AMP v. Myriad – DOJ filed amicus curiae brief

The Department of Justice filed an amicus curiae brief on October 29 before the Federal Circuit in AMP v. Myriad, a case on appeal from the U.S. District Court for the Southern District of New York. Significantly, the brief argued that human genomic DNA, and any unmodified genomic DNA, is not a human-made invention, and is therefore not patent-eligible subject matter under 35 U.S.C. § 101.

In so arguing, the Department of Justice agreed with the ruling of the district court. Isolation or purity of DNA with naturally occurring nucleotide sequence, the Department of Justice argued, does not make that DNA into patentable subject matter. However, the Department of Justice arguments differed from the district court’s opinion in arguing for the patentability of manipulated genetic material, such as cDNA, vectors, recombinant plasmids, and chimeric proteins.

In arguing against patentability of unmodified genomic DNA, the Department of Justice acknowledged that it ran contrary to accepted practices of both the USPTO in admitting such subject matter and of the NIH and other governmental entities in seeking patents on such subject matter.

If these Department of Justice arguments are accepted by the Federal Circuit in its opinion or by the USPTO in its policies, biotechnology innovators will not be able to obtain patent protection for specific sequences of DNA by merely isolating or purifying it. To qualify as patentable subject matter, according to these arguments, genetic material must be the product of “scientists’ manipulation of the natural laws of genetics.”