Gene patents have been issued in the United States for decades, however, a decision from the Southern District of New York in March 2010 put them on the chopping block of patentable subject matter.
The decision comes in the middle of a growing debate over the boundaries of patentable subject matter in what the U.S. Supreme Court recently dubbed the “Information Age,” where inventions pertaining to information in its various forms resemble less and less the devices patented in earlier eras.
In Association for Molecular Pathology et al., v. U.S. Patent and Trademark Office et al., an opinion that is a mix of health policy and patent law, Judge Sweet issued a broad holding invalidating Myriad Genetics’ patents on the BRCA1 and BRCA2 genetic mutations and related diagnostic tests, determining that these inventions did not qualify as patentable subject matter. The court invalidated the patents and granted summary judgment for plaintiffs: the ACLU and a group of physicians, patients, and researchers. The case is now on appeal to the Federal Circuit.
After decades of patenting genes, why now remove them from the realm of patentable subject matter? Isolating DNA sequences and engineering genetic diagnostics may have become, at least in the abstract, a more routine laboratory exercise in recent decades (which more predictably might have contributed to narrower invalidations based on novelty or obviousness). But while such reasoning may implicitly underlie the court’s opinion, it was not the basis for its published decision.
Instead, the court chose to more broadly and categorically remove these innovations from patent eligibility altogether, finding earlier decisions on gene patents inapplicable: “[I]n the absence of a § 101 [patentable subject matter] challenge to patent validity, the fact that courts have previously upheld the validity of patents directed to biological products in response to § 102 [novelty] and/or § 103 [obviousness] challenges has no bearing on the present inquiry.”
If upheld, this decision has potentially far-reaching implications for the two basic types of patents that were at issue in the case: isolated gene sequences and genetic diagnostics.
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.