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U.S. DOJ Reverses Policy – Now Argues Genes Should Not be Eligible for Patent Protection

About Face
As reported in the New York Times, while the United States Department of Justice (DOJ) is maintaining its position that modified genes should be patentable, it pulled a 180 Friday regarding naturally occurring, unmodified genes. In an amicus curiae brief the DOJ stated “Genomic DNA itself, however, is a product of nature that is ineligible for patent protection.” This position places the DOJ squarely at odds with the United States Patent and Trademark Office (USPTO), the National Institute of Health (NIH) and other government agencies that have sought patent protection for human genes.

The Gene
The DOJ filed its brief in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. The case involves the patenting of particular genes involved in breast cancer detection and treatment. In 1998, the USPTO granted Myriad, the patent owner, United States patent number 5,747,282, covering the BRCA1 tumor suppressor genes. Mutation of these genes indicates a substantially increased risk the patient may develop breast cancer. Patenting these genes allows Myriad, to prevent third parties from conducting detection and treatment protocols using the BRCA1 genes. This pits Myriad in a battle against breast cancer patients and the American Civil Liberties Union (ACLU).

Natural v. Man-made
Under United States patent law 35 U.S.C. §101, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” In 1980, the United States Supreme Court in Diamond v. Chakrabarty expanded 35 U.S.C. §101 to include man-made living organisms. In Diamond v. Chakrabarty, the Court held the while “laws of nature, natural phenomenon and abstract ideas” were not patentable, live, human-made organisms were patentable.

Grey Area
But what about human genes isolated from their environment? Are they naturally occurring or man-made? In the intervening thirty years since Diamond v. Chakrabarty no court until now had considered this question. And in that intervening thirty years companies patented about about 2000 genes, including about 20% of human genes. In March however, Judge Robert W. Sweet of the Southern District of New York ruled that in this case isolated genes were more like natural phenomenon, invalidating Myriads patent claims directed toward the BRCA1 and BRCA2 genes and ruling that “DNA’s existence in an ‘isolated’ form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C. §101.” Judge Sweet went even further, directing the United States Patent and Trademark Office (USPTO) to stop issuing patents directed toward DNA from the human body or to the comparison or analysis of such DNA sequences.

The Fallout
Although the DOJ filed its brief in support of neither party, the DOJ’s new position will not sit well with biotech companies investing billions in genetics. There is no word yet as to whether the USPTO has plans to adopt the DOJ’s position. In all likelihood, the UPSTO will wait for a decision from the Federal Circuit in this case and adopt rules in compliance therewith. Stay tuned. With billions of dollars at stake, this could get as ugly as Bilski.

Brett Trout

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