven patents related to the human BRCA1 and BRCA2 genes, better known as the “Breast Cancer Susceptibility Genes.” Although it has long been the practice of the Patent Office to grant patents on DNA sequences in the form of “isolated DNA,” the District Court ruled in favor of the Plaintiffs at the summary judgment stage, reasoning that the patent claims covered “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”

The District Court reasoned that DNA is the physical embodiment of biological information, and is distinct from any other chemical found in nature. Further, isolated DNA neither alters this fundamental quality as it exists in the body, nor does it alter the information that DNA encodes. Therefore, because the patents are directed to sequences found in nature and comparisons of DNA sequences that are abstract mental processes, they are unpatentable subject matter.

In all likelihood, this case will be appealed to and heard by the Court of Appeals for the Federal Circuit, and may ultimately be decided by the Supreme Court against the backdrop of cases like In re Bergy, Diamond v. Chakrabarty, and J.E.M. Ag. Supply v. Pioneer Hi-Bred International. In In re Bergy, the Court of Customs and Patent Appeals (the predecessor of the modern Federal Circuit) upheld a patent directed toward a purified version of an antibiotic producing strain of streptomycin, a substance that appears in nature in an unpurified state. In Chakrabarty, the Supreme Court held that genetically modified micro-organisms not found in nature can be patented. The Supreme Court also held in J.E.M. that newly-developed plant breeds are patentable. The Supreme Court has not, however, specifically considered the patentability of human genes.

The patents covering the BRCA1 and BRCA2 genes are not unusual or unique. The Patent Office currently interprets Chakrabarty as allowing the patenting of living things, regardless of whether they are genetically modified (Chakrabarty) or isolated and purified by man (Bergy). Further, the Patent Office takes the position that genes are treated as chemical compounds and qualify for potential patenting as compositions of matter. Accordingly, the critical question will be: where should the line of patentable subject matter be drawn along the spectrum of “found in nature” to Chakrabarty’s “genetically engineered bacteria”?

It should be noted that the claims challenged in the Breast Cancer Susceptibility Gene patents include two types: (1) composition claims, and (2) method/process claims. The first set of claims was invalid as a “product of nature,” and the second set of claims was invalid as representing an abstract idea. The “kit claims” and most of the “probe claims” of these patents, however, were not challenged. These claims are directed to devices using or including the genes and not to the genes themselves. Presumably, these types of claims as applied to genetic inventions remain patentable. Further, this ruling is not binding on other federal courts, and does not apply to other types of patents.

Although the Intellectual Property Department at SGR cannot know what the ultimate result will be, we will be monitoring the progress of this case and, upon request, will determine any impact it may have on the research and IP portfolios of our clients.

For more information, contact your SGR Intellectual Property counsel.

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