Composition of Matter Patents
Specifically, the court invalidated patents on isolated DNA containing all or part of the BRCA1 and BRCA2 gene sequences, finding that the isolated sequences were not “markedly different” from a product of nature and had not been physically transformed into something sufficiently, fundamentally different. The court drew a distinction between the BRCA patents and those in Diamond v. Chakrabarty, where the Supreme Court upheld patentability of a human DNA sequence placed into a bacterial plasmid, as there the DNA sequence was manipulated and “transformed,” not merely isolated.
Should Judge Sweet’s holding stand, remaining questions regarding what constitutes sufficient “transformation” will create substantial uncertainty for the PTO, the courts, and anyone seeking biotechnology patents.
The court’s holding is also in tension with long-standing opinions upholding patents on extracted and purified natural substances, such as adrenaline. (See Parke-Davis & Co. v. H.K. Mulford and Co.)
Judge Sweet ruled that DNA should be treated differently than other isolated or purified chemical compounds based largely on the conceptualization of DNA as information, Judge Sweet noting that “DNA represents the physical embodiment of biological information,” and 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.”
He went on to state, “This informational quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as ‘no different’ than other chemicals previously the subject of patents.” Therefore, although genetic material is in fact a chemical compound, under Judge Sweet’s opinion it is not patentable because nucleotide sequences carry genetic information.
The Department of Justice (DOJ) recently weighed in, submitting an amicus brief to the Federal Circuit in late October, 2010, arguing that isolated DNA sequences should not be patentable. The DOJ offered consolation that new and useful methods utilizing genetic information (such as therapies and diagnostics) may still be patented, subject to the prohibition against patenting abstract ideas. However, the DOJ’s opinion that therapies and diagnostics should remain patentable offers little comfort, as patentability of genetic diagnostics is also under scrutiny in Molecular Pathology.